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.
Public Citizen spoke with Laura Schmitz, whose mother, Jayne Heisner, died from complications related to Seprafilm.
“My mother died after experiencing what her operating physician described as an intense, inflammatory reaction where Seprafilm had been placed during surgery. She didn’t ask that Seprafilm be placed in her, nor did our family. During routine surgery for a benign ovarian tumor, it was discovered that she had adhesions [fibrous bands of tissues]. At that time Seprafilm was placed in her abdominal cavity to prevent further adhesions. Within a short time she had a severe reaction to Seprafilm. Four weeks later, her system totally failed and, ultimately, we made the painful decision to remove her from life support,” said Schmitz. “Now my family and I are left to share her story in hopes that the FDA or even Genzyme will see the catastrophic outcomes that this device can cause and immediately remove it from the market. Our hope is that no one will ever again have to experience what our family and other victims of Seprafilm and their families have experienced.”
In addition, in 2013, Genzyme settled two lawsuits with the U.S. Department of Justice related to allegations that company representatives had instructed doctors to dissolve pieces of Seprafilm in a “slurry” for injection into patients’ abdomens during surgery. This use has not been approved by the FDA and raises a number of safety concerns.