Another one!
CONFLUENT SPRAYSHIELD POLYMER KIT WITH SPRAYER SPRAYSHIELD KIT
Catalog Number SP10S01
Event Date 01/21/2011
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
(b)(4).
Event Description
According to the reporter: the pt experienced heavy underbelly pains two days post-operatively. The pains were described as burning. At the fourth post-operative day, the stomach had to be re-opened. There were syrinxes that were discovered where the product had been applied, which were operated upon. The pt was released from the hospital free of pain.
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Brand Name SPRAYSHIELD POLYMER KIT WITH SPRAYER
Type of Device SPRAYSHIELD KIT
Manufacturer (Section F) CONFLUENT
101a first ave.
waltham MA 02451
Manufacturer (Section D) CONFLUENT
101a first ave.
waltham MA 02451
Manufacturer (Section G) CONFLUENT
101a first ave.
waltham MA 02451
Manufacturer Contact terry callahan
60 middletown ave.
north haven , CT 06473
(203) 492 -6273
Device Event Key 2070451
MDR Report Key 2037782
Event Key 1934758
Report Number 3003157248-2011-00007
Device Sequence Number 1
Product Code NQR
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 03/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number SP10S01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 01/24/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2037782
Wednesday, December 28, 2011
Tuesday, December 27, 2011
Prevention of peritoneal adhesions: A promising role for gene therapy
More Good News for those who suffer from Adhesion Related Disorder!
Source: World J Gastroenterol
Prevention of peritoneal adhesions: A promising role for gene therapy; Atta HM; World Journal of Gastroenterology 17 (46), 5049-58 (Dec 2011)
Adhesions are the most frequent complication of abdominopelvic surgery, yet the extent of the problem, and its serious consequences, has not been adequately recognized. Adhesions evolved as a life-saving mechanism to limit the spread of intraperitoneal inflammatory conditions. Three different pathophysiological mechanisms can independently trigger adhesion formation. Mesothelial cell injury and loss during operations, tissue hypoxia and inflammation each promotes adhesion formation separately, and potentiate the effect of each other. Studies have repeatedly demonstrated that interruption of a single pathway does not completely prevent adhesion formation. This review summarizes the pathogenesis of adhesion formation and the results of single gene therapy interventions. It explores the promising role of combinatorial gene therapy and vector modifications for the prevention of adhesion formation in order to stimulate new ideas and encourage rapid advancements in this field.
http://www.docguide.com/prevention-peritoneal-adhesions-promising-role-gene-therapy?tsid=5
Source: World J Gastroenterol
Prevention of peritoneal adhesions: A promising role for gene therapy; Atta HM; World Journal of Gastroenterology 17 (46), 5049-58 (Dec 2011)
Adhesions are the most frequent complication of abdominopelvic surgery, yet the extent of the problem, and its serious consequences, has not been adequately recognized. Adhesions evolved as a life-saving mechanism to limit the spread of intraperitoneal inflammatory conditions. Three different pathophysiological mechanisms can independently trigger adhesion formation. Mesothelial cell injury and loss during operations, tissue hypoxia and inflammation each promotes adhesion formation separately, and potentiate the effect of each other. Studies have repeatedly demonstrated that interruption of a single pathway does not completely prevent adhesion formation. This review summarizes the pathogenesis of adhesion formation and the results of single gene therapy interventions. It explores the promising role of combinatorial gene therapy and vector modifications for the prevention of adhesion formation in order to stimulate new ideas and encourage rapid advancements in this field.
http://www.docguide.com/prevention-peritoneal-adhesions-promising-role-gene-therapy?tsid=5
Wednesday, December 21, 2011
Breaking News! Adhesions easily visualised with simple Barium Swallow!
Breaking News!
Adhesions easily visualised with simple
"NONE INVASIVE "
CONTRAST X-RAY BARIUM SWALLOW!
When taking the test, you drink a preparation containing Barium sulfate . The x-ray tracks the chalky like liquid as it makes it way through your digestive system, (inside the organs).....however it also showed what was on the OUTSIDE of the organs of the digestive track, (in the peritoneal cavity within the abdominal cavity!)
The "Contrast Barium Swallow" abdominal x-ray diagnostic was never meant to show anything else, it showed ADHESIONS attaching internal organs in the lower digestive track to the peritoneum and to other organs.
It can also show the "mis-alignment" of intestines from being pulled out of the normal alignment by adhesion attachments!
This diagnostic can also detect bowel obstructions or bowel impactions---and all of this without so much as a surgeons knife!
MORE TO COME
on this magnificent discovery in the world of
ARD!
on this magnificent discovery in the world of
ARD!
Maybe 2012 WILL be a year of good for
"Adhesion Related Disorder"
victims!
victims!
!!!! Visible Adhesions !!!!!
"MERRY CHRISTMAS"
"HAppy Holidays"
or rather
"THank-God"
"HAppy Holidays"
or rather
"THank-God"
!! DEMAND THIS DIAGNOSTIC !!
The "X-Ray Barium Swallow" diagnostic test is NOT used to detect adhesions, or any other "pathological anomalies," OUTSIDE of the organs of the digestive track!
The "X-Ray Barium Swallow" is a diagnostic tool used to solely detect "pathological anomalies, obstructions and/or diseases," WITHIN the organs of the digestive track!
You MUST insist that your attending physician order this diagnostic test if you have had a previous adhesiolysis, or many of them for that matter, and are currently experiencing abdominal/pelvic pain that YOU think is associated with adhesions, or ARD!
Have it ordered for "Pain," as you see listed below!
DO NOT ALLOW YOURSELF
to be denied this diagnostic!
Barium Swallow IntroductionA barium swallow is a test that may be used to determine the cause of painful swallowing, difficulty with swallowing, abdominal pain, bloodstained vomit, or unexplained weight loss.
Barium sulfate is a metallic compound that shows up on x-ray and is used to help see abnormalities in the esophagus and stomach. When taking the test, you drink a preparation containing this solution. The x-rays track its path through your digestive system.
•These problems can be detected with a barium swallow: ◦Narrowing or irritation of the esophagus (the muscular tube between the back of the throat and the stomach)
◦Disorders of swallowing
◦Hiatal hernia (an internal defect that causes the stomach to slide partially into the chest)
◦Abnormally enlarged veins in the esophagus that cause bleeding
◦Ulcers
◦Tumors
◦Polyps (growths that are usually not cancerous, but could be precancerous)
Barium Swallow - Test Results
ALWAYS INSIST YOU RECEIVE A COPY OF THE TEST , BUT MOST IMPORTANT IS THAT YOU SECURE A VISUAL COPY OF THE FILMS OF THE X-RAY ITSELF AS IT IS IN THESE THAT YOU WILL SEE ADHESIONS IF THEY ARE VISIBLE!!!!
The "normal" pathology results your Dr. looks for and will jabber about are listed below here, just listen them out, then make sure you get a visual or the test for yourself! It is imperative that YOU look for your own results and IF adhesions can be seen in these films, you will recognize them!
Usual Test Results:
Ask your doctor for the results of your barium swallow test. You may have to wait a few days until the radiologist (a specialist in x-ray examinations) looks at the x-rays and gives your doctor the final results. Your doctor will recommend a plan of action to you based on the results.
•The x-rays will show the digestive wave (peristalsis) through the length of the esophagus. When barium reaches the end of the esophagus, the barium enters the stomach.
•The barium swallow may reveal problems in the pharynx (the back of the throat), the esophagus, or the stomach. The problems could be narrowing, tumors, polyps, ulcers (erosions), or disorders in moving food through the system. It can also show a hiatal hernia, diverticula (pouches opening along the esophagus), or varices (enlarged veins).
•If the barium swallow test shows any area of concern, your doctor may plan what other tests, procedures, treatments, or medications you may need. The treatment for problems discovered during a barium swallow vary depending on the condition. http://www.emedicinehealth.com/barium_swallow/article_em.htm
A picture is worth a 1000 word...so see for yourselves!
In 2009 a known adhesion sufferer had a GI Barium Swallow for "Chronic Abdominal Pain."
This female suffered "Adhesion Related Disorder" and had undergone multiple surgeries in which abdominal adhesion's were present and lysed in each of her each surgeries. Relief was always fleeting and the pain always returned after each surgery.
When this test was taken in 2009 she was told everything is fine and the test revealed nothing, and it was absolutely right, as long as he made his determination based on what the test was meant to show! She had NO abnormal internal organ pathology showing in this Barium Swallow! The docs said she was just fine and sent her on her way.
She had Cat scans, MRI's every test in the book, you name it and the financial toll was enormous...... and all the doctors said she was fine. They could find nothing wrong and yet she suffered so.
A subsequent surgery was scheduled and records and imagery were sent to the new surgeon.
During pre op...reviews of all the tests...these images below caught the surgeon eye!
The surgeon palpitated each area where adhesions were being visualised on these simple
"Contrast Barium Swallow X-Ray Films."
As an ARD patient advocate watched, knowing what was being seen on the screen in front of them showing what could only be "ADHESIONS," the Dr. asked the patient, "Does it hurt there? Does it hurt here?"
Each time the ARD patient confirmed her pain was exactly where the surgeon indicated it might be in her abdomen. The surgeon then told his surgery team that he wanted these films up on a screen in the operating room during the procedure!
As an ARD patient advocate watched, knowing what was being seen on the screen in front of them showing what could only be "ADHESIONS," the Dr. asked the patient, "Does it hurt there? Does it hurt here?"
Each time the ARD patient confirmed her pain was exactly where the surgeon indicated it might be in her abdomen. The surgeon then told his surgery team that he wanted these films up on a screen in the operating room during the procedure!
You bet he did!
An IHRT patient advocate was scrubbed up and in the OR with the surgeon.....as you will see below, everywhere the wispy white tendrils appeared...is where he lysed adhesion! He used the images below as a guide to lysing the patients adhesions during the entire surgery. He confirmed this for us all!
After surgery, the patient, the surgeon and IHRT advocate were in somewhat of disbelief at what they had just witnessed, and they knew that these images had guided the way...the surgeon confirmed for us that indeed...this simple test reveled adhesions exquisitely!
We feel that this may finally be the end of expensive testing for adhesion patients....the statement that adhesions rarely if ever show up in any type of imaging is now a myth.
No more "Let's have a surgical look, see" to search for the always elusive adhesions.
Use these images to advocate for yourself. Ask for this simple non invasive, inexpensive test!!!!
It is not in your head....it is right there in black and white for all the world to see.
Removing personal information from these images has been difficult but this most generous adhesion sufferer has had that as her only request.
There are more images still to be placed in this posting and each image will be summarised as to what you are looking at anatomically so please check back! Approx a dozen more images from the same series coming soon!
This news is so wonderful we wanted to get it to you as soon as possible!
We wish all who suffer from adhesions all the best this holiday season and we present you a gift from an anonymous adhesion sufferer.
A simple " Contrast Barium Swallow X-Ray!"
"MERRY CHRISTMAS"
"Happy Holidays"
Surgery done by Dr Pagels
We place his information here for your convenience but urge you to exercise due diligence when deciding which surgeon is right for you!
Dr. Pagels is now Chief of Gynecology at St.Josef Krankenhaus Moers. He was chief of Gynecology at Klinikum Duisburg, when this surgery was done.
This is his address: Herr Dr. Med. Jens Pagels
St. Josef Krankenhaus Moers
Asberger Str. 4
47441 Moers
Germany
Telephone Number: +49 (0) 2841 1072430
His email address is: gyn.pagels@st-josef-moer
This first image below ...what do you see in the one o'clock position?
"Happy Holidays"
Surgery done by Dr Pagels
We place his information here for your convenience but urge you to exercise due diligence when deciding which surgeon is right for you!
Dr. Pagels is now Chief of Gynecology at St.Josef Krankenhaus Moers. He was chief of Gynecology at Klinikum Duisburg, when this surgery was done.
This is his address: Herr Dr. Med. Jens Pagels
St. Josef Krankenhaus Moers
Asberger Str. 4
47441 Moers
Germany
Telephone Number: +49 (0) 2841 1072430
His email address is: gyn.pagels@st-josef-moer
This first image below ...what do you see in the one o'clock position?
Do YOU think you are correct!
( NO, that is not a fetus, it is a twisted bowel!)
( NO, that is not a fetus, it is a twisted bowel!)
A Personal Case for Classical Homeopathy, Part I
Exerpt from :A Personal Case for Classical Homeopathy, Part I
Judith Acosta
Many years ago, I suddenly developed abdominal pain. I had not been sick in any other way and had no idea what was happening. I went for a gynecological exam and was told I was fine. The pain continued. I went back and after numerous exams was sent from the table to the couch. The psychiatrist sent me right back to the doctor. After about a year of bouncing back and forth with increasingly intense (searing, stabbing) pain, they finally "discovered" a mass several centimeters in width in the area of my left ovary.
At this point, the surgeons were called in. I was scheduled for an emergency laparotomy. As they wheeled me in, the surgeon said to my mother, "It could be cancer." I was 26.
After surgery, as soon as I stopped vomiting, the doctor told me that it was not cancer. My mother wept. He said it was a streptococcal infection (Strep B) that had created adhesions and that I could forget about having children. He proudly went on to inform us that they had "scraped me clean" and that I'd be on antibiotics for about a month.
I did as I was told. I was raised by a doctor, surrounded by doctors and had complete faith in the system.
Within a short time a whole new sort of pain emerged, this time, however, deeper. It was more localized, again on the left side. I thought the infection had returned. The pain continued for quite a while. I went to the doctor, but there was no infection. After dismissing it (and me) for at least a year again, I finally wound up in hospital. A cyst had burst. This cycle recurred every few months. They recommended birth control pills, pain pills and pills I didn't understand. Nothing helped. By the fourth rupture and hospital visit, they recommended a full hysterectomy.
Read the entire article here: http://www.huffingtonpost.com/judith-acosta/homeopathy_b_1150591.html
Judith Acosta
Many years ago, I suddenly developed abdominal pain. I had not been sick in any other way and had no idea what was happening. I went for a gynecological exam and was told I was fine. The pain continued. I went back and after numerous exams was sent from the table to the couch. The psychiatrist sent me right back to the doctor. After about a year of bouncing back and forth with increasingly intense (searing, stabbing) pain, they finally "discovered" a mass several centimeters in width in the area of my left ovary.
At this point, the surgeons were called in. I was scheduled for an emergency laparotomy. As they wheeled me in, the surgeon said to my mother, "It could be cancer." I was 26.
After surgery, as soon as I stopped vomiting, the doctor told me that it was not cancer. My mother wept. He said it was a streptococcal infection (Strep B) that had created adhesions and that I could forget about having children. He proudly went on to inform us that they had "scraped me clean" and that I'd be on antibiotics for about a month.
I did as I was told. I was raised by a doctor, surrounded by doctors and had complete faith in the system.
Within a short time a whole new sort of pain emerged, this time, however, deeper. It was more localized, again on the left side. I thought the infection had returned. The pain continued for quite a while. I went to the doctor, but there was no infection. After dismissing it (and me) for at least a year again, I finally wound up in hospital. A cyst had burst. This cycle recurred every few months. They recommended birth control pills, pain pills and pills I didn't understand. Nothing helped. By the fourth rupture and hospital visit, they recommended a full hysterectomy.
Read the entire article here: http://www.huffingtonpost.com/judith-acosta/homeopathy_b_1150591.html
Friday, December 16, 2011
Please stand by for World Wide Breaking News ~ The day that changes Adhesion Related Disorder forever
We will be bringing you the story that will change the lives of those suffering from Adhesion Related Disorder forever.
This news will empower you to advocate for yourself and never again be told,
"It's all in your head!"
Thursday, December 15, 2011
Behind the badge with Sheriff Stephens ~ "Back then, they called it heartburn!"
Exerpt from full article: http://www.forest-blade.com/news/community/article_f9faf6aa-25d4-11e1-bbc7-0019bb2963f4.html
In the past year, however, Stephens has faced medical difficulties that made it difficult to keep pace with his many obligations. Twenty-three years ago, Stephens was diagnosed with esophageal cancer as a result of acid reflux disease. Though he's been cancer-free since then, the surgery did lasting damage.
"Back then, they called it heartburn!" he says. "They caught it early and they were able to remove the cancer fully. Through the years, the surgery caused a lot of different problems, and I've had my share of them, but I began to have trouble digesting food and it kept getting worse until this year, when I had to have serious surgery to reconstruct my digestive system."
The surgery has solved a lot of Stephens's problems with adhesions and scar tissue from previous surgeries and he is back on his feet and recovering well.
"I was blessed to get through it. It was a tough time for me and for my department," he says. "I can't say enough good words about my employees. They carried on and never missed a lick while I was down recovering from that major surgery."
In the past year, however, Stephens has faced medical difficulties that made it difficult to keep pace with his many obligations. Twenty-three years ago, Stephens was diagnosed with esophageal cancer as a result of acid reflux disease. Though he's been cancer-free since then, the surgery did lasting damage.
"Back then, they called it heartburn!" he says. "They caught it early and they were able to remove the cancer fully. Through the years, the surgery caused a lot of different problems, and I've had my share of them, but I began to have trouble digesting food and it kept getting worse until this year, when I had to have serious surgery to reconstruct my digestive system."
The surgery has solved a lot of Stephens's problems with adhesions and scar tissue from previous surgeries and he is back on his feet and recovering well.
"I was blessed to get through it. It was a tough time for me and for my department," he says. "I can't say enough good words about my employees. They carried on and never missed a lick while I was down recovering from that major surgery."
What is ovarian remnant syndrome?
Q:What is ovarian remnant syndrome?
A: Ovarian remnant syndrome (ORS) occurs if any ovarian tissue is left after surgery to remove both ovaries and fallopian tubes, called a bilateral salpingo-oophorectomy. The syndrome occurs if this ovarian tissue causes severe pelvic pain and/or a pelvic mass.
The condition typically occurs because of the surgical technique used to remove the ovaries. Although ORS is considered fairly rare, its incidence appears to have increased in the past 40 years, possibly related to the increased use of laparoscopic surgeries.These surgeries allow the surgeon to operate through two or three tiny incisions instead of a large abdominal incision.
Certain factors increase the risk of incomplete ovarian removal, including a history of endometriosis, pelvic inflammatory disease, previous abdominal or pelvic surgeries and pelvic adhesions. Adhesions are scar tissue that forms after pelvic or abdominal surgery and "sticks" to organs and other tissue. Adhesions make it difficult for the surgeon to completely identify and remove the ovaries because of the fibrous tissue that binds an ovary with the other structures or with the peritoneum, the membrane that covers the inside of the abdomen and pelvis.
If any ovarian tissue is left in your pelvis, it can, in some instances, continue to produce hormones.
The most common symptoms of ovarian remnant syndrome are constant, chronic pelvic pain, difficult or painful intercourse, cyclic pelvic pain, and painful urination and bowel movements.
The condition is diagnosed based on a careful medical history. One sign that there may be residual ovarian tissue is if after your ovaries were removed, you didn't immediately start hormone therapy but didn't experience menopausal symptoms, such as hot flashes. This would suggest that you may still be producing estrogens. An alternative situation is if after surgery, you started hormone therapy and then discontinued it for some reason but didn't experience these symptoms.
Your doctor may also perform an ultrasound, CT scan or MRI to identify any ovarian tissue or pelvic mass and may measure blood levels of follicle-stimulating hormone (FSH) and estradiol. Estradiol is produced by the ovaries and FSH by the pituitary gland in response to hormonal signals from the ovaries. Levels of estradiol should be very low and levels of FSH should be very high after both ovaries have been removed.
If your doctor does find ovarian tissue remnants, you may be treated with medication to suppress any ovarian function, surgery to remove the tissue, or, as a last resort, radiation to destroy the tissue.
http://www.healthywomen.org/content/ask-expert/1761/ovarian-remnant-syndrome?context=womentalk/ask-the-expert&context_title=ask-the-expert
A: Ovarian remnant syndrome (ORS) occurs if any ovarian tissue is left after surgery to remove both ovaries and fallopian tubes, called a bilateral salpingo-oophorectomy. The syndrome occurs if this ovarian tissue causes severe pelvic pain and/or a pelvic mass.
The condition typically occurs because of the surgical technique used to remove the ovaries. Although ORS is considered fairly rare, its incidence appears to have increased in the past 40 years, possibly related to the increased use of laparoscopic surgeries.These surgeries allow the surgeon to operate through two or three tiny incisions instead of a large abdominal incision.
Certain factors increase the risk of incomplete ovarian removal, including a history of endometriosis, pelvic inflammatory disease, previous abdominal or pelvic surgeries and pelvic adhesions. Adhesions are scar tissue that forms after pelvic or abdominal surgery and "sticks" to organs and other tissue. Adhesions make it difficult for the surgeon to completely identify and remove the ovaries because of the fibrous tissue that binds an ovary with the other structures or with the peritoneum, the membrane that covers the inside of the abdomen and pelvis.
If any ovarian tissue is left in your pelvis, it can, in some instances, continue to produce hormones.
The most common symptoms of ovarian remnant syndrome are constant, chronic pelvic pain, difficult or painful intercourse, cyclic pelvic pain, and painful urination and bowel movements.
The condition is diagnosed based on a careful medical history. One sign that there may be residual ovarian tissue is if after your ovaries were removed, you didn't immediately start hormone therapy but didn't experience menopausal symptoms, such as hot flashes. This would suggest that you may still be producing estrogens. An alternative situation is if after surgery, you started hormone therapy and then discontinued it for some reason but didn't experience these symptoms.
Your doctor may also perform an ultrasound, CT scan or MRI to identify any ovarian tissue or pelvic mass and may measure blood levels of follicle-stimulating hormone (FSH) and estradiol. Estradiol is produced by the ovaries and FSH by the pituitary gland in response to hormonal signals from the ovaries. Levels of estradiol should be very low and levels of FSH should be very high after both ovaries have been removed.
If your doctor does find ovarian tissue remnants, you may be treated with medication to suppress any ovarian function, surgery to remove the tissue, or, as a last resort, radiation to destroy the tissue.
http://www.healthywomen.org/content/ask-expert/1761/ovarian-remnant-syndrome?context=womentalk/ask-the-expert&context_title=ask-the-expert
Wednesday, December 14, 2011
Marijuana, Narcotics Help Patients Reduce Chronic Pain, Study Finds
WASHINGTON -- A new study out of UC San Francisco has found that medical marijuana, combined with certain opiates, appears to be a safe and effective treatment for patients with chronic pain.
The study, published this month in Clinical Pharmacology and Therapeutics, found that patients who use cannabinoids inhaled through a vaporizer, combined with long-acting morphine or long-acting oxycodone, experienced a greater reduction of pain than those who used opiates alone.
The 21 chronic pain patients involved in the study were split into two groups. Those who combined four consecutive days of exposure to vaporized cannabis with morphine experienced a 33 percent reduction in pain, while those who combined it with oxycodone saw a drop in pain of 20 percent. The study is the first to examine the combined effect of these drugs on humans.
"Pain is a big problem in America and chronic pain is a reason many people utilize the health care system," said lead author Donald Abrams, a professor of clinical medicine at UCSF and chief of the Hematology-Oncology Division at San Francisco General Hospital and Trauma Center. "And chronic pain is, unfortunately, one of the problems we're least capable of managing effectively."
Continue article here: http://www.huffingtonpost.com/2011/12/08/marijuana-narcotics-help-patients-reduce-pain_n_1137416.html
The study, published this month in Clinical Pharmacology and Therapeutics, found that patients who use cannabinoids inhaled through a vaporizer, combined with long-acting morphine or long-acting oxycodone, experienced a greater reduction of pain than those who used opiates alone.
The 21 chronic pain patients involved in the study were split into two groups. Those who combined four consecutive days of exposure to vaporized cannabis with morphine experienced a 33 percent reduction in pain, while those who combined it with oxycodone saw a drop in pain of 20 percent. The study is the first to examine the combined effect of these drugs on humans.
"Pain is a big problem in America and chronic pain is a reason many people utilize the health care system," said lead author Donald Abrams, a professor of clinical medicine at UCSF and chief of the Hematology-Oncology Division at San Francisco General Hospital and Trauma Center. "And chronic pain is, unfortunately, one of the problems we're least capable of managing effectively."
Continue article here: http://www.huffingtonpost.com/2011/12/08/marijuana-narcotics-help-patients-reduce-pain_n_1137416.html
Tuesday, December 13, 2011
Preventing Adhesions in Obstetric and Gynecologic Surgical Procedures
Preventing Adhesions in Obstetric and Gynecologic Surgical Procedures
VÃctor Hugo González-Quintero, MD, MPH and Francisco E Cruz-Pachano, MD
Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Miami School of Medicine, Miami, FL Other Sections▼
AbstractAdhesion FormationAdhesion-Related MorbidityPrevention of Postoperative AdhesionsUse of Adhesion BarriersAdhesion Prevention at the Time of Cesarean DeliverySummaryReferencesAbstractAdhesive disease represents a significant cause of morbidity for postoperative patients. Most surgical procedures performed by obstetrician-gynecologists are associated with pelvic adhesions that cause subsequent serious sequelae, including small bowel obstruction, infertility, chronic pelvic pain, and difficulty in postoperative treatment, including complexity during subsequent surgical procedures. The technology of adhesion prevention has significantly progressed. There are 3 methods approved by the US Food and Drug Administration for the prevention of postoperative adhesions, including Adept®, Interceed®, and Seprafilm®. The latter barrier is the most widely studied. This article reviews the current choices available for adhesion prevention barriers as well as surgical adjuncts that traditionally have been studied for that purpose.Key words: Adhesion prevention, Postoperative morbidity, Cesarean deliveries, Gynecological surgeries
More of the abstract click here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2672996/
VÃctor Hugo González-Quintero, MD, MPH and Francisco E Cruz-Pachano, MD
Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Miami School of Medicine, Miami, FL Other Sections▼
AbstractAdhesion FormationAdhesion-Related MorbidityPrevention of Postoperative AdhesionsUse of Adhesion BarriersAdhesion Prevention at the Time of Cesarean DeliverySummaryReferencesAbstractAdhesive disease represents a significant cause of morbidity for postoperative patients. Most surgical procedures performed by obstetrician-gynecologists are associated with pelvic adhesions that cause subsequent serious sequelae, including small bowel obstruction, infertility, chronic pelvic pain, and difficulty in postoperative treatment, including complexity during subsequent surgical procedures. The technology of adhesion prevention has significantly progressed. There are 3 methods approved by the US Food and Drug Administration for the prevention of postoperative adhesions, including Adept®, Interceed®, and Seprafilm®. The latter barrier is the most widely studied. This article reviews the current choices available for adhesion prevention barriers as well as surgical adjuncts that traditionally have been studied for that purpose.Key words: Adhesion prevention, Postoperative morbidity, Cesarean deliveries, Gynecological surgeries
More of the abstract click here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2672996/
Thursday, December 08, 2011
Perforated IUD? Try Laparoscopic Removal First
Steven Fox
December 7, 2011 — A majority of intrauterine devices (IUDs) that cause uterine perforations may be safely removed with laparoscopy, rather than resorting to more invasive surgery, according to researchers who reviewed nearly 40 years of research on the topic.
On the basis of their review, Richdeep Gill, MD, from the Department of Surgery, University of Alberta, Edmonton, Canada, and colleagues suggest that the laparoscopic approach be first-line therapy in patients who present with symptoms, and that it be considered a reasonable option in patients without symptoms.
Their article appears in the January 2012 issue of Contraception .
"Uterine perforation by [IUDs] is a rare but well recognized complication," they write. However, "[o]ur review demonstrates that a majority of IUD perforations may be amenable to laparoscopic retrieval." Furthermore, they say, the location of the perforated IUD within the abdomen does not appear to be a major factor in outcomes.
According to some estimates, anywhere from 0 to 1.3 per 1000 women implanted with the devices will experience uterine perforation.
In the past, patients who presented with adhesions and perforated viscera often required laparotomy to remove their IUDs, but in recent years improvements in laparoscopic technique and technology have allowed surgeons to use the less-invasive approach to achieve the same results, the authors say.
To find out more about how advances in laparoscopic surgery have affected the management of patients with perforated IUDs, the authors conducted a systematic search of the literature from 1970 through 2009, using MEDLINE/PubMed, Embase, Cochrane Library, and OCLC PapersFirst.
The authors identified 179 cases in which surgeons attempted to use laparoscopy to remove perforated IUDs. Mean age of the patients was 26 years, with an age range from 17 to 49 years. More than three-quarters of the women had previously given birth at least twice.
The patients presented with various symptoms, the most common being pain and unexpected pregnancy, the authors say. All participants initially underwent diagnostic laparoscopy.
The authors report that this initial laparoscopy was successful in all 179 cases. Surgeons subsequently used laparoscopy to successfully remove the perforated IUDs in 64.2% (115/179) of cases.
Laparotomy was done in 34.6% (62/179) of cases, either after diagnostic laparoscopy or after laparoscopic removal had been attempted.
The presence of adhesions appeared to be a factor in unsuccessful outcomes with laparoscopy. Among women who required laparotomy to remove their IUDs, 75% (15/20) reported the presence of adhesions.
In contrast, women whose IUDs were successfully removed by laparoscopy reported a 37.7% (20/53) incidence of adhesions.
Perforated IUDs were found in a variety of locations, including the omentum (26.7%), pouch of Douglas (21.5%), colonic lumen secondary to perforation (10.4%), myometrium (7.4%), broad ligament (6.7%), free within the abdomen (5.2%), small bowel serosa (4.4%), colonic serosa (3.7%), and mesentery (3%). The remaining 11% were found in rare locations, including the bladder, appendix, abdominal wall, fallopian tube, ovary, retroperitoneum, and small bowel. The location appeared to have little effect on the outcomes, the reviewers say.
They conclude: "[T]his systematic review highlights how advances in laparoscopic technique and skill have allowed surgeons to safely retrieve IUDs without laparotomy. We recommend an attempt at laparoscopic removal as first-line treatment in symptomatic patients and as a reasonable treatment option in asymptomatic patients."
The authors have disclosed no relevant financial relationships.
Contraception. 2012;85:15-18. Abstract
December 7, 2011 — A majority of intrauterine devices (IUDs) that cause uterine perforations may be safely removed with laparoscopy, rather than resorting to more invasive surgery, according to researchers who reviewed nearly 40 years of research on the topic.
On the basis of their review, Richdeep Gill, MD, from the Department of Surgery, University of Alberta, Edmonton, Canada, and colleagues suggest that the laparoscopic approach be first-line therapy in patients who present with symptoms, and that it be considered a reasonable option in patients without symptoms.
Their article appears in the January 2012 issue of Contraception .
"Uterine perforation by [IUDs] is a rare but well recognized complication," they write. However, "[o]ur review demonstrates that a majority of IUD perforations may be amenable to laparoscopic retrieval." Furthermore, they say, the location of the perforated IUD within the abdomen does not appear to be a major factor in outcomes.
According to some estimates, anywhere from 0 to 1.3 per 1000 women implanted with the devices will experience uterine perforation.
In the past, patients who presented with adhesions and perforated viscera often required laparotomy to remove their IUDs, but in recent years improvements in laparoscopic technique and technology have allowed surgeons to use the less-invasive approach to achieve the same results, the authors say.
To find out more about how advances in laparoscopic surgery have affected the management of patients with perforated IUDs, the authors conducted a systematic search of the literature from 1970 through 2009, using MEDLINE/PubMed, Embase, Cochrane Library, and OCLC PapersFirst.
The authors identified 179 cases in which surgeons attempted to use laparoscopy to remove perforated IUDs. Mean age of the patients was 26 years, with an age range from 17 to 49 years. More than three-quarters of the women had previously given birth at least twice.
The patients presented with various symptoms, the most common being pain and unexpected pregnancy, the authors say. All participants initially underwent diagnostic laparoscopy.
The authors report that this initial laparoscopy was successful in all 179 cases. Surgeons subsequently used laparoscopy to successfully remove the perforated IUDs in 64.2% (115/179) of cases.
Laparotomy was done in 34.6% (62/179) of cases, either after diagnostic laparoscopy or after laparoscopic removal had been attempted.
The presence of adhesions appeared to be a factor in unsuccessful outcomes with laparoscopy. Among women who required laparotomy to remove their IUDs, 75% (15/20) reported the presence of adhesions.
In contrast, women whose IUDs were successfully removed by laparoscopy reported a 37.7% (20/53) incidence of adhesions.
Perforated IUDs were found in a variety of locations, including the omentum (26.7%), pouch of Douglas (21.5%), colonic lumen secondary to perforation (10.4%), myometrium (7.4%), broad ligament (6.7%), free within the abdomen (5.2%), small bowel serosa (4.4%), colonic serosa (3.7%), and mesentery (3%). The remaining 11% were found in rare locations, including the bladder, appendix, abdominal wall, fallopian tube, ovary, retroperitoneum, and small bowel. The location appeared to have little effect on the outcomes, the reviewers say.
They conclude: "[T]his systematic review highlights how advances in laparoscopic technique and skill have allowed surgeons to safely retrieve IUDs without laparotomy. We recommend an attempt at laparoscopic removal as first-line treatment in symptomatic patients and as a reasonable treatment option in asymptomatic patients."
The authors have disclosed no relevant financial relationships.
Contraception. 2012;85:15-18. Abstract
Sunday, December 04, 2011
Testimony on the Resorbable Adhesion Barrier REPEL-CV
September 19, 2007
Testimony of Peter Lurie, M.D., M.P.H., and Eunice Yu
Public Citizen’s Health Research Group
Public Citizen’s Health Research Group opposes the approval of REPEL-CV, a resorbable polymer adhesion barrier, for the proposed indication of reduction in surgical adhesions. Minimum criteria for the approval of an adhesion barrier should be the demonstration of a clinically significant improvement and a reasonable assurance of safety. Neither is present in this case.
Background
Opening the sternum (sternotomy) during cardiac surgery can result in the formation of dense scar tissue called adhesions between the outside of the heart (epicardium) and the inner portion of the chest wall. REPEL-CV is implanted between the epicardium and the chest wall and, in theory, resorbed within 28 days. During this period, it is supposed to reduce the incidence and severity of adhesions, making subsequent surgery less difficult. It is noteworthy that the sole proposed indication (“reducing the incidence, severity and extent of post-operative adhesion formation in patients undergoing cardiac surgery via sternotomy”[1]) makes no claim of any clinical benefit to the patient.
In its pre-market application (PMA) for REPEL-CV, SyntheMed Inc. submitted a single randomized, evaluator-blinded pivotal trial of 142 pediatric patients (73 treatment, 69 control) who were expected to require at least two sternotomy procedures for repair of congenital heart malformations. The device was implanted in the first surgery and adhesions were measured in the second. In the treatment group, REPEL-CV was sutured to the margins of the open pericardium (a sac surrounding the heart) below the sternum in the first operation, while in the control group the pericardium was left open. Following various patient withdrawals and discontinuations, the trial yielded an intent-to-treat population of 56 patients in the treatment arm and 54 in the control arm, all of whom underwent the second procedure. Most study endpoints were based upon the following four-point scale developed in the feasibility trials.
Grade 0 = No adhesions
Grade 1 = Mild adhesions (filmy, non-cohesive adhesions requiring blunt dissection to separate the space between the epicardium and sternum)
Grade 2 = Moderate adhesions (filmy, non-cohesive adhesions requiring a combination of blunt and selective sharp dissection to separate the space between the epicardium and the sternum)
Grade 3 = Severe adhesions (dense, cohesive adhesions requiring extensive sharp dissection to separate the space between the epicardium and the sternum)[2]
The primary endpoint was the percentage of the surgical site with Grade 3 adhesions detected during the second surgery. Three of the four secondary endpoints also drew from this scale by measuring the prevalence of Grade 0-2 adhesions, or by characterizing the patients by their most severe adhesion grade. The final secondary endpoint measured the time required to dissect adhesions at the second sternotomy.
Efficacy
REPEL-CV Does Not Reduce the Incidence of Adhesions
The trial showed a significant reduction in the prevalence at second sternotomy of Grade 3 adhesions in patients with the REPEL-CV implant (21.3%) compared with those whose pericardiums were left open (47.3%; p=0.0008).[3] However, the product failed to actually prevent adhesions overall, whether measured by the percentage of the operative surface area with Grade 0 adhesions (mean 2.9% vs. 0.9%; p=0.32)[4] or by the percentage of patients who were completely adhesion-free (1.8% vs. 0%).[5] The product did seem to reduce the severity of adhesions. For the primary efficacy variable, there was an overall redistribution from Grade 3 adhesions into Grade 2 and Grade 1 adhesions.[6] The percentage of patients characterized by their worst adhesion showed a similar trend: REPEL-CV resulted in a “one-grade shift downwards,”[7] from Grade 3 into Grade 2. This is very different from “reducing the incidence” of adhesions, part of the indication sought by the company.
Lack of Clinical Endpoints
The above adhesion scale has never been validated with clinical outcomes such as mortality, infection, or complications of adhesions. Indeed, we are aware of no circumstance in which it has been used except for in the development of REPEL-CV. One observer suggests that pericardial adhesions “may be beneficial” for patients because adhesions prevent “excessive movement of the heart devoid of its normal pericardial support.”[8] Lack of clarity over the significance of adhesions makes the demonstration of an actual clinical benefit all the more important.
Given that the apparent purpose of adhesion prevention is the facilitation of follow-up surgeries, the only (secondary) endpoint with a resemblance to clinical significance is adhesion dissection time. Yet this endpoint was not influenced by REPEL-CV (25.9 minutes for the treatment group vs. 25.0 minutes for the control group; p=0.84).[9] The lack of a positive result for the only clinical endpoint calls into question the usefulness of the device.
The major limitations of using adhesions as the primary outcome are underscored by the history of FDA’s guidance on clinical trials for resorbable adhesion barrier devices. In its original 1999 Draft Guidance for such devices in abdominal and/or pelvic surgery, the agency made clear the importance of clinical endpoints: “Optimally, endpoints should directly address clinical outcome measures … The most direct method of providing valid scientific evidence of effectiveness is to select an appropriate clinical endpoint(s) and design a study that may demonstrate a statistically significant and clinically meaningful effect on recognized adhesion-related morbidity.”[10] After discussing particular endpoints for abdominal and pelvic surgery and acknowledging possible impediments to the use of clinical endpoints, the section concludes, “sponsors are encouraged to directly assess clinical endpoints whenever possible.”
This did not sit well with the Adhesion Barrier Task Force, which represented the manufacturers of adhesion barriers including SyntheMed’s predecessor company, Life Medical Sciences. In comments on the Draft Guidance submitted to the FDA, the Task Force declared that, “Until there is more information and standards established for conducting these studies with highly specific clinical endpoints, it would be overly burdensome to suggest that measuring specific clinical outcomes might be the means of assessing product effectiveness as this has never been accomplished to date.”[11]
The objections evidently had the desired effect. In the final Guidance, after stating that clinical outcomes are “the most direct method of providing valid scientific evidence of effectiveness,” the FDA concludes, “The clinical outcomes associated with adhesions may be reasonably assessed by parameters which are more immediately measurable and potentially less confounded.”[12] At least three of five examples of appropriate outcomes given in the final Guidance mention only adhesions; the other two are unclear.
Inadequate Blinding
While the study design rightly emphasized blinding of the evaluating surgeon at second sternotomy, this design was undermined. Although REPEL-CV should be resorbed within 28 days, “implanted test material or a fibrous capsule, or other abnormal tissue”[13] was observed in 30.4% of patients in the REPEL-CV group and 1.9% of patients in the control group at second sternotomy (p<0.0001). Finding this material during the second sternotomy would likely unblind the evaluator, potentially leading to downgrading of adhesion severity in the REPEL-CV group.
Safety
In addition to these efficacy concerns, there were troubling signs of possible dangers associated with the device. There were trends toward higher risk of death (16.4% vs. 13.0%), mediastinial infection (5.5% vs. 1.4%, or 4 vs. 1 patient), and adverse events possibly, probably or definitely related to the study (8.2% vs. 1.4%).[14] These trends were not statistically significant, but with a total population of 142 patients who underwent the first sternotomy, the study was only, by the sponsor’s own admission, “adequate to rule out a 18% disadvantage (15% [mortality rate in the control group] vs. 33% [mortality rate in the treatment group], 2.8 odds ratio) with 80% power and one-sided 5% Type I error.”[15] Thus, REPEL-CV-treated patients would have had to have died at almost three times the control rate for this study to have reached statistical significance. The consistent direction of the adverse effects observed, even if non-significant, is concerning.
Parallels with Intergel
The data on REPEL-CV bring to mind the case of Intergel, a product made from sodium hyaluronate and intended to reduce pelvic adhesions. In that case, adhesions were also shown to be reduced by the product. However, despite the use of an adhesion scale with arguably more validation than that used in the REPEL-CV study, FDA was concerned that, “There is little experience in the clinical literature correlating the [Modified American Fertility Society] score with clinical outcomes.”[16] The pivotal Intergel trial demonstrated, as here, a consistent but non-statistically significant increase in infection rates. Initially, the FDA rejected the sponsor’s application, but the company appealed to an external Dispute Resolution Panel, which recommended approval. The FDA then reversed itself and approved the device. On April 16, 2003, less than two years after the device was approved, the company removed the device from the market due to dozens of reports of post-operative pain requiring repeat surgery, foreign body reactions and tissue adherence, including three deaths.[17] This history should give one pause before approving an adhesion barrier with only surrogate endpoints and a questionable safety record.
Conclusion
SyntheMed has simply failed to demonstrate that its product will have any important impact upon the public health. To do so, the following conditions would have to be met:
1.The patients receiving the device would have to undergo resternotomy; in fact, only a minority of patients will undergo resternotomy and all implanted patients face the potential dangers of the device.
2.The product would have to reduce adhesions; in fact, the product reduces the severity but not the incidence of adhesions.
3.The adhesions would have to have clear clinical significance; in fact, their significance remains unclear and the product had no impact upon the only clinical outcome.
4.The product would have to have an appropriate safety profile; in fact, there are trends in the direction of increased infection and even increased mortality.
For these reasons, Public Citizen’s Health Research Group opposes the approval of this device.
--------------------------------------------------------------------------------
[1] SyntheMed. Proposed Package Insert for REPEL-CV. September 17th, 2007, p. 3.
[2] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 34.
[3] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, Table 17.
[4] ibid.
[5] ibid., Table 18.
[6] ibid., Table 17.
[7] ibid., p. 53.
[8] Nkere UU. Postoperative adhesion formation and the use of adhesion preventing techniques in cardiac and general surgery. ASAIO Journal 2000;46:654-6.
[9] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 40.
[10] Center for Devices and Radiological Health. Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Draft Guidance. Food and Drug Administration, December 16, 1999.
[11] Burns JW. Letter to Dockets Management Branch (Docket 99D-5199). Adhesion Barrier Task Force, March 13, 2000.
[12] Center for Devices and Radiological Health. Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry. Food and Drug Administration, June 18, 2002.
[13] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 51.
[14] ibid., Table 21.
[15] ibid., p. 47.
[16] Richter KC. Letter to Lifecore Biomedical, Inc. Office of Device Evaluation, Center for Devices and Radiological Health, November 15, 2000.
[17] Sullivan MG. Intergel sales halted pending investigation of deaths, pain. Ob/Gyn News, May 15, 2003.
http://www.citizen.org/Page.aspx?pid=731
Testimony of Peter Lurie, M.D., M.P.H., and Eunice Yu
Public Citizen’s Health Research Group
Public Citizen’s Health Research Group opposes the approval of REPEL-CV, a resorbable polymer adhesion barrier, for the proposed indication of reduction in surgical adhesions. Minimum criteria for the approval of an adhesion barrier should be the demonstration of a clinically significant improvement and a reasonable assurance of safety. Neither is present in this case.
Background
Opening the sternum (sternotomy) during cardiac surgery can result in the formation of dense scar tissue called adhesions between the outside of the heart (epicardium) and the inner portion of the chest wall. REPEL-CV is implanted between the epicardium and the chest wall and, in theory, resorbed within 28 days. During this period, it is supposed to reduce the incidence and severity of adhesions, making subsequent surgery less difficult. It is noteworthy that the sole proposed indication (“reducing the incidence, severity and extent of post-operative adhesion formation in patients undergoing cardiac surgery via sternotomy”[1]) makes no claim of any clinical benefit to the patient.
In its pre-market application (PMA) for REPEL-CV, SyntheMed Inc. submitted a single randomized, evaluator-blinded pivotal trial of 142 pediatric patients (73 treatment, 69 control) who were expected to require at least two sternotomy procedures for repair of congenital heart malformations. The device was implanted in the first surgery and adhesions were measured in the second. In the treatment group, REPEL-CV was sutured to the margins of the open pericardium (a sac surrounding the heart) below the sternum in the first operation, while in the control group the pericardium was left open. Following various patient withdrawals and discontinuations, the trial yielded an intent-to-treat population of 56 patients in the treatment arm and 54 in the control arm, all of whom underwent the second procedure. Most study endpoints were based upon the following four-point scale developed in the feasibility trials.
Grade 0 = No adhesions
Grade 1 = Mild adhesions (filmy, non-cohesive adhesions requiring blunt dissection to separate the space between the epicardium and sternum)
Grade 2 = Moderate adhesions (filmy, non-cohesive adhesions requiring a combination of blunt and selective sharp dissection to separate the space between the epicardium and the sternum)
Grade 3 = Severe adhesions (dense, cohesive adhesions requiring extensive sharp dissection to separate the space between the epicardium and the sternum)[2]
The primary endpoint was the percentage of the surgical site with Grade 3 adhesions detected during the second surgery. Three of the four secondary endpoints also drew from this scale by measuring the prevalence of Grade 0-2 adhesions, or by characterizing the patients by their most severe adhesion grade. The final secondary endpoint measured the time required to dissect adhesions at the second sternotomy.
Efficacy
REPEL-CV Does Not Reduce the Incidence of Adhesions
The trial showed a significant reduction in the prevalence at second sternotomy of Grade 3 adhesions in patients with the REPEL-CV implant (21.3%) compared with those whose pericardiums were left open (47.3%; p=0.0008).[3] However, the product failed to actually prevent adhesions overall, whether measured by the percentage of the operative surface area with Grade 0 adhesions (mean 2.9% vs. 0.9%; p=0.32)[4] or by the percentage of patients who were completely adhesion-free (1.8% vs. 0%).[5] The product did seem to reduce the severity of adhesions. For the primary efficacy variable, there was an overall redistribution from Grade 3 adhesions into Grade 2 and Grade 1 adhesions.[6] The percentage of patients characterized by their worst adhesion showed a similar trend: REPEL-CV resulted in a “one-grade shift downwards,”[7] from Grade 3 into Grade 2. This is very different from “reducing the incidence” of adhesions, part of the indication sought by the company.
Lack of Clinical Endpoints
The above adhesion scale has never been validated with clinical outcomes such as mortality, infection, or complications of adhesions. Indeed, we are aware of no circumstance in which it has been used except for in the development of REPEL-CV. One observer suggests that pericardial adhesions “may be beneficial” for patients because adhesions prevent “excessive movement of the heart devoid of its normal pericardial support.”[8] Lack of clarity over the significance of adhesions makes the demonstration of an actual clinical benefit all the more important.
Given that the apparent purpose of adhesion prevention is the facilitation of follow-up surgeries, the only (secondary) endpoint with a resemblance to clinical significance is adhesion dissection time. Yet this endpoint was not influenced by REPEL-CV (25.9 minutes for the treatment group vs. 25.0 minutes for the control group; p=0.84).[9] The lack of a positive result for the only clinical endpoint calls into question the usefulness of the device.
The major limitations of using adhesions as the primary outcome are underscored by the history of FDA’s guidance on clinical trials for resorbable adhesion barrier devices. In its original 1999 Draft Guidance for such devices in abdominal and/or pelvic surgery, the agency made clear the importance of clinical endpoints: “Optimally, endpoints should directly address clinical outcome measures … The most direct method of providing valid scientific evidence of effectiveness is to select an appropriate clinical endpoint(s) and design a study that may demonstrate a statistically significant and clinically meaningful effect on recognized adhesion-related morbidity.”[10] After discussing particular endpoints for abdominal and pelvic surgery and acknowledging possible impediments to the use of clinical endpoints, the section concludes, “sponsors are encouraged to directly assess clinical endpoints whenever possible.”
This did not sit well with the Adhesion Barrier Task Force, which represented the manufacturers of adhesion barriers including SyntheMed’s predecessor company, Life Medical Sciences. In comments on the Draft Guidance submitted to the FDA, the Task Force declared that, “Until there is more information and standards established for conducting these studies with highly specific clinical endpoints, it would be overly burdensome to suggest that measuring specific clinical outcomes might be the means of assessing product effectiveness as this has never been accomplished to date.”[11]
The objections evidently had the desired effect. In the final Guidance, after stating that clinical outcomes are “the most direct method of providing valid scientific evidence of effectiveness,” the FDA concludes, “The clinical outcomes associated with adhesions may be reasonably assessed by parameters which are more immediately measurable and potentially less confounded.”[12] At least three of five examples of appropriate outcomes given in the final Guidance mention only adhesions; the other two are unclear.
Inadequate Blinding
While the study design rightly emphasized blinding of the evaluating surgeon at second sternotomy, this design was undermined. Although REPEL-CV should be resorbed within 28 days, “implanted test material or a fibrous capsule, or other abnormal tissue”[13] was observed in 30.4% of patients in the REPEL-CV group and 1.9% of patients in the control group at second sternotomy (p<0.0001). Finding this material during the second sternotomy would likely unblind the evaluator, potentially leading to downgrading of adhesion severity in the REPEL-CV group.
Safety
In addition to these efficacy concerns, there were troubling signs of possible dangers associated with the device. There were trends toward higher risk of death (16.4% vs. 13.0%), mediastinial infection (5.5% vs. 1.4%, or 4 vs. 1 patient), and adverse events possibly, probably or definitely related to the study (8.2% vs. 1.4%).[14] These trends were not statistically significant, but with a total population of 142 patients who underwent the first sternotomy, the study was only, by the sponsor’s own admission, “adequate to rule out a 18% disadvantage (15% [mortality rate in the control group] vs. 33% [mortality rate in the treatment group], 2.8 odds ratio) with 80% power and one-sided 5% Type I error.”[15] Thus, REPEL-CV-treated patients would have had to have died at almost three times the control rate for this study to have reached statistical significance. The consistent direction of the adverse effects observed, even if non-significant, is concerning.
Parallels with Intergel
The data on REPEL-CV bring to mind the case of Intergel, a product made from sodium hyaluronate and intended to reduce pelvic adhesions. In that case, adhesions were also shown to be reduced by the product. However, despite the use of an adhesion scale with arguably more validation than that used in the REPEL-CV study, FDA was concerned that, “There is little experience in the clinical literature correlating the [Modified American Fertility Society] score with clinical outcomes.”[16] The pivotal Intergel trial demonstrated, as here, a consistent but non-statistically significant increase in infection rates. Initially, the FDA rejected the sponsor’s application, but the company appealed to an external Dispute Resolution Panel, which recommended approval. The FDA then reversed itself and approved the device. On April 16, 2003, less than two years after the device was approved, the company removed the device from the market due to dozens of reports of post-operative pain requiring repeat surgery, foreign body reactions and tissue adherence, including three deaths.[17] This history should give one pause before approving an adhesion barrier with only surrogate endpoints and a questionable safety record.
Conclusion
SyntheMed has simply failed to demonstrate that its product will have any important impact upon the public health. To do so, the following conditions would have to be met:
1.The patients receiving the device would have to undergo resternotomy; in fact, only a minority of patients will undergo resternotomy and all implanted patients face the potential dangers of the device.
2.The product would have to reduce adhesions; in fact, the product reduces the severity but not the incidence of adhesions.
3.The adhesions would have to have clear clinical significance; in fact, their significance remains unclear and the product had no impact upon the only clinical outcome.
4.The product would have to have an appropriate safety profile; in fact, there are trends in the direction of increased infection and even increased mortality.
For these reasons, Public Citizen’s Health Research Group opposes the approval of this device.
--------------------------------------------------------------------------------
[1] SyntheMed. Proposed Package Insert for REPEL-CV. September 17th, 2007, p. 3.
[2] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 34.
[3] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, Table 17.
[4] ibid.
[5] ibid., Table 18.
[6] ibid., Table 17.
[7] ibid., p. 53.
[8] Nkere UU. Postoperative adhesion formation and the use of adhesion preventing techniques in cardiac and general surgery. ASAIO Journal 2000;46:654-6.
[9] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 40.
[10] Center for Devices and Radiological Health. Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Draft Guidance. Food and Drug Administration, December 16, 1999.
[11] Burns JW. Letter to Dockets Management Branch (Docket 99D-5199). Adhesion Barrier Task Force, March 13, 2000.
[12] Center for Devices and Radiological Health. Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry. Food and Drug Administration, June 18, 2002.
[13] SyntheMed. REPEL-CV P07005: Summary of Safety and Effectiveness. September 17th, 2007, p. 51.
[14] ibid., Table 21.
[15] ibid., p. 47.
[16] Richter KC. Letter to Lifecore Biomedical, Inc. Office of Device Evaluation, Center for Devices and Radiological Health, November 15, 2000.
[17] Sullivan MG. Intergel sales halted pending investigation of deaths, pain. Ob/Gyn News, May 15, 2003.
http://www.citizen.org/Page.aspx?pid=731
Saturday, December 03, 2011
Adhesion prevention in gynaecological surgery.
J Obstet Gynaecol Can. 2010 Jun;32(6):598-608.
Adhesion prevention in gynaecological surgery.
[Article in English, French]
Robertson D, Lefebvre G, Leyland N, Wolfman W, Allaire C, Awadalla A, Best C, Contestabile E, Dunn S, Heywood M, Leroux N, Potestio F, Rittenberg D, Senikas V, Soucy R, Singh S; Society of Obstetricians and Gynaecologists of Canada.
SourceToronto ON.
Abstract
OBJECTIVES: To review the etiology and incidence of and associative factors in the formation of adhesions following gynaecological surgery. To review evidence for the use of available means of adhesion prevention following gynaecological surgery.
OPTIONS: Women undergoing pelvic surgery are at risk of developing abdominal and/or pelvic adhesive disease postoperatively. Surgical technique and commercial adhesion prevention systems may decrease the risk of postoperative adhesion formation.
OUTCOMES: The outcomes measured are the incidence of postoperative adhesions, complications related to the formation of adhesions, and further intervention relative to adhesive disease.
EVIDENCE: Medline, EMBASE, and The Cochrane Library were searched for articles published in English from 1990 to March 2009, using appropriate controlled vocabulary and key words. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, cohort studies, and meta-analyses specifically addressing postoperative adhesions, adhesion prevention, and adhesive barriers. Searches were updated on a regular basis and incorporated in the guideline to March 2009. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.
VALUES: The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care SUMMARY STATEMENTS: 1. Meticulous surgical technique is a means of preventing adhesions. This includes minimizing tissue trauma, achieving optimal hemostasis, minimizing the risk of infection, and avoiding contaminants (e.g., fecal matter) and the use of foreign materials (e.g., talcum powder) when possible. (II-2). 2. The risk of adhesions increases with the total number of abdominal and pelvic surgeries performed on one patient; every surgery needs to be carefully considered in this context. (II-2). 3. Polytetrafluoroethylene (Gore-Tex) barrier is more effective than no barrier or oxidized regenerated cellulose in preventing adhesion formation. (I). 4. Oxidized regenerated cellulose (Interceed) adhesion barrier is associated with a reduced incidence of pelvic adhesion formation at both laparoscopy and laparotomy when complete hemostasis is achieved. Oxidized regenerated cellulose may increase the risk of adhesions if optimal hemostasis is not achieved. (II-2). 5. Chemically modified sodium hyaluronate/carboxymethylcellulose (Seprafilm) is effective in preventing adhesion formation, especially following myomectomies. There is insufficient evidence on the effect of sodium hyaluronate/carboxymethylcellulose on long-term clinical outcomes such as fertility, chronic pelvic pain or small bowel obstruction. (II-2). 6. No adverse effects have been reported with the use of oxidized regenerated cellulose, polytetrafluoroethylene, or sodium hyaluronate/carboxymethylcellulose. (II-1). 7. Various pharmacological agents have been marketed as a means of preventing adhesions. None of these agents are presently available in Canada. There is insufficient evidence for the use of pharmacological agents in preventing adhesions. (III-C).
RECOMMENDATIONS: 1. Surgeons should attempt to perform surgical procedures using the least invasive method possible in order to decrease the risk of adhesion formation. (II-1B ). When feasible, for example, a laparoscopic surgical approach is preferable to an abdominal approach, and a vaginal or laparoscopic hysterectomy is preferable to an abdominal hysterectomy. 2. Precautions should be taken at surgery to minimize tissue trauma in order to decrease the risk of postoperative adhesions. These precautions include limiting packing, crushing, and manipulating of tissues to what is strictly required for safe completion of the procedure. (III-B). 3. Surgeons could consider using an adhesion barrier for patients who are at high risk of forming clinically significant adhesions (i.e., patients who have endometriosis or pelvic inflammatory disease or who are undergoing a myomectomy). If there is a risk of ongoing bleeding from the surgical site, oxidized regenerated cellulose (Interceed) should not be used as it may increase the risk of adhesions in this situation. (II-2B).
PMID:20569542[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/20569542
Adhesion prevention in gynaecological surgery.
[Article in English, French]
Robertson D, Lefebvre G, Leyland N, Wolfman W, Allaire C, Awadalla A, Best C, Contestabile E, Dunn S, Heywood M, Leroux N, Potestio F, Rittenberg D, Senikas V, Soucy R, Singh S; Society of Obstetricians and Gynaecologists of Canada.
SourceToronto ON.
Abstract
OBJECTIVES: To review the etiology and incidence of and associative factors in the formation of adhesions following gynaecological surgery. To review evidence for the use of available means of adhesion prevention following gynaecological surgery.
OPTIONS: Women undergoing pelvic surgery are at risk of developing abdominal and/or pelvic adhesive disease postoperatively. Surgical technique and commercial adhesion prevention systems may decrease the risk of postoperative adhesion formation.
OUTCOMES: The outcomes measured are the incidence of postoperative adhesions, complications related to the formation of adhesions, and further intervention relative to adhesive disease.
EVIDENCE: Medline, EMBASE, and The Cochrane Library were searched for articles published in English from 1990 to March 2009, using appropriate controlled vocabulary and key words. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, cohort studies, and meta-analyses specifically addressing postoperative adhesions, adhesion prevention, and adhesive barriers. Searches were updated on a regular basis and incorporated in the guideline to March 2009. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.
VALUES: The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care SUMMARY STATEMENTS: 1. Meticulous surgical technique is a means of preventing adhesions. This includes minimizing tissue trauma, achieving optimal hemostasis, minimizing the risk of infection, and avoiding contaminants (e.g., fecal matter) and the use of foreign materials (e.g., talcum powder) when possible. (II-2). 2. The risk of adhesions increases with the total number of abdominal and pelvic surgeries performed on one patient; every surgery needs to be carefully considered in this context. (II-2). 3. Polytetrafluoroethylene (Gore-Tex) barrier is more effective than no barrier or oxidized regenerated cellulose in preventing adhesion formation. (I). 4. Oxidized regenerated cellulose (Interceed) adhesion barrier is associated with a reduced incidence of pelvic adhesion formation at both laparoscopy and laparotomy when complete hemostasis is achieved. Oxidized regenerated cellulose may increase the risk of adhesions if optimal hemostasis is not achieved. (II-2). 5. Chemically modified sodium hyaluronate/carboxymethylcellulose (Seprafilm) is effective in preventing adhesion formation, especially following myomectomies. There is insufficient evidence on the effect of sodium hyaluronate/carboxymethylcellulose on long-term clinical outcomes such as fertility, chronic pelvic pain or small bowel obstruction. (II-2). 6. No adverse effects have been reported with the use of oxidized regenerated cellulose, polytetrafluoroethylene, or sodium hyaluronate/carboxymethylcellulose. (II-1). 7. Various pharmacological agents have been marketed as a means of preventing adhesions. None of these agents are presently available in Canada. There is insufficient evidence for the use of pharmacological agents in preventing adhesions. (III-C).
RECOMMENDATIONS: 1. Surgeons should attempt to perform surgical procedures using the least invasive method possible in order to decrease the risk of adhesion formation. (II-1B ). When feasible, for example, a laparoscopic surgical approach is preferable to an abdominal approach, and a vaginal or laparoscopic hysterectomy is preferable to an abdominal hysterectomy. 2. Precautions should be taken at surgery to minimize tissue trauma in order to decrease the risk of postoperative adhesions. These precautions include limiting packing, crushing, and manipulating of tissues to what is strictly required for safe completion of the procedure. (III-B). 3. Surgeons could consider using an adhesion barrier for patients who are at high risk of forming clinically significant adhesions (i.e., patients who have endometriosis or pelvic inflammatory disease or who are undergoing a myomectomy). If there is a risk of ongoing bleeding from the surgical site, oxidized regenerated cellulose (Interceed) should not be used as it may increase the risk of adhesions in this situation. (II-2B).
PMID:20569542[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/20569542
Risk of adhesions and medicolegal issues UK ~ So how much should we tell patients?
Excerpt taken from http://onlinelibrary.wiley.com/doi/10.1576/toag.6.2.1.26993/pdf.
The Obstetrician & Gynaecologist
2004;6(2)
SUPPLEMENT
11
There are a number of quality and risk management
issues surrounding adhesions in surgery.The
surgical speciality has given rise to the highest
number and second highest value of negligence
claims reported to the UK National Health
Service Litigations Authority (NHSLA). The
highest numbers of reported Clinical Negligence
Scheme for Trusts (CNST) claims by speciality
are:
• surgery: 3365
• obstetrics and gynaecology 2237
• medicine 1278
• accident and emergency 803.23
Increasingly, complications resulting from
postoperative intra-abdominal adhesions have
been the subject of medical negligence cases.
These have included failure to diagnose adhesion related
problems, delay in diagnosis, bowel damage
at adhesiolysis, adhesive intestinal obstruction,
infertility or risk of infertility and failure to take
precautions to prevent adhesions. 24 Between
1994–1999, for example, the UK Medical
Defence Union received 77 adhesion-related
claims that resulted in 14 out of court settlements
in 11 years ranging from £7,960 to £124,261
(average £50,765 per case).24 The Medical
Defence Union is one of several insurers for the
private sector; figures are not available for claims
made by the National Health Service.
Anecdotal evidence suggests that the number of
claims and out of court settlements has increased
largely since then.
Duty of care
There is a duty of care to provide careful advice
and sufficient information upon which women
can reach a rational, informed decision on whether
to accept or refuse treatment. In negligence cases
people usually claim that insufficient information
was provided and that, if it had been provided,
consent would not have been granted.
So how is negligence established?
In order for this to be successful it is necessary to:
1) establish a duty of care
2) show a breach of this duty
3) demonstrate that this breach caused the injury.
All three aspects need to be present for negligence
to be established. Recently, in addition to this, the
UK Health Act has also established a duty of
quality.
The Bolam test of negligence (1957) had for
many years set the precedent in determining
negligence. This ruling stated that practitioners
are not negligent if they act in accordance with
practice accepted by a responsible body of
medical opinion. However, recent judgements
suggest that judges are moving away from
accepting what reasonable doctors might do,
towards supporting what reasonable patients
might expect. Recent case law suggests that the
Bolam test is being modified to enable a court to
reject medical opinion if it is not ‘reasonable or
responsible’.25 Physicians are required to understand
their obligations and have a duty to warn a
patient of any material risk inherent in a
proposed procedure, however small.
So how much should we tell patients? It is not
necessary to canvass every risk. However, it is
important to take account of the personality of
the patient, the likelihood of misfortune and what
in the way of warning is needed for the particular
patient’s welfare. Are gynaecologists and surgeons
informing patients about the risk of adhesions?
According to the International Adhesions Society
Patient Survey, the answer is no. Results from this
survey showed that adhesions were mentioned as
part of the consent process in only 10.4% of
cases.26 In 14.4% of cases, adhesions were discussed
but not as part of the consent process. For patients
undergoing adhesiolysis procedures, 54% were
given some information before surgery and 46%
were given specific information about antiadhesion
agents. In nonadhesiolysis procedures
only 10% of patients were advised about adhesions
and only 6% were given information on antiadhesion
agents.
Negligence cases relating to adhesions are
becoming more common. It is important to be
aware that the law governing negligence has
changed. Doctors are obliged to understand their
obligations and this will mean warning of the
risk of adhesions prior to abdominal or pelvic
surgery.
The Obstetrician & Gynaecologist
2004;6(2)
SUPPLEMENT
11
There are a number of quality and risk management
issues surrounding adhesions in surgery.The
surgical speciality has given rise to the highest
number and second highest value of negligence
claims reported to the UK National Health
Service Litigations Authority (NHSLA). The
highest numbers of reported Clinical Negligence
Scheme for Trusts (CNST) claims by speciality
are:
• surgery: 3365
• obstetrics and gynaecology 2237
• medicine 1278
• accident and emergency 803.23
Increasingly, complications resulting from
postoperative intra-abdominal adhesions have
been the subject of medical negligence cases.
These have included failure to diagnose adhesion related
problems, delay in diagnosis, bowel damage
at adhesiolysis, adhesive intestinal obstruction,
infertility or risk of infertility and failure to take
precautions to prevent adhesions. 24 Between
1994–1999, for example, the UK Medical
Defence Union received 77 adhesion-related
claims that resulted in 14 out of court settlements
in 11 years ranging from £7,960 to £124,261
(average £50,765 per case).24 The Medical
Defence Union is one of several insurers for the
private sector; figures are not available for claims
made by the National Health Service.
Anecdotal evidence suggests that the number of
claims and out of court settlements has increased
largely since then.
Duty of care
There is a duty of care to provide careful advice
and sufficient information upon which women
can reach a rational, informed decision on whether
to accept or refuse treatment. In negligence cases
people usually claim that insufficient information
was provided and that, if it had been provided,
consent would not have been granted.
So how is negligence established?
In order for this to be successful it is necessary to:
1) establish a duty of care
2) show a breach of this duty
3) demonstrate that this breach caused the injury.
All three aspects need to be present for negligence
to be established. Recently, in addition to this, the
UK Health Act has also established a duty of
quality.
The Bolam test of negligence (1957) had for
many years set the precedent in determining
negligence. This ruling stated that practitioners
are not negligent if they act in accordance with
practice accepted by a responsible body of
medical opinion. However, recent judgements
suggest that judges are moving away from
accepting what reasonable doctors might do,
towards supporting what reasonable patients
might expect. Recent case law suggests that the
Bolam test is being modified to enable a court to
reject medical opinion if it is not ‘reasonable or
responsible’.25 Physicians are required to understand
their obligations and have a duty to warn a
patient of any material risk inherent in a
proposed procedure, however small.
So how much should we tell patients? It is not
necessary to canvass every risk. However, it is
important to take account of the personality of
the patient, the likelihood of misfortune and what
in the way of warning is needed for the particular
patient’s welfare. Are gynaecologists and surgeons
informing patients about the risk of adhesions?
According to the International Adhesions Society
Patient Survey, the answer is no. Results from this
survey showed that adhesions were mentioned as
part of the consent process in only 10.4% of
cases.26 In 14.4% of cases, adhesions were discussed
but not as part of the consent process. For patients
undergoing adhesiolysis procedures, 54% were
given some information before surgery and 46%
were given specific information about antiadhesion
agents. In nonadhesiolysis procedures
only 10% of patients were advised about adhesions
and only 6% were given information on antiadhesion
agents.
Negligence cases relating to adhesions are
becoming more common. It is important to be
aware that the law governing negligence has
changed. Doctors are obliged to understand their
obligations and this will mean warning of the
risk of adhesions prior to abdominal or pelvic
surgery.
[Postoperative abdominal adhesions and their prevention in gynaecological surgery: I. What should you know?
Gynecol Obstet Fertil. 2011 Nov 28. [Epub ahead of print]
[Postoperative abdominal adhesions and their prevention in gynaecological surgery: I. What should you know?]
[Article in French]
Audebert A, Darai E, Bénifla JL, Yazbeck C, Déchaud H, Wattiez A, Crowe A, Pouly JL.
SourceService d'endoscopie gynécologique, polyclinique de Bordeaux, 145, rue du Tondu, 33000 Bordeaux, France.
Abstract
Adhesions are the most frequent complications of abdominopelvic surgery, causing important short- and long-term problems, including infertility, chronic pelvic pain and a lifetime risk of small bowel obstruction. They also complicate future surgery with increased morbidity and mortality risk. They pose serious quality of life issues for many patients with associated social and healthcare costs. Despite advances in surgical techniques, including laparoscopy, the healthcare burden of adhesion-related complications has not changed in recent years. Adhesiolysis remains the main treatment although adhesions reform in many patients. The extent of the problem of adhesions has been underestimated by surgeons and the health authorities. There is rising evidence however that surgeons can take important steps to reduce the impact of adhesions. As well as improvements in surgical technique, developments in adhesion-reduction strategies and new agents offer a realistic possibility of reducing adhesion formation and improving outcomes for patients. This paper is the first of a two-part publication providing a comprehensive overview of the evidence on adhesions to allow gynaecological surgeons to be best informed on adhesions, their development, impact on patients, health systems and surgical outcomes. In the second paper we review the various strategies to reduce the impact of adhesions and improve surgical outcomes to assist fellow surgeons in France to consider the adoption of adhesion reduction strategies in their own practice.
http://www.ncbi.nlm.nih.gov/pubmed/22129851
[Postoperative abdominal adhesions and their prevention in gynaecological surgery: I. What should you know?]
[Article in French]
Audebert A, Darai E, Bénifla JL, Yazbeck C, Déchaud H, Wattiez A, Crowe A, Pouly JL.
SourceService d'endoscopie gynécologique, polyclinique de Bordeaux, 145, rue du Tondu, 33000 Bordeaux, France.
Abstract
Adhesions are the most frequent complications of abdominopelvic surgery, causing important short- and long-term problems, including infertility, chronic pelvic pain and a lifetime risk of small bowel obstruction. They also complicate future surgery with increased morbidity and mortality risk. They pose serious quality of life issues for many patients with associated social and healthcare costs. Despite advances in surgical techniques, including laparoscopy, the healthcare burden of adhesion-related complications has not changed in recent years. Adhesiolysis remains the main treatment although adhesions reform in many patients. The extent of the problem of adhesions has been underestimated by surgeons and the health authorities. There is rising evidence however that surgeons can take important steps to reduce the impact of adhesions. As well as improvements in surgical technique, developments in adhesion-reduction strategies and new agents offer a realistic possibility of reducing adhesion formation and improving outcomes for patients. This paper is the first of a two-part publication providing a comprehensive overview of the evidence on adhesions to allow gynaecological surgeons to be best informed on adhesions, their development, impact on patients, health systems and surgical outcomes. In the second paper we review the various strategies to reduce the impact of adhesions and improve surgical outcomes to assist fellow surgeons in France to consider the adoption of adhesion reduction strategies in their own practice.
http://www.ncbi.nlm.nih.gov/pubmed/22129851
Adhesiolysis ~ 3-D Imaging of adhesiolysis and what you can expect from this procedure
3-D Imaging of adhesiolysis and what you can expect from this procedure.
http://www.youtube.com/watch?v=0EtueSRTRyY
http://www.youtube.com/watch?v=0EtueSRTRyY
Friday, December 02, 2011
Severe inflammatory reaction induced by peritoneal trauma is the key driving mechanism of postoperative adhesion formation
Many factors have been put forward as a driving mechanism of surgery-triggered adhesion formation (AF). In this study, we underline the key role of specific surgical trauma related with open surgery (OS) and laparoscopic (LS) conditions in postoperative AF and we aimed to study peritoneal tissue inflammatory reaction (TIR), remodelling specific complications of open surgery (OS) versus LS and subsequently evaluating AF induced by these conditions.
Methods: A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups.
Specific traumatic OS conditions were induced by midline incision line (MLI) extension and tissue drying and specific LS conditions were remodelled by CO2 insufflation. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale.
http://7thspace.com/headlines/399719/severe_inflammatory_reaction_induced_by_peritoneal_
trauma_is_the_key_driving_mechanism_of_postoperative_adhesion_formation_.html
Statistical analysis was performed by the non parametric t test and two-way ANOVA using Bonferroni post-tests.
Results: More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p<0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p<0.05 at the 24th and 72nd; p<0.01 - 120th and p<0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p>0.05).
However larger adhesion size (41.6733.63) was observed after OS in comparison with LS (20.3116.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p=0.03).
Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.
Conclusions: MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences.
CO2 insufflation however, led to moderate inflammation and less adhesion formation.
Author: Sergei PismenskyZhomart KalzhanovMarina EliseevaIoannis KosmasOspan Mynbaev
Credits/Source: BMC Surgery 2011, 11:30
Methods: A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups.
Specific traumatic OS conditions were induced by midline incision line (MLI) extension and tissue drying and specific LS conditions were remodelled by CO2 insufflation. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale.
http://7thspace.com/headlines/399719/severe_inflammatory_reaction_induced_by_peritoneal_
trauma_is_the_key_driving_mechanism_of_postoperative_adhesion_formation_.html
Statistical analysis was performed by the non parametric t test and two-way ANOVA using Bonferroni post-tests.
Results: More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p<0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p<0.05 at the 24th and 72nd; p<0.01 - 120th and p<0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p>0.05).
However larger adhesion size (41.6733.63) was observed after OS in comparison with LS (20.3116.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p=0.03).
Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.
Conclusions: MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences.
CO2 insufflation however, led to moderate inflammation and less adhesion formation.
Author: Sergei PismenskyZhomart KalzhanovMarina EliseevaIoannis KosmasOspan Mynbaev
Credits/Source: BMC Surgery 2011, 11:30
Wednesday, November 30, 2011
AdeTherapeutics, Inc.: Health Canada Approves Clinical Trial for Adhesion Prevention
press release
Nov. 28, 2011, 11:21 a.m. EST
SASKATOON, Saskatchewan, Nov 28, 2011 (BUSINESS WIRE) -- AdeTherapeutics, Inc. received Health Canada approval in November to conduct a double-blind randomized placebo controlled study in 30 patients to test its therapeutic to reduce adhesion (scar tissue) formation following laparoscopic procedure to remove an ectopic pregnancy.
Designed by surgeons, the trial is powered to potentially establish standard of care. The novel mechanism, which modulates normal healing process, is also being studied in other surgical areas of high unmet medical need.
The trial will be conducted at teaching hospitals in Canada with first patient enrolment expected in December 2011.
Click here to read the rest: http://www.marketwatch.com/story/adetherapeutics-inc-health-canada-approves-clinical-trial-for-adhesion-prevention-2011-11-28
Nov. 28, 2011, 11:21 a.m. EST
SASKATOON, Saskatchewan, Nov 28, 2011 (BUSINESS WIRE) -- AdeTherapeutics, Inc. received Health Canada approval in November to conduct a double-blind randomized placebo controlled study in 30 patients to test its therapeutic to reduce adhesion (scar tissue) formation following laparoscopic procedure to remove an ectopic pregnancy.
Designed by surgeons, the trial is powered to potentially establish standard of care. The novel mechanism, which modulates normal healing process, is also being studied in other surgical areas of high unmet medical need.
The trial will be conducted at teaching hospitals in Canada with first patient enrolment expected in December 2011.
Click here to read the rest: http://www.marketwatch.com/story/adetherapeutics-inc-health-canada-approves-clinical-trial-for-adhesion-prevention-2011-11-28
Saturday, November 26, 2011
Solos Endoscopy Poised for Tremendous Growth in Multi-Billion Dollar Endoscopic Market
By Solos Endoscopy, Inc.
Solos Endoscopy, Inc.
Last modified: 2011-11-17T15:54:24Z
Published: Thursday, Nov. 17, 2011 - 7:54 am
BOSTON, Nov. 17, 2011 -- /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company is positioned for tremendous growth in the multi-billion dollar endoscopic market. Solos Endoscopy currently has its endoscopic instruments in over 60 Hospitals, Clinics, Healthcare Centers, Medical Centers and Surgery Centers across the United States with plans to market its endoscopic instrument internationally upon receiving the CE Mark.
Meltwater News Inc., a global specialist in online media monitoring, has delivered a report highlighting significant growth in the endoscopy market over the next five years. According to MarketResearch.com in its July 2011 report, the overall medical device market is very large; endoscopy is a significant component of that market. The endoscopy market is positioned for significant growth in the next 5 years. The endoscopy market worldwide was $23.3 billion in 2010 and is projected to reach nearly $24.8 billion in 2011. This is further anticipated to increase to $33.7 billion by 2016 at a compound annual growth rate (CAGR) of 6.4%.
Laparoscopy accounts for more than 26% of the total market and is expected to reach $6.8 billion by end of 2011 and to increase up to $10.6 billion by 2016 at a compound annual growth rate (CAGR) of 9.2%.
Endoscopy of the GI track for tumors, adhesions, diverticulitis, etc. is projected to experience an increase from $3.7 billion in 2011 to more than $4.9 billion in 2016, a CAGR of 5.7%.
This is due, in part, to new applications for the technology, as well as new innovations in the technology itself. The other major factor that will contribute to this growth is the recognition of this technology in emerging markets like Japan and Vietnam. Continued worldwide growth is expected in other geographic areas due to a growing middle class in countries such as India, China, Brazil, and Russia.
For more information on Meltwater News Inc., please visit; www.meltwater.com
About Solos Endoscopy, Inc.:
Solos Endoscopy, Inc. is a HealthCare instrument company whose mission is to develop and market high quality and innovative instruments for the screening, diagnosis, treatment and management of medical conditions. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.com.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.
Contact: Amanda Segersten, rsegersten@solosendoscopy.com
SOURCE Solos Endoscopy, Inc.
Read more: http://www.sacbee.com/2011/11/17/4061951/solos-endoscopy-poised-for-tremendous.html#ixzz1eoZSvUI f
Solos Endoscopy, Inc.
Last modified: 2011-11-17T15:54:24Z
Published: Thursday, Nov. 17, 2011 - 7:54 am
BOSTON, Nov. 17, 2011 -- /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company is positioned for tremendous growth in the multi-billion dollar endoscopic market. Solos Endoscopy currently has its endoscopic instruments in over 60 Hospitals, Clinics, Healthcare Centers, Medical Centers and Surgery Centers across the United States with plans to market its endoscopic instrument internationally upon receiving the CE Mark.
Meltwater News Inc., a global specialist in online media monitoring, has delivered a report highlighting significant growth in the endoscopy market over the next five years. According to MarketResearch.com in its July 2011 report, the overall medical device market is very large; endoscopy is a significant component of that market. The endoscopy market is positioned for significant growth in the next 5 years. The endoscopy market worldwide was $23.3 billion in 2010 and is projected to reach nearly $24.8 billion in 2011. This is further anticipated to increase to $33.7 billion by 2016 at a compound annual growth rate (CAGR) of 6.4%.
Laparoscopy accounts for more than 26% of the total market and is expected to reach $6.8 billion by end of 2011 and to increase up to $10.6 billion by 2016 at a compound annual growth rate (CAGR) of 9.2%.
Endoscopy of the GI track for tumors, adhesions, diverticulitis, etc. is projected to experience an increase from $3.7 billion in 2011 to more than $4.9 billion in 2016, a CAGR of 5.7%.
This is due, in part, to new applications for the technology, as well as new innovations in the technology itself. The other major factor that will contribute to this growth is the recognition of this technology in emerging markets like Japan and Vietnam. Continued worldwide growth is expected in other geographic areas due to a growing middle class in countries such as India, China, Brazil, and Russia.
For more information on Meltwater News Inc., please visit; www.meltwater.com
About Solos Endoscopy, Inc.:
Solos Endoscopy, Inc. is a HealthCare instrument company whose mission is to develop and market high quality and innovative instruments for the screening, diagnosis, treatment and management of medical conditions. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.com.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.
Contact: Amanda Segersten, rsegersten@solosendoscopy.com
SOURCE Solos Endoscopy, Inc.
Read more: http://www.sacbee.com/2011/11/17/4061951/solos-endoscopy-poised-for-tremendous.html#ixzz1eoZSvUI f
Monday, November 21, 2011
Clinical trial will aim to reduce surgical scarring
By Janet French, The StarPhoenix November 19, 2011
A Saskatoon biotechnology company is preparing to launch a clinical trial of a new drug it says could help reduce surgical complications.
Health Canada has given AdeTherapeutics permission to proceed with clinical trials for Evitar, a compound the company says can help reduce scarring from surgery.
Obstetricians and Gynecologists in Saskatoon will be the first to try out Evitar on humans, starting with women who have ectopic pregnancies. An ectopic pregnancy is a non-viable embryo that implants in tissue outside a woman’s womb. A rupture can threaten a woman’s life, and the embryo must be surgically removed.
Lead by principal investigator Dr. Donna Chizen, participating surgeons at City and Royal University hospitals will ask women diagnosed with ectopic pregnancies if they’re willing to join the trial, says Sanj Singh, president and CEO if AdeTherapeutics.
“The patients will be more than willing (to join) because the ectopics lead to such bad complications for future pregnancies that they’re very keen on any type of treatment that will help with future fertility,” Singh said.
According to the U.S. National Institutes of Health, only a third of women who have an ectopic pregnancy are able to later have a baby.
Many surgeries leave scar tissue in their wake as the body heals imperfectly, and that scarring often causes pain and complications, Singh said.
“Ninety-three per cent of surgeries result in scar tissue,” Singh said. “One in three readmissions back in hospital are due to complications like scar tissue.”
Read more: http://www.thestarphoenix.com/health/Clinical+trial+will+reduce+surgical+scarring/5734819/story.html#ixzz1eKpvZGGL
A Saskatoon biotechnology company is preparing to launch a clinical trial of a new drug it says could help reduce surgical complications.
Health Canada has given AdeTherapeutics permission to proceed with clinical trials for Evitar, a compound the company says can help reduce scarring from surgery.
Obstetricians and Gynecologists in Saskatoon will be the first to try out Evitar on humans, starting with women who have ectopic pregnancies. An ectopic pregnancy is a non-viable embryo that implants in tissue outside a woman’s womb. A rupture can threaten a woman’s life, and the embryo must be surgically removed.
Lead by principal investigator Dr. Donna Chizen, participating surgeons at City and Royal University hospitals will ask women diagnosed with ectopic pregnancies if they’re willing to join the trial, says Sanj Singh, president and CEO if AdeTherapeutics.
“The patients will be more than willing (to join) because the ectopics lead to such bad complications for future pregnancies that they’re very keen on any type of treatment that will help with future fertility,” Singh said.
According to the U.S. National Institutes of Health, only a third of women who have an ectopic pregnancy are able to later have a baby.
Many surgeries leave scar tissue in their wake as the body heals imperfectly, and that scarring often causes pain and complications, Singh said.
“Ninety-three per cent of surgeries result in scar tissue,” Singh said. “One in three readmissions back in hospital are due to complications like scar tissue.”
Read more: http://www.thestarphoenix.com/health/Clinical+trial+will+reduce+surgical+scarring/5734819/story.html#ixzz1eKpvZGGL
Sunday, November 20, 2011
Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.
Eur J Obstet Gynecol Reprod Biol. 2010 Jun;150(2):180-9. Epub 2010 Mar 16.
Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.
Hackethal A, Sick C, Brueggmann D, Tchartchian G, Wallwiener M, Muenstedt K, Tinneberg HR.
SourceDepartment of Obstetrics and Gynaecology, Justus-Liebig-University of Giessen, Giessen, Germany. andreas.hackethal@gyn.med.uni-giessen.de
Abstract
OBJECTIVE: Intra-abdominal adhesion formation after abdominal surgery is the most common postsurgical complication, and the consequences are a considerable burden for patients, surgeons and health systems. Since a wide variety of factors influence adhesion formation, it is difficult to define clear guidelines on how to reduce adhesion formation in daily practice. Given this dilemma, this study assessed the awareness and perception of adhesion formation among gynaecologists in Germany in order to define a baseline for further research and education.
STUDY DESIGN: The Clinical Adhesion Research and Evaluation (CARE) group of the University of Giessen designed a questionnaire that was sent to the heads of all gynaecological departments in Germany. The director or one of the surgical consultants was asked to complete the questionnaire and return it for evaluation.
RESULTS: The completed questionnaire was returned by 279 of 833 gynaecological departments. Interviewed surgeons expected adhesions to form in 15% of cases after laparoscopy and 40% after laparotomy. Before surgery, 83.1% of the respondents told their patients about the risk of prior adhesion formation. More than 60% believed that postsurgical adhesion accounts for major morbidity. Infections within the abdomen, previous surgery and extensive tissue trauma were thought to have the most influence on adhesion formation. Risk of adhesion formation was thought to be highest in endometriosis and adhesiolysis surgery. The respondents agreed on performing adhesiolysis in symptomatic but not in all patients. Only 38.4% used adhesion reduction agents regularly. A total of 65.1% of a repertoire of adhesion prevention agents were familiar to the interviewed surgeons. Only 22.0% of them used anti-adhesion products in clinical practice. In general, the respondents were uncertain whether these products play an important role in adhesion reduction, represented by a range of 1.97+/-0.98% on a scale from 0 to 4.
CONCLUSIONS: Even though postoperative adhesions are recognized as a major cause for morbidity, and it is widely agreed that infections, extensive tissue trauma and surgery lead to adhesion formation, there is uncertainty about the treatment and prophylactic strategies for dealing with adhesions. This dilemma reflects the awareness and perception of gynaecologists in Germany and is an initial point for further research.
Copyright 2010 Elsevier Ireland Ltd. All rights reserved.
PMID:20236750[PubMed - indexed for MEDLINE]
Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.
Hackethal A, Sick C, Brueggmann D, Tchartchian G, Wallwiener M, Muenstedt K, Tinneberg HR.
SourceDepartment of Obstetrics and Gynaecology, Justus-Liebig-University of Giessen, Giessen, Germany. andreas.hackethal@gyn.med.uni-giessen.de
Abstract
OBJECTIVE: Intra-abdominal adhesion formation after abdominal surgery is the most common postsurgical complication, and the consequences are a considerable burden for patients, surgeons and health systems. Since a wide variety of factors influence adhesion formation, it is difficult to define clear guidelines on how to reduce adhesion formation in daily practice. Given this dilemma, this study assessed the awareness and perception of adhesion formation among gynaecologists in Germany in order to define a baseline for further research and education.
STUDY DESIGN: The Clinical Adhesion Research and Evaluation (CARE) group of the University of Giessen designed a questionnaire that was sent to the heads of all gynaecological departments in Germany. The director or one of the surgical consultants was asked to complete the questionnaire and return it for evaluation.
RESULTS: The completed questionnaire was returned by 279 of 833 gynaecological departments. Interviewed surgeons expected adhesions to form in 15% of cases after laparoscopy and 40% after laparotomy. Before surgery, 83.1% of the respondents told their patients about the risk of prior adhesion formation. More than 60% believed that postsurgical adhesion accounts for major morbidity. Infections within the abdomen, previous surgery and extensive tissue trauma were thought to have the most influence on adhesion formation. Risk of adhesion formation was thought to be highest in endometriosis and adhesiolysis surgery. The respondents agreed on performing adhesiolysis in symptomatic but not in all patients. Only 38.4% used adhesion reduction agents regularly. A total of 65.1% of a repertoire of adhesion prevention agents were familiar to the interviewed surgeons. Only 22.0% of them used anti-adhesion products in clinical practice. In general, the respondents were uncertain whether these products play an important role in adhesion reduction, represented by a range of 1.97+/-0.98% on a scale from 0 to 4.
CONCLUSIONS: Even though postoperative adhesions are recognized as a major cause for morbidity, and it is widely agreed that infections, extensive tissue trauma and surgery lead to adhesion formation, there is uncertainty about the treatment and prophylactic strategies for dealing with adhesions. This dilemma reflects the awareness and perception of gynaecologists in Germany and is an initial point for further research.
Copyright 2010 Elsevier Ireland Ltd. All rights reserved.
PMID:20236750[PubMed - indexed for MEDLINE]
Laparoscopic Lysis of Abdominal Adhesions
A really simple 3D video of what will happen to you during an adhesiolysis ~ surgery to tkae down adhesions.
Saturday, November 19, 2011
December 15, 1886 Cause of Death: Adhesions of Bowels
Deceased Name: Parker Boggs
Gender: Male
Date of Death: December 15, 1886
Cause of Death: Adhesions of Bowels
Age: 18
Father's Name: E. Boggs
Mother's Name: E. J.
Mother's Maiden Name: Naper
http://www.ingenweb.org/inrandolph/HealthDept/Death/RichardsonCollection.htm
Gender: Male
Date of Death: December 15, 1886
Cause of Death: Adhesions of Bowels
Age: 18
Father's Name: E. Boggs
Mother's Name: E. J.
Mother's Maiden Name: Naper
http://www.ingenweb.org/inrandolph/HealthDept/Death/RichardsonCollection.htm
Thursday, November 17, 2011
Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats.
J Diabetes Complications. 2011 Jan-Feb;25(1):39-43. Epub 2009 Oct 13.
Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats.
Abbasian B, Kazemini H, Esmaeili A, Adibi S.
SourceFaculty of Veterinary Medicine, Shahrekord Azad University, Shahrekord, Iran.
Abstract
BACKGROUND: Postsurgical adhesion formation is a significant clinical problem within every surgical specialty. In type I diabetic patients, the problem is more severe and wound healing is slow. A wide variety of treatments have been proposed to deal with the problems that adhesion causes. One of the modalities that have not been studied extensively yet is the use of amniotic fluid. The purpose of the present study was to evaluate the clinical value of bovine amniotic fluid (BAF) efficacy in the treatment of postsurgical adhesion formation in diabetic male rats.
MATERIALS AND METHODS: Fifty male Wistar rats in five groups were used for our study, with animal identification being facilitated by a microchip implant system. Diabetes was induced in all groups except for the control group by intraperitoneal alloxan injection (120 mg/kg). Based upon blood glucose concentration, rats received either one third of the required insulin (two groups) or all the required insulin (remaining groups). After 2 weeks, a laparotomy was performed on each rat and adhesions were scaled. Bovine amniotic fluid was then applied to two groups, and, as a control, sterilized water was applied to the other groups. After 2 weeks, a laparotomy was again performed on each rat and adhesion was rescored.
RESULTS AND CONCLUSION: Significant reductions (P<.05) in adhesions were seen with BAF only in those diabetic rats that had received the required insulin. The results of our study suggest that BAF could be effective in the treatment of adhesion formation during diabetes.
Copyright © 2011 Elsevier Inc. All rights reserved.
PMID:19828333[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/19828333
Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats.
Abbasian B, Kazemini H, Esmaeili A, Adibi S.
SourceFaculty of Veterinary Medicine, Shahrekord Azad University, Shahrekord, Iran.
Abstract
BACKGROUND: Postsurgical adhesion formation is a significant clinical problem within every surgical specialty. In type I diabetic patients, the problem is more severe and wound healing is slow. A wide variety of treatments have been proposed to deal with the problems that adhesion causes. One of the modalities that have not been studied extensively yet is the use of amniotic fluid. The purpose of the present study was to evaluate the clinical value of bovine amniotic fluid (BAF) efficacy in the treatment of postsurgical adhesion formation in diabetic male rats.
MATERIALS AND METHODS: Fifty male Wistar rats in five groups were used for our study, with animal identification being facilitated by a microchip implant system. Diabetes was induced in all groups except for the control group by intraperitoneal alloxan injection (120 mg/kg). Based upon blood glucose concentration, rats received either one third of the required insulin (two groups) or all the required insulin (remaining groups). After 2 weeks, a laparotomy was performed on each rat and adhesions were scaled. Bovine amniotic fluid was then applied to two groups, and, as a control, sterilized water was applied to the other groups. After 2 weeks, a laparotomy was again performed on each rat and adhesion was rescored.
RESULTS AND CONCLUSION: Significant reductions (P<.05) in adhesions were seen with BAF only in those diabetic rats that had received the required insulin. The results of our study suggest that BAF could be effective in the treatment of adhesion formation during diabetes.
Copyright © 2011 Elsevier Inc. All rights reserved.
PMID:19828333[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/19828333
Severe inflammatory reaction induced by peritoneal trauma is the key driving mechanism of postoperative adhesion formation
CO2 insufflation however, led to moderate inflammation and less adhesion formation.
http://7thspace.com/headlines/399719/severe_inflammatory_reaction_induced
_by_peritoneal_trauma_is_the_key_driving_mechanism_of_postoperative_adhesion_formation_.html
Many factors have been put forward as a driving mechanism of surgery-triggered adhesion formation (AF). In this study, we underline the key role of specific surgical trauma related with open surgery (OS) and laparoscopic (LS) conditions in postoperative AF and we aimed to study peritoneal tissue inflammatory reaction (TIR), remodelling specific complications of open surgery (OS) versus LS and subsequently evaluating AF induced by these conditions.
Methods: A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups.
Specific traumatic OS conditions were induced by midline incision line (MLI) extension and tissue drying and specific LS conditions were remodelled by CO2 insufflation. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale.
Statistical analysis was performed by the non parametric t test and two-way ANOVA using Bonferroni post-tests.
Results: More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p<0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p<0.05 at the 24th and 72nd; p<0.01 - 120th and p<0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p>0.05).
However larger adhesion size (41.6733.63) was observed after OS in comparison with LS (20.3116.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p=0.03).
Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.
Conclusions: MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences.
CO2 insufflation however, led to moderate inflammation and less adhesion formation.
Author: Sergei PismenskyZhomart KalzhanovMarina EliseevaIoannis KosmasOspan Mynbaev
Credits/Source: BMC Surgery 2011, 11:30
http://7thspace.com/headlines/399719/severe_inflammatory_reaction_induced
_by_peritoneal_trauma_is_the_key_driving_mechanism_of_postoperative_adhesion_formation_.html
Many factors have been put forward as a driving mechanism of surgery-triggered adhesion formation (AF). In this study, we underline the key role of specific surgical trauma related with open surgery (OS) and laparoscopic (LS) conditions in postoperative AF and we aimed to study peritoneal tissue inflammatory reaction (TIR), remodelling specific complications of open surgery (OS) versus LS and subsequently evaluating AF induced by these conditions.
Methods: A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups.
Specific traumatic OS conditions were induced by midline incision line (MLI) extension and tissue drying and specific LS conditions were remodelled by CO2 insufflation. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale.
Statistical analysis was performed by the non parametric t test and two-way ANOVA using Bonferroni post-tests.
Results: More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p<0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p<0.05 at the 24th and 72nd; p<0.01 - 120th and p<0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p>0.05).
However larger adhesion size (41.6733.63) was observed after OS in comparison with LS (20.3116.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p=0.03).
Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.
Conclusions: MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences.
CO2 insufflation however, led to moderate inflammation and less adhesion formation.
Author: Sergei PismenskyZhomart KalzhanovMarina EliseevaIoannis KosmasOspan Mynbaev
Credits/Source: BMC Surgery 2011, 11:30
Agreement With Innocoll for Surgical Adhesion Barrier CollaGUARD
TORONTO, ONTARIO, Nov 14, 2011 (MARKETWIRE via COMTEX) -- Envoy Capital Group Inc. /quotes/zigman/38441 CA:ECG +8.46% /quotes/zigman/38429/quotes/nls/ecgi ECGI +0.94% ("Envoy") announces that Merus Labs International Inc. (cnsx:MR) ("Merus") has entered into a License and Distribution Agreement with Innocoll in Canada for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery. Envoy and Merus Labs have agreed to amalgamate subject to shareholder and regulatory approval as earlier announced. Meetings of shareholder of Envoy and Merus have been scheduled for December 9, 2011.
"Adhesions occur after most surgical procedures, and are of major clinical, social and economic concern. The addition of CollaGUARD to our portfolio means that thousands of patients at risk of adhesion will have a clinically proven superior solution. We look forward to obtaining Health Canada approval and the launch of CollaGUARD in 2012." said Ali Moghaddam, Vice President at Merus Labs.
Dr. Michael Myers, President and CEO of Innocoll stated, "We are pleased to announce the expansion of our partnership with Merus to include CollaGUARD and we look forward to the successful launch of the product in Canada."
About CollaGUARD(R)
CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P less than 0.001) and significantly reduced the extent and severity of adhesions (P less than 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R), CollaFilm, DermaSil(TM), CollaPress(TM) and Liquicoll(R). Approved products based on the Company's technologies include: Collatamp(R) G, Septocoll(R), CollaGUARD, Collieva(R), CollaCare(R), Collexa(R), Zorpreva(TM), and LidoColl(R).
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com .
Read More : http://www.marketwatch.com/story/envoy-capital-announces-merus-labs-licensing-agreement-with-innocoll-for-surgical-adhesion-barrier-collaguard-2011-11-14-943190?reflink=MW_news_stmp
"Adhesions occur after most surgical procedures, and are of major clinical, social and economic concern. The addition of CollaGUARD to our portfolio means that thousands of patients at risk of adhesion will have a clinically proven superior solution. We look forward to obtaining Health Canada approval and the launch of CollaGUARD in 2012." said Ali Moghaddam, Vice President at Merus Labs.
Dr. Michael Myers, President and CEO of Innocoll stated, "We are pleased to announce the expansion of our partnership with Merus to include CollaGUARD and we look forward to the successful launch of the product in Canada."
About CollaGUARD(R)
CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P less than 0.001) and significantly reduced the extent and severity of adhesions (P less than 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R), CollaFilm, DermaSil(TM), CollaPress(TM) and Liquicoll(R). Approved products based on the Company's technologies include: Collatamp(R) G, Septocoll(R), CollaGUARD, Collieva(R), CollaCare(R), Collexa(R), Zorpreva(TM), and LidoColl(R).
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com .
Read More : http://www.marketwatch.com/story/envoy-capital-announces-merus-labs-licensing-agreement-with-innocoll-for-surgical-adhesion-barrier-collaguard-2011-11-14-943190?reflink=MW_news_stmp
Saturday, November 12, 2011
Bowel Obstruction: Gas Pattern and Presentations
http://www.youtube.com/watch?v=H0Rg9FvynqE&feature=related
Thursday, November 10, 2011
Immune Response to Biologic Scaffold Materials
Immune Response to Biologic Scaffold MaterialsCorresponding author: Stephen F. Badylak, McGowan Institute for Regenerative Medicine, University of Pittsburgh, 100 Technology Drive, Suite 200, Pittsburgh, PA 15219, P: (412) 235-5144, F: (412) 235-5110, Email: badylaks@upmc.edu
Stephen F. Badylak and Thomas W. Gilbert
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA
Summary
In summary, allogeneic and xenogeneic biologic scaffolds composed of extracellular matrix are commonly used in numerous tissue engineering and regenerative medicine applications, and in many reconstructive surgical procedures. The effect of such scaffolds upon the host immune response has been largely unexplored. In addition, the association between the host immune response and tissue remodeling events is a factor that logically plays an important, if not determinative, role in the successful clinical application of these devices. There are many variables in the manufacturing of matrix derived scaffolds and all of these variables can affect the host immune response. An improved understanding of the immune response to biologic scaffold materials can only lead to greater safety and efficiency of devices and applications that utilize such materials.
Read Full abstract here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2605275/
Stephen F. Badylak and Thomas W. Gilbert
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA
Summary
In summary, allogeneic and xenogeneic biologic scaffolds composed of extracellular matrix are commonly used in numerous tissue engineering and regenerative medicine applications, and in many reconstructive surgical procedures. The effect of such scaffolds upon the host immune response has been largely unexplored. In addition, the association between the host immune response and tissue remodeling events is a factor that logically plays an important, if not determinative, role in the successful clinical application of these devices. There are many variables in the manufacturing of matrix derived scaffolds and all of these variables can affect the host immune response. An improved understanding of the immune response to biologic scaffold materials can only lead to greater safety and efficiency of devices and applications that utilize such materials.
Read Full abstract here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2605275/
Wednesday, November 09, 2011
Innocoll Enters Partnership With Pioneer Pharma in China for the Distribution of CollaGUARD
ASHBURN, Va. ,Oct. 19, 2011 /PRNewswire/ -- Innocoll, Inc. announced it has entered into a License and Distribution Agreement with Pioneer Pharma in China for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery.
Dr. Michael Myers, President and CEO stated "This is an exciting development for Innocoll. China is becoming an increasingly important and dynamic market for medical products and we are very pleased to have established this partnership with such an innovative company as Pioneer. I look forward to exploring additional partnership opportunities between our two companies."
Mr. XinZhou Li, President and CEO from Pioneer Pharma stated "We are very excited to have finally reached the partnership agreement with Innocoll. Let us mark this day with remembrance as CollaGUARD will become a very important product in our current distribution channel. We believe that CollaGUARD® has significant market potential and Pioneer will try to make it happen. "
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Pioneer
Pioneer Pharma, founded in Hainan in 1996, imports and distributes high-end pharmaceutical products into China. Pioneer markets and distributes over 30 products across a wide range of therapeutic categories on behalf of its strategic partners and has filed over 10 additional products that are pending approval. The company has over 34 representative offices across China and covers over 7,500 hospitals and 40,000 drugstores.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPress™ and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
CONTACT: Veronica Kelly, +353 9064 86834, vkelly@innocoll-pharma.com
SOURCE Innocoll, Inc.
Back to top
RELATED LINKS
http://www.innocollinc.com/
http://www.prnewswire.com/news-releases/innocoll-enters-partnership-with-pioneer-pharma-in-china-for-the-distribution-of-collaguard-132127138.html
Dr. Michael Myers, President and CEO stated "This is an exciting development for Innocoll. China is becoming an increasingly important and dynamic market for medical products and we are very pleased to have established this partnership with such an innovative company as Pioneer. I look forward to exploring additional partnership opportunities between our two companies."
Mr. XinZhou Li, President and CEO from Pioneer Pharma stated "We are very excited to have finally reached the partnership agreement with Innocoll. Let us mark this day with remembrance as CollaGUARD will become a very important product in our current distribution channel. We believe that CollaGUARD® has significant market potential and Pioneer will try to make it happen. "
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Pioneer
Pioneer Pharma, founded in Hainan in 1996, imports and distributes high-end pharmaceutical products into China. Pioneer markets and distributes over 30 products across a wide range of therapeutic categories on behalf of its strategic partners and has filed over 10 additional products that are pending approval. The company has over 34 representative offices across China and covers over 7,500 hospitals and 40,000 drugstores.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPress™ and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
CONTACT: Veronica Kelly, +353 9064 86834, vkelly@innocoll-pharma.com
SOURCE Innocoll, Inc.
Back to top
RELATED LINKS
http://www.innocollinc.com/
http://www.prnewswire.com/news-releases/innocoll-enters-partnership-with-pioneer-pharma-in-china-for-the-distribution-of-collaguard-132127138.html
Tuesday, November 08, 2011
Conservative Management of Mesh-Site Infection
Conservative Management of Mesh-Site Infection
in Hernia Repair
Brenda Aguilar, MD, Alyssa B. Chapital, MD,
James A. Madura, II, MD, and Kristi L. Harold, MD
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
Abstract
Background: Mesh hernioplasty is the preferred surgical procedure for large abdominal wall hernias. Infection
remains one of the most challenging complications of this operation. Salvaging infected prosthetic material after
ventral hernia repair is rarely successful. Most cases require mesh excision and complex abdominal wall reconstruction,
with variable success rates. In this article, we report 3 cases of mesh salvage after laparoscopic
ventral herniorrhapy with a novel use of percutaneous drainage and antibiotic irrigation.
Results: Three patients developed infected seromas after laparoscopic ventral hernia repair. The fascial defect
of the first patient was repaired with a commercially available 20 18 cm polytetrafluoroethylene (PTFE) mesh.
A complex fluid collection developed the following month in the anterior abdominal wall overlying the patient’s
mesh. The cultures grew Staphylococcus aureus. The second patient had a 30 20 cm PTFE mesh placed, which
developed a fluid collection with Enterococcus faecalis and Escherichia coli. The third case underwent repair, using
a another commercially available 22 28 cm PTFE mesh. A fluid collection measuring 20 10 cm in the anterior
abdominal wall developed, growing Staphylococcus lugdunensis. In all 3 cases, a percutaneous drain was placed
within the fluid collection and long-term intravenous (i.v.) access was obtained. I.v. antibiotics were initiated. In
addition, gentamicin (80 mg) with 20mL of saline was infused through the drain 3 times a day. All patients have
remained free of clinical signs of infection following the completion of therapy.
Conclusions: Infected mesh after laparoscopic ventral herniorrhapy without systemic sepsis may be amenable to
nonoperative treatment. A conservative approach that includes percutaneous drainage followed by antibiotic
irrigation is a potential alternative to prosthetic removal in carefully selected patients. Further evaluation of this
technique is warranted to define the most appropriate management strategies for these patients.
Introduction
The placement of prosthetic biomaterials has become a
standard procedure during ventral hernia repair surgery.
Clinical evidence support lower recurrence rates as they
generate ‘‘tension-free’’ closure of hernia defects and provide a
permanent replacement for native fascia that frequently has
been weakened or removed by previous surgery. Reduction
of ventral hernia recurrence by 30%1–3 has been shown.
However, the lower recurrence rates come at the price of
mesh-related complications, including seromas, adhesions,
chronic severe pain, migration, and mesh-related infections.4,5
The exact incidence of mesh infections is difficult to obtain
due to the variable presentation period after surgery. Infections
can arise anywhere from 2 to 39 months6 following repair.
The incidence has been reported from 0.001 to 8%7–14
in the literature. While this appears relatively infrequent,
when compared with other device-related infections, the
clinical significance of this diagnosis portends a complex,9,10
extended course for both the patient and the surgeon.8,12
The rate of mesh infection is influenced considerably by
underlying comorbidity, immunosuppression, incision size,
obesity, history of previous hernia repair or wound infection,
and tobacco use.7–14 Unfortunately, patients with these same
risk factors are also likely to have a recurrent hernia, if the
prosthetic mesh is not utilized in the repair.8
Standard surgical practice has traditionally advocated the
removal of contaminated or exposed prosthetics. Unfortunately,
the removal of the prosthetic materials is often
technically difficult when there is good tissue incorporation
and can increase the risk of subsequent enterocutaneous fistula
formation.15 Achieving closure of the fascial defect after
mesh removal is not usually possible; therefore, a larger
ventral hernia than at the time of original repair may result.
Department of General Surgery, Mayo Clinic Hospital, Phoenix, Arizona.
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
DOI: 10.1089=lap.2009.0274
249
These issues have generated interest in a successful, conservative
treatment algorithm that does not involve mesh removal.
13,14,16,17 In this article, we describe a novel approach to
manage the complex problem of infected prosthetic mesh
following laparoscopic ventral hernia repair (LVHR).
Materials and Methods
This study was conducted by the Department of Surgery at
Mayo Clinic Hospital (Phoenix, AZ). We report 3 cases of
mesh infection after laparoscopic hernia repair with a prosthetic
mesh. The infection was diagnosed by clinical evidence
of pain, redness, induration, fever, and purulent discharge on
aspiration. We attempted to treat these cases with a conservative
approach.
After ultrasonografic confirmation of a fluid collection
surrounding the prosthetic mesh, a computed tomography
(CT)-guided placement of a drain was perform in all cases.
The skin overlying the left abdomen was sterilely prepped,
then draped to infiltrate 1% lidocaine. An 18-gauge needle
was advanced into the fluid collection. Through the needle, an
Amplatz wire was placed in the collection, the tract was
dilated with a 6.8- and 10-Fr fascial dilator, followed by the
placement of a 10-Fr locking loop all-purpose drainage catheter
that was then placed into the fluid collection. Repeat CT
was performed, confirming appropriate placement. A specimen
was sent to the lab for microbiology analysis. The tube
was secured with the skin by using a 2-0 Prolene suture. The
catheter was left to external bulb suction. The patients and
their relatives were instructed to irrigate the catheter with
gentamicin (80 mg) in 20mL of normal saline, leaving the
solution in the cavity for 30 minutes and then returning the
drain to bulb suction. This was performed 3 times per day.
We chose gentamicin as the primary antibiotic for the irrigation
therapy for its properties as a bactericidal agent at low
concentrations and its known activity against Staphylococcus
spp. as well as gram-negative cocci. Local use of gentamicin
provides much higher concentrations at wound sites, so blood
concentrations remain low, thus preventing toxicity. Special
recognition has been given to the use of gentamicin for the
treatment of infected skin cysts and other skin abscesses,
when preceded by incision and drainage to permit adequate
contact between the drug and the infecting bacteria.7
Case 1
A 50-year-old female underwent a robotic bilateral ovarian
cystectomy, at which time she had an abdominal wall mesh
place for an umbilical hernia. This mesh became infected and
was removed. Six months following removal, an LVHR was
performed with a 20 18cm polytetrafluoroethylene (PTFE)
Gore DualMesh (Creative Technologies Worldwide, Flagstaff,
AZ) for a recurrent hernia. One month later, the patient
was found to have erythema over her abdominal wall as well
as an elevated white blood cell count.ACT scan demonstrated
a complex fluid collection in the anterior abdominal wall
overlying the patient’s mesh. Percutaneous drainage of the
abscess was then undertaken, where approximately 100mL of
purulent material was aspirated. A drain was left in place. The
cultures revealed Staphylococcus aureus sensitive to ampicillin
and sulbactam. Drain irrigation with gentamicin (80 mg) in
20mLof normal saline (NS) 3 times a day as well as 1 month of
intravenous (i.v.) antibiotics was initiated. The drain and
central line were then removed. There has been no clinical
evidence of recurrent infection at 18 months of follow-up.
Case 2
A 63-year-old male with end-stage liver disease secondary
to primary sclerosing cholangitis underwent an orthotopic
liver transplant and Roux-en-Y choledochojejunostomy performed
in 2005. He subsequently developed a large ventral
hernia, which was repaired laparoscopically with a 30 20cm
PTFE Gore DualMesh in September 2007. In January 2009, the
patient underwent a routine colonoscopy and developed
Enterococcus faecalis and Escherichia coli bacteremia. An abdominal
CT scan demonstrated a fluid collection posterior to
the abdominal mesh. At that time, an external drain was
placed to treat the infection with gentamicin flushes (80mg in
20mL of NS 3 times a day), as well as i.v. antibiotics through a
peripherally inserted central catheter (PICC line), including
ceftriaxone (2 g once-daily) and ampicillin (2 g 3 times a day).
After 1 month of treatment, there were no clinical signs of
infection. The drain and antibiotics were then discontinued.
He continues to have no sign of infection currently at 11
months of follow-up.
Case 3
A 41-year-old female underwent multiple cesarean sections,
followed by the development of a ventral hernia. This
was repaired 8 times with mesh placement, in most cases. On
one occasion, the mesh had to be removed secondary to infection.
We performed an LVHR with a 22 28 cm PTFE Gore
DualMesh.
The patient presented the following month with generalized
body aches, chills, and fever. An abdominal CT scan was
performed that demonstrated a large fluid collection in the
anterior abdominal wall measuring 20 10 cm. It was drained,
producing 450mL of fluid. A percutaneous drain and a
PICC line were placed. Cultures grew 1þ S. lugdunensis. I.v.
amipicillin and sulbactam as well as gentamicin irrigation
(80mg in 20mL of NS) through the drain 3 times a day was
initiated.
At the end of treatment, a follow-up CT scan performed on
her abdomen and pelvis demonstrated improvement of the
anterior fluid collection previously drained. There remained a
seroma posterior to the mesh that was 9 cm in size without
evidence of abscess features. An attempt to aspirate the seroma
was unsuccessful due to its depth. The patient was
placed on amoxicillin=clavulanate (875 mg) by mouth twicedaily
for an additional 3 weeks of antibiotic therapy. The
anterior drain remained in place during this time and was
removed after it produced less than 10mL of serous fluid
daily. At 13 months of follow-up, she has done well with no
signs of infection.
Discussion
Surgical-site infections continue to be a major source of
morbidity throughout the world, accounting for almost 40–
60%10,18 of all postoperative infectious complications. This
concern, along with the increased costs associated with extended
hospitalization and reparative treatment, justifies
efforts to identify patient populations at risk and optimize
preoperative preparation and perioperative care. In the past
250 AGUILAR ET AL.
few years, the hernia repair with alloplastic prothesis has
become the standard treatment due to lower rates of recurrence,
when compared with simple suture closure. However,
the implantation of synthetic materials are related with
wound-associated complications in up to one third of cases.5
Mesh-related infectious complications occur in up to 13.6%
and usually require recurrent surgical intervention.12 The
more common agents associated with mesh infection are
Staphylococcus species (spp.) (especially S. aureus), Streptococcus
spp. (including group B streptococci), gram-negative
bacteria (mainly Enterobacteriaceae), and anaerobic bacteria
(including Peptostreptococcus spp.).18–21 In a study of meshrelated
infections following ventral herniorrhaphies, 63% of
the microorganisms isolated were methicillin-resistant S. aureus
(MRSA). Rarely, mesh infections are caused by Candida
spp. or Mycobacterium spp.21
Various factors are predictive of prosthetic infections, such
as patient-related illness, including diabetes mellitus, malnutrition,
chronic obstructive pulmonary disease, tobacco
and=or alcohol use, medical therapy with steroids, renal
failure, and morbid obesity.5–10,12,17,18,21 These medical comorbidities
are associated with decreased perfusion of the
skin and subcutaneous (s.c.) tissues as well as immunosuppressive
attributes. Factors directly to the operation, such as
the choice of mesh material and type of surgical procedure,
are still the subject of critical debate. In a meta-analysis of 20
trials (5016 participants) of open versus open nonmesh repair
of groin hernias, it was shown that the rate of postoperative
complications, including infections, was similar in both procedures.
4 A similar clinical trial with 200 adult umbilical
hernia repairs with or without mesh showed no differences in
results between techniques, including infection rate.21 Korenkov
et al.,22 in a clinical, randomized trial of 160 patients
with simple or complex hernias that underwent either suture
repair, autodermal skin graft, or onlay polypropylene mesh
repair, found fewer infectious complications after suture repair
(9%) than after skin graft or mesh repair (18%) for simple
hernias and 23–35% for complex hernias. White et al.23 reported
that the use of a mesh and hernia defect >10 cm were
associated with significantly more wound complications
(44 versus 26%; P<0.05), especially a increased incidence
of seroma (21 versus 7%). They also reported that patients
undergoing mesh repair were more likely to receive antibiotics
(91 versus 71%) and have s.c. drains placed (57 versus
25%), compared to simple primary repair.
The traditional surgical management for infection after
hernia repair with prosthetic materials advocates that all infected
prosthetic materials must be removed, but this leads to
a high risk of hernia recurrence. Innovative studies aim to
provide evidence that a conservative approach may be a
suitable alternative. Carbonell et al.26 studied hernia repairs
by using seven prosthetic mesh biomaterials innoculated with
bacteria in a live animal and concluded that ePTFE was the
least susceptible to infection, and with silver=chlorhexidine
coating, the prosthesis was able to kill all the inoculated
bacteria. Silver-chlorhexidine-impregnated meshes may be
the prosthetics of choice to prevent the occurrence of mesh
infection in LVHR. The literature would support that the
debridement of all purulent material and necrotic tissue is
essential, but it remains debatable whether to remove the
prostheses. Irrigation with antimicrobial solutions has been
attempted in a few trials. Trunzo et al.13 reported 2 cases of
infected seroma after laparoscopic ventral repair: A 20 23 cm
Parietex composite polyester mesh was used in 1 patient,
and a 32 33 cm piece of expanded PTFE was used in the
other. After the infections were diagnosed, the patients were
treated by abscess drainage, parenteral antibiotics, and 4
weeks of gentamicin irrigation (80mg in 30mL of solution)
via a drain 3 times per day. Both patients remained free of
clinical signs of infection at 12 and 16 months, respectively.
Ahmad et al.14 described 13 cases of open ventral hernia repair
with using polypropylene mesh resulting in infection.
They treated their patients with local management, including
incision, drainage, and debridement of the wound, followed
by irrigation with saline=povidone iodine. Eight patients
(62%) required daily dressing changes and five to seven debridements.
Three patients (23%) developed severe sepsis and
complete dehiscence of the wound. These patients averaged
10–12 debridements during recovery. Two patients (15%)
with cellulitis were discharged after 10–12 days with full recovery.
All the patients were followed for 3 months and did
not have recurrence of infection.
Some researchers believe that an individualized approach
is necessary to treat patients with mesh infections, and special
considerations must be taken regarding the type of mesh.27
The use of a multifilament polyester mesh is related to a
higher incidence of infection, small-bowel obstruction, and
enterocutaneous fistula formation than the use of other types
of mesh (e.g., knitted monofilament polypropylene, PTFE, or
woven polypropylene).2,12,19,17 Further, experimental studies
in animals relate the use of microporous mesh to a higher rate
of infections and development of seromas, whereas macroporous
material was shown to be associated with a higher
incidence of adhesive and erosive events.23–25 The ePTFE
mesh has generated conflicting theories as to its ability to be
salvaged in the face of infection. Paton et al.27 concluded that
patients with limited ePTFE mesh infections could be treated
with abscess drainage, antibiotics, and local wound care, but
more extensive infections require mesh removal. Petersen
et al.12 concluded that in their experience with 8 mesh-infected
cases, adequate drainage seemed to be sufficient for polypropylene
or polyester meshes; however, infected ePTFE
patches should be removed early. The researchers explained
that the structural matrix of ePTFE permits fluid retention and
bacterial growth due to inadecuate leucocyte invasion
through the 10-mm pores. Bellon et al.29,30 demonstrated that
S. aureus colonies produce alterations in the structure of
ePTFE. From using electron microscopy, they demonstrated
the deformation of internodal filaments and the creation of
fissures in the ePTFE microstructure, and that alteration of the
biomaterial facilitated the attachment and invasion of bacteria.
Despite these findings, we have had success with the
salvage of ePTFE after laparoscopic ventral hernia repair. In
our experience, infection of ePTFE does not always mandate
removal. Our 3 cases were successfully managed with
drainage, parenteral antibiotics, and gentamicin irrigation
through a drain, with no recurrence of infection.
Conclusions
For patients with an infected mesh in the absence of systemic
sepsis, a conservative approach that includes percutaneous
drainage, followed by antibiotic irrigation, is a potential
alternative to prosthetic removal. Further evaluation of this
MESH-SITE INFECTION 251
technique is warranted to define the most appropriate management
strategies for these patients.
Disclosure Statement
No competing financial interests exist.
References
1. Wassenaar EB, Schoenmaeckers EJ, Raymakers JT, Rakic S.
Recurrences after laparoscopic repair of ventral and incisional
hernia: Lessons learned from 505 repairs. Surg Endosc
2009;23:825–832.
2. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term
complications associated with prosthetic repair of incisional
hernias. Arch Surg 1998;133:378–382.
3. Vrijland WW, Van den Tol MP, Luijendijk RW et al. Randomized,
clinical trial of nonmesh versus mesh repair of
primary inguinal hernia. Br J Surg 2002;89:293–297.
4. Grant AM. Open mesh versus nonmesh repair of groin
hernia: Meta-analysis of randomized trials based on individual
patient data [corrected]. Hernia 2002;6:130–136.
5. Jezupovs A, Mihelsons M. The analysis of infection after
polypropylene mesh repair of abdominal wall hernia. World
J Surg 2006;30:2270–2278.
6. Delikoukos S, Tzovaras G, Liakou P, et al. Late-onset deep
mesh infection after inguinal hernia repair. Hernia 2007;11:
15–17.
7. Falagas ME, Kasiakou SK. Mesh-related infections after
hernia repair surgery. Clin Microb Infect 2005;11:3–8.
8. Kercher KW, Sing RF, Matthews BD, Heniford BT. Successful
salvage of infected PTFE mesh after ventral hernia
repair. Ostom Wound Manag 2002;48:40–45.
9. Bliziotis IA, Kasiakou SK, Kapaskelis AM, Falagas ME.
Mesh-related infection after herniarepair: Case report of an
emergencing type of foreing-body relatedinfection. Infection
2006;34:46–48.
10. Paton BL, Novitsky Y, Zerey M, et al. Management of infections
of polytetrafluoroethylene-based mesh. Surg Infect
2007;8:337–341.
11. Praveen S, Rohaizak M. Local antibiotics are equivalent
to intravenous antibiotics in the prevention of superficial
wound infection in inguinal hernioplasty. Asian J Surg 2009;
32:59–63.
12. Petersen S, Henke G, Freitag M, et al. Deep prosthesis infection
in incisional hernia repair: Predictive factors and
clinical outcome. Eur J Surg 2001;167:453–457.
13. Trunzo JA, Ponsky JL, Jin J, et al. A novel approach for
salvaging infected prosthetic mesh after ventral hernia repair.
Hernia 2009;13:545–549.
14. Ahmad S, Mufti TS, Zafar A, Akbar I. Conservative managment
of mesh-site infection in ventral hernia repair. Ayub
Med Coll Abbottabad 2007;19:75–77.
15. Fawole AS, Chaparala RP, Ambrose NS. Fate of the inguinal
hernia following removal of infected prosthetic mesh. Hernia
2006;10:58–61.
16. Luijendijk RW, Hop WC, Van den Tol MP, et al. A comparison
of suture repair with mesh repair for incisional
hernia. NEJM 2000;343:392–398.
17. Stoppa RE. The treatment of complicated groin and incisional
hernias. World J Surg 1989;13:545–554.
18. Malone DL, Genuit T, Tracy JK, et al. Surgical site infections:
Reanalysis of risk factors. J Surg Res 2002;103:89–95.
19. Demiter S, Gecim IE, Aydinuraz K, et al. Affinity of Staphylococcus
epidermidis to various prosthetic graft materials.
J Surg Res 2001;99:70–74.
20. Cobb WS, Harris JB, Lokey JS, McGill ES, et al. Incisional
herniorrhaphy with intraperitoneal composite mesh: A report
of 95 cases. Am Surg 2003;69:784–787.
21. Arroyo A,Garcia P, Perez F, et al. Randomized, clinical trial
comparing suture and mesh repair of umbilical hernia in
adults. Br J Surg 2001;88:1321–1323.
22. Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer
EA, Troidl H. Randomized, clinical trial of suture repair,
polypropylene mesh, or autodermal hernioplasty for incisional
hernia. Br J Surg 2002;89:50–56.
23. White TJ, Santos MC, Thompson JS. Factors affecting wound
complications in repair of ventral hernias. Am Surg 1998;
64:276–280.
24. Amid PK. Classification of biomaterials and their related
complications in abdominal wall hernia surgery. Hernia
1997;1:15–21.
25. Zheng F, Xu L, Verbiest L, et al. Cytokine production following
experimental implantation of xenogenic dermal collagen
and polypropylene grafts in mice. Neurourol Urodyn
2007;26:280–289.
26. Carbonell AM, Matthews BD, Dre´au D, et al. The susceptibility
of prosthetic biomaterials to infection. Surg Endosc
2005;19:430–443.
27. Paton LB, Novitsky YW, Zerey M, Sing RF, et al. Management
of infections of polytetrafluoroethylene-based mesh.
Surg Infect 2007;8:337–341.
28. Bellon JM, Bujan J, Contreras L, et al. Macrophage response
to experimental implantation of polypropylene protheses.
Eur Surg Res 1994;26:46–53.
29. Bleichrodt RP, Simmermacher RK, Van der Lei B,
Schakenraad JM. Expanded polytetrafluoroethylene patch
versus polypropylene mesh for the repair of contaminated
defects of the abdominal wall. Surg Gynecol Obstet 1993;
176:18–24.
30. Bellon JM, Contreras LA, Bujan J. Effect of relaparotomy
through previously integrated polypropylene and polytetrafluoroethylene
experimental implants in the abdominal
wall. J Am Coll Surg 1999;188:466–472.
31. Bellon JM, Jurado F, Carranza A. In vitro interaction of
bacteria with polypropylene=ePTFEprostheses. Biomaterials
2001;22:2021–2024.
Address correspondence to:
Brenda Aguilar, MD
Department of General Surgery
Mayo Clinic Hospital
5777 East Mayo Boulevard
Phoenix, AZ 85054
E-mail: Aguilar.Brenda@mayo.edu
in Hernia Repair
Brenda Aguilar, MD, Alyssa B. Chapital, MD,
James A. Madura, II, MD, and Kristi L. Harold, MD
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
Abstract
Background: Mesh hernioplasty is the preferred surgical procedure for large abdominal wall hernias. Infection
remains one of the most challenging complications of this operation. Salvaging infected prosthetic material after
ventral hernia repair is rarely successful. Most cases require mesh excision and complex abdominal wall reconstruction,
with variable success rates. In this article, we report 3 cases of mesh salvage after laparoscopic
ventral herniorrhapy with a novel use of percutaneous drainage and antibiotic irrigation.
Results: Three patients developed infected seromas after laparoscopic ventral hernia repair. The fascial defect
of the first patient was repaired with a commercially available 20 18 cm polytetrafluoroethylene (PTFE) mesh.
A complex fluid collection developed the following month in the anterior abdominal wall overlying the patient’s
mesh. The cultures grew Staphylococcus aureus. The second patient had a 30 20 cm PTFE mesh placed, which
developed a fluid collection with Enterococcus faecalis and Escherichia coli. The third case underwent repair, using
a another commercially available 22 28 cm PTFE mesh. A fluid collection measuring 20 10 cm in the anterior
abdominal wall developed, growing Staphylococcus lugdunensis. In all 3 cases, a percutaneous drain was placed
within the fluid collection and long-term intravenous (i.v.) access was obtained. I.v. antibiotics were initiated. In
addition, gentamicin (80 mg) with 20mL of saline was infused through the drain 3 times a day. All patients have
remained free of clinical signs of infection following the completion of therapy.
Conclusions: Infected mesh after laparoscopic ventral herniorrhapy without systemic sepsis may be amenable to
nonoperative treatment. A conservative approach that includes percutaneous drainage followed by antibiotic
irrigation is a potential alternative to prosthetic removal in carefully selected patients. Further evaluation of this
technique is warranted to define the most appropriate management strategies for these patients.
Introduction
The placement of prosthetic biomaterials has become a
standard procedure during ventral hernia repair surgery.
Clinical evidence support lower recurrence rates as they
generate ‘‘tension-free’’ closure of hernia defects and provide a
permanent replacement for native fascia that frequently has
been weakened or removed by previous surgery. Reduction
of ventral hernia recurrence by 30%1–3 has been shown.
However, the lower recurrence rates come at the price of
mesh-related complications, including seromas, adhesions,
chronic severe pain, migration, and mesh-related infections.4,5
The exact incidence of mesh infections is difficult to obtain
due to the variable presentation period after surgery. Infections
can arise anywhere from 2 to 39 months6 following repair.
The incidence has been reported from 0.001 to 8%7–14
in the literature. While this appears relatively infrequent,
when compared with other device-related infections, the
clinical significance of this diagnosis portends a complex,9,10
extended course for both the patient and the surgeon.8,12
The rate of mesh infection is influenced considerably by
underlying comorbidity, immunosuppression, incision size,
obesity, history of previous hernia repair or wound infection,
and tobacco use.7–14 Unfortunately, patients with these same
risk factors are also likely to have a recurrent hernia, if the
prosthetic mesh is not utilized in the repair.8
Standard surgical practice has traditionally advocated the
removal of contaminated or exposed prosthetics. Unfortunately,
the removal of the prosthetic materials is often
technically difficult when there is good tissue incorporation
and can increase the risk of subsequent enterocutaneous fistula
formation.15 Achieving closure of the fascial defect after
mesh removal is not usually possible; therefore, a larger
ventral hernia than at the time of original repair may result.
Department of General Surgery, Mayo Clinic Hospital, Phoenix, Arizona.
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
DOI: 10.1089=lap.2009.0274
249
These issues have generated interest in a successful, conservative
treatment algorithm that does not involve mesh removal.
13,14,16,17 In this article, we describe a novel approach to
manage the complex problem of infected prosthetic mesh
following laparoscopic ventral hernia repair (LVHR).
Materials and Methods
This study was conducted by the Department of Surgery at
Mayo Clinic Hospital (Phoenix, AZ). We report 3 cases of
mesh infection after laparoscopic hernia repair with a prosthetic
mesh. The infection was diagnosed by clinical evidence
of pain, redness, induration, fever, and purulent discharge on
aspiration. We attempted to treat these cases with a conservative
approach.
After ultrasonografic confirmation of a fluid collection
surrounding the prosthetic mesh, a computed tomography
(CT)-guided placement of a drain was perform in all cases.
The skin overlying the left abdomen was sterilely prepped,
then draped to infiltrate 1% lidocaine. An 18-gauge needle
was advanced into the fluid collection. Through the needle, an
Amplatz wire was placed in the collection, the tract was
dilated with a 6.8- and 10-Fr fascial dilator, followed by the
placement of a 10-Fr locking loop all-purpose drainage catheter
that was then placed into the fluid collection. Repeat CT
was performed, confirming appropriate placement. A specimen
was sent to the lab for microbiology analysis. The tube
was secured with the skin by using a 2-0 Prolene suture. The
catheter was left to external bulb suction. The patients and
their relatives were instructed to irrigate the catheter with
gentamicin (80 mg) in 20mL of normal saline, leaving the
solution in the cavity for 30 minutes and then returning the
drain to bulb suction. This was performed 3 times per day.
We chose gentamicin as the primary antibiotic for the irrigation
therapy for its properties as a bactericidal agent at low
concentrations and its known activity against Staphylococcus
spp. as well as gram-negative cocci. Local use of gentamicin
provides much higher concentrations at wound sites, so blood
concentrations remain low, thus preventing toxicity. Special
recognition has been given to the use of gentamicin for the
treatment of infected skin cysts and other skin abscesses,
when preceded by incision and drainage to permit adequate
contact between the drug and the infecting bacteria.7
Case 1
A 50-year-old female underwent a robotic bilateral ovarian
cystectomy, at which time she had an abdominal wall mesh
place for an umbilical hernia. This mesh became infected and
was removed. Six months following removal, an LVHR was
performed with a 20 18cm polytetrafluoroethylene (PTFE)
Gore DualMesh (Creative Technologies Worldwide, Flagstaff,
AZ) for a recurrent hernia. One month later, the patient
was found to have erythema over her abdominal wall as well
as an elevated white blood cell count.ACT scan demonstrated
a complex fluid collection in the anterior abdominal wall
overlying the patient’s mesh. Percutaneous drainage of the
abscess was then undertaken, where approximately 100mL of
purulent material was aspirated. A drain was left in place. The
cultures revealed Staphylococcus aureus sensitive to ampicillin
and sulbactam. Drain irrigation with gentamicin (80 mg) in
20mLof normal saline (NS) 3 times a day as well as 1 month of
intravenous (i.v.) antibiotics was initiated. The drain and
central line were then removed. There has been no clinical
evidence of recurrent infection at 18 months of follow-up.
Case 2
A 63-year-old male with end-stage liver disease secondary
to primary sclerosing cholangitis underwent an orthotopic
liver transplant and Roux-en-Y choledochojejunostomy performed
in 2005. He subsequently developed a large ventral
hernia, which was repaired laparoscopically with a 30 20cm
PTFE Gore DualMesh in September 2007. In January 2009, the
patient underwent a routine colonoscopy and developed
Enterococcus faecalis and Escherichia coli bacteremia. An abdominal
CT scan demonstrated a fluid collection posterior to
the abdominal mesh. At that time, an external drain was
placed to treat the infection with gentamicin flushes (80mg in
20mL of NS 3 times a day), as well as i.v. antibiotics through a
peripherally inserted central catheter (PICC line), including
ceftriaxone (2 g once-daily) and ampicillin (2 g 3 times a day).
After 1 month of treatment, there were no clinical signs of
infection. The drain and antibiotics were then discontinued.
He continues to have no sign of infection currently at 11
months of follow-up.
Case 3
A 41-year-old female underwent multiple cesarean sections,
followed by the development of a ventral hernia. This
was repaired 8 times with mesh placement, in most cases. On
one occasion, the mesh had to be removed secondary to infection.
We performed an LVHR with a 22 28 cm PTFE Gore
DualMesh.
The patient presented the following month with generalized
body aches, chills, and fever. An abdominal CT scan was
performed that demonstrated a large fluid collection in the
anterior abdominal wall measuring 20 10 cm. It was drained,
producing 450mL of fluid. A percutaneous drain and a
PICC line were placed. Cultures grew 1þ S. lugdunensis. I.v.
amipicillin and sulbactam as well as gentamicin irrigation
(80mg in 20mL of NS) through the drain 3 times a day was
initiated.
At the end of treatment, a follow-up CT scan performed on
her abdomen and pelvis demonstrated improvement of the
anterior fluid collection previously drained. There remained a
seroma posterior to the mesh that was 9 cm in size without
evidence of abscess features. An attempt to aspirate the seroma
was unsuccessful due to its depth. The patient was
placed on amoxicillin=clavulanate (875 mg) by mouth twicedaily
for an additional 3 weeks of antibiotic therapy. The
anterior drain remained in place during this time and was
removed after it produced less than 10mL of serous fluid
daily. At 13 months of follow-up, she has done well with no
signs of infection.
Discussion
Surgical-site infections continue to be a major source of
morbidity throughout the world, accounting for almost 40–
60%10,18 of all postoperative infectious complications. This
concern, along with the increased costs associated with extended
hospitalization and reparative treatment, justifies
efforts to identify patient populations at risk and optimize
preoperative preparation and perioperative care. In the past
250 AGUILAR ET AL.
few years, the hernia repair with alloplastic prothesis has
become the standard treatment due to lower rates of recurrence,
when compared with simple suture closure. However,
the implantation of synthetic materials are related with
wound-associated complications in up to one third of cases.5
Mesh-related infectious complications occur in up to 13.6%
and usually require recurrent surgical intervention.12 The
more common agents associated with mesh infection are
Staphylococcus species (spp.) (especially S. aureus), Streptococcus
spp. (including group B streptococci), gram-negative
bacteria (mainly Enterobacteriaceae), and anaerobic bacteria
(including Peptostreptococcus spp.).18–21 In a study of meshrelated
infections following ventral herniorrhaphies, 63% of
the microorganisms isolated were methicillin-resistant S. aureus
(MRSA). Rarely, mesh infections are caused by Candida
spp. or Mycobacterium spp.21
Various factors are predictive of prosthetic infections, such
as patient-related illness, including diabetes mellitus, malnutrition,
chronic obstructive pulmonary disease, tobacco
and=or alcohol use, medical therapy with steroids, renal
failure, and morbid obesity.5–10,12,17,18,21 These medical comorbidities
are associated with decreased perfusion of the
skin and subcutaneous (s.c.) tissues as well as immunosuppressive
attributes. Factors directly to the operation, such as
the choice of mesh material and type of surgical procedure,
are still the subject of critical debate. In a meta-analysis of 20
trials (5016 participants) of open versus open nonmesh repair
of groin hernias, it was shown that the rate of postoperative
complications, including infections, was similar in both procedures.
4 A similar clinical trial with 200 adult umbilical
hernia repairs with or without mesh showed no differences in
results between techniques, including infection rate.21 Korenkov
et al.,22 in a clinical, randomized trial of 160 patients
with simple or complex hernias that underwent either suture
repair, autodermal skin graft, or onlay polypropylene mesh
repair, found fewer infectious complications after suture repair
(9%) than after skin graft or mesh repair (18%) for simple
hernias and 23–35% for complex hernias. White et al.23 reported
that the use of a mesh and hernia defect >10 cm were
associated with significantly more wound complications
(44 versus 26%; P<0.05), especially a increased incidence
of seroma (21 versus 7%). They also reported that patients
undergoing mesh repair were more likely to receive antibiotics
(91 versus 71%) and have s.c. drains placed (57 versus
25%), compared to simple primary repair.
The traditional surgical management for infection after
hernia repair with prosthetic materials advocates that all infected
prosthetic materials must be removed, but this leads to
a high risk of hernia recurrence. Innovative studies aim to
provide evidence that a conservative approach may be a
suitable alternative. Carbonell et al.26 studied hernia repairs
by using seven prosthetic mesh biomaterials innoculated with
bacteria in a live animal and concluded that ePTFE was the
least susceptible to infection, and with silver=chlorhexidine
coating, the prosthesis was able to kill all the inoculated
bacteria. Silver-chlorhexidine-impregnated meshes may be
the prosthetics of choice to prevent the occurrence of mesh
infection in LVHR. The literature would support that the
debridement of all purulent material and necrotic tissue is
essential, but it remains debatable whether to remove the
prostheses. Irrigation with antimicrobial solutions has been
attempted in a few trials. Trunzo et al.13 reported 2 cases of
infected seroma after laparoscopic ventral repair: A 20 23 cm
Parietex composite polyester mesh was used in 1 patient,
and a 32 33 cm piece of expanded PTFE was used in the
other. After the infections were diagnosed, the patients were
treated by abscess drainage, parenteral antibiotics, and 4
weeks of gentamicin irrigation (80mg in 30mL of solution)
via a drain 3 times per day. Both patients remained free of
clinical signs of infection at 12 and 16 months, respectively.
Ahmad et al.14 described 13 cases of open ventral hernia repair
with using polypropylene mesh resulting in infection.
They treated their patients with local management, including
incision, drainage, and debridement of the wound, followed
by irrigation with saline=povidone iodine. Eight patients
(62%) required daily dressing changes and five to seven debridements.
Three patients (23%) developed severe sepsis and
complete dehiscence of the wound. These patients averaged
10–12 debridements during recovery. Two patients (15%)
with cellulitis were discharged after 10–12 days with full recovery.
All the patients were followed for 3 months and did
not have recurrence of infection.
Some researchers believe that an individualized approach
is necessary to treat patients with mesh infections, and special
considerations must be taken regarding the type of mesh.27
The use of a multifilament polyester mesh is related to a
higher incidence of infection, small-bowel obstruction, and
enterocutaneous fistula formation than the use of other types
of mesh (e.g., knitted monofilament polypropylene, PTFE, or
woven polypropylene).2,12,19,17 Further, experimental studies
in animals relate the use of microporous mesh to a higher rate
of infections and development of seromas, whereas macroporous
material was shown to be associated with a higher
incidence of adhesive and erosive events.23–25 The ePTFE
mesh has generated conflicting theories as to its ability to be
salvaged in the face of infection. Paton et al.27 concluded that
patients with limited ePTFE mesh infections could be treated
with abscess drainage, antibiotics, and local wound care, but
more extensive infections require mesh removal. Petersen
et al.12 concluded that in their experience with 8 mesh-infected
cases, adequate drainage seemed to be sufficient for polypropylene
or polyester meshes; however, infected ePTFE
patches should be removed early. The researchers explained
that the structural matrix of ePTFE permits fluid retention and
bacterial growth due to inadecuate leucocyte invasion
through the 10-mm pores. Bellon et al.29,30 demonstrated that
S. aureus colonies produce alterations in the structure of
ePTFE. From using electron microscopy, they demonstrated
the deformation of internodal filaments and the creation of
fissures in the ePTFE microstructure, and that alteration of the
biomaterial facilitated the attachment and invasion of bacteria.
Despite these findings, we have had success with the
salvage of ePTFE after laparoscopic ventral hernia repair. In
our experience, infection of ePTFE does not always mandate
removal. Our 3 cases were successfully managed with
drainage, parenteral antibiotics, and gentamicin irrigation
through a drain, with no recurrence of infection.
Conclusions
For patients with an infected mesh in the absence of systemic
sepsis, a conservative approach that includes percutaneous
drainage, followed by antibiotic irrigation, is a potential
alternative to prosthetic removal. Further evaluation of this
MESH-SITE INFECTION 251
technique is warranted to define the most appropriate management
strategies for these patients.
Disclosure Statement
No competing financial interests exist.
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Address correspondence to:
Brenda Aguilar, MD
Department of General Surgery
Mayo Clinic Hospital
5777 East Mayo Boulevard
Phoenix, AZ 85054
E-mail: Aguilar.Brenda@mayo.edu
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