Public Citizen, a consumer watchdog group, is calling on the U.S. Food and Drug Administration (FDA) to revoke approval of Sanofi’s Seprafilm and issue a recall. According to Reuters, the group says the device has been linked to serious, sometimes fatal side effects and that data used to show its efficacy was flawed. Public Citizen filed a 39-page petition with the agency on Tuesday.
Seprafilm was developed by Genzyme, which was bought by Sanofi in 2011. The FDA approved the device in 1996; it is intended to prevent abnormal scarring by keeping tissues and organs separate after surgery. According to Public Citizen, two crucial studies used to gain approval were flawed. The group raised questions about the design of the studies, pointing out 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.
Public Citizen is aware of at least 21 deaths related to Seprafilm, Reuters reports. The anti-adhesion barrier was implicated in at least nine patient deaths in the past 10 years, the U.S. FDA database of Manufacturer and User Facility Device Experience indicates. The device was associated with 524 adverse events in a limited search of an FDA database covering Jan. 1, 1998 through May 27, 2015.
Public Citizen also took issue with a re-analysis of data from a postmarketing study mandated by the FDA to assess the safety of Seprafilm. The watchdog cited experts who raised concerns with the products, including 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,”
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”,