Withdraw Approval for Seprafilm - Public Citizen to FDA

Public Citizen to FDA: Withdraw Approval of Seprafilm and Initiate Mandatory Recall

Medical Device Not Shown to Be Safe and Effective; Associated With Patient Death and Injury

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should remove the medical device Seprafilm from the market because it has not been shown to be safe and effective, and has been associated with patient death and severe injury, Public Citizen told the agency in a petition filed today.

Seprafilm – approved by the FDA in August 1996 – is a thin sheet of gel-like material that surgeons use during abdominal and pelvic surgery to prevent internal organs from forming fibrous bands of tissues that can block the intestine and cause other complications following surgery.

The clinical studies the FDA relied on when approving Seprafilm were plagued with problems. A study researcher at one hospital did not follow the study protocol or report all adverse event data and filed incomplete and inaccurate paperwork. There were also high numbers of serious adverse events in patients receiving Seprafilm. At the time of approval, the FDA ordered the product’s manufacturer, Genzyme, to conduct a post-approval safety study to address the agency’s concerns with the initial trials.

Yet this postmarket study, when finally completed, used highly questionable forms of analysis and failed to establish that Seprafilm offers any important clinical benefits for patients. More troublingly, evidence from this study, along with reports filed with the FDA over the years, shows that Seprafilm may interfere with wound healing and cause severe reactions – including death – in some patients.

“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,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The FDA needs to immediately withdraw the approval of Seprafilm and initiate a mandatory recall of the device.”

Through records in the FDA’s Manufacturer and User Facility Device Experience database, Public Citizen found 21 reports of death in patients in whom Seprafilm was placed during surgery. It is likely that many other deaths have gone unreported. In addition to the death reports, Public Citizen identified a total of 524 reports of adverse events linked to Seprafilm.