July 8, 2015 — The consumer advocacy group Public Citizen has petitioned the FDA to recall Seprafilm, a surgical implant made by Genzyme, due to the risk of severe side effects and death.
Seprafilm is a thin sheet of gel-like material that surgeons use during abdominal and pelvic surgery. It is an anti-adhesion barrier that keeps tissues and organs separate after surgery, which prevents the formation of fibrous bands of tissue that can block the intestines or cause other complications.
According to Reuters, Public Citizen is aware of at least 21 reports of deaths associated with Seprafilm and 524 adverse events.
Serious adverse events linked to Seprafilm:
- Severe inflammatory reactions
- Anastomotic leak
- Pelvic sepsis
- Wound infection
- Intra-abdominal fluid accumulation
- Bacterial abscess
- Interfere with healing
- And more
Public Citizen also raised concerns about three studies Genzyme used to gain approval for Seprafilm, calling them “seriously flawed.” One study involving nearly 1,800 patients failed to show that Seprafilm was effective at reducing the rate of bowel obstruction. 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.”
In 2013, Genzyme paid $22.28 million after the Justice Department accused the company of “off-label” (unapproved) marketing of Seprafilm. Genzyme sales representatives allegedly taught doctors to cut Seprafilm into small pieces, add saline, and allow the pieces to dissolve to a consistency referred to as “slurry.”
The slurry was used in laparoscopic (“keyhole”) surgery by inserting a catheter filled with the mixture and squirting it into the abdominal cavity. Seprafilm is only approved for open abdominal surgery — not laparoscopic surgery.