The surgical anti-adhesion implant Seprafilm has been linked to hundreds of adverse events, including nearly two dozen deaths. Recently, Genzyme paid over $22 million to settle a lawsuit accusing the company of illegally marketing it for “off-label” surgeries.
UPDATE: Genzyme Settles Seprafilm Criminal Case for $33 Million
September 3, 2015 — The U.S. Department of Justice has announced a $32.6 million criminal fine against Genzyme Corp. for unlawfully marketing the surgical barrier Seprafilm for “off-label” surgeries between 2005 and 2010. Click here to read more.
What is Seprafilm?
Seprafilm is a gel-like barrier that is used in abdominal and pelvic surgery. It is placed between organs and tissues to prevent the formation of post-operative adhesions (fibrous bands of scar-tissue) during the healing process. Seprafilm is made by Genzyme and has been on the market since 1996.
Seprafilm Recall Petition Filed with FDA
In July 2015, the consumer watchdog group Public Citizen has petitioned (PDF) the FDA to recall Seprafilm because it has not been shown to be safe or effective and it could cause serious side effects or death.
In one particularly dramatic case report published by the Journal of the Royal Society of Medicine, a 71 year-old woman who was implanted with Seprafilm had to have multiple surgeries to remove a “dense, thick, glue-like mass involving 95% of the small bowel and part of the transverse colon, anchoring the abdominal contents to the anterior abdominal wall.”
Seprafilm Side Effects
Public Citizen says it is aware of at least 21 reports of death and 524 adverse events associated with Seprafilm between January 1998 and May 2015.
Adverse events submitted to the FDA include:
- Bowel obstruction
- Bacterial abscess
- Fluid collection in the abdomen
- Inflammatory reaction
- Poor healing after surgery
- And more
Approval Based on “Seriously Flawed” Studies
Seprafilm has been studied in three clinical trials, two of which were used to gain approval from the FDA, and one post-marketing study ordered by the FDA at the time of approval.
Public Citizen found serious flaws with all three studies, including major protocol violations and a “highly questionable” re-analyses of data from the post-marketing study. According to the group:
“Most importantly, none of these three studies … established the product’s efficacy in improving any important clinically meaningful outcomes, and two of the studies raised serious safety concerns that have not been adequately addressed by the product’s sponsor.”
Genzyme Pay $22 Million for “Off-Label” Marketing
December 2013 — The Justice Department has announced a $22.28 million settlement with Genzyme for illegal “off-label” (unapproved) marketing of Seprafilm.
The government alleges that Genzyme sales representative told doctors to cut Seprafilm into smaller pieces, add saline to allow the pieces to dissolve, and squirt the “slurry” into a patient’s body through a catheter during laparoscopic surgery. Seprafilm is not approved for laparoscopic surgery — only open abdominal surgery — and the use of “slurry” has never been approved or evaluated for safety and effectiveness.