(Reuters) — Consumer watchdog Public Citizen said it petitioned the FDA to withdraw approval of Sanofi‘s (NYSE:SNY) Seprafilm and order a recall, saying the surgical implant has been associated with side effects including death.
Seprafilm, developed by Sanofi subsidiary 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 FDA 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 FDA database of Manufacturer & User Facility Device Experience cites at least 9 reports that link Seprafilm to patient deaths in the last 10 years.
All 3 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 yesterday.
Re-analyses of data from an FDA-mandated post-market study were highly questionable and the device has drawn criticism from experts, the advocacy group said. Public Citizen, a nonprofit organization, also questioned the design of 2 pivotal studies on which Seprafilm’s original marketing application was based. 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 group claimed.
“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 group, founded in 1971, said it was aware of at least 21 reports of deaths associated with Seprafilm; 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 a slurry version of Seprafilm.
“I don’t know what [the FDA is] 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.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.