December 12, 2016 — A lawsuit has been filed by a man from Massachusetts who was seriously injured by the Ethicon Physiomesh hernia mesh patch.
The lawsuit (PDF) was filed on November 12, 2016 in the U.S. District Court for Massachusetts (Boston Division) — In Re: David Watring v. Ethcon Inc. — Case No. 1:16-cv-12278.
Physiomesh is a hernia patch that has been sold since 2010. It is made of plastic-like polypropylene fibers that are woven into a patch and laminated between two layers of Monocryl (poliglecaprone).
Monocryl coatings are advertised as “anti-adhesion barriers” to stop scar-tissues from sticking organs together abnormally during healing.
However, lawyers say the coating is “known to incite an inflammatory response” and it “increases the risk that the graft will not incorporate … causing the graft to fold, buckle and migrate.”
This coating also requires a sterilization process that is not effective against “dry spores,” which is why lawyers say Physiomesh has high rates of infections — sometimes months or years after implantation.
The lawsuit was filed by David Watring, a man who was implanted with a 15×20 cm Physiomesh patch in April 2013 to repair a parastomal hernia. The hernia returned within seven months.
In March 2016, he went to the hospital with symptoms of a recurrent hernia. “There were several loops of small bowel contained within the hernia, with dense adhesions between the loops of bowel,” according to the lawsuit.
He underwent extensive surgery to fix the complications, but the hernia soon returned where Physiomesh was implanted. His doctors are currently determining if another surgery is possible.
Ethicon recalled Physiomesh in Australia and Europe earlier this year. The recall was classified as a “market withdrawal” in the United States, which is why the FDA never issued safety warnings for patients.
On May 25, Ethicon issued an Urgent Field Safety Notice (PDF) to surgeons to announce the recall. Physiomesh was pulled off the market after a large study of hernia surgery outcomes in Germany and Denmark. The study linked Physiomesh with higher rates of hernias returning and needing another surgery (called “recurrence and re-operation”) compared to similar types of hernia mesh on the market.
Ethicon blamed the problem on multiple factors, including possible “product characteristics, operative and patient factors.” Instead of trying to fix these complications, Ethicon stopped selling Physiomesh and asked surgeons to return all unused stock of the hernia mesh patch.
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