July 8, 2015 — Public Citizen, a D.C.-based consumer watchdog group, has asked the FDA to recall Seprafilm due to the risk of severe side effects, including death.
Seprafilm is a gel-like surgical implant made by Genzyme that has been on the market since 1996. It is an anti-adhesion device that prevents the formation of scar tissue between organs and tissues.
Reuters reports that Public Citizen has found at least 21 reports of death and 524 reports of adverse events associated with Seprafilm between January 1998 and May 2015.
Some of the most serious adverse events included:
- Inflammatory reactions
- Anastomotic leak
- Pelvic sepsis
- Fluid accumulation in the abdomen
- Bacterial abscess
- Interfere with healing
- And more
Public Citizen also said three studies Genzyme used to convince the FDA to approve Seprafilm were “seriously flawed,” failed to show any benefit, or raised serious safety concerns. According to Public Citizen:
“Most importantly, none of these three studies … established the product’s efficacy in improving any important clinically meaningful outcomes, and two of the studies raised serious safety concerns that have not been adequately addressed by the product’s sponsor.”
This is not the first time concerns have been raised regarding Seprafilm. In 2013, the Justice Department ordered Genzyme to pay $22.28 million for illegally promoting Seprafilm for “off-label” (unapproved) uses in laparoscopic surgery.
The FDA has only approved Seprafilm for open abdominal surgery. Specifically, sales representatives were telling doctors they could cut Seprafilm into tiny pieces, mix it with saline, and create a “slurry” that could be squirted into a patient’s abdomen through a catheter. This procedure has never been evaluated for safety or effectiveness.