Consumer advocates are calling on the FDA to ban Seprafilm, a gel-like surgical barrier that has been linked to severe inflammatory reactions, adhesions, infection, and even death.
UPDATE: Genzyme Pays $33 Million Criminal Fine for Seprafilm Marketing
September 3, 2015 — Genzyme Corp. has agreed to pay a $32.6 million to resolve criminal charges that Seprafilm was unlawfully marketed for unapproved uses from 2005-2010, according to a statement from the Justice Department. Click here to read more.
What is Seprafilm?
Seprafilm is a thin sheet of gel-like material that is implanted in patients after surgery in the abdomen or pelvis. It is an anti-adhesion device that prevents organs and tissues from sticking together when fibrous bands of scar-tissue form during the healing process. Seprafilm was approved by the FDA in 1996 and is made by Genzyme.
What is the problem?
The consumer safety group Public Citizen has recently petitioned (PDF) the U.S. Food and Drug Administration (FDA) to ban Seprafilm due to the risk of severe side effects, including death. The group is also concerned about “highly questionable” clinical trials and the increasing use of Seprafilm for unapproved surgeries.
Seprafilm Side Effects
Public Citizen has reviewed the FDA database of adverse events and found at least 21 reports of death and 524 adverse events linked to Seprafilm between 1998-2015. Many of those reports involve life-threatening side effects.
Side effects linked to Seprafilm:
- Bowel obstruction
- Bacterial abscess
- Fluid collection in the abdomen
- Inflammatory reaction
- Poor healing after surgery
- And more
Should Seprafilm Be Recalled?
In July 2015, Public Citizen asked the FDA to issue a mandatory recall for Seprafilm. According to the group, clinical trials found safety issues and did not show that it was effective.
The petition quotes a case report involving a 71 year-old woman who died from post-operative complications after being implanted with Seprafilm. According to report, she had to have several 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.”
“Highly Questionable” Clinical Trials
Genzyme gained approval for Seprafilm with two clinical trials. After approval, Genzyme also completed a post-marketing study ordered by the FDA. Public Citizen documented extensive flaws in all three studies, including protocol violations and questionable analyses of 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 Settles “Off-Label” Marketing Lawsuit for $22 Million
Whistleblowers filed a lawsuit against Genzyme accusing the drug-maker of illegally marketing Seprafilm for “off-label” (unapproved) surgeries. In December 2013, Genzyme agreed to pay a $22.28 million settlement to the Justice Department.
Genzyme sales representatives were accused of telling doctors to cut tiny pieces of Seprafilm, mix them with saline, and squirt the “slurry” into patients via catheters during laparoscopic surgeries. This use is not approved or recommended by the FDA and has never been evaluated for safety or effectiveness.