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
Showing posts with label SprayGel. Show all posts
Showing posts with label SprayGel. Show all posts
Friday, January 06, 2012
Saturday, June 25, 2011
Seprafilm death goes unreported to FDA
I am Mrs. Heisner's daughter. I realize that this is not the proper forum to discuss what happened to my mother and our family. A proper forum would be in a court of law, however, because we have been denied that forum, I would like to take this opportunity to tell my mother's story and, by doing so, illustrate just how confused our legal system has become.
My mother died after experiencing what we suspect was a massive reaction to Seprafilm. Seprafilm is a class 3 medical device. It is a bioresorbable membrane manufactured and sold by Genzyme to prevent adhesions following surgery. It is absorbed into the body several days after being placed. My mother didn't ask that Seprafilm be placed in her nor did our family. During routine gynecological surgery, it was discovered that she had adhesions in her small bowel area and so the surgeons “took care of it” while they had her in the operating room. After removing the adhesions, Seprafilm was placed on her small bowel to prevent the formation of further adhesions. It appeared that the surgery had gone well. After four days, she was sent home from the hospital. Within 24 hours, she was unable to keep down any food and became severely dehydrated. She was readmitted to the hospital a week after her surgery and, when the doctors re-opened her to discover what was going on, they found that her small bowel had entirely matted together. The doctor described it as looking and reacting like a bowl of left over spaghetti. We were also told that her intestines were “concrete” or, in other words, dead. The doctors had never seen this reaction and had no idea what to do. My mother spent three weeks in intensive care. Her system totally failed. Ultimately, we made the painful decision to remove her from life-support and she passed away.
I am describing this because we later learned that other people have reacted in a very similar way after receiving Seprafilm. Although most people didn't die as a result of their reaction, they did appear to be fine after Seprafilm was placed and then, within a few days, the reaction became apparent. We know this is the case because we have read adverse event reports on the FDA's MAUDE database that appear to mirror my mother's reaction. MAUDE, in fact, has 302 adverse event reports for Seprafilm, 14 of which are reports of deaths.
My mother's doctor reported her reaction while she was in intensive care. Genzyme provided their report to the FDA during that time, as well. They stated that the event type was “injury” and the patient outcome “required intervention”. There are no reports from Genzyme on the MAUDE database that state that my mother's outcome was death. I suspect that they reported to the FDA so quickly because they wanted to avoid having to file such a report.
My family decided to bring a lawsuit against Genzyme because we want them to figure out why people are reacting in this way after Seprafilm is used. We also want them to tell doctors about the possibility of this reaction and let them know what to do if it happens. We consider that to be Genzyme's responsibility, not ours. And yet, in order to be granted the privilege of standing before a judge and telling him or her our situation, we feel as though we have to tell the judge what exactly went wrong. We don't know why our mother reacted like she did, we only know that she reacted and died and there is no doubt in our minds that the reaction was caused by Seprafilm.
10:33 AM
Laura (cont) said...
So now, what seems like such a basic right, our right to a day in court, has been taken away from us because of what we consider “loopholes” that lawyers have discovered and made law. Even though we suspect that Genzyme has not reported properly to the FDA, because of Buckman, we can't claim it. Even though we suspect that Genzyme is not providing the warnings that they should on Seprafilm's labeling, because of Riegel, we can't claim it. We are left with absolutely no recourse. Jayne Heisner's life has been taken and the only thing that we can do is to let people know what happened on this blog.
Ultimately, I hope that someone from the FDA reads this and discovers why Genzyme has been allowed to sell a product that can possibly cause such catastrophic outcomes and not warn people of this possibility. I hope that someone from Congress reads this and decides that the Medical Device Safety Act needs to be passed quickly. I hope that someone from Genzyme reads this and decides that something should be done. If anyone from the FDA , Congress or Genzyme would like to contact me, my email is Lauras6320@yahoo.com. I would be happy discuss this with them and then, possibly something good will come from this horrible situation.
10:36 AM
ARTILCLE THIS COMMENT WAS FOUND WITH
Friday, March 12, 2010
Heisner - Strike 3
Like a bad penny, this Heisner v. Genzyme complaint keeps turning up, getting dismissed for lack of facts, and coming back again in yet another iteration. Now at the "third amended" stage, it's been dismissed again. See Heisner v. Genzyme Corp., No. 08-C-593, slip op. (N.D. Ill. March 8, 2010). As you'll see from our device preemption scorecard, previous versions were dismissed at Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008) (plaintiff didn't pleas any parallel claims), and Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009) (negligence per se claims weren't parallel). Heisner has now been around for some two years and the plaintiffs haven't mustered a decent complaint yet.
Strike three and you're out? Yes. This time the court dismissed the complaint with prejudice. Slip op. at 8.
Anyway, the latest decision, which we'll call "Heisner III," found essentially more of the same. Each time plaintiff gets told to go back to the drawing board, he comes back with more words and less (or at least no more) substance. There doesn't seem to be any way around preemption in this case, as much as plaintiff has tried. You can't have a "parallel" claim that isn't really parallel - or as the court puts it, "state and federal requirements are not equivalent if a manufacturer could be held liable under state law while complying with federal requirements." Slip op. at 5 (citation omitted).
This time the plaintiff tried to equate the FDA's CBE warning update regulations with a common law claim for post-sale duty to warn. But that didn't fare any better (even after plaintiff belated discovered that the CBE regulation for devices was different than the one for drugs), because the CBE regulation is voluntary, whereas the tort claim would make it mandatory. Slip op. at 5-6.
Everything else in the plaintiff's, longer complaint remained too vague and devoid of facts. "Plaintiff utilizes more words, but verbosity cannot substitute for factual allegations." Slip op. at 7.
A claimed failure to file adverse reaction reports didn't constitute a product defect. Slip op. at 6 ("failure to report adverse events to the FDA may violate the FDCA, but does not constitute a product “condition” or defect"). Negligence per se claims still couldn't possibly be causal, since they postdated the alleged injury. Id.
We thank another of our anonymous (by request) readers for passing Heisner III along.
http://druganddevicelaw.blogspot.com/2010/03/heisner-strike-3.html
My mother died after experiencing what we suspect was a massive reaction to Seprafilm. Seprafilm is a class 3 medical device. It is a bioresorbable membrane manufactured and sold by Genzyme to prevent adhesions following surgery. It is absorbed into the body several days after being placed. My mother didn't ask that Seprafilm be placed in her nor did our family. During routine gynecological surgery, it was discovered that she had adhesions in her small bowel area and so the surgeons “took care of it” while they had her in the operating room. After removing the adhesions, Seprafilm was placed on her small bowel to prevent the formation of further adhesions. It appeared that the surgery had gone well. After four days, she was sent home from the hospital. Within 24 hours, she was unable to keep down any food and became severely dehydrated. She was readmitted to the hospital a week after her surgery and, when the doctors re-opened her to discover what was going on, they found that her small bowel had entirely matted together. The doctor described it as looking and reacting like a bowl of left over spaghetti. We were also told that her intestines were “concrete” or, in other words, dead. The doctors had never seen this reaction and had no idea what to do. My mother spent three weeks in intensive care. Her system totally failed. Ultimately, we made the painful decision to remove her from life-support and she passed away.
I am describing this because we later learned that other people have reacted in a very similar way after receiving Seprafilm. Although most people didn't die as a result of their reaction, they did appear to be fine after Seprafilm was placed and then, within a few days, the reaction became apparent. We know this is the case because we have read adverse event reports on the FDA's MAUDE database that appear to mirror my mother's reaction. MAUDE, in fact, has 302 adverse event reports for Seprafilm, 14 of which are reports of deaths.
My mother's doctor reported her reaction while she was in intensive care. Genzyme provided their report to the FDA during that time, as well. They stated that the event type was “injury” and the patient outcome “required intervention”. There are no reports from Genzyme on the MAUDE database that state that my mother's outcome was death. I suspect that they reported to the FDA so quickly because they wanted to avoid having to file such a report.
My family decided to bring a lawsuit against Genzyme because we want them to figure out why people are reacting in this way after Seprafilm is used. We also want them to tell doctors about the possibility of this reaction and let them know what to do if it happens. We consider that to be Genzyme's responsibility, not ours. And yet, in order to be granted the privilege of standing before a judge and telling him or her our situation, we feel as though we have to tell the judge what exactly went wrong. We don't know why our mother reacted like she did, we only know that she reacted and died and there is no doubt in our minds that the reaction was caused by Seprafilm.
10:33 AM
Laura (cont) said...
So now, what seems like such a basic right, our right to a day in court, has been taken away from us because of what we consider “loopholes” that lawyers have discovered and made law. Even though we suspect that Genzyme has not reported properly to the FDA, because of Buckman, we can't claim it. Even though we suspect that Genzyme is not providing the warnings that they should on Seprafilm's labeling, because of Riegel, we can't claim it. We are left with absolutely no recourse. Jayne Heisner's life has been taken and the only thing that we can do is to let people know what happened on this blog.
Ultimately, I hope that someone from the FDA reads this and discovers why Genzyme has been allowed to sell a product that can possibly cause such catastrophic outcomes and not warn people of this possibility. I hope that someone from Congress reads this and decides that the Medical Device Safety Act needs to be passed quickly. I hope that someone from Genzyme reads this and decides that something should be done. If anyone from the FDA , Congress or Genzyme would like to contact me, my email is Lauras6320@yahoo.com. I would be happy discuss this with them and then, possibly something good will come from this horrible situation.
10:36 AM
ARTILCLE THIS COMMENT WAS FOUND WITH
Friday, March 12, 2010
Heisner - Strike 3
Like a bad penny, this Heisner v. Genzyme complaint keeps turning up, getting dismissed for lack of facts, and coming back again in yet another iteration. Now at the "third amended" stage, it's been dismissed again. See Heisner v. Genzyme Corp., No. 08-C-593, slip op. (N.D. Ill. March 8, 2010). As you'll see from our device preemption scorecard, previous versions were dismissed at Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008) (plaintiff didn't pleas any parallel claims), and Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009) (negligence per se claims weren't parallel). Heisner has now been around for some two years and the plaintiffs haven't mustered a decent complaint yet.
Strike three and you're out? Yes. This time the court dismissed the complaint with prejudice. Slip op. at 8.
Anyway, the latest decision, which we'll call "Heisner III," found essentially more of the same. Each time plaintiff gets told to go back to the drawing board, he comes back with more words and less (or at least no more) substance. There doesn't seem to be any way around preemption in this case, as much as plaintiff has tried. You can't have a "parallel" claim that isn't really parallel - or as the court puts it, "state and federal requirements are not equivalent if a manufacturer could be held liable under state law while complying with federal requirements." Slip op. at 5 (citation omitted).
This time the plaintiff tried to equate the FDA's CBE warning update regulations with a common law claim for post-sale duty to warn. But that didn't fare any better (even after plaintiff belated discovered that the CBE regulation for devices was different than the one for drugs), because the CBE regulation is voluntary, whereas the tort claim would make it mandatory. Slip op. at 5-6.
Everything else in the plaintiff's, longer complaint remained too vague and devoid of facts. "Plaintiff utilizes more words, but verbosity cannot substitute for factual allegations." Slip op. at 7.
A claimed failure to file adverse reaction reports didn't constitute a product defect. Slip op. at 6 ("failure to report adverse events to the FDA may violate the FDCA, but does not constitute a product “condition” or defect"). Negligence per se claims still couldn't possibly be causal, since they postdated the alleged injury. Id.
We thank another of our anonymous (by request) readers for passing Heisner III along.
http://druganddevicelaw.blogspot.com/2010/03/heisner-strike-3.html
Wednesday, June 15, 2011
FDA Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices
Ummm do you mean like Sprayshield too???????Does Kruschinski know about this...another way to maim his poor patients. Is Carl aware of this too? I'm betting he does not!
FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices
Date Issued: July 9, 2010
Audience: Surgeons, Operating Room Nurses, and other support personnel in the Operating Room
Products:
Air- or gas-pressurized sprayers are dual syringe products that simultaneously mix and apply two non-homogeneous liquids within a single spray head that is connected to a pressure regulator and a source of compressed air or gas. Air- or gas-pressurized sprayers can be used to mix and apply hemostatic drug or biological products (products that help control bleeding from blood vessels during surgery) including fibrin and non-fibrin sealants.
They include devices such as:
EasySpray and spray set used with Duploject system(Baxter Healthcare Corporation)
Tissomat and spray set used with Duploject system (Baxter Healthcare Corporation)
Evicel application device (Omrix Medical)
FibriJet Aerosol Applicator (MicroMedics)
HemaMyst Surgical Applicator System (Heamacuare Corporation)
MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)
Vitagel Hemostat Spray Set (Orthovita, Inc.)
Summary of Problem and Scope:
FDA has received reports of air or gas embolisms occurring during or immediately after application of hemostatic drug or biological products using air- or gas- pressurized sprayers. Although rare, the reports describe air embolisms that are life threatening and include one fatality.
These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site.
Recommendations/Actions:
Given the life-threatening consequences of an air or gas embolism, FDA is recommending that clinicians using air- or gas- pressurized spray devices for application of hemostatic drug or biological products:
Use the applicator, spray set, and pressure control device or regulator as recommended in the labeling or Information For Use (IFU) of the hemostatic agent.
Use an air or gas pressure setting within the range recommended by the manufacturer of the sprayer.
Ensure that distance between the spray head and the tissue surface is not less than the minimum recommended by the manufacturer of the sprayer.
Monitor blood pressure, pulse, oxygen saturation and end tidal CO 2 for signs of an air or gas embolism.
Make sure the regulators are maintained properly and checked for safe performance regularly.
FDA Activities:
In cooperation with the FDA, Baxter Healthcare Corporation and Omrix Pharmaceuticals, the manufacturers of all fibrin sealants licensed in the U.S., have updated the Warning and Precautions sections of the labels of EVICEL, T isseel and ARTISS to emphasize the risk of air embolism and the need to use the recommended ranges of pressure and distance.
The labeling of the spray devices and non-fibrin hemostatic drug or biological products also includes information on recommended pressures and distances.
Report Problems to FDA:
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical products. If you suspect problems with the use of fibrin sealants and/or air or gas pressurized fibrin sprayers, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program1. Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements2 should follow the reporting procedures established by their facilities.
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 or 800-638-2041.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm218523.htm
FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices
Date Issued: July 9, 2010
Audience: Surgeons, Operating Room Nurses, and other support personnel in the Operating Room
Products:
Air- or gas-pressurized sprayers are dual syringe products that simultaneously mix and apply two non-homogeneous liquids within a single spray head that is connected to a pressure regulator and a source of compressed air or gas. Air- or gas-pressurized sprayers can be used to mix and apply hemostatic drug or biological products (products that help control bleeding from blood vessels during surgery) including fibrin and non-fibrin sealants.
They include devices such as:
EasySpray and spray set used with Duploject system(Baxter Healthcare Corporation)
Tissomat and spray set used with Duploject system (Baxter Healthcare Corporation)
Evicel application device (Omrix Medical)
FibriJet Aerosol Applicator (MicroMedics)
HemaMyst Surgical Applicator System (Heamacuare Corporation)
MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)
Vitagel Hemostat Spray Set (Orthovita, Inc.)
Summary of Problem and Scope:
FDA has received reports of air or gas embolisms occurring during or immediately after application of hemostatic drug or biological products using air- or gas- pressurized sprayers. Although rare, the reports describe air embolisms that are life threatening and include one fatality.
These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site.
Recommendations/Actions:
Given the life-threatening consequences of an air or gas embolism, FDA is recommending that clinicians using air- or gas- pressurized spray devices for application of hemostatic drug or biological products:
Use the applicator, spray set, and pressure control device or regulator as recommended in the labeling or Information For Use (IFU) of the hemostatic agent.
Use an air or gas pressure setting within the range recommended by the manufacturer of the sprayer.
Ensure that distance between the spray head and the tissue surface is not less than the minimum recommended by the manufacturer of the sprayer.
Monitor blood pressure, pulse, oxygen saturation and end tidal CO 2 for signs of an air or gas embolism.
Make sure the regulators are maintained properly and checked for safe performance regularly.
FDA Activities:
In cooperation with the FDA, Baxter Healthcare Corporation and Omrix Pharmaceuticals, the manufacturers of all fibrin sealants licensed in the U.S., have updated the Warning and Precautions sections of the labels of EVICEL, T isseel and ARTISS to emphasize the risk of air embolism and the need to use the recommended ranges of pressure and distance.
The labeling of the spray devices and non-fibrin hemostatic drug or biological products also includes information on recommended pressures and distances.
Report Problems to FDA:
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical products. If you suspect problems with the use of fibrin sealants and/or air or gas pressurized fibrin sprayers, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program1. Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements2 should follow the reporting procedures established by their facilities.
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 or 800-638-2041.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm218523.htm
Friday, May 13, 2011
SprayShield EU Post Market Study Terminated
Sorry everyone...
SprayShield EU Post Market Study
This study has been terminated.
http://clinicaltrials.gov/ct2/show/NCT01002287
First Received on October 26, 2009. Last Updated on May 4, 2010 History of Changes
Sponsor: Confluent Surgical
Information provided by: Confluent Surgical
ClinicalTrials.gov Identifier: NCT01002287
Purpose
This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.
Condition Intervention Phase
Ulcerative Colitis
Familial Polyposis
Device: SprayShield Adhesion Barrier System
Procedure: Good Surgical Technique Alone
Phase IV
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
Resource links provided by NLM:
Genetics Home Reference related topics: Crohn disease familial adenomatous polyposis Help Me Understand Genetics
MedlinePlus related topics: Adhesions Ulcerative Colitis
U.S. FDA Resources
Further study details as provided by Confluent Surgical:
Primary Outcome Measures:
•To evaluate the incidence of adhesions, defined as the proportion of subjects presenting at the follow-up surgery (10-12 weeks) with one or more adhesions to the midline incision, regardless of extent and/or severity. [ Time Frame: 10-12 Weeks post Initial Surgery for J-Pouch ] [ Designated as safety issue: No ]
Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SprayShield Adhesion Barrier: Experimental
SprayShield Adhesion Barrier + Good Surgical Technique
Intervention: Device: SprayShield Adhesion Barrier System Device: SprayShield Adhesion Barrier System
Adhesion Barrier Device Plus Good Surgical Technique
Control: No Intervention
Good Surgical Technique Alone
Intervention: Procedure: Good Surgical Technique Alone Procedure: Good Surgical Technique Alone
Good Surgical Technique Alone
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002287
Locations
United States, Massachusetts
Confluent Surgical
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Confluent Surgical
More Information
No publications provided
Responsible Party: Confluent Surgical ( Jennifer Doyle/Director, Clinical Affairs )
ClinicalTrials.gov Identifier: NCT01002287 History of Changes
Other Study ID Numbers: ABD-08-001
Study First Received: October 26, 2009
Last Updated: May 4, 2010
Health Authority: Czech Republic: Ethics Committee; Poland: Ministry of Health
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Adenomatous Polyposis Coli
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Pathologic Processes
ClinicalTrials.gov processed this record on May 12, 2011
Pity
SprayShield EU Post Market Study
This study has been terminated.
http://clinicaltrials.gov/ct2/show/NCT01002287
First Received on October 26, 2009. Last Updated on May 4, 2010 History of Changes
Sponsor: Confluent Surgical
Information provided by: Confluent Surgical
ClinicalTrials.gov Identifier: NCT01002287
Purpose
This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.
Condition Intervention Phase
Ulcerative Colitis
Familial Polyposis
Device: SprayShield Adhesion Barrier System
Procedure: Good Surgical Technique Alone
Phase IV
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
Resource links provided by NLM:
Genetics Home Reference related topics: Crohn disease familial adenomatous polyposis Help Me Understand Genetics
MedlinePlus related topics: Adhesions Ulcerative Colitis
U.S. FDA Resources
Further study details as provided by Confluent Surgical:
Primary Outcome Measures:
•To evaluate the incidence of adhesions, defined as the proportion of subjects presenting at the follow-up surgery (10-12 weeks) with one or more adhesions to the midline incision, regardless of extent and/or severity. [ Time Frame: 10-12 Weeks post Initial Surgery for J-Pouch ] [ Designated as safety issue: No ]
Estimated Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SprayShield Adhesion Barrier: Experimental
SprayShield Adhesion Barrier + Good Surgical Technique
Intervention: Device: SprayShield Adhesion Barrier System Device: SprayShield Adhesion Barrier System
Adhesion Barrier Device Plus Good Surgical Technique
Control: No Intervention
Good Surgical Technique Alone
Intervention: Procedure: Good Surgical Technique Alone Procedure: Good Surgical Technique Alone
Good Surgical Technique Alone
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002287
Locations
United States, Massachusetts
Confluent Surgical
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Confluent Surgical
More Information
No publications provided
Responsible Party: Confluent Surgical ( Jennifer Doyle/Director, Clinical Affairs )
ClinicalTrials.gov Identifier: NCT01002287 History of Changes
Other Study ID Numbers: ABD-08-001
Study First Received: October 26, 2009
Last Updated: May 4, 2010
Health Authority: Czech Republic: Ethics Committee; Poland: Ministry of Health
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Adenomatous Polyposis Coli
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Pathologic Processes
ClinicalTrials.gov processed this record on May 12, 2011
Pity
Tuesday, June 09, 2009
Surgical gel gets blame for pain
By RUTH HILL - The Dominion Post
NATALIE SLADE/Dominion Post
SCARRED: Carla Gardiner had to have a four-hour operation to remove the scar tissue caused by anti-scarring gel during her initial surgery
Related Links'Scarring more painful than original illness'
A surgical spray gel that may have left hundreds of New Zealand women with painful internal scarring and fertility problems has been modified but doctors have not been told why.
Wellington gynaecologist Hanifa Koya, who first raised concerns about Confluent SprayGel in 2005, accuses the manufacturer of evading its responsibility toward "millions of women" worldwide who have been potentially injured by the gel.
The blue gel renamed SprayShield was supposed to prevent scarring during gynaecological surgery, but left some women with their reproductive organs "super-glued" together.
Up to 1200 New Zealand women were treated with the gel between 2004 and 2008.
Mrs Koya has learned that Covidien, which manufactures and distributes the gel, has replaced the suspect dye, methylene blue, with a vegetable dye. "The fact they withdrew it voluntarily suggests they know there was something wrong with it."
She began using the gel in October 2002, but stopped in April 2006 after her rate of repeat keyhole laparoscopies went from under 2 per cent to 10 per cent. Since switching to an alternative product, she has not repeated any laparoscopies, but patients were still returning from four years ago with "sheets of scarring".
She complained to American manufacturer Confluent Surgical and wrote repeatedly to MedSafe the Government's drug safety agency and professional bodies asking for action, but says she was stonewalled.
Medsafe investigated but accepted the manufacturers' assurances that the product was safe and that clinical trials were continuing.
"[But] methylene blue has never been tested on humans and the gel has never been approved for use in the United States," Mrs Koya said.
At the World Congress on Endometriosis in Melbourne last year, Mrs Koya was appalled to meet other specialists who had stopped using the gel because of complications.
ACC has not accepted any claims by victims for treatment injuries. Most of her patients' repeat operations which cost between $6000 and $12,000 have been covered by insurance, and she has waived her own fee for those with partial cover.
"That's a huge cost to the health system, it leads to increased insurance premiums and makes it harder for people to have their claims accepted. Ultimately it's patients who pay the price."
Health Minister Tony Ryall declined to be interviewed, referring comment to Medsafe.
Medsafe group manager Stewart Jessamine said because the gel was classified as a medical device under the Medicines Act rather than a drug, the legislation did not allow Medsafe to assess its safety or efficacy before it entered the market.
"However ... it has been assessed to very high standards by medical device regulatory authorities in Europe and Australia."
Some studies had showed increased rates of complications, including those described by Mrs Koya, he said. "However, there was no evidence that the rate of adverse effects was significantly different from that expected historically."
TIMELINE
2001: American-made Confluent SprayGel approved for use in Europe and subsequently Australia and New Zealand but not the United States.
OCTOBER 2002: Wellington gynaecologist Hanifa Koya begins using the gel.
2005: Mrs Koya first notices patients coming for repeat surgery and contacts the company, which tells her the product is being monitored in clinical trials.
APRIL 2006: Mrs Koya stops using the gel because of ongoing concerns. She alerts the College of Obstetricians and Gynaecologists and the Centre for Adverse Reaction Monitoring. Both refer her to Medsafe, the Government's drug-safety body.
FEBRUARY 2007: Mrs Koya complains to Medsafe.
NOVEMBER 2007: After reviewing international literature, Medsafe finds some reports of complications similar to those described by Mrs Koya. It asks the company include "additional precautions" on packaging but says the product is still safe.
DECEMBER 2007: Mrs Koya writes to the college again with her concerns.
JANUARY 2008: The college says Medsafe appears to have investigated the issue thoroughly.
FEBRUARY 2008: An affected patient talks to The Dominion Post and Mrs Koya speaks publicly about her concerns.
APRIL 2008: Mrs Koya writes to Medical Assurance Committee of the college.
JUNE 2008: Pharmaceutical company Covidien Tyco takes over distributing the gel in New Zealand from Intermed Medical.
AUGUST 2008: Mrs Koya writes to the health and disability commissioner, but is told the matter is outside the commission's jurisdiction.
OCTOBER 2008: Covidien relaunches the product as SprayShield Adhesion Barrier, which uses a vegetable dye instead of chemical dye methylene blue. The gel is available in Europe, the Middle East, South Africa, Australia and New Zealand but still not approved for use in the US.
http://www.stuff.co.nz/national/health/2480461/Scarring-more-painful-than-original-illness
NATALIE SLADE/Dominion Post
SCARRED: Carla Gardiner had to have a four-hour operation to remove the scar tissue caused by anti-scarring gel during her initial surgery
Related Links'Scarring more painful than original illness'
A surgical spray gel that may have left hundreds of New Zealand women with painful internal scarring and fertility problems has been modified but doctors have not been told why.
Wellington gynaecologist Hanifa Koya, who first raised concerns about Confluent SprayGel in 2005, accuses the manufacturer of evading its responsibility toward "millions of women" worldwide who have been potentially injured by the gel.
The blue gel renamed SprayShield was supposed to prevent scarring during gynaecological surgery, but left some women with their reproductive organs "super-glued" together.
Up to 1200 New Zealand women were treated with the gel between 2004 and 2008.
Mrs Koya has learned that Covidien, which manufactures and distributes the gel, has replaced the suspect dye, methylene blue, with a vegetable dye. "The fact they withdrew it voluntarily suggests they know there was something wrong with it."
She began using the gel in October 2002, but stopped in April 2006 after her rate of repeat keyhole laparoscopies went from under 2 per cent to 10 per cent. Since switching to an alternative product, she has not repeated any laparoscopies, but patients were still returning from four years ago with "sheets of scarring".
She complained to American manufacturer Confluent Surgical and wrote repeatedly to MedSafe the Government's drug safety agency and professional bodies asking for action, but says she was stonewalled.
Medsafe investigated but accepted the manufacturers' assurances that the product was safe and that clinical trials were continuing.
"[But] methylene blue has never been tested on humans and the gel has never been approved for use in the United States," Mrs Koya said.
At the World Congress on Endometriosis in Melbourne last year, Mrs Koya was appalled to meet other specialists who had stopped using the gel because of complications.
ACC has not accepted any claims by victims for treatment injuries. Most of her patients' repeat operations which cost between $6000 and $12,000 have been covered by insurance, and she has waived her own fee for those with partial cover.
"That's a huge cost to the health system, it leads to increased insurance premiums and makes it harder for people to have their claims accepted. Ultimately it's patients who pay the price."
Health Minister Tony Ryall declined to be interviewed, referring comment to Medsafe.
Medsafe group manager Stewart Jessamine said because the gel was classified as a medical device under the Medicines Act rather than a drug, the legislation did not allow Medsafe to assess its safety or efficacy before it entered the market.
"However ... it has been assessed to very high standards by medical device regulatory authorities in Europe and Australia."
Some studies had showed increased rates of complications, including those described by Mrs Koya, he said. "However, there was no evidence that the rate of adverse effects was significantly different from that expected historically."
TIMELINE
2001: American-made Confluent SprayGel approved for use in Europe and subsequently Australia and New Zealand but not the United States.
OCTOBER 2002: Wellington gynaecologist Hanifa Koya begins using the gel.
2005: Mrs Koya first notices patients coming for repeat surgery and contacts the company, which tells her the product is being monitored in clinical trials.
APRIL 2006: Mrs Koya stops using the gel because of ongoing concerns. She alerts the College of Obstetricians and Gynaecologists and the Centre for Adverse Reaction Monitoring. Both refer her to Medsafe, the Government's drug-safety body.
FEBRUARY 2007: Mrs Koya complains to Medsafe.
NOVEMBER 2007: After reviewing international literature, Medsafe finds some reports of complications similar to those described by Mrs Koya. It asks the company include "additional precautions" on packaging but says the product is still safe.
DECEMBER 2007: Mrs Koya writes to the college again with her concerns.
JANUARY 2008: The college says Medsafe appears to have investigated the issue thoroughly.
FEBRUARY 2008: An affected patient talks to The Dominion Post and Mrs Koya speaks publicly about her concerns.
APRIL 2008: Mrs Koya writes to Medical Assurance Committee of the college.
JUNE 2008: Pharmaceutical company Covidien Tyco takes over distributing the gel in New Zealand from Intermed Medical.
AUGUST 2008: Mrs Koya writes to the health and disability commissioner, but is told the matter is outside the commission's jurisdiction.
OCTOBER 2008: Covidien relaunches the product as SprayShield Adhesion Barrier, which uses a vegetable dye instead of chemical dye methylene blue. The gel is available in Europe, the Middle East, South Africa, Australia and New Zealand but still not approved for use in the US.
http://www.stuff.co.nz/national/health/2480461/Scarring-more-painful-than-original-illness
Friday, February 27, 2009
Adhesion Barrier return on investment
INVESTORS BEWARE!
As IHRT contemplates the desperation of consumers to have adhesion barriers provided in their surgeries and industries willingness to provide them, we are disheartened.
Patients aware of adhesion barriers or indeed adhesions are a slim minority.
Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013PR Newswire (press release), NY - Feb 2, 20092 /PRNewswire/ -- According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 ...
As we reflect on this headline, one wonders where this number comes from?
IHRT then looks at the source of this press release.
IRONICALLY, Millennium Research Group is based in Waltham, MA, home of Confluent SprayGel and SprayShield !
If an effective adhesion barrier were found and put into use….the number would be enormous!
Here is an example of a guess on what that number might truly be.
_____
Cesarean Fact Sheet - Childbirth.org
Some facts about cesarean sections from Childbirth.org. ... The latest statistics indicate that 967000 cesareans were performed in the US in 1989. ...www.childbirth.org/section/CSFact.html - 16k - Cached - Similar pages
_______
Lets say each of these c-sections had and adhesion barrier applied at the cost of $200.00 per procedure. We feel that this would be a very conservative estimate. The cost would be $193,400,000 for just one procedure in which the number of c-section has increased dramatically since this statistic was reported…
Take the history of Spraygel to it’s current incarnation as SprayShield TM.
All IHRT can think to say is, “return on investment”.
Here is an example to see.
_____
Tuesday, October 28, 2008
Falling apart over Omrix
When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment.
_____________
The founder of Confluent Surgical knew his product would not pass FDA standards so the product was taken out of clinical trials….
Somehow, with fraudulent information SprayGel got it’s CE mark and was used throughout the world as an anti-adhesion barrier. Those in the United States remained safe.
IHRT was founded by the victims of ongoing study of Spraygel until we realized we were being experimented on and paying for the pleasure. In of all places Germany!
The gig was up and Confluent was sold to Tyco which was then sold to Covidien.
As IHRT continues to watch Covidiens stocks fall we become more concerned about them seeking a quick return on their investment!
_____
Top of Form
COV (Common Stock)
Exchange
NYSE(US Dollar)
Price
$34.46
Change (%)
0.69 (1.96%)
Volume
1,019,293
As of 02/26/09 11:23 a.m. ETMinimum 20 minute delay
Bottom of Form
http://investor.covidien.com/preview/phoenix.zhtml?c=207592&p=irol-alerts
_____
It looks like Covidien may have learned to save money by moving it all offshore just as Confluent did.
Is it the old lets see if it works ON THEM and then go to the FDA?
The same scenario is happening again with of all people, Kruschinski and Mettler. In of all places Germany!
http://www.or-live.com/covidien/2457/Pre-clinical%20Data.pdf
Kruschinski D, Homburg S, D’Souza F, Campbell P, Reich H.
Adhesiolysis in severe and reccurent cases of adhesions related
disorder (ARD) - a novel approach utilizing lift (gasless)
laparoscopy and SprayGel™ adhesion barrier. Surg Technol Int.
2006;15:131-9.
Mettler L, Audebert A, Lehmann-Willenbrock E, Schive-Peterhansl
K, Jacobs VR. A randomized, prospective, controlled,
multicenter clinical trial of a sprayable, site-specific adhesion
barrier system in patients undergoing
______
Somehow the bogus science in the above studies are being used once again to tout a product and way after the fact are we learning how the bogus studies of SprayGel made thing worse for us for all of us. Victims of this fraud would tell you there are things worse than death....
It is IHRT’s opinion that until there are actually surgeons learned enough to perform an adhesiolysis that needs no barrier, these products are just a panacea…
Skill is what’s needed and compensation for the time it takes to perform a successful adhesiolyis.
Until then we fell everyone’s just kidding themselves and no product can compensate for, quick or ultra conservative surgery.
So think hard and do your research, be careful of patients who claim this is the best or only way.
_____
...and then you have Karen Steward!!!! Beware!
How many doctors (surgeons) encourage those who are sick to contact his former patients? No doubt, Dr. Kruschinski has raised the bar of excellence when it comes to "treating" a patient. See: Patient List
Thanks Dr. Kruschinski. Our daughter has regained her life due to your brilliance, commitment and compassion for those who suffer from this dread disorder.
http://www.adhesionpain.net/2008/09/five-yearsthank.html
This is what IHRT calls “Harvesting” a dreadful practice that can lead a person to an unwanted intervention.
_____
Remember that these biomedical companies and surgeons are expecting a return on their investments and patients are a dime a dozen. We must remember always “people are willing to profit from others pain”. Our capitulation to the adhesion barrier craze just seems to make us “a return on investment”
As IHRT contemplates the desperation of consumers to have adhesion barriers provided in their surgeries and industries willingness to provide them, we are disheartened.
Patients aware of adhesion barriers or indeed adhesions are a slim minority.
Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013PR Newswire (press release), NY - Feb 2, 20092 /PRNewswire/ -- According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 ...
As we reflect on this headline, one wonders where this number comes from?
IHRT then looks at the source of this press release.
IRONICALLY, Millennium Research Group is based in Waltham, MA, home of Confluent SprayGel and SprayShield !
If an effective adhesion barrier were found and put into use….the number would be enormous!
Here is an example of a guess on what that number might truly be.
_____
Cesarean Fact Sheet - Childbirth.org
Some facts about cesarean sections from Childbirth.org. ... The latest statistics indicate that 967000 cesareans were performed in the US in 1989. ...www.childbirth.org/section/CSFact.html - 16k - Cached - Similar pages
_______
Lets say each of these c-sections had and adhesion barrier applied at the cost of $200.00 per procedure. We feel that this would be a very conservative estimate. The cost would be $193,400,000 for just one procedure in which the number of c-section has increased dramatically since this statistic was reported…
Take the history of Spraygel to it’s current incarnation as SprayShield TM.
All IHRT can think to say is, “return on investment”.
Here is an example to see.
_____
Tuesday, October 28, 2008
Falling apart over Omrix
When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment.
_____________
The founder of Confluent Surgical knew his product would not pass FDA standards so the product was taken out of clinical trials….
Somehow, with fraudulent information SprayGel got it’s CE mark and was used throughout the world as an anti-adhesion barrier. Those in the United States remained safe.
IHRT was founded by the victims of ongoing study of Spraygel until we realized we were being experimented on and paying for the pleasure. In of all places Germany!
The gig was up and Confluent was sold to Tyco which was then sold to Covidien.
As IHRT continues to watch Covidiens stocks fall we become more concerned about them seeking a quick return on their investment!
_____
Top of Form
COV (Common Stock)
Exchange
NYSE(US Dollar)
Price
$34.46
Change (%)
0.69 (1.96%)
Volume
1,019,293
As of 02/26/09 11:23 a.m. ETMinimum 20 minute delay
Bottom of Form
http://investor.covidien.com/preview/phoenix.zhtml?c=207592&p=irol-alerts
_____
It looks like Covidien may have learned to save money by moving it all offshore just as Confluent did.
Is it the old lets see if it works ON THEM and then go to the FDA?
The same scenario is happening again with of all people, Kruschinski and Mettler. In of all places Germany!
http://www.or-live.com/covidien/2457/Pre-clinical%20Data.pdf
Kruschinski D, Homburg S, D’Souza F, Campbell P, Reich H.
Adhesiolysis in severe and reccurent cases of adhesions related
disorder (ARD) - a novel approach utilizing lift (gasless)
laparoscopy and SprayGel™ adhesion barrier. Surg Technol Int.
2006;15:131-9.
Mettler L, Audebert A, Lehmann-Willenbrock E, Schive-Peterhansl
K, Jacobs VR. A randomized, prospective, controlled,
multicenter clinical trial of a sprayable, site-specific adhesion
barrier system in patients undergoing
______
Somehow the bogus science in the above studies are being used once again to tout a product and way after the fact are we learning how the bogus studies of SprayGel made thing worse for us for all of us. Victims of this fraud would tell you there are things worse than death....
It is IHRT’s opinion that until there are actually surgeons learned enough to perform an adhesiolysis that needs no barrier, these products are just a panacea…
Skill is what’s needed and compensation for the time it takes to perform a successful adhesiolyis.
Until then we fell everyone’s just kidding themselves and no product can compensate for, quick or ultra conservative surgery.
So think hard and do your research, be careful of patients who claim this is the best or only way.
_____
...and then you have Karen Steward!!!! Beware!
How many doctors (surgeons) encourage those who are sick to contact his former patients? No doubt, Dr. Kruschinski has raised the bar of excellence when it comes to "treating" a patient. See: Patient List
Thanks Dr. Kruschinski. Our daughter has regained her life due to your brilliance, commitment and compassion for those who suffer from this dread disorder.
http://www.adhesionpain.net/2008/09/five-yearsthank.html
This is what IHRT calls “Harvesting” a dreadful practice that can lead a person to an unwanted intervention.
_____
Remember that these biomedical companies and surgeons are expecting a return on their investments and patients are a dime a dozen. We must remember always “people are willing to profit from others pain”. Our capitulation to the adhesion barrier craze just seems to make us “a return on investment”
Monday, June 30, 2008
After Scar II
Self explanatory
The steps leading to the formation of adhesions and some of the factors that can influence the development of adhesions during surgery are illustrated.
How adhesions develop:
The tissue surface becomes damaged, either through surgery or injury, leading to disruption of the mesothelial lining
Bleeding and leakage of plasma proteins lead to fibrin deposits at injured sites, which is augmented by post-traumatic inflammation
The enlarging fibrin mesh might attach to an adjoining surface, a process that is counteracted by locally generated fibrinolytic factors
Depending on local peritoneal conditions, the fibrin mesh could either be degraded, resulting in scarless repair, or transformed into an adhesion consisting of connective tissue
If the fibrin is degraded within the first few days, the defect heals scarlessly
If remnants of fibrin remain for long enough, recruited reparative cells transform the initially reversible fibrinous adhesion to a fibrous, collagen-containing structure
Various factors can influence the development of adhesions during surgery - e.g. infection, heat, light, glove powder.
From the basic processes that result in the formation of adhesions, there are various steps that can be taken during surgery to minimise the risk of adhesions
These are:
increase vascular permeability
reduce infection risk
avoid GI contamination
minimise tissue handling by careful technique and microsurgery
reduce drying of tissues by using lubrication
limit use of cautery
limit use of sutures
avoid materials with fibres
use starch-free gloves
Although these measures will minimise the risks, they cannot eliminate the problem completely
Thus there is a clear need for improved adhesion-reduction strategies
Adhesion-reduction strategies involve:
Careful surgical technique
Minimisation of inflammatory response by use of
corticosteroids
NSAIDs
antibiotics
Augmentation of fibrinolysis
tissue plasminogen activator
Use of various adhesion-reduction agents
Risberg B. Eur J Surg 1997;577:32-39
Risberg reviewed a number of adhesion prevention strategies and techniques. The two major prevention strategies discussed are (1) adjusting surgical technique and (2) application of adjuvants.
NSAIDs (e.g. ibuprofen, tolmetin and oxyphenbutazone) can be applied systematically as well as intraperitoneally. Clinically efficacy remains questionable possibly because of drug delivery difficulties.
Corticosteroids (dexamethasone, hydrocortisone and prednisolone) can be administered intraperitoneally. Efficacy is doubtful due to associations with immunosuppression and delayed wound healing, e.g. infection, incisional hernia and wound dehiscence. Also, they do not remain in the peritoneal cavity for the duration of adhesion formation (4-5 days post surgery)
Fibrinolytics are designed to prevent or reverse fibrin deposition. Intraperitoneally or systematically administered plasminogen activator (tPA), streptokinase and elastase have undergone considerable laboratory evaluation with conflicting results, and in some cases, haemorrhagic complications. This lack of efficacy may be attributable to the problem of rapid peritoneal absorption and clearance.
To assess European opinion on post-operative adhesions two surveys were conducted, one at ESHRE 2002 (European Society of Human Reproduction and Embryology) and EACP (European Association of Coloproctology).
The respondents from ESHRE were all gynaecologists and results were as follows:
14.2% of respondents cited safety as an attribute associated with an ideal anti-adhesion agent
13.4% cited effectiveness
36.2% cited ease of use
15.7% cited low cost
Published in ANV 4
Note:
Preclude is referenced as ‘generally unavailable’ as clinical experience shows there are limitations in its use.
Hyskon is included in this slide as there is anecdotal evidence to suggest off-license use. However, cases of anaphylaxis have been recorded.
Mathias Korell – well recognised German gynae laparoscopy specialist has done studies with Spraygel and uses in endometriosis cases – where they do a lot of surgery (like colorectal in terms of extent of work in the abdomen – ie not neat and dainty stuff) and he is quoting need 5 kits to then coat the peritoneum to ensure adequate coverage – will be in Adhesions News & Vies Issue 5
Cost they quote around £150/sheet that would be a good size in abdominal surgery – but they won’t be more specific or detail how many sheets a colorectal surgeon might need to use
Adept® (icodextrin 4%) is a new potential solution to adhesions
Adept is approved throughout Europe for use in abdominal and pelvic surgery as an intraoperative wash and postoperative instillate for the reduction of adhesions
It is available as a 1 litre bag and most recently as a 1.5 litre bag to allow use of one bag for irrigating during surgery and to provide 1000ml to leave behind as a postoperative instillate
Work from a registry of routine use (ARIEL) which is now progressing in 150+ centres in Europe showed that a 1.5 litre presentation of Adept would be useful for most surgical cases allowing surgeons to irrigate with up to 500ml during surgery and then instil 1000ml to leave behind at the end of surgery
Icodextrin is a 1,4 linked glucose polymer
The structure is different from Dextran; the key difference lies in the linkage of carbon 1 and 4 (versus Dextran 1,6 which the human body cannot break down easily)
Icodextrin was developed from hydrolysis of corn starch (so it is a natural product)
Icodextrin is used for adhesion reduction as a 4% solution
This 4% solution is isosmolar and biocompatible with other drugs
Icodextrin is a large polymer and attracts a ‘water of hydration’ around it, increasing its size still further.
It is absorbed from the abdomino–pelvic cavity by the lymphatic system. In the blood it is broken down readily by amylase (acts on the 1,4 link) to maltose/isomaltose and then glucose, and is then excreted
Icodextrin has a well-established safety profile at the higher concentration of 7.5% where it is used in peritoneal dialysis - with > 36,000 patient years of safety data and use of Adept in >50,000 as at end January
Icodextrin was developed originally to overcome the issues associated with existing peritoneal dialysis fluids, specifically irritation to the peritoneum, etc
As a result of its structure, icodextrin with its ‘water of hydration’ stays in the abdomino–pelvic cavity over time (it is absorbed solely by the lymphatic system). It is this persisting presence in the abdomino–pelvic cavity that is thought to reduce adhesion formation/reformation as a result of ‘hydroflotation’
Hydroflotation is not a new concept, but the problem has been in finding a fluid that would stay in the abdomino–pelvic cavity long enough to keep tissues apart in the critical time after surgery when adhesions develop, but which does not have an irritant effect on the peritoneum, nor causes problems when absorbed (e.g. Dextran)
This slide looks at the persistence of 4% icodextrin over time compared to saline and glucose
It comes from a study in patients receiving peritoneal chemotherapy in whom 4% icodextrin was used as the carrier fluid1. In the periods between chemotherapy the icodextrin was used as a ‘dwell’ and aliquots drawn off through the Tenckhoff catheter
The results show that 50% of the icodextrin 4% solution was still retained after ~92+ hours, whereas within a day all the saline or glucose was absorbed by the lymphatics
This is the reason why crystalloid solutions such as saline are not very effective in the reduction of adhesions, as they do not stay in the abdomen for long enough to keep the organs and tissues ‘hydroflotated’
Reference
1. Hosie K, Gilbert JA, Kerr D et al. Fluid dynamics in man of an intraperitoneal drug delivery solution: 4% icodextrin. Drug Delivery 2001; 8: 9–12.
Video clips showing instillation at end of surgery
This slide shows the cost comparison of recent agents at current UK prices
Note the costs of agents is different in Finland but comparatively the relative price differentials will be the same
Two kits of Spraygel are often used to get adequate coverage of the surgical site and as per Prof Mathias Korell’s experience in major gynaecological surgery – 5 kits may be needed to ensure adequate coverage of the peritoneal cavity!
The US outcomes study with Seprafilm is using a mean 4.4 sheets/patients1
Intergel was withdrawn in April 2003
Reference
1. Beck DE, Cohen Z, Fleshman JW, Kaufman HS, vanGoor H, Wolff BG. Prospective, randomized, multicentre, controlled study of the safety of Seprafilm Adhesion Barrier in abdominopelvic surgery. Dis Colon Rectum 2003
This slide shows the cost comparison of recent agents at current UK prices illustrating costs of using 4.4 sheets Seprafilm (as per Beck) and 5 kits of Spraygel as (per Korell).
SurgiWrap not included as they don’t give a precise list price or how many sheets are used – when asked – and ?? Anyone using it yet??
Wilson MS et al. Colorectal Disease 2002;4:355-360
Wilson et al. modelled data from a lower abdominal surgery cohort from the SCAR data to assess cost effectiveness.
Results showed that:
Routine use of adhesion reduction products costing £50 per patient will payback the cost for such investment if they reduce adhesion-related readmissions by 16% after 3 years
A product costing £200 will need to offer a 64.1% reduction in readmissions after 3 years to recoup its direct costs
For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year the cumulative costs of adhesion related readmissions over 10 years are estimated at £569 million
At year 3 – 64% reduction would be needed
And at 3 years
Wilson MS et al. Colorectal Disease 2002;4:355-360
Wilson et al. modelled data from a lower abdominal surgery cohort from the SCAR data to assess cost effectiveness.
Results showed that:
Routine use of adhesion reduction products costing £50 per patient will payback the cost for such investment if they reduce adhesion-related readmissions by 16% after 3 years
A product costing £200 will need to offer a 64.1% reduction in readmissions after 3 years to recoup its direct costs
For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year the cumulative costs of adhesion related readmissions over 10 years are estimated at £569 million
This slide looks at cumulative costs of using an adhesion reduction agent over 9 years scaling up to the UK as a whole.
Using a £50 agent with a 25% efficacy would result in a saving of £71m
But using a £200 product with similar efficacy would result in a £142m loss – ie the health system would have to spend an extra £142m over the 9 years to reduce adhesion related readmissions by 25%.
In only 10.4% of cases were adhesions mentioned as part of the informed consent process
14.4% adhesions were discussed but not part of the consent
In those undergoing specific adhesiolysis operations 54% of patients reported being given some kind of information on adhesions before surgery
46% were given information on anti-adhesion agents
In procedures not involving adhesiolysis only 10% of patients reported receiving any adhesion information
Only 6% of cases were given information on anti-adhesion agents
Is this acceptable practice?
Most common adhesion-related claims
Failure to diagnose adhesion-related problems
Delay in diagnosis
Bowel damage at adhesiolysis
– laparoscopy > laparotomy
Infertility or risk of infertility
Starch granuloma – (use of starch-powdered gloves)
Failure to take precautions to prevent adhesions
1994 -1999 UK Medical Defence Union received 77 adhesion-related claims
Out of court settlements in 14 cases in 11 years ranged from £7960 - £124,261 (~€11,701 - €182,664)
– average £50,765 (€74,625)/case
And that was up until 1999
Since 1999
More evidence of burden of adhesions
SCAR study
Van Krabben enterotomy risk
SCAR-2
etc
Discuss high risk options then lead to prohylaxis
Before SCAR
Before we knew the real extent of the problem
Before we had newer anti-adhesion agents
Adhesions continue to be a significant burden
For the patient:
pain, SBO, infertility, re-operative complications
For the surgeon
increased workload, lengthy and complex procedures, medicolegal consequences
For the healthcare system
increased workloads, costs, bed stay
Where are we now?
Any advances in surgery have had little impact
Action on adhesions has received low priority
even in high risk procedures
New developments in anti-adhesion agents
not all are difficult or costly to use
emerging evidence of efficacy
Adopt use of anti-adhesion agents in ‘High Risk’ surgery
Adhesiolysis
Small bowel resection
Formation of stoma
Hartmann’s procedure
Anterior resection
Abdomino-perineal excision
Colectomy
Surgical treatment of peritonitis & fistulae
Thank you
Fellow SCAR Panel Members
Prof Harold Ellis, UMDS, London
Malcolm Wilson, Christie Hospital, Manchester
Don Menzies, Colchester Hospital, Colchester
Jeremy Thompson, Chelsea & Westminster Hospital, London
Brendan Moran, North Hampshire Hospital, Hampshire
Adrian Lower, St Bartholomew's Hospital, London
Rob Hawthorn, Southern General Hospital, Glasgow
Prof Alastair McGuire, City University, London
Graham Sunderland, Southern General Hospital, Glasgow
David Clark, James Boyd, Alan Finlayson, ISD, NHS Scotland, Edinburgh
Prof Ian Ford, Robertson Centre Biostatistics, Glasgow
Alastair Knight & Alison Crowe, Corvus
Shire Pharmaceuticals Group plc
Powerpoint template
Please read more
http://www.euuzlet.hu/koloproktologus/2004/parker.ppt.
The steps leading to the formation of adhesions and some of the factors that can influence the development of adhesions during surgery are illustrated.
How adhesions develop:
The tissue surface becomes damaged, either through surgery or injury, leading to disruption of the mesothelial lining
Bleeding and leakage of plasma proteins lead to fibrin deposits at injured sites, which is augmented by post-traumatic inflammation
The enlarging fibrin mesh might attach to an adjoining surface, a process that is counteracted by locally generated fibrinolytic factors
Depending on local peritoneal conditions, the fibrin mesh could either be degraded, resulting in scarless repair, or transformed into an adhesion consisting of connective tissue
If the fibrin is degraded within the first few days, the defect heals scarlessly
If remnants of fibrin remain for long enough, recruited reparative cells transform the initially reversible fibrinous adhesion to a fibrous, collagen-containing structure
Various factors can influence the development of adhesions during surgery - e.g. infection, heat, light, glove powder.
From the basic processes that result in the formation of adhesions, there are various steps that can be taken during surgery to minimise the risk of adhesions
These are:
increase vascular permeability
reduce infection risk
avoid GI contamination
minimise tissue handling by careful technique and microsurgery
reduce drying of tissues by using lubrication
limit use of cautery
limit use of sutures
avoid materials with fibres
use starch-free gloves
Although these measures will minimise the risks, they cannot eliminate the problem completely
Thus there is a clear need for improved adhesion-reduction strategies
Adhesion-reduction strategies involve:
Careful surgical technique
Minimisation of inflammatory response by use of
corticosteroids
NSAIDs
antibiotics
Augmentation of fibrinolysis
tissue plasminogen activator
Use of various adhesion-reduction agents
Risberg B. Eur J Surg 1997;577:32-39
Risberg reviewed a number of adhesion prevention strategies and techniques. The two major prevention strategies discussed are (1) adjusting surgical technique and (2) application of adjuvants.
NSAIDs (e.g. ibuprofen, tolmetin and oxyphenbutazone) can be applied systematically as well as intraperitoneally. Clinically efficacy remains questionable possibly because of drug delivery difficulties.
Corticosteroids (dexamethasone, hydrocortisone and prednisolone) can be administered intraperitoneally. Efficacy is doubtful due to associations with immunosuppression and delayed wound healing, e.g. infection, incisional hernia and wound dehiscence. Also, they do not remain in the peritoneal cavity for the duration of adhesion formation (4-5 days post surgery)
Fibrinolytics are designed to prevent or reverse fibrin deposition. Intraperitoneally or systematically administered plasminogen activator (tPA), streptokinase and elastase have undergone considerable laboratory evaluation with conflicting results, and in some cases, haemorrhagic complications. This lack of efficacy may be attributable to the problem of rapid peritoneal absorption and clearance.
To assess European opinion on post-operative adhesions two surveys were conducted, one at ESHRE 2002 (European Society of Human Reproduction and Embryology) and EACP (European Association of Coloproctology).
The respondents from ESHRE were all gynaecologists and results were as follows:
14.2% of respondents cited safety as an attribute associated with an ideal anti-adhesion agent
13.4% cited effectiveness
36.2% cited ease of use
15.7% cited low cost
Published in ANV 4
Note:
Preclude is referenced as ‘generally unavailable’ as clinical experience shows there are limitations in its use.
Hyskon is included in this slide as there is anecdotal evidence to suggest off-license use. However, cases of anaphylaxis have been recorded.
Mathias Korell – well recognised German gynae laparoscopy specialist has done studies with Spraygel and uses in endometriosis cases – where they do a lot of surgery (like colorectal in terms of extent of work in the abdomen – ie not neat and dainty stuff) and he is quoting need 5 kits to then coat the peritoneum to ensure adequate coverage – will be in Adhesions News & Vies Issue 5
Cost they quote around £150/sheet that would be a good size in abdominal surgery – but they won’t be more specific or detail how many sheets a colorectal surgeon might need to use
Adept® (icodextrin 4%) is a new potential solution to adhesions
Adept is approved throughout Europe for use in abdominal and pelvic surgery as an intraoperative wash and postoperative instillate for the reduction of adhesions
It is available as a 1 litre bag and most recently as a 1.5 litre bag to allow use of one bag for irrigating during surgery and to provide 1000ml to leave behind as a postoperative instillate
Work from a registry of routine use (ARIEL) which is now progressing in 150+ centres in Europe showed that a 1.5 litre presentation of Adept would be useful for most surgical cases allowing surgeons to irrigate with up to 500ml during surgery and then instil 1000ml to leave behind at the end of surgery
Icodextrin is a 1,4 linked glucose polymer
The structure is different from Dextran; the key difference lies in the linkage of carbon 1 and 4 (versus Dextran 1,6 which the human body cannot break down easily)
Icodextrin was developed from hydrolysis of corn starch (so it is a natural product)
Icodextrin is used for adhesion reduction as a 4% solution
This 4% solution is isosmolar and biocompatible with other drugs
Icodextrin is a large polymer and attracts a ‘water of hydration’ around it, increasing its size still further.
It is absorbed from the abdomino–pelvic cavity by the lymphatic system. In the blood it is broken down readily by amylase (acts on the 1,4 link) to maltose/isomaltose and then glucose, and is then excreted
Icodextrin has a well-established safety profile at the higher concentration of 7.5% where it is used in peritoneal dialysis - with > 36,000 patient years of safety data and use of Adept in >50,000 as at end January
Icodextrin was developed originally to overcome the issues associated with existing peritoneal dialysis fluids, specifically irritation to the peritoneum, etc
As a result of its structure, icodextrin with its ‘water of hydration’ stays in the abdomino–pelvic cavity over time (it is absorbed solely by the lymphatic system). It is this persisting presence in the abdomino–pelvic cavity that is thought to reduce adhesion formation/reformation as a result of ‘hydroflotation’
Hydroflotation is not a new concept, but the problem has been in finding a fluid that would stay in the abdomino–pelvic cavity long enough to keep tissues apart in the critical time after surgery when adhesions develop, but which does not have an irritant effect on the peritoneum, nor causes problems when absorbed (e.g. Dextran)
This slide looks at the persistence of 4% icodextrin over time compared to saline and glucose
It comes from a study in patients receiving peritoneal chemotherapy in whom 4% icodextrin was used as the carrier fluid1. In the periods between chemotherapy the icodextrin was used as a ‘dwell’ and aliquots drawn off through the Tenckhoff catheter
The results show that 50% of the icodextrin 4% solution was still retained after ~92+ hours, whereas within a day all the saline or glucose was absorbed by the lymphatics
This is the reason why crystalloid solutions such as saline are not very effective in the reduction of adhesions, as they do not stay in the abdomen for long enough to keep the organs and tissues ‘hydroflotated’
Reference
1. Hosie K, Gilbert JA, Kerr D et al. Fluid dynamics in man of an intraperitoneal drug delivery solution: 4% icodextrin. Drug Delivery 2001; 8: 9–12.
Video clips showing instillation at end of surgery
This slide shows the cost comparison of recent agents at current UK prices
Note the costs of agents is different in Finland but comparatively the relative price differentials will be the same
Two kits of Spraygel are often used to get adequate coverage of the surgical site and as per Prof Mathias Korell’s experience in major gynaecological surgery – 5 kits may be needed to ensure adequate coverage of the peritoneal cavity!
The US outcomes study with Seprafilm is using a mean 4.4 sheets/patients1
Intergel was withdrawn in April 2003
Reference
1. Beck DE, Cohen Z, Fleshman JW, Kaufman HS, vanGoor H, Wolff BG. Prospective, randomized, multicentre, controlled study of the safety of Seprafilm Adhesion Barrier in abdominopelvic surgery. Dis Colon Rectum 2003
This slide shows the cost comparison of recent agents at current UK prices illustrating costs of using 4.4 sheets Seprafilm (as per Beck) and 5 kits of Spraygel as (per Korell).
SurgiWrap not included as they don’t give a precise list price or how many sheets are used – when asked – and ?? Anyone using it yet??
Wilson MS et al. Colorectal Disease 2002;4:355-360
Wilson et al. modelled data from a lower abdominal surgery cohort from the SCAR data to assess cost effectiveness.
Results showed that:
Routine use of adhesion reduction products costing £50 per patient will payback the cost for such investment if they reduce adhesion-related readmissions by 16% after 3 years
A product costing £200 will need to offer a 64.1% reduction in readmissions after 3 years to recoup its direct costs
For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year the cumulative costs of adhesion related readmissions over 10 years are estimated at £569 million
At year 3 – 64% reduction would be needed
And at 3 years
Wilson MS et al. Colorectal Disease 2002;4:355-360
Wilson et al. modelled data from a lower abdominal surgery cohort from the SCAR data to assess cost effectiveness.
Results showed that:
Routine use of adhesion reduction products costing £50 per patient will payback the cost for such investment if they reduce adhesion-related readmissions by 16% after 3 years
A product costing £200 will need to offer a 64.1% reduction in readmissions after 3 years to recoup its direct costs
For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year the cumulative costs of adhesion related readmissions over 10 years are estimated at £569 million
This slide looks at cumulative costs of using an adhesion reduction agent over 9 years scaling up to the UK as a whole.
Using a £50 agent with a 25% efficacy would result in a saving of £71m
But using a £200 product with similar efficacy would result in a £142m loss – ie the health system would have to spend an extra £142m over the 9 years to reduce adhesion related readmissions by 25%.
In only 10.4% of cases were adhesions mentioned as part of the informed consent process
14.4% adhesions were discussed but not part of the consent
In those undergoing specific adhesiolysis operations 54% of patients reported being given some kind of information on adhesions before surgery
46% were given information on anti-adhesion agents
In procedures not involving adhesiolysis only 10% of patients reported receiving any adhesion information
Only 6% of cases were given information on anti-adhesion agents
Is this acceptable practice?
Most common adhesion-related claims
Failure to diagnose adhesion-related problems
Delay in diagnosis
Bowel damage at adhesiolysis
– laparoscopy > laparotomy
Infertility or risk of infertility
Starch granuloma – (use of starch-powdered gloves)
Failure to take precautions to prevent adhesions
1994 -1999 UK Medical Defence Union received 77 adhesion-related claims
Out of court settlements in 14 cases in 11 years ranged from £7960 - £124,261 (~€11,701 - €182,664)
– average £50,765 (€74,625)/case
And that was up until 1999
Since 1999
More evidence of burden of adhesions
SCAR study
Van Krabben enterotomy risk
SCAR-2
etc
Discuss high risk options then lead to prohylaxis
Before SCAR
Before we knew the real extent of the problem
Before we had newer anti-adhesion agents
Adhesions continue to be a significant burden
For the patient:
pain, SBO, infertility, re-operative complications
For the surgeon
increased workload, lengthy and complex procedures, medicolegal consequences
For the healthcare system
increased workloads, costs, bed stay
Where are we now?
Any advances in surgery have had little impact
Action on adhesions has received low priority
even in high risk procedures
New developments in anti-adhesion agents
not all are difficult or costly to use
emerging evidence of efficacy
Adopt use of anti-adhesion agents in ‘High Risk’ surgery
Adhesiolysis
Small bowel resection
Formation of stoma
Hartmann’s procedure
Anterior resection
Abdomino-perineal excision
Colectomy
Surgical treatment of peritonitis & fistulae
Thank you
Fellow SCAR Panel Members
Prof Harold Ellis, UMDS, London
Malcolm Wilson, Christie Hospital, Manchester
Don Menzies, Colchester Hospital, Colchester
Jeremy Thompson, Chelsea & Westminster Hospital, London
Brendan Moran, North Hampshire Hospital, Hampshire
Adrian Lower, St Bartholomew's Hospital, London
Rob Hawthorn, Southern General Hospital, Glasgow
Prof Alastair McGuire, City University, London
Graham Sunderland, Southern General Hospital, Glasgow
David Clark, James Boyd, Alan Finlayson, ISD, NHS Scotland, Edinburgh
Prof Ian Ford, Robertson Centre Biostatistics, Glasgow
Alastair Knight & Alison Crowe, Corvus
Shire Pharmaceuticals Group plc
Powerpoint template
Please read more
http://www.euuzlet.hu/koloproktologus/2004/parker.ppt.
Friday, June 20, 2008
Fluid and pharmacological agents for adhesion prevention after gynaecological surgery
Fluid and pharmacological agents for adhesion prevention after gynaecological surgery
The use of fluids and pharmacological agents (medicinal drugs) to prevent the formation of adhesions (scar tissue) that may interfere with becoming pregnant after surgery of the female pelvis.
Adhesion formation is a condition in which bodily tissues that are normally separate grow together. This can occur after surgical procedures such as operations on the female pelvis to remove a cyst, treat endometriosis, remove a tubal pregnancy, or remove a fibroid (a benign tumour of the womb). This scar tissue can have serious effects on the woman's future fertility as it can lead to blockage of her tubes. Careful tissue handling at the time of surgery and control of the blood loss are important ways of reducing scar tissue, however, over the years other methods have been developed to minimise the risk of scar tissue formation. Surgeons have tried using different types of drugs or leaving different types of fluids inside the pelvis at the end of surgery to prevent tissue surfaces from sticking to each other. Fluids include dextran, icodextrin (Adept), SprayGel, and fluids containing the chemical hyaluronic acid (Intergel, auto-crosslinked hyaluronic acid, Sepracoat). Drugs that have been tried include steroids (anti-inflammatory drug), the anti-coagulant heparin, promethazine, and noxytioline.This review aimed to evaluate the role of these different agents in the prevention of adhesion formation. The results showed that there is currently insufficient evidence to recommend the use of steroids, icodextrin, SprayGel or dextran. The review did show that fluids that contained hyaluronic acid may help lower the chance of scar tissue forming; however, more studies are needed to confirm this. There are also some major safety issues concerning the use of one of these agents (Intergel), which has been withdrawn from the market due to reports of serious side effects such as allergic reactions and pain.A major problem with studies in this review is that most of them did not look at the rate of pregnancy following the use of these substances. Since the occurrence of pregnancy is the gold standard for measuring how well these agents work to preserve fertility, it is important that future studies take this into consideration.http://www.cochrane.org/reviews/en/ab001298.html
Main resultsThere is no evidence of benefit from the use of steroids, dextran or other pharmacological agents in any of the outcomes. The use of hyaluronic acid agents may decrease adhesion formation (OR 0.31, 95% CI 0.19 to 0.51) and prevent the deterioration of pre-existing adhesions (OR 0.28 (95% CI 0.12 to 0.66). There is insufficient evidence for the use of icodextrin 4% or SprayGel as adhesion-preventing agents. None of the studied agents has been shown to improve the pregnancy rate when used as an adjunct during pelvic surgery.
Authors' conclusionsThe current evidence for the use of fluid and pharmacological agents for the prevention of adhesions is limited. There is no evidence on any benefit for improving pregnancy outcomes when pharmacological and fluid agents are used as an adjunct during pelvic surgery.There is insufficient evidence for the use of the following agents: steroids, icodextrin 4%, SprayGel and dextran in improving adhesions following surgery.There is some evidence that hyaluronic acid agents may decrease the proportion of adhesions and prevent the deterioration of pre existing adhesions. However, due to the limited number of studies available, this evidence should be interpreted with caution and further studies are needed.
Full study
http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001298/frame.html
and who do they as one of the references??????
METTLER!!!!
The use of fluids and pharmacological agents (medicinal drugs) to prevent the formation of adhesions (scar tissue) that may interfere with becoming pregnant after surgery of the female pelvis.
Adhesion formation is a condition in which bodily tissues that are normally separate grow together. This can occur after surgical procedures such as operations on the female pelvis to remove a cyst, treat endometriosis, remove a tubal pregnancy, or remove a fibroid (a benign tumour of the womb). This scar tissue can have serious effects on the woman's future fertility as it can lead to blockage of her tubes. Careful tissue handling at the time of surgery and control of the blood loss are important ways of reducing scar tissue, however, over the years other methods have been developed to minimise the risk of scar tissue formation. Surgeons have tried using different types of drugs or leaving different types of fluids inside the pelvis at the end of surgery to prevent tissue surfaces from sticking to each other. Fluids include dextran, icodextrin (Adept), SprayGel, and fluids containing the chemical hyaluronic acid (Intergel, auto-crosslinked hyaluronic acid, Sepracoat). Drugs that have been tried include steroids (anti-inflammatory drug), the anti-coagulant heparin, promethazine, and noxytioline.This review aimed to evaluate the role of these different agents in the prevention of adhesion formation. The results showed that there is currently insufficient evidence to recommend the use of steroids, icodextrin, SprayGel or dextran. The review did show that fluids that contained hyaluronic acid may help lower the chance of scar tissue forming; however, more studies are needed to confirm this. There are also some major safety issues concerning the use of one of these agents (Intergel), which has been withdrawn from the market due to reports of serious side effects such as allergic reactions and pain.A major problem with studies in this review is that most of them did not look at the rate of pregnancy following the use of these substances. Since the occurrence of pregnancy is the gold standard for measuring how well these agents work to preserve fertility, it is important that future studies take this into consideration.http://www.cochrane.org/reviews/en/ab001298.html
Main resultsThere is no evidence of benefit from the use of steroids, dextran or other pharmacological agents in any of the outcomes. The use of hyaluronic acid agents may decrease adhesion formation (OR 0.31, 95% CI 0.19 to 0.51) and prevent the deterioration of pre-existing adhesions (OR 0.28 (95% CI 0.12 to 0.66). There is insufficient evidence for the use of icodextrin 4% or SprayGel as adhesion-preventing agents. None of the studied agents has been shown to improve the pregnancy rate when used as an adjunct during pelvic surgery.
Authors' conclusionsThe current evidence for the use of fluid and pharmacological agents for the prevention of adhesions is limited. There is no evidence on any benefit for improving pregnancy outcomes when pharmacological and fluid agents are used as an adjunct during pelvic surgery.There is insufficient evidence for the use of the following agents: steroids, icodextrin 4%, SprayGel and dextran in improving adhesions following surgery.There is some evidence that hyaluronic acid agents may decrease the proportion of adhesions and prevent the deterioration of pre existing adhesions. However, due to the limited number of studies available, this evidence should be interpreted with caution and further studies are needed.
Full study
http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001298/frame.html
and who do they as one of the references??????
METTLER!!!!
Tuesday, February 12, 2008
Scarring gel in spotlight
By JANINE RANKIN - Manawatu Standard
Tuesday, 12 February 2008
The one in five Palmerston North women and girls who suffer from endometriosis need not be alarmed at reports that a product used in surgical treatment could make their condition worse.
The surgical spray gel at the centre of a Wellington gynaecologist's concerns that it causes internal scarring isn't widely used in Palmerston North.
MidCentral Health and private specialist Digby Ngan Kee says he doesn't use the product and isn't aware of any other surgeons locally who use it.
"It is a very expensive product, and there is no good evidence that it is effective," he said.
Wellington gynaecologist Hanifa Koya says she's stopped using the gel since she's had endometriosis patients returning for repeat surgery after its use, to repair the sort of scarring the product was supposed to prevent.
Endometriosis New Zealand chief executive Deborah Bush, who originally set up the national support group in Palmerston North, said she didn't believe women should be alarmed.
The evidence that the gel actually caused scarring over and above the damage done by endometriosis was anecdotal rather than scientific, she said.
"It's a horrible disease, and we don't know what causes it. Surgeons can excise the disease, but that doesn't mean a woman won't develop more adhesions."
In women with endometriosis the tissue that developed in the uterus each month also formed in other parts of the abdomen causing pain, scarring, and often damaging fertility.
Ms Bush said although some surgeons were reporting an increased rate of women coming back for repeat surgery, there was no good evidence the scarring was a result of the gel rather than a result of surgery or the disease.
Dr Ngan Kee said the numbers of women returning for surgery were still too small to give an accurate view. Women struggling with endometriosis will be able to attend a seminar at Palmerston North Hospital next month when Ms Bush, a gynaecologist, and an authority on nutrition and fertility will talk about latest treatments and self-help options
Tuesday, 12 February 2008
The one in five Palmerston North women and girls who suffer from endometriosis need not be alarmed at reports that a product used in surgical treatment could make their condition worse.
The surgical spray gel at the centre of a Wellington gynaecologist's concerns that it causes internal scarring isn't widely used in Palmerston North.
MidCentral Health and private specialist Digby Ngan Kee says he doesn't use the product and isn't aware of any other surgeons locally who use it.
"It is a very expensive product, and there is no good evidence that it is effective," he said.
Wellington gynaecologist Hanifa Koya says she's stopped using the gel since she's had endometriosis patients returning for repeat surgery after its use, to repair the sort of scarring the product was supposed to prevent.
Endometriosis New Zealand chief executive Deborah Bush, who originally set up the national support group in Palmerston North, said she didn't believe women should be alarmed.
The evidence that the gel actually caused scarring over and above the damage done by endometriosis was anecdotal rather than scientific, she said.
"It's a horrible disease, and we don't know what causes it. Surgeons can excise the disease, but that doesn't mean a woman won't develop more adhesions."
In women with endometriosis the tissue that developed in the uterus each month also formed in other parts of the abdomen causing pain, scarring, and often damaging fertility.
Ms Bush said although some surgeons were reporting an increased rate of women coming back for repeat surgery, there was no good evidence the scarring was a result of the gel rather than a result of surgery or the disease.
Dr Ngan Kee said the numbers of women returning for surgery were still too small to give an accurate view. Women struggling with endometriosis will be able to attend a seminar at Palmerston North Hospital next month when Ms Bush, a gynaecologist, and an authority on nutrition and fertility will talk about latest treatments and self-help options
Monday, February 11, 2008
Scarring caused by surgical gel spray
Surgical treatment hurts women but is allowed to continueBy LANE NICHOLS - The Dominion Post Monday, 11 February 2008
ANDREW GORRIE/ Dominion Post
ANGRY AND AMAZED: Hanifa Koya has stopped using SprayGel after her patients required further surgery to remove scars. She says the product should be put on hold till surgeons and patients can be assured of its safety.
Related Links
• Subscribe to Archivestuff• Have your say
A surgical gel - containing a drug untested on humans - has caused excruciating internal scarring in dozens of women that could lead to infertility, claims a leading gynaecologist.
Many of the endometriosis patients have already forked out thousands of dollars for repeat surgery. Some are now pursuing compensation from ACC.
Endometriosis is a condition where abnormal growths develop in pelvic organs, causing inflammatory reactions leading to scarring and pain. It affects millions of women worldwide.
Though some gynaecologists have stopped using the anti-scarring gel because of concerns about its safety and effectiveness, others still use the treatment, Wellington specialist Hanifa Koya said.
Medsafe, the Government agency that approves medicines, has told the American manufacturer to add additional precautions to the instruction pamphlet.
But it maintains the product is safe, and refuses to ban its sale without conclusive evidence of harm - even though the gel is considered high risk under proposed legislation.
Dr Koya - who first raised concerns in December 2005 - was disillusioned at the response of health agencies, which she claimed had let Confluent SprayGel be used internally on thousands of Kiwi women since about 2002 without adequate clinical testing or ongoing monitoring of its effects.
She had spoken out because of concern for her patients and to highlight the need for immediate law changes to protect people.
"Confluent SprayGel is a product sprayed inside human beings and contains a section 29 drug (methylene blue) which has not been tested on human beings, and this product was allowed to be used ... [with] no quality assurance in terms of monitoring," she wrote to Medsafe in December.
"It's quite amazing - we're using it inside human beings," she told The Dominion Post. "I would have expected ... that they would have said, `Let's put this product on hold or start asking some questions', but that didn't happen."
Dr Koya began using the gel in October 2002, but stopped in April 2006 after her rate of repeat laparoscopies - keyhole operations - jumped from less than 2 per cent to around 10 per cent.
Women who would usually have made swift recoveries developed severe pain or discomfort after their initial operations.
Dozens of the many hundred women she treated with the gel needed repeat surgery to remove scarring - which could cause infertility - even though their endometriosis had not returned. "It's only where I've sprayed the SprayGel. It's like sheets of scarring which I've never seen in my practice."
Dr Koya said she had not repeated any laparoscopies since using an alternative product.
She complained to American manufacturer Confluent Surgical and has written repeatedly to MedSafe and the Health Ministry asking them to investigate, but felt her concerns had been ignored.
New Zealand distributor Covidien Tyco did not return calls.
Medsafe interim manager Stewart Jessamine said SprayGel was classed as a device under the Medicines Act, not a medicine.
No clinical assessment was required before its sale, though manufacturers had to ensure the device was safe. Medical practitioners had the ultimate responsibility for its use on patients.
After a review, it it concluded the gel was safe "when used as intended".
There had been no other complaints and there were no plans to restrict its supply, it said.
http://www.stuff.co.nz/stuff/4395993a11.html
'I shouldn't have to pay for it'The Dominion Post, New Zealand - 21 hours agoTwo years after she had invasive surgery to treat her endometriosis, Anastasia Spallas-Blades has had to go back to have painful scarring caused by a ...
Expert: Surgical gel has injured womenUnited Press International - 14 hours agoKoya said these women now suffer from endometriosis, a medical condition in which abnormal growths appear in a woman's pelvic organs. ...
Gynaecologist calls for ban on surgical gelRadio New Zealand, New Zealand - 9 hours agoA Wellington gynaecologist is calling for a ban on a gel used in operations to treat endometriosis. Hanifa Koya, a surgeon at Wellington's Wakefield ...
IHRT.....the jury is out here. We will wait for science and not accusation before we give up hope on Spraygel.
As we all were told....Spraygel is only as effective as the surgeon using it.
The blue coloring in question is used to run the bowel and bladder all the time.
Maybe they were using too many kits ( like some surgeons we know)
Science please.
ANDREW GORRIE/ Dominion Post
ANGRY AND AMAZED: Hanifa Koya has stopped using SprayGel after her patients required further surgery to remove scars. She says the product should be put on hold till surgeons and patients can be assured of its safety.
Related Links
• Subscribe to Archivestuff• Have your say
A surgical gel - containing a drug untested on humans - has caused excruciating internal scarring in dozens of women that could lead to infertility, claims a leading gynaecologist.
Many of the endometriosis patients have already forked out thousands of dollars for repeat surgery. Some are now pursuing compensation from ACC.
Endometriosis is a condition where abnormal growths develop in pelvic organs, causing inflammatory reactions leading to scarring and pain. It affects millions of women worldwide.
Though some gynaecologists have stopped using the anti-scarring gel because of concerns about its safety and effectiveness, others still use the treatment, Wellington specialist Hanifa Koya said.
Medsafe, the Government agency that approves medicines, has told the American manufacturer to add additional precautions to the instruction pamphlet.
But it maintains the product is safe, and refuses to ban its sale without conclusive evidence of harm - even though the gel is considered high risk under proposed legislation.
Dr Koya - who first raised concerns in December 2005 - was disillusioned at the response of health agencies, which she claimed had let Confluent SprayGel be used internally on thousands of Kiwi women since about 2002 without adequate clinical testing or ongoing monitoring of its effects.
She had spoken out because of concern for her patients and to highlight the need for immediate law changes to protect people.
"Confluent SprayGel is a product sprayed inside human beings and contains a section 29 drug (methylene blue) which has not been tested on human beings, and this product was allowed to be used ... [with] no quality assurance in terms of monitoring," she wrote to Medsafe in December.
"It's quite amazing - we're using it inside human beings," she told The Dominion Post. "I would have expected ... that they would have said, `Let's put this product on hold or start asking some questions', but that didn't happen."
Dr Koya began using the gel in October 2002, but stopped in April 2006 after her rate of repeat laparoscopies - keyhole operations - jumped from less than 2 per cent to around 10 per cent.
Women who would usually have made swift recoveries developed severe pain or discomfort after their initial operations.
Dozens of the many hundred women she treated with the gel needed repeat surgery to remove scarring - which could cause infertility - even though their endometriosis had not returned. "It's only where I've sprayed the SprayGel. It's like sheets of scarring which I've never seen in my practice."
Dr Koya said she had not repeated any laparoscopies since using an alternative product.
She complained to American manufacturer Confluent Surgical and has written repeatedly to MedSafe and the Health Ministry asking them to investigate, but felt her concerns had been ignored.
New Zealand distributor Covidien Tyco did not return calls.
Medsafe interim manager Stewart Jessamine said SprayGel was classed as a device under the Medicines Act, not a medicine.
No clinical assessment was required before its sale, though manufacturers had to ensure the device was safe. Medical practitioners had the ultimate responsibility for its use on patients.
After a review, it it concluded the gel was safe "when used as intended".
There had been no other complaints and there were no plans to restrict its supply, it said.
http://www.stuff.co.nz/stuff/4395993a11.html
'I shouldn't have to pay for it'The Dominion Post, New Zealand - 21 hours agoTwo years after she had invasive surgery to treat her endometriosis, Anastasia Spallas-Blades has had to go back to have painful scarring caused by a ...
Expert: Surgical gel has injured womenUnited Press International - 14 hours agoKoya said these women now suffer from endometriosis, a medical condition in which abnormal growths appear in a woman's pelvic organs. ...
Gynaecologist calls for ban on surgical gelRadio New Zealand, New Zealand - 9 hours agoA Wellington gynaecologist is calling for a ban on a gel used in operations to treat endometriosis. Hanifa Koya, a surgeon at Wellington's Wakefield ...
IHRT.....the jury is out here. We will wait for science and not accusation before we give up hope on Spraygel.
As we all were told....Spraygel is only as effective as the surgeon using it.
The blue coloring in question is used to run the bowel and bladder all the time.
Maybe they were using too many kits ( like some surgeons we know)
Science please.
Subscribe to:
Posts (Atom)