Seprafilm protected from liability suits after killing surgical patients
No woman should die from a routine gynecological surgery.
But that’s exactly what happened to Jayne Heisner after her doctors treated her with Seprafilm. It’s a thin, gel-like sheet that’s placed on organs after surgery to keep scar tissue and adhesions from forming.
Jayne had such a severe allergic reaction to Seprafilm that it literally shut down her immune system. In less than a month she was dead.
But Jayne’s reaction to Seprafilm is just the tip of the iceberg. It’s being used in abdominal and pelvic surgeries all across America right now, even though it’s been linked to hundreds of serious reactions and dozens of deaths.
A public interest group is trying to force the FDA to pull this dangerous product off the market once and for all. But you shouldn’t wait for our government to act to protect yourself — or someone you love — from becoming the next Seprafilm victim.
And she learned that when a loved one dies due to a dangerous medical device, there’s not much you can do about it — except, of course, to try and warn others.
But now Laura finally has some friends on the front lines to help her get the word out, and maybe, just maybe, even get Seprafilm out of circulation.
The consumer group Public Citizen recently petitioned the FDA to take away Seprafilm’s approval, and also to recall every single piece of it out there in hospitals and clinics all around the country.
In fact, when you look at the product’s history, Public Citizen Director Dr. Michael Carome says it “never should have been approved.”
Seprafilm was introduced by Genzyme (now owned by mega-drug maker Sanofi) to prevent adhesions — scar tissue that can essentially bind your organs and tissue together — after surgeries.
But even during the first clinical studies in the 1990s, patients were having serious allergic reactions, bowel obstructions, and life-threatening infections after getting Seprafilm.
Of course the FDA did what it does best — held its nose, looked the other way, and approved Seprafilm anyway. And the results since have been tragic.
Even the FDA admits that there have been 524 serious reactions and 21 deaths after surgical use of Seprafilm. But only a fraction of adverse events ever get reported to the agency, so the real number of people harmed and killed by Seprafilm will likely never be known.
What we do know is that you practically have to move heaven and earth to get the FDA or a manufacturer to pull an approved medical device off the market. No matter how many people die.
And that’s because of a frustrating policy called “medical device preemption.”
MDP prevents you from having your day in court when a medical device harms you. The Supreme Court even upheld that concept seven years ago. So if the FDA has given market approval to some disastrous device that hurts or kills — as it did with Seprafilm — tough luck.
Sanofi has no financial or legal incentive to ever pull Seprafilm off the market, even as the number of victims continues to pile up.
Since Seprafilm is still being sold and used, there’s only one way to prevent another tragedy. That’s to tell you doctor — actually make sure it’s written on your chart — that you don’t, under any circumstances, want this killer product put inside your body.
As Laura Schmitz said, “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.”
If you have a friend or loved one scheduled for abdominal or pelvic surgery, please take a moment to share this email. That simple act just may end up saving a life.
Sources:
“Watchdog urges FDA to revoke approval of Genzyme surgical implant” Natalie Grover, July 7, 2015, Reuters, reuters.com
“Public Citizen to FDA: Withdraw approval of Seprafilm and initiate mandatory recall” Public Citizen, July 7, 2015, citizen.org
“Biotech company Genzyme to pay $22.3 million in Tampa whistle-blower case” Peter Jamison, December 23, 2013, Tampa Bay Times, tampabay.com
