Seprafilm Recall Urged by Public Citizen, Indicating Side Effects Outweigh Benefits

The prominent consumer watchdog group Public Citizen is calling for the FDA to recall Seprafilm, a medical device used during abdominal and pelvic surgery, indicating that it has been linked to severe patient injury and death. 

A petition (PDF) was field with the FDA earlier this week, indicating that a Seprafilm recall should be issued, as the Sanofi-Aventis adhesion barrier is neither safe or effective. Public Citizen indicates that at least 21 deaths have been linked to Seprafilm.

Seprafilm is a sheet of gel-like material that is placed in the body during abdominal and pelvic surgery. Approved by the FDA in 1996, it is designed to prevent internal organs from accidentally knitting together while healing, which can cause intestinal blockages and other post-surgical complications. The device is marketed by Sanofi-Aventis subsidiary Genzyme. However, Public Citizen indicates that at least 524 adverse event reports have been filed with the FDA involving Seprafilm problems, and the group indicates that it is likely many more Seprafilm injuries and deaths have gone unreported.

In addition, the group raises questions about the clinical trials used to approve Seprafilm. The group says numerous errors were made during the study, including failure to follow study protocols, incomplete and inaccurate data, and the study indicated a high number of complications were linked to Seprafilm use.

Public Citizen also raised questions about the veracity of a post-marketing study, ordered by the FDA due to concerns over the original clinical trials. According to the group, the study used “highly questionable forms of analysis” and even then showed no important clinical benefits.

The post-marketing study and the adverse event reports suggest that Seprafilm may interfere with wound healing and cause severe reactions, the group warns.

“Seprafilm never should have been approved. There is no evidence that this device achieves any important clinical benefit for patients — but ample evidence showing serious adverse health consequences,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a press release. “The FDA needs to immediately withdraw the approval of Seprafilm and initiate a mandatory recall of the device.”