Public Citizen Petitions FDA to Withdraw Seprafilm Surgical ImplantJul 8, 2015
In 1996, the U.S. Food and Drug Administration (FDA) approved Seprafilm, a surgical implant that separates tissues and organs after surgery to prevent abnormal scarring. The anti-adhesion barrier was developed by Genzyme, which was acquired by Sanofi in 2011. Now, Reuters reports, consumer advocacy group Public Citizen is calling on the FDA to revoke the device's approval due to serious, potentially-fatal side effects.
The group said in a 39-page petition to the FDA that studies used to approve the device and demonstrate its efficacy were flawed. Public Citizen also pointed out that experts have criticized the product, citing Dr. Neil Hyman, a professor of surgery at the University of Chicago, who wrote in 2006 "Evidence of (Seprafilm's) clinical efficacy has been sorely lacking despite widespread adoption,”
Public Citizen pointed to two major studies used to gain Seprafilm's approval. The group took issue with the design of the studies, stating that Genzyme focused on the incidence and severity of adhesions and hypothesized about the improved outcomes with the device rather than evaluating the efficacy of the device itself. The watchdog also criticized a re-analysis of post marketing study data, Reuters reports.
According to Reuters, the U.S. FDA database of Manufacturer and User Facility Device Experience shows that Seprafilm has been linked to at least nine patients’ deaths in the past 10 years. Public Citizen said it knew of at least 21 Seprafilm-linked deaths; the device was associated with 524 adverse events in a limited search of an FDA database covering Jan. 1, 1998 through May 27, 2015.
Dr. Michael Carome, the director of Public Citizen's Health Research Group, told Reuters "I don't know what they're (the FDA) going to do in this case... but it looks like it will take a couple of years before we know the answer",