Sunday January 8, 2012
Pain in the pelvis
WOMEN'S WORLD by DR NOR ASHIKIN MOKHTAR
The concluding article on pelvic pain, which can be caused by a wide range of conditions, some of which are easily treated, while others require more urgent medical attention.
IN my last article, I shared with readers a list of conditions that could possibly account for symptoms of pelvic or lower abdomen pain.
Some of these conditions are related to the reproductive system, while others may be related to the digestive or urinary system.
Not all causes of pelvic pain are medical emergencies – nonetheless, it is always better to see your doctor when you experience such symptoms, as there could be any number of causes.
In this article, I will continue to elaborate on more of these potential causes of pelvic pain.
Kidney stones are minerals that form in the kidney. They can be as small as a grain of sand or as big as a golf ball, so you can imagine what pain it can cause.
Endometriosis
When endometrial cells grow outside the uterus and form implants (growths) on the ovaries, bowel, rectum, bladder, and on the lining of the pelvic area, this is called endometriosis.
Pain is the most significant symptom of endometriosis. The pain could be in the lower abdomen or the lower back, before, during or after menstruation. You may also experience cramps, pain during or after sexual intercourse, or pain with bowel movements.
Unfortunately, there is no way to reverse the scarring caused by endometriosis. However, there are treatments that can stop the disease from getting worse.
In severe cases, surgery can be carried out to remove all endometrial implants and scar tissue, or more drastically, to remove your uterus, fallopian tubes and ovaries.
Vulvar pain
In some cases, the pain may originate lower down the pelvis, namely at the vaginal area. Chronic pain around the opening of the vagina is a condition called vulvodynia, where no cause is known.
The pain could be a burning, stinging, or experienced as a throbbing sensation, and it may be there constantly or come and go. Certain activities like sexual intercourse or riding a bicycle may make the pain worse.
Since there is no known cause of vulvodynia, there is no way to treat the source of the pain. However, medications and physical therapy may help to relieve the symptoms.
Interstitial cystitis
There is a condition called interstitial cystitis (IC), which is related to long-term inflammation of the bladder wall.
The pain is felt during urination and sex, as well as a sensation of pressure above the pubic area. You may also feel the need to urinate multiple times every hour throughout the course of the day.
IC also has no known cause. You should work with your doctor to try out treatments that can relieve the symptoms.
Pelvic organ prolapse
A prolapsed pelvic organ is when the organ, such as the bladder or uterus, slips out of its normal place and drops into a lower position. This happens when the ligaments or muscles supporting the organs weaken, which is usually due to age.
Prolapse can cause some form of pain or pressure in the groin or lower back and against the vaginal wall. You may also have a feeling of “fullness” in the lower belly and pain during intercourse.
Treating prolapsed organs usually requires some form of surgery, although there are now minimally invasive techniques that result in faster recovery.
Irritable Bowel Syndrome (IBS)
If you have constantly recurring stomach pain that comes with cramps, bloating and diarrhoea or constipation, you could have IBS.
IBS describes the presence of these symptoms together without any known cause. It is strongly believed that stress in your life has a lot to do with IBS, as these symptoms tend to flare up in people when they go through highly stressful or demanding periods in their life.
Lifestyle changes like modifying your diet and managing your stress can help to keep the symptoms of IBS under control.
Urinary tract infection (UTI)
Have you ever experienced pain while urinating, along with a frequent urge to urinate? You could have a urinary tract infection, which is caused by bacteria getting into the urinary tract and causing infection to the urethra, bladder, ureters or the kidneys. You may also have the feeling of pressure in your lower pelvis.
If you suspect that you have a UTI, you should see a doctor and get it treated with some simple antibiotics.
Don’t let it progress to kidney infection, which is characterised by symptoms like fever, nausea, vomiting and pain on one side of the lower back.
Kidney stones
If you see your urine turning pink or red, and you have a sudden sharp pain in the stomach or pelvic area, you may have kidney stones.
Kidney stones are minerals that form in the kidney and move to the bladder. They can be as small as a grain of sand or as big as a golf ball, so you can imagine what pain it can cause.
Your doctor can recommend treatments to remove the kidney stones, if they cannot pass out through the urine on their own.
Pelvic congestion syndrome
You’ve probably heard of varicose veins, which is when veins become swollen, twisted and filled with blood. Although varicose veins commonly occur in the legs, they can also develop in the pelvis, causing pelvic congestion syndrome.
The pelvic veins become swollen and painful, causing pain especially when you sit or stand. You may find that lying down eases the pain.
This condition is not easily diagnosed because the pelvic veins are not visible from outside the body. Your doctor will need to rule out other possible conditions.
Ask your doctor about minimally invasive surgical procedures to treat this condition.
Scar tissue or adhesions
Have you had surgery in your pelvic or lower abdominal region before? It could be surgery to remove your appendix or uterus, or a C-section for delivery.
These surgical procedures can cause scar tissue to form between organs or structures in the pelvic area, causing them to stick or adhere to each other. In normal situations, these organs should have a slippery surface, allowing them to shift easily as the body moves.
These adhesions can cause long-term abdominal or pelvic pain in some people, and even blockage of the intestines. In these situations, surgery may be needed to break the adhesions, although doctors only resort to surgery if there is no other option.
As you can see, pelvic pain can be caused by a wide range of conditions, some of which can be easily treated and others that require more urgent medical attention.
The most important thing to remember when you experience pain in the pelvis or lower abdomen area is to take note of other symptoms and things occuring in your body. For instance, take note of what you are doing when the pain occurs, and whether certain activities make it worse.
Observe your menstrual periods, bleeding, urine and bowel movements, and whether you have nausea, vomiting or fever.
Knowing these details will help your doctor to make a more accurate diagnosis. Sometimes, even after a lot of testing, the cause of pelvic pain remains a mystery. But your doctor can still help you find ways to feel better and prescribe the appropriate treatment for you.
> Datuk Dr Nor Ashikin Mokhtar is a consultant obstetrician & gynaecologist (FRCOG, UK). For further information, visit www.primanora.com. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.
http://thestar.com.my/health/story.asp?file=/2012/1/8/health/10210283&sec=health
Friday, January 27, 2012
Thursday, January 26, 2012
About Adhesion Related Disorder ~ How can abdominal adhesions cause intestinal obstruction?
Abdominal Adhesions
On this page:
•What are abdominal adhesions?
•What causes abdominal adhesions?
•How can abdominal adhesions cause intestinal obstruction?
•How can abdominal adhesions cause female infertility?
•What are the symptoms of abdominal adhesions?
•What are the symptoms of an intestinal obstruction?
•How are abdominal adhesions and intestinal obstructions diagnosed?
•How are abdominal adhesions and intestinal obstructions treated?
•Can abdominal adhesions be prevented?
•Points to Remember
•Hope through Research
•For More Information
What are abdominal adhesions?
Abdominal adhesions are bands of tissue that form between abdominal tissues and organs. Normally, internal tissues and organs have slippery surfaces, which allow them to shift easily as the body moves. Adhesions cause tissues and organs to stick together.
The intestines are part of the digestive system. Abdominal adhesions can cause an intestinal obstruction.
Although most adhesions cause no symptoms or problems, others cause chronic abdominal or pelvic pain. Adhesions are also a major cause of intestinal obstruction and female infertility.
What causes abdominal adhesions?
Abdominal surgery is the most frequent cause of abdominal adhesions. Almost everyone who undergoes abdominal surgery develops adhesions; however, the risk is greater after operations on the lower abdomen and pelvis, including bowel and gynecological surgeries. Adhesions can become larger and tighter as time passes, causing problems years after surgery.
Surgery-induced causes of abdominal adhesions include
•tissue incisions, especially those involving internal organs
•the handling of internal organs
•the drying out of internal organs and tissues
•contact of internal tissues with foreign materials, such as gauze, surgical gloves, and stitches
•blood or blood clots that were not rinsed out during surgery
A less common cause of abdominal adhesions is inflammation from sources not related to surgery, including
•appendicitis—in particular, appendix rupture
•radiation treatment for cancer
•gynecological infections
•abdominal infections
Rarely, abdominal adhesions form without apparent cause.
How can abdominal adhesions cause intestinal obstruction?
Abdominal adhesions can kink, twist, or pull the intestines out of place, causing an intestinal obstruction. An intestinal obstruction partially or completely restricts the movement of food or stool through the intestines. A complete intestinal obstruction is life threatening and requires immediate medical attention and often surgery.
How can abdominal adhesions cause female infertility?
Abdominal adhesions cause female infertility by preventing fertilized eggs from reaching the uterus, where fetal development takes place. Adhesions can kink, twist, or pull out of place the fallopian tubes, which carry eggs from the ovaries—where eggs are stored and released—to the uterus.
What are the symptoms of abdominal adhesions?
Although most abdominal adhesions go unnoticed, the most common symptom is chronic abdominal or pelvic pain. The pain often mimics that of other conditions, including appendicitis, endometriosis, and diverticulitis.
What are the symptoms of an intestinal obstruction?
Symptoms of an intestinal obstruction include
•severe abdominal pain or cramping
•vomiting
•bloating
•loud bowel sounds
•swelling of the abdomen
•inability to pass gas
•constipation
A person with these symptoms should seek medical attention immediately.
How are abdominal adhesions and intestinal obstructions diagnosed?
No tests are available to diagnose adhesions, and adhesions cannot be seen through imaging techniques such as x rays or ultrasound. Most adhesions are found during exploratory surgery. An intestinal obstruction, however, can be seen through abdominal x rays, barium contrast studies—also called a lower GI series—and computerized tomography.
How are abdominal adhesions and intestinal obstructions treated?
Treatment for abdominal adhesions is usually not necessary, as most do not cause problems. Surgery is currently the only way to break adhesions that cause pain, intestinal obstruction, or fertility problems. More surgery, however, carries the risk of additional adhesions and is avoided when possible.
A complete intestinal obstruction usually requires immediate surgery. A partial obstruction can sometimes be relieved with a liquid or low-residue diet. A low-residue diet is high in dairy products, low in fiber, and more easily broken down into smaller particles by the digestive system.
Can abdominal adhesions be prevented?
Abdominal adhesions are difficult to prevent; however, surgical technique can minimize adhesions.
Laparoscopic surgery avoids opening up the abdomen with a large incision. Instead, the abdomen is inflated with gas while special surgical tools and a video camera are threaded through a few, small abdominal incisions. Inflating the abdomen gives the surgeon room to operate.
If a large abdominal incision is required, a special filmlike material (Seprafilm) can be inserted between organs or between the organs and the abdominal incision at the end of surgery. The filmlike material, which looks similar to wax paper, is absorbed by the body in about a week.
Other steps during surgery to reduce adhesion formation include using starch- and latex-free gloves, handling tissues and organs gently, shortening surgery time, and not allowing tissues to dry out.
Points to Remember
•Abdominal adhesions are bands of tissue that form between abdominal tissues and organs, causing tissues and organs to stick together.
•Although most adhesions cause no symptoms or problems, others cause chronic abdominal or pelvic pain, bowel obstruction, or female infertility.
•Abdominal surgery is the most frequent cause of abdominal adhesions.
•Abdominal adhesions can kink, twist, or pull the intestines out of place, causing an intestinal obstruction.
•A complete intestinal obstruction is life threatening and requires immediate medical attention and often surgery.
•Abdominal adhesions cause female infertility by preventing fertilized eggs from reaching the uterus, where fetal development takes place.
•No tests are available to diagnose adhesions, and adhesions cannot be seen through imaging techniques such as x rays or ultrasound.
•An intestinal obstruction can be seen through abdominal x rays, barium contrast studies—also called a lower GI series—and computerized tomography.
•Surgery is currently the only way to break adhesions that cause pain, intestinal obstruction, or fertility problems.
Hope through Research
The National Institute of Diabetes and Digestive and Kidney Diseases conducts and supports basic and clinical research into many digestive disorders.
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. For information about current studies, visit http://www.clinicaltrials.gov/.
The U.S. Government does not endorse or favor any specific commercial product or company. Trade, proprietary, or company names appearing in this document are used only because they are considered necessary in the context of the information provided. If a product is not mentioned, the omission does not mean or imply that the product is unsatisfactory.
For More Information
American College of Gastroenterology
P.O. Box 342260
Bethesda, MD 20827–2260
Phone: 301–263–9000
Fax: 301–263–9025
Email: info@acg.gi.org
Internet: www.acg.gi.org
International Foundation for Functional Gastrointestinal Disorders
P.O. Box 170864
Milwaukee, WI 53217–8076
Phone: 1–888–964–2001 or 414–964–1799
Fax: 414–964–7176
Email: iffgd@iffgd.org
Internet: www.iffgd.org
You may also find additional information about this topic by visiting MedlinePlus at www.medlineplus.gov.
This publication may contain information about medications. When prepared, this publication included the most current information available. For updates or for questions about any medications, contact the U.S. Food and Drug Administration toll-free at 1–888–INFO–FDA (1–888–463–6332) or visit www.fda.gov. Consult your doctor for more information.
http://digestive.niddk.nih.gov/ddiseases/pubs/intestinaladhesions/
On this page:
•What are abdominal adhesions?
•What causes abdominal adhesions?
•How can abdominal adhesions cause intestinal obstruction?
•How can abdominal adhesions cause female infertility?
•What are the symptoms of abdominal adhesions?
•What are the symptoms of an intestinal obstruction?
•How are abdominal adhesions and intestinal obstructions diagnosed?
•How are abdominal adhesions and intestinal obstructions treated?
•Can abdominal adhesions be prevented?
•Points to Remember
•Hope through Research
•For More Information
What are abdominal adhesions?
Abdominal adhesions are bands of tissue that form between abdominal tissues and organs. Normally, internal tissues and organs have slippery surfaces, which allow them to shift easily as the body moves. Adhesions cause tissues and organs to stick together.
The intestines are part of the digestive system. Abdominal adhesions can cause an intestinal obstruction.
Although most adhesions cause no symptoms or problems, others cause chronic abdominal or pelvic pain. Adhesions are also a major cause of intestinal obstruction and female infertility.
What causes abdominal adhesions?
Abdominal surgery is the most frequent cause of abdominal adhesions. Almost everyone who undergoes abdominal surgery develops adhesions; however, the risk is greater after operations on the lower abdomen and pelvis, including bowel and gynecological surgeries. Adhesions can become larger and tighter as time passes, causing problems years after surgery.
Surgery-induced causes of abdominal adhesions include
•tissue incisions, especially those involving internal organs
•the handling of internal organs
•the drying out of internal organs and tissues
•contact of internal tissues with foreign materials, such as gauze, surgical gloves, and stitches
•blood or blood clots that were not rinsed out during surgery
A less common cause of abdominal adhesions is inflammation from sources not related to surgery, including
•appendicitis—in particular, appendix rupture
•radiation treatment for cancer
•gynecological infections
•abdominal infections
Rarely, abdominal adhesions form without apparent cause.
How can abdominal adhesions cause intestinal obstruction?
Abdominal adhesions can kink, twist, or pull the intestines out of place, causing an intestinal obstruction. An intestinal obstruction partially or completely restricts the movement of food or stool through the intestines. A complete intestinal obstruction is life threatening and requires immediate medical attention and often surgery.
How can abdominal adhesions cause female infertility?
Abdominal adhesions cause female infertility by preventing fertilized eggs from reaching the uterus, where fetal development takes place. Adhesions can kink, twist, or pull out of place the fallopian tubes, which carry eggs from the ovaries—where eggs are stored and released—to the uterus.
What are the symptoms of abdominal adhesions?
Although most abdominal adhesions go unnoticed, the most common symptom is chronic abdominal or pelvic pain. The pain often mimics that of other conditions, including appendicitis, endometriosis, and diverticulitis.
What are the symptoms of an intestinal obstruction?
Symptoms of an intestinal obstruction include
•severe abdominal pain or cramping
•vomiting
•bloating
•loud bowel sounds
•swelling of the abdomen
•inability to pass gas
•constipation
A person with these symptoms should seek medical attention immediately.
How are abdominal adhesions and intestinal obstructions diagnosed?
No tests are available to diagnose adhesions, and adhesions cannot be seen through imaging techniques such as x rays or ultrasound. Most adhesions are found during exploratory surgery. An intestinal obstruction, however, can be seen through abdominal x rays, barium contrast studies—also called a lower GI series—and computerized tomography.
How are abdominal adhesions and intestinal obstructions treated?
Treatment for abdominal adhesions is usually not necessary, as most do not cause problems. Surgery is currently the only way to break adhesions that cause pain, intestinal obstruction, or fertility problems. More surgery, however, carries the risk of additional adhesions and is avoided when possible.
A complete intestinal obstruction usually requires immediate surgery. A partial obstruction can sometimes be relieved with a liquid or low-residue diet. A low-residue diet is high in dairy products, low in fiber, and more easily broken down into smaller particles by the digestive system.
Can abdominal adhesions be prevented?
Abdominal adhesions are difficult to prevent; however, surgical technique can minimize adhesions.
Laparoscopic surgery avoids opening up the abdomen with a large incision. Instead, the abdomen is inflated with gas while special surgical tools and a video camera are threaded through a few, small abdominal incisions. Inflating the abdomen gives the surgeon room to operate.
If a large abdominal incision is required, a special filmlike material (Seprafilm) can be inserted between organs or between the organs and the abdominal incision at the end of surgery. The filmlike material, which looks similar to wax paper, is absorbed by the body in about a week.
Other steps during surgery to reduce adhesion formation include using starch- and latex-free gloves, handling tissues and organs gently, shortening surgery time, and not allowing tissues to dry out.
Points to Remember
•Abdominal adhesions are bands of tissue that form between abdominal tissues and organs, causing tissues and organs to stick together.
•Although most adhesions cause no symptoms or problems, others cause chronic abdominal or pelvic pain, bowel obstruction, or female infertility.
•Abdominal surgery is the most frequent cause of abdominal adhesions.
•Abdominal adhesions can kink, twist, or pull the intestines out of place, causing an intestinal obstruction.
•A complete intestinal obstruction is life threatening and requires immediate medical attention and often surgery.
•Abdominal adhesions cause female infertility by preventing fertilized eggs from reaching the uterus, where fetal development takes place.
•No tests are available to diagnose adhesions, and adhesions cannot be seen through imaging techniques such as x rays or ultrasound.
•An intestinal obstruction can be seen through abdominal x rays, barium contrast studies—also called a lower GI series—and computerized tomography.
•Surgery is currently the only way to break adhesions that cause pain, intestinal obstruction, or fertility problems.
Hope through Research
The National Institute of Diabetes and Digestive and Kidney Diseases conducts and supports basic and clinical research into many digestive disorders.
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. For information about current studies, visit http://www.clinicaltrials.gov/.
The U.S. Government does not endorse or favor any specific commercial product or company. Trade, proprietary, or company names appearing in this document are used only because they are considered necessary in the context of the information provided. If a product is not mentioned, the omission does not mean or imply that the product is unsatisfactory.
For More Information
American College of Gastroenterology
P.O. Box 342260
Bethesda, MD 20827–2260
Phone: 301–263–9000
Fax: 301–263–9025
Email: info@acg.gi.org
Internet: www.acg.gi.org
International Foundation for Functional Gastrointestinal Disorders
P.O. Box 170864
Milwaukee, WI 53217–8076
Phone: 1–888–964–2001 or 414–964–1799
Fax: 414–964–7176
Email: iffgd@iffgd.org
Internet: www.iffgd.org
You may also find additional information about this topic by visiting MedlinePlus at www.medlineplus.gov.
This publication may contain information about medications. When prepared, this publication included the most current information available. For updates or for questions about any medications, contact the U.S. Food and Drug Administration toll-free at 1–888–INFO–FDA (1–888–463–6332) or visit www.fda.gov. Consult your doctor for more information.
http://digestive.niddk.nih.gov/ddiseases/pubs/intestinaladhesions/
Texas Jury Orders Kelsey-Seybold to Pay $1.9 Million for "Secret" Surgeon
Texas Jury Orders Kelsey-Seybold to Pay $1.9 Million for "Secret" Surgeon
Attorneys Randy Sorrels and Chelsie King Garza of Abraham, Watkins, Nichols, Sorrels, Agosto & Friend recently received a $1.9 million verdict from a Texas jury for a medical malpractice client.
HOUSTON, TX, January 24, 2012 /24-7PressRelease/ -- On Friday, January 20, 2012, a Harris County jury ordered Kelsey-Seybold Medical Clinic, PLLC, and its employee, Jim Patrick Benge, MD, to pay $1.9 million for permanently injuring Lauren Williams for her past and future damages, including a lifetime of colostomy care and medications.
In August 2008, Ms. Williams had a hysterectomy understanding that Dr. Benge would be her surgeon. After she went under anesthesia, a resident came in and performed at least 50 percent of the surgery without the patient's knowledge. This was the first time the resident had performed the procedure. "The jury rejected Kelsey Seybold's position that an unknown resident can perform surgery on a patient without full disclosure to the patient," said Williams' attorney Randall O. Sorrels.
During that August 2008 surgery, two of Ms. Williams' organs, including her bowel, were perforated. The injuries were not discovered until three days later at which point Ms. Williams was septic and her injuries were irreversible. Ms. Williams spent three weeks in a coma as a result, and thereafter spent months re-learning to walk, talk and care for herself. Ms. Williams now lives with a permanent colostomy and testimony was presented that she will be an intestinal cripple as she grows older, due to the dense internal adhesions resulting from gastrointestinal damage. She has undergone five major surgeries following the August 26, 2008 procedure.
Dr. Benge, his colleague Dr. Thornton (a co-defendant who was not found liable for her role in Ms. Williams' post-operative care), and the experts for Kelsey-Seybold offered testimony that a patient does not have the right to know when a resident would be operating on them or cutting inside their bodies. By virtue of this medical malpractice verdict, a Harris County jury has rejected this as the standard of care. "When a doctor agrees to perform surgery on a patient, it should be that surgeon who operates, unless the patient agrees otherwise," said Williams' lawyer Chelsie King Garza.
For further information, please contact attorney Randall O. Sorrels or attorney Chelsie King Garza by calling 713-222-7211 or via email at rsorrels@abrahamwatkins.com and cgarza@abrahamwatkins.com. Ms. Williams is available for comment upon request.
Attorneys Randall O. Sorrels and Chelsie King Garza are attorneys at the Houston law firm of Abraham, Watkins, Nichols, Sorrels, Agosto & Friend. Since 1951, the firm has advocated for the rights of thousands of catastrophically injured clients in cases involving car and truck accidents, work-related injuries, medical malpractice, defective products, aviation accidents and other types of personal injury matters. For more information on the firm, visit their website at www.abrahamwatkins.com.
http://world.einnews.com/247pr/258879
Attorneys Randy Sorrels and Chelsie King Garza of Abraham, Watkins, Nichols, Sorrels, Agosto & Friend recently received a $1.9 million verdict from a Texas jury for a medical malpractice client.
HOUSTON, TX, January 24, 2012 /24-7PressRelease/ -- On Friday, January 20, 2012, a Harris County jury ordered Kelsey-Seybold Medical Clinic, PLLC, and its employee, Jim Patrick Benge, MD, to pay $1.9 million for permanently injuring Lauren Williams for her past and future damages, including a lifetime of colostomy care and medications.
In August 2008, Ms. Williams had a hysterectomy understanding that Dr. Benge would be her surgeon. After she went under anesthesia, a resident came in and performed at least 50 percent of the surgery without the patient's knowledge. This was the first time the resident had performed the procedure. "The jury rejected Kelsey Seybold's position that an unknown resident can perform surgery on a patient without full disclosure to the patient," said Williams' attorney Randall O. Sorrels.
During that August 2008 surgery, two of Ms. Williams' organs, including her bowel, were perforated. The injuries were not discovered until three days later at which point Ms. Williams was septic and her injuries were irreversible. Ms. Williams spent three weeks in a coma as a result, and thereafter spent months re-learning to walk, talk and care for herself. Ms. Williams now lives with a permanent colostomy and testimony was presented that she will be an intestinal cripple as she grows older, due to the dense internal adhesions resulting from gastrointestinal damage. She has undergone five major surgeries following the August 26, 2008 procedure.
Dr. Benge, his colleague Dr. Thornton (a co-defendant who was not found liable for her role in Ms. Williams' post-operative care), and the experts for Kelsey-Seybold offered testimony that a patient does not have the right to know when a resident would be operating on them or cutting inside their bodies. By virtue of this medical malpractice verdict, a Harris County jury has rejected this as the standard of care. "When a doctor agrees to perform surgery on a patient, it should be that surgeon who operates, unless the patient agrees otherwise," said Williams' lawyer Chelsie King Garza.
For further information, please contact attorney Randall O. Sorrels or attorney Chelsie King Garza by calling 713-222-7211 or via email at rsorrels@abrahamwatkins.com and cgarza@abrahamwatkins.com. Ms. Williams is available for comment upon request.
Attorneys Randall O. Sorrels and Chelsie King Garza are attorneys at the Houston law firm of Abraham, Watkins, Nichols, Sorrels, Agosto & Friend. Since 1951, the firm has advocated for the rights of thousands of catastrophically injured clients in cases involving car and truck accidents, work-related injuries, medical malpractice, defective products, aviation accidents and other types of personal injury matters. For more information on the firm, visit their website at www.abrahamwatkins.com.
http://world.einnews.com/247pr/258879
Tuesday, January 24, 2012
FzioMed Receives CE Mark for DYNAVISC® Gel
FzioMed Receives CE Mark for DYNAVISC® Gel
New Adhesion Barrier Gel for Tendon and Peripheral Nerve Surgery
January 23, 2012 09:03 AM Eastern Time
SAN LUIS OBISPO, Calif.--(EON: Enhanced Online News)--FzioMed, Inc. is pleased to announce that it has received CE Mark approval to market DYNAVISC® adhesion barrier gel in Europe for tendon and peripheral nerve surgery.
DYNAVISC is a clear, absorbable gel supplied ready-to-use in a 1mL syringe. It is designed to coat tissues during tendon and peripheral nerve surgery. DYNAVISC gel acts as a temporary, protective barrier that separates tissues and reduces fibrosis and the formation of post-surgical adhesions.
DYNAVISC was developed by FzioMed and is based on the Company’s world-leading anti-adhesion biomaterial technology.
Adhesions are internal bands of scar tissue that can develop following surgery as the body attempts to heal. Adhesions tether tissues and surfaces that are normally not connected, later causing pain, nerve compression and impaired motion. Adhesions are a significant complication of many surgical procedures and a prevalent cause of post-surgical morbidity.
“Well over a million procedures to repair tendons are performed in the EU each year and one-third of traumatic injuries involve damage to tendons and nerves,” said John Krelle, President & CEO of FzioMed. “Adhesions can impact an otherwise successful procedure, leaving a patient with pain and diminished quality of life.”
Complete press release click here:
http://eon.businesswire.com/news/eon/20120123005273/en
New Adhesion Barrier Gel for Tendon and Peripheral Nerve Surgery
January 23, 2012 09:03 AM Eastern Time
SAN LUIS OBISPO, Calif.--(EON: Enhanced Online News)--FzioMed, Inc. is pleased to announce that it has received CE Mark approval to market DYNAVISC® adhesion barrier gel in Europe for tendon and peripheral nerve surgery.
DYNAVISC is a clear, absorbable gel supplied ready-to-use in a 1mL syringe. It is designed to coat tissues during tendon and peripheral nerve surgery. DYNAVISC gel acts as a temporary, protective barrier that separates tissues and reduces fibrosis and the formation of post-surgical adhesions.
DYNAVISC was developed by FzioMed and is based on the Company’s world-leading anti-adhesion biomaterial technology.
Adhesions are internal bands of scar tissue that can develop following surgery as the body attempts to heal. Adhesions tether tissues and surfaces that are normally not connected, later causing pain, nerve compression and impaired motion. Adhesions are a significant complication of many surgical procedures and a prevalent cause of post-surgical morbidity.
“Well over a million procedures to repair tendons are performed in the EU each year and one-third of traumatic injuries involve damage to tendons and nerves,” said John Krelle, President & CEO of FzioMed. “Adhesions can impact an otherwise successful procedure, leaving a patient with pain and diminished quality of life.”
Complete press release click here:
http://eon.businesswire.com/news/eon/20120123005273/en
Sunday, January 22, 2012
U.S. to Force Drug Firms to Report Money Paid to Doctors
U.S. to Force Drug Firms to Report Money Paid to Doctors
By ROBERT PEAR
Published: January 16, 2012
WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.
Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.
Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.
Click link to continue: http://www.nytimes.com/2012/01/17/health/policy/us-to-tell-drug-makers-to-disclose-payments-to-doctors.html?_r=1&pagewanted=all
By ROBERT PEAR
Published: January 16, 2012
WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.
Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.
Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.
Click link to continue: http://www.nytimes.com/2012/01/17/health/policy/us-to-tell-drug-makers-to-disclose-payments-to-doctors.html?_r=1&pagewanted=all
Thursday, January 19, 2012
Barrier agents for adhesion prevention after gynaecological surgery.
Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000475.
Barrier agents for adhesion prevention after gynaecological surgery.
Ahmad G, Duffy JM, Farquhar C, Vail A, Vandekerckhove P, Watson A, Wiseman D.
SourceStepping Hill Hospital, Obstetric & Gynaecology, 30 Badger Road, Altrincham, Cheshire, UK, WA14 5UZ. gaityahmad@hotmail.com
Abstract
BACKGROUND: Pelvic adhesion can form as a result of inflammation, endometriosis or surgical trauma. During pelvic surgery, strategies to reduce pelvic adhesion formation may include placing synthetic barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene or Fibrin sheets between the pelvic structures.
OBJECTIVES: To assess the effect of physical barriers used during pelvic surgery in women of reproductive age on pregnancy rates, pelvic pain, or postoperative adhesion reformation.
SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched September 2007) which is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, plus handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. In addition, companies were contacted for unpublished trials.
SELECTION CRITERIA: Any randomised controlled trials (RCTs) comparing the use of physical barriers versus no treatment or other physical barriers in the prevention of adhesions in women undergoing gynaecological surgery.
DATA COLLECTION AND ANALYSIS: Review authors assessed trial eligibility and quality.
MAIN RESULTS: Sixteen RCTs were included. Five trials randomised patients while the remainder randomised pelvic organs. Laparoscopy (six trials) and laparotomy (10 trials) were the primary surgical techniques. Indications for surgery included myomectomy (five trials), ovarian surgery (five trials), pelvic adhesions (four trials), endometriosis (one trial), and mixed (one trial). Eleven trials assessed Interceed versus no treatment, two assessed Interceed versus Gore-Tex, one trial assessed Gore-Tex versus no treatment, and one trial assessed Seprafilm versus no treatment. A single trial assessed Fibrin sheet versus no treatment. No studies reported pregnancy or reduction in pain as outcomes. The use of Interceed was associated with reduced incidence of pelvic adhesion formation, both new formation and reformation following laparoscopic surgery or laparotomy. However, this result should be interpreted with caution. Gore-Tex was more effective than no barrier or Interceed in preventing adhesion formation. There was only limited evidence that Seprafilm was effective in preventing adhesion formation following myomectomy and no evidence to support Fibrin sheet.
AUTHORS' CONCLUSIONS: The absorbable adhesion barrier Interceed reduces the incidence of adhesion formation following laparoscopy and laparotomy, but there are insufficient data to support its use to improve pregnancy rates. Gore-Tex may be superior to Interceed in preventing adhesion formation but its usefulness is limited by the need for suturing and later removal. There was no evidence of effectiveness of Seprafilm and Fibrin sheet in preventing adhesion formation.
Update of
Cochrane Database Syst Rev. 2000;(2):CD000475.
http://www.ncbi.nlm.nih.gov/pubmed/18425865
Barrier agents for adhesion prevention after gynaecological surgery.
Ahmad G, Duffy JM, Farquhar C, Vail A, Vandekerckhove P, Watson A, Wiseman D.
SourceStepping Hill Hospital, Obstetric & Gynaecology, 30 Badger Road, Altrincham, Cheshire, UK, WA14 5UZ. gaityahmad@hotmail.com
Abstract
BACKGROUND: Pelvic adhesion can form as a result of inflammation, endometriosis or surgical trauma. During pelvic surgery, strategies to reduce pelvic adhesion formation may include placing synthetic barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene or Fibrin sheets between the pelvic structures.
OBJECTIVES: To assess the effect of physical barriers used during pelvic surgery in women of reproductive age on pregnancy rates, pelvic pain, or postoperative adhesion reformation.
SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched September 2007) which is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, plus handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. In addition, companies were contacted for unpublished trials.
SELECTION CRITERIA: Any randomised controlled trials (RCTs) comparing the use of physical barriers versus no treatment or other physical barriers in the prevention of adhesions in women undergoing gynaecological surgery.
DATA COLLECTION AND ANALYSIS: Review authors assessed trial eligibility and quality.
MAIN RESULTS: Sixteen RCTs were included. Five trials randomised patients while the remainder randomised pelvic organs. Laparoscopy (six trials) and laparotomy (10 trials) were the primary surgical techniques. Indications for surgery included myomectomy (five trials), ovarian surgery (five trials), pelvic adhesions (four trials), endometriosis (one trial), and mixed (one trial). Eleven trials assessed Interceed versus no treatment, two assessed Interceed versus Gore-Tex, one trial assessed Gore-Tex versus no treatment, and one trial assessed Seprafilm versus no treatment. A single trial assessed Fibrin sheet versus no treatment. No studies reported pregnancy or reduction in pain as outcomes. The use of Interceed was associated with reduced incidence of pelvic adhesion formation, both new formation and reformation following laparoscopic surgery or laparotomy. However, this result should be interpreted with caution. Gore-Tex was more effective than no barrier or Interceed in preventing adhesion formation. There was only limited evidence that Seprafilm was effective in preventing adhesion formation following myomectomy and no evidence to support Fibrin sheet.
AUTHORS' CONCLUSIONS: The absorbable adhesion barrier Interceed reduces the incidence of adhesion formation following laparoscopy and laparotomy, but there are insufficient data to support its use to improve pregnancy rates. Gore-Tex may be superior to Interceed in preventing adhesion formation but its usefulness is limited by the need for suturing and later removal. There was no evidence of effectiveness of Seprafilm and Fibrin sheet in preventing adhesion formation.
Update of
Cochrane Database Syst Rev. 2000;(2):CD000475.
http://www.ncbi.nlm.nih.gov/pubmed/18425865
Tuesday, January 17, 2012
Is “Adhesion Related Disorder” A Chronic Disease?
Is “Adhesion Related Disorder” A Chronic Disease?
Q. Is “Adhesion Related Disorder” A Chronic Disease?
A. Yes it is!
(Based on the “Centers for Disease Control and Prevention” & The National Digestive Diseases Information Clearinghouse (NDDIC) "Adhesion Related Disorder” IS considered a “Disease.”
The following information is important to take with you when you see your “Medical Appointments” or to appointments associated with applying for “Social Security Benefits” as this information correlates directly with the “debilitating and often untreatable” symptoms experienced by those afflicted with “Adhesion Related Disorder.”
Chronic Disease Overview
The profile of diseases contributing most heavily to death, illness, and disability among Americans changed dramatically during the last century. Today, chronic diseases—such as cardiovascular disease (primarily heart disease and stroke), cancer, and diabetes—are among the most prevalent, costly, and preventable of all health problems. Seven of every 10 Americans who die each year, or more than 1.7 million people, die of a chronic disease. The prolonged course of illness and disability from such chronic diseases as diabetes and arthritis results in extended pain and suffering and decreased quality of life for millions of Americans. Chronic, disabling conditions cause major limitations in activity for more than one of every 10 Americans, or 25 million people
Costs of Chronic Disease
The United States cannot effectively address escalating health care costs without addressing the problem of chronic diseases:
More than 90 million Americans live with chronic illnesses.
Chronic diseases account for 70% of all deaths in the United States.
The medical care costs of people with chronic diseases account for more than 75% of the nation’s $1.4 trillion medical care costs.
Chronic diseases account for one-third of the years of potential life lost before age 65.
Hospitalizations for pregnancy-related complications occurring before delivery account for more than $1 billion annually.
The direct and indirect costs of diabetes are nearly $132 billion a year.
Each year, arthritis results in estimated medical care costs of more than $22 billion, and estimated total costs (medical care and lost productivity) of almost $82 billion.
The estimated direct and indirect costs associated with smoking exceed $75 billion annually.
In 2001, approximately $300 billion was spent on all cardiovascular diseases. Over $129 in lost productivity was due to cardiovascular disease.
The direct medical costs associated with physical inactivity was nearly $76.6 billion in 2000.
Nearly $68 billion is spent on dental services each year.
Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333, U.S.A
Tel: (404) 639-3311 / Public Inquiries: (404) 639-3534 / (800) 311-3435
The National Digestive Diseases Information Clearinghouse (NDDIC) "Adhesion Related Disorder"
National Institutes of Health | Department of Health & Human Services
Intestinal Adhesions
Treatment
Some adhesions will cause no symptoms and go away by themselves. For people whose intestines are only partially blocked, a diet low in fiber, called a low-residue diet, allows food to move more easily through the affected area. In some cases, surgery may be necessary to remove the adhesions, reposition the intestine, and relieve symptoms. But the risk of developing more adhesions increases with each additional surgery.
Prevention
Methods to prevent adhesions include using biodegradable membranes or gels to separate organs at the end of surgery or performing laparoscopic (keyhole) surgery, which reduces the size of the incision and the handling of the organs. More...... http://www.adhesionrelateddisorder.com/ardnews9.html
DISEASE.,
Definitions of:
an impairment of health or a condition of abnormal functioning wordnet.princeton.edu/perl/webwn
A disease is any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the person affected or those in contact with the person. Sometimes the term is used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function, while in other contexts these may be considered distinguishable categories. en.wikipedia.org/wiki/Disease
a term of health status; when something is wrong with a bodily function
www.jhsph.edu/publichealthexperts/Glossary.htm
Disease can be defined in three ways: www.med.uwo.ca/ecosystemhealth/education/glossary.htm
Process injurious to health and/or longevity www.weightlosssurgery.com.au/index.php
A condition of an organic being or of one of its parts that impairs normal living functioning.
www.iffgd.org/GIDisorders/glossary.html
A condition of being sick from a particular cause. Different plants and animals often suffer from certain diseases. Some animals are known to carry diseases that effect other organisms. For example, a beetle carries a fungus which causes Dutch Elm Disease in elm trees.
www.fcps.k12.va.us/StratfordLandingES/Ecology/mpages/glossary.htm
An abnormal condition of a plant in which its physiology, morphology, and/or development is altered under the continuous influence of a pathogen. (3)
ppathw3.cals.cornell.edu/glossary/Defs_D.htm
an abnormal bodily condition of a living plant or animal that interferes with functioning and can usually be recognized by signs, symptoms, and illness. whyfiles.larc.nasa.gov/text/kids/Problem_Board/problems/biosphere/glossary.html
stress condition produced by the effects of a pathogen on a susceptible host.
scarab.msu.montana.edu/historybug/glossary.htm
Any condition that prevents the body from working as it should other that direct injury.
ricegenomics.plbr.cornell.edu/glossary.htm
A condition of an organism that impairs normal physiological function. Also see Infectious Disease.
fightaidsathome.scripps.edu/glossary.html
Any abnormality of bodily structure or function, other than those arising directly from injury. www.canadapharma.org/Patient_Pathways/Glossary_Terms/
A deleterious change in the body's condition in response to destabilizing factors, such as nutrition, chemicals, or biological agents.
highered.mcgraw-hill.com/sites/0070294267/student_view0/glossary_a-d.html
Diseases may be caused by microorganisms or by environmental factors such as a lack of available iron in the soil or excess water.
www.ottawa.ca/residents/healthy_lawns/lawns/links/glossary_en.shtm l
Illness, sickness. An interruption, cessation, or disorder of body functions, systems, or organs. Top of page
www.rationaltherapeutics.com/reference/glossary.htm
can be defined as a derangement in the function of the whole body of the host or any of its parts. www.fao.org/Wairdocs/ILRI/x5436E/x5436e04.htm
A condition of the body in which there is incorrect function due to heredity, infection, diet, or environment.
www.mdk12.org/instruction/curriculum/science/glossary.shtml
a pathological condition that is cross-culturally defined and recognized.
oregonstate.edu/instruct/anth370/gloss.html
a condition, caused by living organisms or environmental changes, that impairs the normal functions of a living organism.
www.ipmalmanac.com/glossary/index.asp
a state in which a function or part of the body is no longer in a healthy condition
lib1.store.vip.sc5.yahoo.com/lib/allergybegone/glossary.htm
A medical concept, which serves for communication between doctors. Disease does not exist as such in nature. What medicine conceives as disease is a tolerance decline accompanied by WOB complaints www.what-is-cancer.com/papers/newmedicine/glossary.html
a medically definable process, in terms of pathophysiology and pathology. Illness is what the patient experiences.
www.therubins.com/geninfo/Definit.htm
Presence of some pathology or abnormality in a part of the body. Bacteria and viruses cause many such diseases Tolerance – In pharmacology, the ability to tolerate larger and larger doses of a drug after each exposure to it.
www.uwic.ac.uk/shss/dom/newweb/General/Glossary.htm
Disorder or pathology that affects health.
www.moh.govt.nz/moh.nsf/0/15f5c5045e7a1dd4cc256b6b0002b038
Any departure from health; a particular destructive process in an organ or organism with a specific cause and symptoms.
www.michigan.gov/dnr/0,1607,7-153-10364_10950-27394--,00.htm l
Sickness, illness or loss of health.
www.sabin.org/vaccine_science_GlossaryB_D.htm
http://www.adhesionrelateddisorder.com/beyourownbestdoctor.html
Q. Is “Adhesion Related Disorder” A Chronic Disease?
A. Yes it is!
(Based on the “Centers for Disease Control and Prevention” & The National Digestive Diseases Information Clearinghouse (NDDIC) "Adhesion Related Disorder” IS considered a “Disease.”
The following information is important to take with you when you see your “Medical Appointments” or to appointments associated with applying for “Social Security Benefits” as this information correlates directly with the “debilitating and often untreatable” symptoms experienced by those afflicted with “Adhesion Related Disorder.”
Chronic Disease Overview
The profile of diseases contributing most heavily to death, illness, and disability among Americans changed dramatically during the last century. Today, chronic diseases—such as cardiovascular disease (primarily heart disease and stroke), cancer, and diabetes—are among the most prevalent, costly, and preventable of all health problems. Seven of every 10 Americans who die each year, or more than 1.7 million people, die of a chronic disease. The prolonged course of illness and disability from such chronic diseases as diabetes and arthritis results in extended pain and suffering and decreased quality of life for millions of Americans. Chronic, disabling conditions cause major limitations in activity for more than one of every 10 Americans, or 25 million people
Costs of Chronic Disease
The United States cannot effectively address escalating health care costs without addressing the problem of chronic diseases:
More than 90 million Americans live with chronic illnesses.
Chronic diseases account for 70% of all deaths in the United States.
The medical care costs of people with chronic diseases account for more than 75% of the nation’s $1.4 trillion medical care costs.
Chronic diseases account for one-third of the years of potential life lost before age 65.
Hospitalizations for pregnancy-related complications occurring before delivery account for more than $1 billion annually.
The direct and indirect costs of diabetes are nearly $132 billion a year.
Each year, arthritis results in estimated medical care costs of more than $22 billion, and estimated total costs (medical care and lost productivity) of almost $82 billion.
The estimated direct and indirect costs associated with smoking exceed $75 billion annually.
In 2001, approximately $300 billion was spent on all cardiovascular diseases. Over $129 in lost productivity was due to cardiovascular disease.
The direct medical costs associated with physical inactivity was nearly $76.6 billion in 2000.
Nearly $68 billion is spent on dental services each year.
Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333, U.S.A
Tel: (404) 639-3311 / Public Inquiries: (404) 639-3534 / (800) 311-3435
The National Digestive Diseases Information Clearinghouse (NDDIC) "Adhesion Related Disorder"
National Institutes of Health | Department of Health & Human Services
Intestinal Adhesions
Treatment
Some adhesions will cause no symptoms and go away by themselves. For people whose intestines are only partially blocked, a diet low in fiber, called a low-residue diet, allows food to move more easily through the affected area. In some cases, surgery may be necessary to remove the adhesions, reposition the intestine, and relieve symptoms. But the risk of developing more adhesions increases with each additional surgery.
Prevention
Methods to prevent adhesions include using biodegradable membranes or gels to separate organs at the end of surgery or performing laparoscopic (keyhole) surgery, which reduces the size of the incision and the handling of the organs. More...... http://www.adhesionrelateddisorder.com/ardnews9.html
DISEASE.,
Definitions of:
an impairment of health or a condition of abnormal functioning wordnet.princeton.edu/perl/webwn
A disease is any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the person affected or those in contact with the person. Sometimes the term is used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function, while in other contexts these may be considered distinguishable categories. en.wikipedia.org/wiki/Disease
a term of health status; when something is wrong with a bodily function
www.jhsph.edu/publichealthexperts/Glossary.htm
Disease can be defined in three ways: www.med.uwo.ca/ecosystemhealth/education/glossary.htm
Process injurious to health and/or longevity www.weightlosssurgery.com.au/index.php
A condition of an organic being or of one of its parts that impairs normal living functioning.
www.iffgd.org/GIDisorders/glossary.html
A condition of being sick from a particular cause. Different plants and animals often suffer from certain diseases. Some animals are known to carry diseases that effect other organisms. For example, a beetle carries a fungus which causes Dutch Elm Disease in elm trees.
www.fcps.k12.va.us/StratfordLandingES/Ecology/mpages/glossary.htm
An abnormal condition of a plant in which its physiology, morphology, and/or development is altered under the continuous influence of a pathogen. (3)
ppathw3.cals.cornell.edu/glossary/Defs_D.htm
an abnormal bodily condition of a living plant or animal that interferes with functioning and can usually be recognized by signs, symptoms, and illness. whyfiles.larc.nasa.gov/text/kids/Problem_Board/problems/biosphere/glossary.html
stress condition produced by the effects of a pathogen on a susceptible host.
scarab.msu.montana.edu/historybug/glossary.htm
Any condition that prevents the body from working as it should other that direct injury.
ricegenomics.plbr.cornell.edu/glossary.htm
A condition of an organism that impairs normal physiological function. Also see Infectious Disease.
fightaidsathome.scripps.edu/glossary.html
Any abnormality of bodily structure or function, other than those arising directly from injury. www.canadapharma.org/Patient_Pathways/Glossary_Terms/
A deleterious change in the body's condition in response to destabilizing factors, such as nutrition, chemicals, or biological agents.
highered.mcgraw-hill.com/sites/0070294267/student_view0/glossary_a-d.html
Diseases may be caused by microorganisms or by environmental factors such as a lack of available iron in the soil or excess water.
www.ottawa.ca/residents/healthy_lawns/lawns/links/glossary_en.shtm l
Illness, sickness. An interruption, cessation, or disorder of body functions, systems, or organs. Top of page
www.rationaltherapeutics.com/reference/glossary.htm
can be defined as a derangement in the function of the whole body of the host or any of its parts. www.fao.org/Wairdocs/ILRI/x5436E/x5436e04.htm
A condition of the body in which there is incorrect function due to heredity, infection, diet, or environment.
www.mdk12.org/instruction/curriculum/science/glossary.shtml
a pathological condition that is cross-culturally defined and recognized.
oregonstate.edu/instruct/anth370/gloss.html
a condition, caused by living organisms or environmental changes, that impairs the normal functions of a living organism.
www.ipmalmanac.com/glossary/index.asp
a state in which a function or part of the body is no longer in a healthy condition
lib1.store.vip.sc5.yahoo.com/lib/allergybegone/glossary.htm
A medical concept, which serves for communication between doctors. Disease does not exist as such in nature. What medicine conceives as disease is a tolerance decline accompanied by WOB complaints www.what-is-cancer.com/papers/newmedicine/glossary.html
a medically definable process, in terms of pathophysiology and pathology. Illness is what the patient experiences.
www.therubins.com/geninfo/Definit.htm
Presence of some pathology or abnormality in a part of the body. Bacteria and viruses cause many such diseases Tolerance – In pharmacology, the ability to tolerate larger and larger doses of a drug after each exposure to it.
www.uwic.ac.uk/shss/dom/newweb/General/Glossary.htm
Disorder or pathology that affects health.
www.moh.govt.nz/moh.nsf/0/15f5c5045e7a1dd4cc256b6b0002b038
Any departure from health; a particular destructive process in an organ or organism with a specific cause and symptoms.
www.michigan.gov/dnr/0,1607,7-153-10364_10950-27394--,00.htm l
Sickness, illness or loss of health.
www.sabin.org/vaccine_science_GlossaryB_D.htm
http://www.adhesionrelateddisorder.com/beyourownbestdoctor.html
Adhesion related Disorder ~ Adhesion Products Adhesion Reduction Agents
Adhesion Products
Please Note:
Information provided here is intended as a lay overview only and not as any fort of endorsement. Any product described here must be used by a medical doctorin accordance with the Instructions for Use and after taking a Patient's individual circumstances into account.
Reposted from the International Adhesion Society. Please visit the International Adhesion Society at;
http://www.adhesions.org/
--------------------------------------------------------------------------------
http://www.adhesions.org/products.htm
Products Approved by FDA for Adhesion Prevention, Reduction in Pelvice and/or Abdominal Cavities
* INTERCEED (TC7), made by Johnson & Johnson
Placed over the site of surgical injury, this knitted fabric dissolves within 30 days or so. The idea is that the sheet keeps organs apart that would otherwise stick (adhere) together. Once healing is complete, the sheet dissolves leaving the two organs properly separated.
Since 1989, it has been approved only for open (non-keyhole) gynecologic surgery with a good record of safety and effectiveness documented in this paper authored by Dr. Wiseman in 1999.
Althought it is not approved in the USA for use in laparoscopice (key-hole) surgery, INTERCEED is often used "off-label". Only small clinical studies to evaluate INTERCEED in laparoscopy have been performed with mixed results, possibly because almost perfect control of bleeding (required for INTERCEED's action) may not have been achieved, or INTERCEED was dislodged from its site of placement.
Early studies suggested that a small amount of Heparin added to the INTERCEED may not only enhance its action, but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. Unfortunately, this work was never pursued, neither was a modified form of INTERCEED, which also functioned better than the original INTERCEED, both in the absence and presence of bleeding.
* Seprafilm, made by Genzyme (previously called HAL-F)
This film looks like a thin, slightly brittle clear "fruit roll-up" that gels soon after contact with moist body tissues. It workes and is used in much the same way as INTERCEED, except that it is also approved for General Surgery. Like INTERCEED, it is not approved in the USA for laparoscopic use, aothought with considerable technical difficulty, it can be applied in laparoscopic surgery "off-label". Approved in 1996, it has now had a long history of safety and effectiveness similar to that of INTERCEED and a number of studies have preorted its use in a variety of procedures as well as the reduction of obstruction in some cases. It should not be wrapped around the bowel that has been cut open.
Some surgeons have made a gel by cutting small pieces of Seprafilm and mixing them with saline. A study conducted by Genzyme with a standard preparation called "SepraSpray" has yielded what appear to be unimpressive results.
* Adept, marketed by Baxter
Adept is a solution containing a carbohydrate polymer. A large volume (about 3 liters) is instilled into the abdominal cavity after surgery causing them to float, keeping them apart and and preventing them from sticking to each other. Because of the the composition of the product, liquid stays in the abdominal cavity for several more days that plain saline (salt) solutions commonly used by surgeons. Altough, it has the advantage that it is easy to apply and it can be used laparoscopically, the clinical data suggest that its effectiveness is at best marginally better than salt solutions, also when used in large volume.
It should be noted that small (eg 300ml) volumes of saline used to float tissues apart do not appear to reduce adhesions, thus the data from the Adept study does suggest that large volumes of physiological saline solutions may have some benefit in reducing adhesions.
--------------------------------------------------------------------------------
Products not approved for Adhesions prevention, but often used "off-label" (USA)
*Note that some of these products may be approved in countries other than the USA for adhesion prevention.
* Evicel - made by Johnson & Johnson
Evicel is a type of "Fibrin Glue", a two component product made from naturally occurring molecules extracted from human blood. It is mainly used to control bleeding during surgery. A number of studies in animals and humans have suggested that fibrin glues of various types can reduce adhesions. One study using a similar, but not identical experimental version of Evicel did suggest that indeed this type of fibrin glue may reduce adhesions in humans.
Evicel has the advantage that is can easily be applied laparoscopically, it can be spayed over a large area, is a naturally occurring material and can control mild bleeding.
Other types of fibrin glue, such as Tisseel and Tissucol, made by Baxter has also been used by some surgeons to reduce adhesions.
Note - there are a number of important differences between different types of fibrin glue that could determine how effective each type is.
* Coseal, made by Baxter
Coseal is a two-component, synthetic product used to seal leakage after surgery on blood vessels. It has been sprayed or applied over areas of surgical injury to reduce adhesions both in animal models and in one human trial with 71 patients undergoing myomectomy.
Coseal is marketed in Europe not only as a sealant, but also to prevent or reduce post surgical adhesions. Coseal is the same as what was formerly known as Adhibit.
* Surgiwrap, made by MAST BioSurgery
SurgiWrap (and its cousins OrthoWrap and CardioWrap) is a clear thin sheet of a dissolvable polymer similar to the kind used in dissolvable sutures. Full clinical studies of the kind conducted for INTERCEED or Seprafilm showing that it prevents or reduces adhesions have not been published and the product is approved in the USA to “reinforce soft tissues where weakness exists”.
Based primarily on animal studies and due to technicalities in the regulation of medical devices in the USA, the company’s marketing literature for the USA states that the product “Maintains a physical barrier between opposing soft tissues” and “Retains tensile strength for 6-8 weeks ensuring tissue separation during the critical wound healing period” and implies that the product reduces or minimizes “Soft Tissue Attachments”. The company’s literature for Surgiwrap intended for marketing outside the USA clearly claims that that SurgiWrap “prevents adhesion formation”. Naturally this difference has come to the attention of American surgeons who have traveled abroad and combined with a number of reports of adverse events such as the presence of a tissue reaction and the emergence of fragments of the sheet through the vagina which in one case was reported to have “lacerated her partner”, the product does not seem to enjoy popular use.
* PRECLUDE Peritoneal Membrane made by WL Gore
This product is being discontinued after December 2011. It never had the same kind of formal approval in the USA that INTERCEED, Seprafilm or ADEPT did of adhesion prevention, but after enjoying a fairly long period of use to reconstruct tissues, for example in hernia repair, the claim was added sometime in the early 1990s “for use in peritoneal reconstruction where minimal adhesions to a prosthetic material are desired”. PRECLUDE is a thin sheet of porous ePTFE (Teflon). Although some studies showed in the 1990s that Preclude (previously known as GoreTex surgical Membrane) reduced adhesions, many surgeons were reluctant to use it since it did not degrade and required a subsequent operation to remove it.
Versions of the product to minimize adhesions in cardiac and cranial (dural) surgery.
Drugs for Adhesion Prevention
There are no drugs currently approved for the prevention or removal of adhesions. Research in this area, most of it in animals, has focused mainly on drugs that can be applied directly into the abdominal cavity at the time of surgery. Most of the drugs tested have been directed either at the clotting process (preventing or reversing the deposition of fibrin - the natural glue that causes the initial attachment or adhesion of tissues) or the inflammatory process (which results in the formation of scar).
Some promising clinical data did suggest that heparin, when applied to INTERCEED may not only enhance its action but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. This was never pursued formally. Data from the pivotal general surgical trial for Seprafilm in patients with ulcerative colitis undergoing bowel surgery did suggest that patients receiving long term corticosteroids prior to surgery had lower rates of adhesion formation than those that did not. The effect was best seen in patients also receiving Seprafilm.
Studies, never published but widely known to have been performed in the 1980s and 1990s using Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen and tolmetin applied as solutions to the peritoneal cavity failed to result in the use of these drugs clinically.
tPA (Tissue Plasminogen Activiator) is a drug causes the dissolution of fibrin. Several small pilot studies had been performed but never pursued and a recent study failed to show a difference between treatment and control groups.
Newer generations of these classes of drugs have been tested in animals, bit so far without any formal clinical trials. Other classes of drugs tested include anti-oxidants, anti-angiogenic drugs, anti-fibrotic drugs, hormonal drugs, cytokine inhibitors, anti-inflammatory cytokines and COX-2 inhibitors.
Hernia and Tissue Reconstruction Meshes
A number of products exist for the reinforcement of soft tissues after major dissections, including hernias. Adhesions to these meshes is a common problem and the designers of some products have attempted to reduce this problem. These products may feature claims akin to those of the Preclude products and include (not exhaustively): Sepramesh (Davol) and PROCEED (Johnson & Johnson).
These and other surgical meshes may be used not only in hernia repair but also for Pelvic Organ Prolapse and Stress Urinary Incontinence. Regarding these kinds of products in general, FDA has issued a Public Health Notification on October 20 2008. There was also an update on July 13, 2011 regarding complications associated with some of these meshes that when used for hernia repair complications include “adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.”
When used for Pelvic Organ Prolapse and Stress Urinary Incontinence the “most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence. In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.”
Since serious complications may occur with the use of Surgical Meshes it is important that you discuss with your doctor the risks and benefits of meshes as well as the type of mesh you may be given and its likelihood of producing an adverse reaction.
Other Products of Interest
* INSUFLOW, made by Lexion Medical
This novel device warms and humidifies the gases used to inflate the abdominal cavity during laparoscopic surgery. Because these cold, dry gases (carbon dioxide) are pumped at pressure they create a “wind-chill effect” which damages the surface layer (peritoneum) of organs in the abdominal cavity, a finding made in a study by Dr. Wiseman
Although the company does not claim it, it is well accepted that damage to the peritoneal layer contributes to the formation of adhesions. In addition use of the device helps to reduce hypothermia, postoperative pain and recovery time after surgery.
Products Marketed Outside of the USA
* SprayGel and SprayShield, made by Covidien
SprayShield is a synthetic two component product that forms a gel when applied to an organ. It is a modified version of SprayGel which demonstrated clinical effectiveness in reducing adhesions in small studies involving gynecologicand general surgery
Although all the details are unclear, it seems that SprayGel was discontinued because of problems relating to possible adverse reasons and the ability of the gel to form properly in the carbon dioxide environment that is used in laparoscopic surgery. SprayGel was, and SprayShield is marketed in Europe and we understand that a recent clinical trial in the USA was discontinued because the product failed to demonstrate efficacy.
* Hyalobarrier and Hyalobarrier Endo, made by Fidia Advanced Biopolymers, now Anika Therapeutics
Hyalobarrier, sometimes referred to as ACP Gel, is made from hyaluronic acid, a naturally occurring lubricant in the body.
Some small clinical trials have demonstrated effectiveness of in gynecologic surgery
* INTERCOAT, also known as Oxiplex AP made by Johnson & Johnson, licensed from Fziomed
This gel made is applied directly to raw surgical surfaces. Efficacy in gynecologic study was demonstrated in two small studies.
Study 1
Study 2
* Prevadh, made by Sofradim-Covidien in France
A collagen film and fleece composite that in animals was able to reduce adhesions even in the presence of bleeding and appeared safe in an uncontrolled clinical study of 78 patients.
--------------------------------------------------------------------------------
Products Marketed for reducing adhesions in procedures outside of the abdominal or pelvic cavities.
(This is not an exhaustive list, and it also includes products that have no formal claim of adhesion prevention)
Products (USA) Company Composition Indication
Repel CV Synthemed PLA/PEO Cardiac
TENOGLIDE Integra Collagen Tendon
Sepragel ENT
Seprapack
Genzyme Hyaluronic Acid Nasal / Sinus
Preclude Pericardial Gore ePTFE Pericardial
Preclude Dura Substitute Gore ePTFE
Products (non-USA) Company Composition Indication
INCERT-S Anika Hyaluronic Acid Spinal Surgery
ACP Gel Fidia Hyaluronic Acid Uterine Adhesions
MeroGel Fidia Hyaluronic Acid ENT
Oxiplex (also Medishield) Fziomed CMC/PEO Spinal
ADCON L Bioscompass Dextran Sulphate Spinal Surgery
ADCON T/N Biocompass Dextran Sulphate Tendon & Nerve Surgery
Products where data exists for prevention of clinical outcomes related to adhesions
Note that products may or may not have regulatory approval to market their products based on these studies. Only a selection of positive studies are shown below.
Prevention of IntraUterine Adhesions
Seprafilm Tsapanos et al., 2002
SprayGel Abbott et al., 2004
ACP Gel Guida et al., 2004
ACP Gel Acunzo et al., 2003
Intercoat Sardo et al., 2011
Prevention of adhesions after C Section
Seprafilm Fushiki H; Ikoma T; Kobayashi H, and Yoshimoto H. Efficacy of Seprafilm as an Adhesion Barrier in Cesarean Sections. Obstetric and Gynecological Treatment [Japanese]. 2005; 91(5):557-561.
Reduction of pain after adhesion-related surgery
Seprafilm Khaitan et al., 2003
Reduction of bowel obstruction
Seprafilm
Mohri et al., 2005
Fazio et al., 2006
Products where data exists for improvement of fertility after adhesion-related surgery (not necessarily with regulatory approval)
INTERCEED Sawada et al.,2000
Discontinued Products
* Sepracoat (also HAL-C), made by Genzyme was a hyaluronic acid based liquid that was used to coat tissue surfaces during surgery. It demonstrated clinical efficacy against de novo adhesions caused by tissue handling.
Its approval in the USA was rejected, and the product sold for a short time in Europe before poor sales led to its voluntary discontinuation sometime around 2000.
* INTERGEL, made by LifeCore, marketed by Johnson & Johnson was a gel of hyaluronic acid cross-linked with iron. With demonstration of clinical efficacy in the US and Europe .long it received FDA approval in 2002 after an unusual and controversial route but was withdrawn about one year later after reports of tissue reactions, increased rates of infection, late onset pain and some deaths.
Research conducted by the IAS suggested that these effects may have been more prevalent in patients who carried gene mutations for Haemochromatosis, a disorder of iron regulation, or women who had had prior hysterectomies, possibly because of an increased tendency to accumulate iron. Additional article.
* ADCON L is a gel containing Dextran Sulphate made by Gliatech for use in spinal surgery. It was approved by FDA in 1997. A version for tendon and nerve surgery was available in Europe and after a successful preclinical study conducted by Dr. Wiseman, a clinical trial, also designed by Dr. Wiseman had began to show promising results in pelvic surgery. Rapid sales of the ADCON L product began to be marred by a series of issues relating to problems in manufacturing, the company’s failure to report adverse events, and their alleged manipulation of data in a clinical trial. The company essentially placed in a “regulatory” limbo by FDA until it could, to FDA’s satisfaction put its house in order. A new management did indeed do this, but the effect of the FDA action forced the company to declare bankruptcy in 2002. Although not available in the USA, the product continues to be sold in Europe and elsewhere both in the ADCON L version and the ADCON T/N (tendon and nerve) version.
* Hyskon, made by Pharmacia, was a syrupy liquid used to expand the uterus during hysteroscpic evaluation. In the mid 1980s its was used off-label in the USA to prevent adhesions by pouring it into the abdominal cavity in the aim that it would lubricate raw tissue surfaces and prevent them from sticking. Some studies provided somewhat positive data, and while others provided the reverse and concerns of adverse reactions as well the emergence of other barriers led to its demise.
Adverse Reactions
Information about adverse reactions reported to FDA can be obtained through:
MAUDE - Manufacturer and User Facility Device Experience
If you think you have suffered an adverse reaction to any medical product, you should certainly contact your doctor and if necessary call the Emergency Services or go to the nearest Emergency Room. You are also free to report the event to the FDA by contacting the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.
Online : MedWatch Online Voluntary Reporting Form (3500)
Mail : use postage-paid FDA form 3500 available at: MedWatch Forms
Mail to:
MedWatch
5600 Fishers Lane,
Rockville, MD 20852-9787
FAX: 1-800-FDA-0178
Interested in participating in a clinical trial?
Go to ClincalTrials.gov to search for clinical trials relating to adhesions, or any other therapeutic area.
Please Note:
Information provided here is intended as a lay overview only and not as any fort of endorsement. Any product described here must be used by a medical doctorin accordance with the Instructions for Use and after taking a Patient's individual circumstances into account.
Reposted from the International Adhesion Society. Please visit the International Adhesion Society at;
http://www.adhesions.org/
--------------------------------------------------------------------------------
http://www.adhesions.org/products.htm
Products Approved by FDA for Adhesion Prevention, Reduction in Pelvice and/or Abdominal Cavities
* INTERCEED (TC7), made by Johnson & Johnson
Placed over the site of surgical injury, this knitted fabric dissolves within 30 days or so. The idea is that the sheet keeps organs apart that would otherwise stick (adhere) together. Once healing is complete, the sheet dissolves leaving the two organs properly separated.
Since 1989, it has been approved only for open (non-keyhole) gynecologic surgery with a good record of safety and effectiveness documented in this paper authored by Dr. Wiseman in 1999.
Althought it is not approved in the USA for use in laparoscopice (key-hole) surgery, INTERCEED is often used "off-label". Only small clinical studies to evaluate INTERCEED in laparoscopy have been performed with mixed results, possibly because almost perfect control of bleeding (required for INTERCEED's action) may not have been achieved, or INTERCEED was dislodged from its site of placement.
Early studies suggested that a small amount of Heparin added to the INTERCEED may not only enhance its action, but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. Unfortunately, this work was never pursued, neither was a modified form of INTERCEED, which also functioned better than the original INTERCEED, both in the absence and presence of bleeding.
* Seprafilm, made by Genzyme (previously called HAL-F)
This film looks like a thin, slightly brittle clear "fruit roll-up" that gels soon after contact with moist body tissues. It workes and is used in much the same way as INTERCEED, except that it is also approved for General Surgery. Like INTERCEED, it is not approved in the USA for laparoscopic use, aothought with considerable technical difficulty, it can be applied in laparoscopic surgery "off-label". Approved in 1996, it has now had a long history of safety and effectiveness similar to that of INTERCEED and a number of studies have preorted its use in a variety of procedures as well as the reduction of obstruction in some cases. It should not be wrapped around the bowel that has been cut open.
Some surgeons have made a gel by cutting small pieces of Seprafilm and mixing them with saline. A study conducted by Genzyme with a standard preparation called "SepraSpray" has yielded what appear to be unimpressive results.
* Adept, marketed by Baxter
Adept is a solution containing a carbohydrate polymer. A large volume (about 3 liters) is instilled into the abdominal cavity after surgery causing them to float, keeping them apart and and preventing them from sticking to each other. Because of the the composition of the product, liquid stays in the abdominal cavity for several more days that plain saline (salt) solutions commonly used by surgeons. Altough, it has the advantage that it is easy to apply and it can be used laparoscopically, the clinical data suggest that its effectiveness is at best marginally better than salt solutions, also when used in large volume.
It should be noted that small (eg 300ml) volumes of saline used to float tissues apart do not appear to reduce adhesions, thus the data from the Adept study does suggest that large volumes of physiological saline solutions may have some benefit in reducing adhesions.
--------------------------------------------------------------------------------
Products not approved for Adhesions prevention, but often used "off-label" (USA)
*Note that some of these products may be approved in countries other than the USA for adhesion prevention.
* Evicel - made by Johnson & Johnson
Evicel is a type of "Fibrin Glue", a two component product made from naturally occurring molecules extracted from human blood. It is mainly used to control bleeding during surgery. A number of studies in animals and humans have suggested that fibrin glues of various types can reduce adhesions. One study using a similar, but not identical experimental version of Evicel did suggest that indeed this type of fibrin glue may reduce adhesions in humans.
Evicel has the advantage that is can easily be applied laparoscopically, it can be spayed over a large area, is a naturally occurring material and can control mild bleeding.
Other types of fibrin glue, such as Tisseel and Tissucol, made by Baxter has also been used by some surgeons to reduce adhesions.
Note - there are a number of important differences between different types of fibrin glue that could determine how effective each type is.
* Coseal, made by Baxter
Coseal is a two-component, synthetic product used to seal leakage after surgery on blood vessels. It has been sprayed or applied over areas of surgical injury to reduce adhesions both in animal models and in one human trial with 71 patients undergoing myomectomy.
Coseal is marketed in Europe not only as a sealant, but also to prevent or reduce post surgical adhesions. Coseal is the same as what was formerly known as Adhibit.
* Surgiwrap, made by MAST BioSurgery
SurgiWrap (and its cousins OrthoWrap and CardioWrap) is a clear thin sheet of a dissolvable polymer similar to the kind used in dissolvable sutures. Full clinical studies of the kind conducted for INTERCEED or Seprafilm showing that it prevents or reduces adhesions have not been published and the product is approved in the USA to “reinforce soft tissues where weakness exists”.
Based primarily on animal studies and due to technicalities in the regulation of medical devices in the USA, the company’s marketing literature for the USA states that the product “Maintains a physical barrier between opposing soft tissues” and “Retains tensile strength for 6-8 weeks ensuring tissue separation during the critical wound healing period” and implies that the product reduces or minimizes “Soft Tissue Attachments”. The company’s literature for Surgiwrap intended for marketing outside the USA clearly claims that that SurgiWrap “prevents adhesion formation”. Naturally this difference has come to the attention of American surgeons who have traveled abroad and combined with a number of reports of adverse events such as the presence of a tissue reaction and the emergence of fragments of the sheet through the vagina which in one case was reported to have “lacerated her partner”, the product does not seem to enjoy popular use.
* PRECLUDE Peritoneal Membrane made by WL Gore
This product is being discontinued after December 2011. It never had the same kind of formal approval in the USA that INTERCEED, Seprafilm or ADEPT did of adhesion prevention, but after enjoying a fairly long period of use to reconstruct tissues, for example in hernia repair, the claim was added sometime in the early 1990s “for use in peritoneal reconstruction where minimal adhesions to a prosthetic material are desired”. PRECLUDE is a thin sheet of porous ePTFE (Teflon). Although some studies showed in the 1990s that Preclude (previously known as GoreTex surgical Membrane) reduced adhesions, many surgeons were reluctant to use it since it did not degrade and required a subsequent operation to remove it.
Versions of the product to minimize adhesions in cardiac and cranial (dural) surgery.
Drugs for Adhesion Prevention
There are no drugs currently approved for the prevention or removal of adhesions. Research in this area, most of it in animals, has focused mainly on drugs that can be applied directly into the abdominal cavity at the time of surgery. Most of the drugs tested have been directed either at the clotting process (preventing or reversing the deposition of fibrin - the natural glue that causes the initial attachment or adhesion of tissues) or the inflammatory process (which results in the formation of scar).
Some promising clinical data did suggest that heparin, when applied to INTERCEED may not only enhance its action but also overcome the detrimental effect that bleeding has on the beneficial action of INTERCEED. This was never pursued formally. Data from the pivotal general surgical trial for Seprafilm in patients with ulcerative colitis undergoing bowel surgery did suggest that patients receiving long term corticosteroids prior to surgery had lower rates of adhesion formation than those that did not. The effect was best seen in patients also receiving Seprafilm.
Studies, never published but widely known to have been performed in the 1980s and 1990s using Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen and tolmetin applied as solutions to the peritoneal cavity failed to result in the use of these drugs clinically.
tPA (Tissue Plasminogen Activiator) is a drug causes the dissolution of fibrin. Several small pilot studies had been performed but never pursued and a recent study failed to show a difference between treatment and control groups.
Newer generations of these classes of drugs have been tested in animals, bit so far without any formal clinical trials. Other classes of drugs tested include anti-oxidants, anti-angiogenic drugs, anti-fibrotic drugs, hormonal drugs, cytokine inhibitors, anti-inflammatory cytokines and COX-2 inhibitors.
Hernia and Tissue Reconstruction Meshes
A number of products exist for the reinforcement of soft tissues after major dissections, including hernias. Adhesions to these meshes is a common problem and the designers of some products have attempted to reduce this problem. These products may feature claims akin to those of the Preclude products and include (not exhaustively): Sepramesh (Davol) and PROCEED (Johnson & Johnson).
These and other surgical meshes may be used not only in hernia repair but also for Pelvic Organ Prolapse and Stress Urinary Incontinence. Regarding these kinds of products in general, FDA has issued a Public Health Notification on October 20 2008. There was also an update on July 13, 2011 regarding complications associated with some of these meshes that when used for hernia repair complications include “adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.”
When used for Pelvic Organ Prolapse and Stress Urinary Incontinence the “most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence. In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.”
Since serious complications may occur with the use of Surgical Meshes it is important that you discuss with your doctor the risks and benefits of meshes as well as the type of mesh you may be given and its likelihood of producing an adverse reaction.
Other Products of Interest
* INSUFLOW, made by Lexion Medical
This novel device warms and humidifies the gases used to inflate the abdominal cavity during laparoscopic surgery. Because these cold, dry gases (carbon dioxide) are pumped at pressure they create a “wind-chill effect” which damages the surface layer (peritoneum) of organs in the abdominal cavity, a finding made in a study by Dr. Wiseman
Although the company does not claim it, it is well accepted that damage to the peritoneal layer contributes to the formation of adhesions. In addition use of the device helps to reduce hypothermia, postoperative pain and recovery time after surgery.
Products Marketed Outside of the USA
* SprayGel and SprayShield, made by Covidien
SprayShield is a synthetic two component product that forms a gel when applied to an organ. It is a modified version of SprayGel which demonstrated clinical effectiveness in reducing adhesions in small studies involving gynecologicand general surgery
Although all the details are unclear, it seems that SprayGel was discontinued because of problems relating to possible adverse reasons and the ability of the gel to form properly in the carbon dioxide environment that is used in laparoscopic surgery. SprayGel was, and SprayShield is marketed in Europe and we understand that a recent clinical trial in the USA was discontinued because the product failed to demonstrate efficacy.
* Hyalobarrier and Hyalobarrier Endo, made by Fidia Advanced Biopolymers, now Anika Therapeutics
Hyalobarrier, sometimes referred to as ACP Gel, is made from hyaluronic acid, a naturally occurring lubricant in the body.
Some small clinical trials have demonstrated effectiveness of in gynecologic surgery
* INTERCOAT, also known as Oxiplex AP made by Johnson & Johnson, licensed from Fziomed
This gel made is applied directly to raw surgical surfaces. Efficacy in gynecologic study was demonstrated in two small studies.
Study 1
Study 2
* Prevadh, made by Sofradim-Covidien in France
A collagen film and fleece composite that in animals was able to reduce adhesions even in the presence of bleeding and appeared safe in an uncontrolled clinical study of 78 patients.
--------------------------------------------------------------------------------
Products Marketed for reducing adhesions in procedures outside of the abdominal or pelvic cavities.
(This is not an exhaustive list, and it also includes products that have no formal claim of adhesion prevention)
Products (USA) Company Composition Indication
Repel CV Synthemed PLA/PEO Cardiac
TENOGLIDE Integra Collagen Tendon
Sepragel ENT
Seprapack
Genzyme Hyaluronic Acid Nasal / Sinus
Preclude Pericardial Gore ePTFE Pericardial
Preclude Dura Substitute Gore ePTFE
Products (non-USA) Company Composition Indication
INCERT-S Anika Hyaluronic Acid Spinal Surgery
ACP Gel Fidia Hyaluronic Acid Uterine Adhesions
MeroGel Fidia Hyaluronic Acid ENT
Oxiplex (also Medishield) Fziomed CMC/PEO Spinal
ADCON L Bioscompass Dextran Sulphate Spinal Surgery
ADCON T/N Biocompass Dextran Sulphate Tendon & Nerve Surgery
Products where data exists for prevention of clinical outcomes related to adhesions
Note that products may or may not have regulatory approval to market their products based on these studies. Only a selection of positive studies are shown below.
Prevention of IntraUterine Adhesions
Seprafilm Tsapanos et al., 2002
SprayGel Abbott et al., 2004
ACP Gel Guida et al., 2004
ACP Gel Acunzo et al., 2003
Intercoat Sardo et al., 2011
Prevention of adhesions after C Section
Seprafilm Fushiki H; Ikoma T; Kobayashi H, and Yoshimoto H. Efficacy of Seprafilm as an Adhesion Barrier in Cesarean Sections. Obstetric and Gynecological Treatment [Japanese]. 2005; 91(5):557-561.
Reduction of pain after adhesion-related surgery
Seprafilm Khaitan et al., 2003
Reduction of bowel obstruction
Seprafilm
Mohri et al., 2005
Fazio et al., 2006
Products where data exists for improvement of fertility after adhesion-related surgery (not necessarily with regulatory approval)
INTERCEED Sawada et al.,2000
Discontinued Products
* Sepracoat (also HAL-C), made by Genzyme was a hyaluronic acid based liquid that was used to coat tissue surfaces during surgery. It demonstrated clinical efficacy against de novo adhesions caused by tissue handling.
Its approval in the USA was rejected, and the product sold for a short time in Europe before poor sales led to its voluntary discontinuation sometime around 2000.
* INTERGEL, made by LifeCore, marketed by Johnson & Johnson was a gel of hyaluronic acid cross-linked with iron. With demonstration of clinical efficacy in the US and Europe .long it received FDA approval in 2002 after an unusual and controversial route but was withdrawn about one year later after reports of tissue reactions, increased rates of infection, late onset pain and some deaths.
Research conducted by the IAS suggested that these effects may have been more prevalent in patients who carried gene mutations for Haemochromatosis, a disorder of iron regulation, or women who had had prior hysterectomies, possibly because of an increased tendency to accumulate iron. Additional article.
* ADCON L is a gel containing Dextran Sulphate made by Gliatech for use in spinal surgery. It was approved by FDA in 1997. A version for tendon and nerve surgery was available in Europe and after a successful preclinical study conducted by Dr. Wiseman, a clinical trial, also designed by Dr. Wiseman had began to show promising results in pelvic surgery. Rapid sales of the ADCON L product began to be marred by a series of issues relating to problems in manufacturing, the company’s failure to report adverse events, and their alleged manipulation of data in a clinical trial. The company essentially placed in a “regulatory” limbo by FDA until it could, to FDA’s satisfaction put its house in order. A new management did indeed do this, but the effect of the FDA action forced the company to declare bankruptcy in 2002. Although not available in the USA, the product continues to be sold in Europe and elsewhere both in the ADCON L version and the ADCON T/N (tendon and nerve) version.
* Hyskon, made by Pharmacia, was a syrupy liquid used to expand the uterus during hysteroscpic evaluation. In the mid 1980s its was used off-label in the USA to prevent adhesions by pouring it into the abdominal cavity in the aim that it would lubricate raw tissue surfaces and prevent them from sticking. Some studies provided somewhat positive data, and while others provided the reverse and concerns of adverse reactions as well the emergence of other barriers led to its demise.
Adverse Reactions
Information about adverse reactions reported to FDA can be obtained through:
MAUDE - Manufacturer and User Facility Device Experience
If you think you have suffered an adverse reaction to any medical product, you should certainly contact your doctor and if necessary call the Emergency Services or go to the nearest Emergency Room. You are also free to report the event to the FDA by contacting the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.
Online : MedWatch Online Voluntary Reporting Form (3500)
Mail : use postage-paid FDA form 3500 available at: MedWatch Forms
Mail to:
MedWatch
5600 Fishers Lane,
Rockville, MD 20852-9787
FAX: 1-800-FDA-0178
Interested in participating in a clinical trial?
Go to ClincalTrials.gov to search for clinical trials relating to adhesions, or any other therapeutic area.
Prevention of peritoneal adhesions: A promising role for gene therapy
World J Gastroenterol. 2011 December 14; 17(46): 5049–5058.
Published online 2011 December 14. doi: 10.3748/wjg.v17.i46.5049 PMCID: PMC3235588
Copyright ©2011 Baishideng Publishing Group Co., Limited. All rights reserved.
Prevention of peritoneal adhesions: A promising role for gene therapy
Hussein M Atta
Hussein M Atta, Department of Surgery, Faculty of Medicine, Minia University, El-Minia 61519, Egypt
Author contributions: Atta HM solely contributed to this paper.
Correspondence to: Hussein M Atta, MD, PhD, Professor, Department of Surgery, Faculty of Medicine, Minia University, Misr-Aswan Road, El-Minia 61519, Egypt. attahm@ems.org.egTelephone: +20-1-001407222 Fax: +20-2-22917077
Received May 15, 2011; Revised July 14, 2011; Accepted July 21, 2011.
Abstract:
Published online 2011 December 14. doi: 10.3748/wjg.v17.i46.5049 PMCID: PMC3235588
Copyright ©2011 Baishideng Publishing Group Co., Limited. All rights reserved.
Prevention of peritoneal adhesions: A promising role for gene therapy
Hussein M Atta
Hussein M Atta, Department of Surgery, Faculty of Medicine, Minia University, El-Minia 61519, Egypt
Author contributions: Atta HM solely contributed to this paper.
Correspondence to: Hussein M Atta, MD, PhD, Professor, Department of Surgery, Faculty of Medicine, Minia University, Misr-Aswan Road, El-Minia 61519, Egypt. attahm@ems.org.egTelephone: +20-1-001407222 Fax: +20-2-22917077
Received May 15, 2011; Revised July 14, 2011; Accepted July 21, 2011.
Abstract:
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.
Keywords: Peritoneal adhesions, Tissue plasminogen activator, Gene therapy, Plasminogen activator inhibitor, Tissue inhibitor of metalloproteinase, Transforming growth factor β
Full article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3235588/?tool=pubmed
Full article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3235588/?tool=pubmed
Saturday, January 14, 2012
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Date Issued: July 13, 2011
Audience:
Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence
Health care providers involved in the care of patients with surgical mesh implanted to repair pelvic organ prolapse and/or stress urinary incontinence
Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence
Medical Specialties: gynecology, urogynecology, urology, general surgery, internal medicine, family practice, emergency medicine
Device:
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
Background:
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.
Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.
Purpose:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.
Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.
The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.
For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.1
Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.
From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.
In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.
In particular, the literature review revealed that:
Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.
The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.
Recommendations for Health Care Providers:
As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:
Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.
Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.
In addition, the FDA also recommends that health care providers:
Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
Consider these factors before placing surgical mesh:
Surgical mesh is a permanent implant that may make future surgical repair more challenging.
A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.
Recommendations for Patients:
Before Surgery
Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.
In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used:
Are you planning to use mesh in my surgery?
Why do you think I am a good candidate for surgical mesh?
Why is surgical mesh being chosen for my repair?
What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
What can I expect to feel after surgery and for how long?
Which specific side effects should I report to you after the surgery?
What if the mesh surgery doesn’t correct my problem?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
After Surgery
Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.
Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
Talk to your health care provider about any questions you may have.
If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.
FDA Activities:
The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will:
Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.
Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now being marketed and those that will be reviewed for marketing in the future.
Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements2 should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations3.
To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available:
Manufacturer's name
Product name (brand name)
Catalog number
Lot number
Size
Date of implant
Date of explant (if mesh was removed)
Details of the adverse event and medical and/or surgical interventions (if required)
Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.
-Additional Information
Urogynecologic Surgical Mesh Implants4
Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July 2011) (PDF - 243KB)5
Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks6
Federal Register Notice: Urogynecologic Surgical Mesh7
Federal Register Notice Ammendment: Urogynecologic Surgical Mesh8
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
Date Issued: July 13, 2011
Audience:
Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence
Health care providers involved in the care of patients with surgical mesh implanted to repair pelvic organ prolapse and/or stress urinary incontinence
Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence
Medical Specialties: gynecology, urogynecology, urology, general surgery, internal medicine, family practice, emergency medicine
Device:
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
Background:
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.
Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.
Purpose:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.
Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.
The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.
For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.1
Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.
From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.
In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.
In particular, the literature review revealed that:
Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.
The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.
Recommendations for Health Care Providers:
As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:
Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.
Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.
In addition, the FDA also recommends that health care providers:
Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
Consider these factors before placing surgical mesh:
Surgical mesh is a permanent implant that may make future surgical repair more challenging.
A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.
Recommendations for Patients:
Before Surgery
Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.
In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used:
Are you planning to use mesh in my surgery?
Why do you think I am a good candidate for surgical mesh?
Why is surgical mesh being chosen for my repair?
What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
What can I expect to feel after surgery and for how long?
Which specific side effects should I report to you after the surgery?
What if the mesh surgery doesn’t correct my problem?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
After Surgery
Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.
Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
Talk to your health care provider about any questions you may have.
If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.
FDA Activities:
The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will:
Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.
Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now being marketed and those that will be reviewed for marketing in the future.
Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements2 should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations3.
To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available:
Manufacturer's name
Product name (brand name)
Catalog number
Lot number
Size
Date of implant
Date of explant (if mesh was removed)
Details of the adverse event and medical and/or surgical interventions (if required)
Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.
-Additional Information
Urogynecologic Surgical Mesh Implants4
Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July 2011) (PDF - 243KB)5
Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks6
Federal Register Notice: Urogynecologic Surgical Mesh7
Federal Register Notice Ammendment: Urogynecologic Surgical Mesh8
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
Thursday, January 12, 2012
What is adhesion related disorder (ARD)?
What is adhesion related disorder (ARD)?
Adhesion related disorder is a complex set of symptoms related to adhesions. Patient’s primary complaint is usually chronic abdominal pain. Their symptoms can be primarily in one area of the abdomen but are often generalized, vague, crampy and difficult to define. The symptoms of ARD could include:
•Chronic pain
•Infertility
•Bowel obstruction
•Gastro-esophageal reflux disease, (GERD)
•Urinary Bladder dysfunction
•Pain and difficulty having a bowel movement
•Pain on movement such as: Walking, sitting or laying in certain positions.
•Loss of Nutrients due to poor eating habits or loss of appetite.
•Loss of employment due to lost work days
•Loss of family and social life
•Emotional Disorders such as: Depression, Thoughts of Suicide, Hopelessness
Other intestinal problems can accompany the pain. Constipation or obstruction is sometimes encountered. Alternating constipation with diarrhea from partial obstruction can also be seen. Symptoms may also be related
Adhesion related disorder is a complex set of symptoms related to adhesions. Patient’s primary complaint is usually chronic abdominal pain. Their symptoms can be primarily in one area of the abdomen but are often generalized, vague, crampy and difficult to define. The symptoms of ARD could include:
•Chronic pain
•Infertility
•Bowel obstruction
•Gastro-esophageal reflux disease, (GERD)
•Urinary Bladder dysfunction
•Pain and difficulty having a bowel movement
•Pain on movement such as: Walking, sitting or laying in certain positions.
•Loss of Nutrients due to poor eating habits or loss of appetite.
•Loss of employment due to lost work days
•Loss of family and social life
•Emotional Disorders such as: Depression, Thoughts of Suicide, Hopelessness
Other intestinal problems can accompany the pain. Constipation or obstruction is sometimes encountered. Alternating constipation with diarrhea from partial obstruction can also be seen. Symptoms may also be related
Wednesday, January 11, 2012
Beyonce Says Birth ‘Natural,’ Despite Cesarean Reports
Beyonce Says Birth ‘Natural,’ Despite Cesarean Reports: Royal rap couple Beyonce and Jay-Z have issued a statement that she had given birth “naturally” to daughter Blue Ivy on Jan. 7. But first reports from TMZ prompted Internet buzz over questions about whether the Cesarean birth had been planned. Some asked: “Is natural...
Robot performs hysterectomy on South Bend woman
Robot performs hysterectomy on South Bend woman
South Bend, Ind.
http://www.wndu.com/hometop/headlines/Robot_performs_hysterectomy_on_South_Bend_woman_136830448.html
A South Bend woman wanted to make sure the estrogen factor that led to her breast cancer did not spread to her female organs, so her doctor offered her a laparoscopic robotic hysterectomy
Posted: 3:49 PM Jan 6, 2012
Reporter: Maureen McFadden
Email Address: maureen.mcfadden@wndu.com
South Bend, Ind.
http://www.wndu.com/hometop/headlines/Robot_performs_hysterectomy_on_South_Bend_woman_136830448.html
A South Bend woman wanted to make sure the estrogen factor that led to her breast cancer did not spread to her female organs, so her doctor offered her a laparoscopic robotic hysterectomy
Posted: 3:49 PM Jan 6, 2012
Reporter: Maureen McFadden
Email Address: maureen.mcfadden@wndu.com
Tuesday, January 10, 2012
FDA Whose who in adhesion barriers
FDA Home; Medical Devices Databases Establishment Registration Device Listing1 to 12 of 12 Results
Results per Page 35102550100500
Product Code : MCN
Establishment
Name
Registration Number Current
Registration Yr
BAXTER AG AUSTRIA
9616848 2012
barrier, absorable, adhesion - ADEPT
Manufacturer
BAXTER HEALTHCARE CORPORATION CA/USA
2032282 2012
barrier, absorable, adhesion - Adept
Specification Developer
Covidien, formerly Confluent Surgical, Inc. MA/USA
3008196149 2012
barrier, absorable, adhesion - Spray Gel; Spray Shield
Specification Developer
Covidien, formerly US Surgical a divison of Tyco Healthcare CT/USA
1219930 2012
barrier, absorable, adhesion - Spray Gel; Spray Shield
U.S. Manufacturer of Export Only Devices
ETHICON INC SWITZERLAND
3006795579 2012
barrier, absorable, adhesion
Manufacturer
ETHICON INC SWITZERLAND
3003702646 2012
barrier, absorable, adhesion
Manufacturer
ETHICON, INC. NJ/USA
2210968 2012
barrier, absorable, adhesion
Specification Developer
ETHICON, LLC. PR/USA
2648650 2012
barrier, absorable, adhesion
Manufacturer
FZIOMED, INC. CA/USA
2031637 2012
barrier, absorable, adhesion - Ethicon Intercoat; Oxiplex/AP Gel
U.S. Manufacturer of Export Only Devices
GENZYME CORPORATION MA/USA
1220423 2012
barrier, absorable, adhesion - Seprafilm Adhesion Barrier
Manufacturer
NORAMCO, INC. GA/USA
1033845 2012
barrier, absorable, adhesion
Manufacturer
Pathfinder Cell Therapy, Inc. MA/USA
2248031 2012
barrier, absorable, adhesion - REPEL-CV
Specification Developer
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?start_search=1&establishmentName=&StateName=&CountryName=
&RegistrationNumber=&OwnerOperatorNumber=&OwnerOperatorName=&ProductCode=MCN&DeviceName=&ProprietaryName=&establishmentType=&PAGENUM=5 0
Results per Page 35102550100500
Product Code : MCN
Establishment
Name
Registration Number Current
Registration Yr
BAXTER AG AUSTRIA
9616848 2012
barrier, absorable, adhesion - ADEPT
Manufacturer
BAXTER HEALTHCARE CORPORATION CA/USA
2032282 2012
barrier, absorable, adhesion - Adept
Specification Developer
Covidien, formerly Confluent Surgical, Inc. MA/USA
3008196149 2012
barrier, absorable, adhesion - Spray Gel; Spray Shield
Specification Developer
Covidien, formerly US Surgical a divison of Tyco Healthcare CT/USA
1219930 2012
barrier, absorable, adhesion - Spray Gel; Spray Shield
U.S. Manufacturer of Export Only Devices
ETHICON INC SWITZERLAND
3006795579 2012
barrier, absorable, adhesion
Manufacturer
ETHICON INC SWITZERLAND
3003702646 2012
barrier, absorable, adhesion
Manufacturer
ETHICON, INC. NJ/USA
2210968 2012
barrier, absorable, adhesion
Specification Developer
ETHICON, LLC. PR/USA
2648650 2012
barrier, absorable, adhesion
Manufacturer
FZIOMED, INC. CA/USA
2031637 2012
barrier, absorable, adhesion - Ethicon Intercoat; Oxiplex/AP Gel
U.S. Manufacturer of Export Only Devices
GENZYME CORPORATION MA/USA
1220423 2012
barrier, absorable, adhesion - Seprafilm Adhesion Barrier
Manufacturer
NORAMCO, INC. GA/USA
1033845 2012
barrier, absorable, adhesion
Manufacturer
Pathfinder Cell Therapy, Inc. MA/USA
2248031 2012
barrier, absorable, adhesion - REPEL-CV
Specification Developer
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?start_search=1&establishmentName=&StateName=&CountryName=
&RegistrationNumber=&OwnerOperatorNumber=&OwnerOperatorName=&ProductCode=MCN&DeviceName=&ProprietaryName=&establishmentType=&PAGENUM=5 0
Progel® Adhesion Barrier Sealant Receives CE Mark
Progel® Adhesion Barrier Sealant Receives CE Mark
January 09, 2012 08:15 AM Eastern Time
Neomend Strengthens Position in Europe with Unique Sealant Technology
IRVINE, Calif.--(BUSINESS WIRE)--Neomend, Inc., a leading innovator in sealant and adhesion-prevention products for the surgical marketplace, announced it has received the European Union CE Mark for the company’s Progel® Adhesion Barrier (AB) product.
Read the rest of the press release here: http://www.businesswire.com/news/home/20120109005499/en/Progel%C2%AE-Adhesion-Barrier-Sealant-Receives-CE-Mark
January 09, 2012 08:15 AM Eastern Time
Neomend Strengthens Position in Europe with Unique Sealant Technology
IRVINE, Calif.--(BUSINESS WIRE)--Neomend, Inc., a leading innovator in sealant and adhesion-prevention products for the surgical marketplace, announced it has received the European Union CE Mark for the company’s Progel® Adhesion Barrier (AB) product.
Read the rest of the press release here: http://www.businesswire.com/news/home/20120109005499/en/Progel%C2%AE-Adhesion-Barrier-Sealant-Receives-CE-Mark
Friday, January 06, 2012
A direct comparison of seprafilm, adept, intercoat, and spraygel for adhesion prophylaxis.
J Surg Res. 2010 Jun 15;161(2):246-9. Epub 2008 Dec 10.
A direct comparison of seprafilm, adept, intercoat, and spraygel for adhesion prophylaxis.
Rajab TK, Wallwiener M, Planck C, Brochhausen C, Kraemer B, Wallwiener CW.
SourceUniversity of Tübingen, Tübingen, Germany. Taufiek.Rajab@imperial.ac.uk
Abstract
BACKGROUND: Commercially available agents for adhesion prophylaxis are legion but there is a lack of direct comparisons between them. Here we compare four of the most commonly used adhesion barriers against a control group in a clinically relevant rat model.
MATERIAL AND METHODS: Standardized lesions were created in Wistar rats using electrocautery and suturing. Subsequently, the experimental lesions were treated with Seprafilm (n = 30), Adept (n = 30), Intercoat (n = 30), Spraygel (n = 30), or no barrier (n = 30). The resulting adhesions were examined 14 d postoperatively.
RESULTS: The mean area covered by adhesion was 77% in the control group, 46% in animals treated with Seprafilm, 54% in animals treated with Adept, 55% in animals treated with Intercoat, and 68% in animals treated with Spraygel. The adhesion-free incidence was 20% (n = 6) of lesions treated with Seprafilm, 20% (n = 6) of lesions treated with Intercoat, 3% of lesions treated with Spraygel (n = 1), and 0% of lesions treated with Adept or the control group.
CONCLUSIONS: There were statistically significant differences between the barriers with regards to the area covered by adhesions and the adhesion-free incidence. In spite of this, a significant adhesion burden remains with all of the tested barriers.
http://www.ncbi.nlm.nih.gov/pubmed/19375716
A direct comparison of seprafilm, adept, intercoat, and spraygel for adhesion prophylaxis.
Rajab TK, Wallwiener M, Planck C, Brochhausen C, Kraemer B, Wallwiener CW.
SourceUniversity of Tübingen, Tübingen, Germany. Taufiek.Rajab@imperial.ac.uk
Abstract
BACKGROUND: Commercially available agents for adhesion prophylaxis are legion but there is a lack of direct comparisons between them. Here we compare four of the most commonly used adhesion barriers against a control group in a clinically relevant rat model.
MATERIAL AND METHODS: Standardized lesions were created in Wistar rats using electrocautery and suturing. Subsequently, the experimental lesions were treated with Seprafilm (n = 30), Adept (n = 30), Intercoat (n = 30), Spraygel (n = 30), or no barrier (n = 30). The resulting adhesions were examined 14 d postoperatively.
RESULTS: The mean area covered by adhesion was 77% in the control group, 46% in animals treated with Seprafilm, 54% in animals treated with Adept, 55% in animals treated with Intercoat, and 68% in animals treated with Spraygel. The adhesion-free incidence was 20% (n = 6) of lesions treated with Seprafilm, 20% (n = 6) of lesions treated with Intercoat, 3% of lesions treated with Spraygel (n = 1), and 0% of lesions treated with Adept or the control group.
CONCLUSIONS: There were statistically significant differences between the barriers with regards to the area covered by adhesions and the adhesion-free incidence. In spite of this, a significant adhesion burden remains with all of the tested barriers.
http://www.ncbi.nlm.nih.gov/pubmed/19375716
Monday, January 02, 2012
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