Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000475.
Barrier agents for adhesion prevention after gynaecological surgery.
Ahmad G, Duffy JM, Farquhar C, Vail A, Vandekerckhove P, Watson A, Wiseman D.
SourceStepping Hill Hospital, Obstetric & Gynaecology, 30 Badger Road, Altrincham, Cheshire, UK, WA14 5UZ. gaityahmad@hotmail.com
Abstract
BACKGROUND: Pelvic adhesion can form as a result of inflammation, endometriosis or surgical trauma. During pelvic surgery, strategies to reduce pelvic adhesion formation may include placing synthetic barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene or Fibrin sheets between the pelvic structures.
OBJECTIVES: To assess the effect of physical barriers used during pelvic surgery in women of reproductive age on pregnancy rates, pelvic pain, or postoperative adhesion reformation.
SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched September 2007) which is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, plus handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. In addition, companies were contacted for unpublished trials.
SELECTION CRITERIA: Any randomised controlled trials (RCTs) comparing the use of physical barriers versus no treatment or other physical barriers in the prevention of adhesions in women undergoing gynaecological surgery.
DATA COLLECTION AND ANALYSIS: Review authors assessed trial eligibility and quality.
MAIN RESULTS: Sixteen RCTs were included. Five trials randomised patients while the remainder randomised pelvic organs. Laparoscopy (six trials) and laparotomy (10 trials) were the primary surgical techniques. Indications for surgery included myomectomy (five trials), ovarian surgery (five trials), pelvic adhesions (four trials), endometriosis (one trial), and mixed (one trial). Eleven trials assessed Interceed versus no treatment, two assessed Interceed versus Gore-Tex, one trial assessed Gore-Tex versus no treatment, and one trial assessed Seprafilm versus no treatment. A single trial assessed Fibrin sheet versus no treatment. No studies reported pregnancy or reduction in pain as outcomes. The use of Interceed was associated with reduced incidence of pelvic adhesion formation, both new formation and reformation following laparoscopic surgery or laparotomy. However, this result should be interpreted with caution. Gore-Tex was more effective than no barrier or Interceed in preventing adhesion formation. There was only limited evidence that Seprafilm was effective in preventing adhesion formation following myomectomy and no evidence to support Fibrin sheet.
AUTHORS' CONCLUSIONS: The absorbable adhesion barrier Interceed reduces the incidence of adhesion formation following laparoscopy and laparotomy, but there are insufficient data to support its use to improve pregnancy rates. Gore-Tex may be superior to Interceed in preventing adhesion formation but its usefulness is limited by the need for suturing and later removal. There was no evidence of effectiveness of Seprafilm and Fibrin sheet in preventing adhesion formation.
Update of
Cochrane Database Syst Rev. 2000;(2):CD000475.
http://www.ncbi.nlm.nih.gov/pubmed/18425865
Showing posts with label Seprafilm. Show all posts
Showing posts with label Seprafilm. Show all posts
Thursday, January 19, 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
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