A prominent consumer watchdog group is calling on the FDA to recall Seprafilm, a medical device used during abdominal and pelvic surgery that has been linked to hundreds of severe health complications, including 21 deaths.
What is Seprafilm?
Seprafilm is a surgical implant used to reduce internal scarring (adhesions) following surgery by forming a thin film between abdominal tissue and organs. The product was developed by Genzyme Corp., and approved by the U.S. Food & Drug Administration (FDA) in August 1996 for use in any open abdominal or pelvic surgery.
Watchdog Group Urges Seprafilm Recall
On July 7, 2015, the consumer advocacy group Public Citizen petitioned the FDA to recall Seprafilm nationwide. The group said it was aware of at least 524 adverse events — including 21 deaths — linked to Seprafilm from Jan. 1, 1998 to May 27, 2015.
“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.”
Seprafilm Side Effects
- Inflammatory reactions
- Bowel obstruction
- Adhesion barrier interferes with healing
- Other complications
Genzyme Pays $22M to Resolve “Seprafilm Slurry” FCA Claims
On December 20 2013, the U.S. Justice Department announced that Genzyme Corp. had agreed to pay $22.28 million to resolve 2 whistleblower lawsuits that alleged the company promoted Seprafilm for unapproved or “off-label” purposes.
According to the complaints, Genzyme sales representatives taught doctors and other medical staff to cut Seprafilm into small pieces, add saline and dissolve it into a “slurry,” which was then used during laparoscopic surgery by inserting a catheter into the body and squirting the substance into the abdominal cavity. This is an off-label use for Seprafilm, since the device has only been approved for use in open abdominal surgery and not for laparoscopic or keyhole surgery, according to the lawsuit.
“There will be consequences when medical device companies alter products to increase sales and profits without regard for risks to patient safety,” said Stuart F. Delery of the Justice Department.
Adhesion Barrier Approved Based on ‘Highly Questionable’ Studies
According to Public Citizen, all 3 studies used to prove Seprafilm’s efficacy were “highly questionable” and had fundamental errors, including protocol violations at a trial site.
“Evidence of (Seprafilm’s) clinical efficacy has been sorely lacking despite widespread adoption,” said Dr. Neil Hyman, a professor of surgery at the University of Chicago.