Seprafilm Recall Urged by Public Citizen, Indicating Side Effects Outweigh Benefits
The prominent consumer watchdog group Public Citizen is calling for the FDA to recall Seprafilm, a medical device used during abdominal and pelvic surgery, indicating that it has been linked to severe patient injury and death.
A petition (PDF) was field with the FDA earlier this week, indicating that a Seprafilm recall should be issued, as the Sanofi-Aventis adhesion barrier is neither safe or effective. Public Citizen indicates that at least 21 deaths have been linked to Seprafilm.
Seprafilm is a sheet of gel-like material that is placed in the body during abdominal and pelvic surgery. Approved by the FDA in 1996, it is designed to prevent internal organs from accidentally knitting together while healing, which can cause intestinal blockages and other post-surgical complications. The device is marketed by Sanofi-Aventis subsidiary Genzyme. However, Public Citizen indicates that at least 524 adverse event reports have been filed with the FDA involving Seprafilm problems, and the group indicates that it is likely many more Seprafilm injuries and deaths have gone unreported.
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Learn MoreIn addition, the group raises questions about the clinical trials used to approve Seprafilm. The group says numerous errors were made during the study, including failure to follow study protocols, incomplete and inaccurate data, and the study indicated a high number of complications were linked to Seprafilm use.
Public Citizen also raised questions about the veracity of a post-marketing study, ordered by the FDA due to concerns over the original clinical trials. According to the group, the study used “highly questionable forms of analysis” and even then showed no important clinical benefits.
The post-marketing study and the adverse event reports suggest that Seprafilm may interfere with wound healing and cause severe reactions, the group warns.
“Seprafilm never should have been approved. There is no evidence that this device achieves any important clinical benefit for patients — but ample evidence showing serious adverse health consequences,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a press release. “The FDA needs to immediately withdraw the approval of Seprafilm and initiate a mandatory recall of the device.”
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9 Comments
ShirleyJuly 6, 2023 at 3:27 pm
Seprafilm has migrated throughout my body and cannot be removed. Stay in constant pain.
JuneSeptember 1, 2017 at 1:49 am
I also have been suffering since 2012!! I have been on pain meds since a small bowl obstruction and 2 pieces of seprafilm were used. I can't ride my horse, 4 wheeler, can't walk to fast can't even really touch the outside of my skin on my right side. After I eat I get a large knot right under my rib cage. I wear a maternity belt as tight as I can stand it to keep my innards from jarring. I do 3 to[Show More]I also have been suffering since 2012!! I have been on pain meds since a small bowl obstruction and 2 pieces of seprafilm were used. I can't ride my horse, 4 wheeler, can't walk to fast can't even really touch the outside of my skin on my right side. After I eat I get a large knot right under my rib cage. I wear a maternity belt as tight as I can stand it to keep my innards from jarring. I do 3 to 5 doses of miralax a day, I never pass gas or burp since the seprafilm was used, I have cronic pain since that will wake me up at times, I was fired from my job because of this disability I've kept a food and bm journal since. I can gain or lose 7 to 8 lbs in a day. It has affected my whole life!!! Doctor's really just want you to learn to live with it and with no insurance ( on and off) I really feel in the 5 years that it just gets worse everyday and that I just have to wait until something spectacular happens they just expect me to live off miralax and pain meds for the rest of my life. I can barely make it due to having to find another job after I was fired due to the disability ( I did win a small law suit against the employer due to this) I feel that something is not right inside my intestines, all most like there is so much movement sometimes going on in there and then there will be a hard as a rock feeling in there. I sometimes just live off protein shakes and miralax for up to 3 days at a time worst feeling ever, I've asked if it could be removed? And was told probably not?
debraApril 11, 2017 at 12:19 pm
how should I go about getting my Seprafilm out. it was used to avoid scarring inside. my stomach burns and have pain always on the opposite side. please give me your thoughts. thank you, debra
DarleneFebruary 17, 2017 at 12:34 pm
I am a victim of Seprafilm. I experienced swelling, infections, high fever, tearing of abdomen. I am experiencing bowels cemented to my abdominal wall. I have # 9 surgery to schedule tomorrow. I have no help when I come home to assist me. I never did. People just don't want to be by anyone like this.
ReneeOctober 6, 2016 at 3:45 am
Seprafilm has cemented by bowel to my abdominal wall. I suffer everyday.
BCAugust 30, 2016 at 4:17 pm
I also want to know if it can be removed. I had it put in in 2012 after bowel surgery. The minute I eat or drink something my stomach within less than one hour swells by 2 inches. I've measured it. Then when I sleep or obstain from all it goes flat again. I actually have two wear a size larger to get dressed. Its like I'm always bloated. I only weight 115 lbs.
GaryMay 23, 2016 at 12:52 am
Sepra film causing me pain and suffering
teresaDecember 16, 2015 at 6:21 am
Had this seprafilm after a kugal patch hernia was put in abdomen they used seprafilm for adhesions.I complained from the beginning about inflammation ,bloating ,feeling like there is a mass all bunched together like a ball in my stomach. Feels like foreign to me like biting on foil. Lost insurance so was never able to follow up on it. Feel like I have gained an extra stomach.,Talked to a surgeon a[Show More]Had this seprafilm after a kugal patch hernia was put in abdomen they used seprafilm for adhesions.I complained from the beginning about inflammation ,bloating ,feeling like there is a mass all bunched together like a ball in my stomach. Feels like foreign to me like biting on foil. Lost insurance so was never able to follow up on it. Feel like I have gained an extra stomach.,Talked to a surgeon at a free seminar they told me to go back to my dr; but,I have no insurance, It hurts ,feeling of fullness uncomfortable. Also ended up in the hospital with low potassium never have before just want to know can it be removed? Teresa
MarcieNovember 17, 2015 at 12:09 am
I agree seprafilm should never be used as it was used during my surgery in 2008 and as a result my incision ruptured and i had multiple complications and a wound vac for 3 months attached to my stomach and have permanent damage and scarring. ive tried multiple times to reach out on my behalf and other patients and families that have had to deal with complications from seprafilm. no one seems to wa[Show More]I agree seprafilm should never be used as it was used during my surgery in 2008 and as a result my incision ruptured and i had multiple complications and a wound vac for 3 months attached to my stomach and have permanent damage and scarring. ive tried multiple times to reach out on my behalf and other patients and families that have had to deal with complications from seprafilm. no one seems to want to help those who have had to suffer from it. its not safe at all no matter how you look at it!