Watchdog urges FDA to revoke approval of Genzyme surgical implant

By Natalie Grover (Reuters) - Consumer watchdog Public Citizen said it petitioned U.S. health regulators to withdraw approval of Sanofi SA's Seprafilm and order a recall, saying the surgical implant has been associated with side effects including death. Seprafilm, developed by Genzyme, is used to reduce abnormal internal scarring following surgery, by separating tissues and organs while they heal. The anti-adhesion barrier device was approved by the U.S. Food and Drug Administration in 1996. Sanofi, which bought Genzyme in 2011, was not immediately available for comment. An FDA spokesperson said the petition was still being filed, and that the agency would directly respond to Public Citizen following its review. The U.S. FDA database of Manufacturer and User Facility Device Experience cites at least nine reports that link Seprafilm to patient deaths in the last 10 years. (http://1.usa.gov/1dJNsYi) All three key studies used to prove Seprafilm's efficacy were plagued by serious issues, including protocol violations at a trial site, Public Citizen said in a 39-page petition to the FDA on Tuesday. Re-analyses of data from a postmarketing study were highly questionable and the device has drawn criticism from experts, the advocacy group said. The FDA had mandated a large postmarketing study to further assess Seprafilm's safety. Public Citizen, a nonprofit organization, also questioned the design of two pivotal studies on which Seprafilm's original marketing application was based on. Instead of assessing its effectiveness at improving outcomes, Genzyme evaluated the incidence and severity of adhesions and hypothesized that such improvements would imply meaningful clinical benefit, the watchdog said. "Evidence of (Seprafilm's) clinical efficacy has been sorely lacking despite widespread adoption," Dr. Neil Hyman, a professor of surgery at the University of Chicago, wrote in 2006, Public Citizen said. The advocacy group, founded in 1971, said it was aware of at least 21 reports of deaths associated with Seprafilm, and a limited search of an FDA database covering Jan. 1, 1998 through May 27, 2015 threw up 524 reports of related adverse events. Off-label use of the product has proliferated in recent years, amplifying concerns, the group said. In 2013, Genzyme agreed to pay the U.S. government $22.3 million to resolve allegations of encouraging inappropriate use of the device. (http://1.usa.gov/1KKbf91) "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", Dr. Michael Carome, the director of Public Citizen's Health Research Group, told Reuters. (Editing by Joyjeet Das)