Device Has Been Linked to 21 Patient Deaths
WASHINGTON, D.C. – Public Citizen today sued the U.S. Food and Drug Administration (FDA) over its failure to act on a five-year-old petition asking the agency to ban the dangerous and ineffective medical device, Seprafilm, which continues to put patients at risk.
Seprafilm – approved by the FDA in 1996 – is a thin sheet of gel-like material 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. Clinical studies on which the FDA relied when approving the device were plagued with problems. As of July 2015, when Public Citizen filed its petition, the agency had received more than 500 reports of serious adverse events experienced by patients receiving Seprafilm, including at least 21 patient deaths following surgery.
Public Citizen’s petition asked the FDA to withdraw approval of the device and remove it from shelves, but, five years later, the agency has yet to respond. Public Citizen is seeking a declaration that the agency violated the Administrative Procedure Act by failing to act on Public Citizen’s petition and an order requiring the agency to respond. The suit was filed in the U.S. District Court for the District of Columbia.
“There is no evidence that Seprafilm achieves any important clinical benefit for patients – but ample evidence showing serious adverse health consequences, including death,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The FDA needs to act now before additional patients are harmed or killed by this device.”
View the lawsuit here.