December 12, 2016 — A man from Massachusetts who was seriously injured by hernia mesh has filed a Physiomesh lawsuit against Ethicon Inc., a subsidiary of Johnson & Johnson.
In April 2013, the man was implanted with a 15×20 cm patch of Physiomesh to repair a parastomal hernia on his abdomen. The hernia returned less than seven months later.
In March 2016, he had another surgery to fix the hernia. There were “several loops of small bowel contained within the hernia, with dense adhesions between the loops of bowel,” according to the lawsuit.
Despite multiple surgeries, his hernia quickly returned where Physiomesh was implanted. Doctors are currently determining whether another surgery is feasible.
Physiomesh is laminated with Monocryl (poliglecaprone). It is advertised as an “anti-adhesion” barrier, but lawyers say it is “known to incite an inflammatory response” that “increases the risk that the graft will not incorporate … causing the graft to fold, buckle and migrate.” It also requires a sterilization process that does not kill “dry spores” that can cause infections, according to the lawsuit.
The lawsuit (PDF) was filed on November 12, 2016 in the U.S. District Court for Massachusetts (Boston Division) — In Re: David Watring v. Ethicon Inc. — Case No. 1:16-cv-12278.
Earlier this year, Ethicon recalled Physiomesh hernia mesh in Europe and Australia due to the risk of hernias returning and needing another surgery. The recall was not announced in the United States because the FDA classified it as a “market withdrawal,” which is why patients were never warned.
According to an Urgent Field Safety Notice (PDF) issued to surgeons on May 25, Physiomesh was recalled because a large study in Germany and Denmark found higher rates of hernia recurrence and re-operation compared to similar hernia mesh for laparoscopic ventral hernia repair.
Instead of trying to fix the problems, Ethicon decided to pull Physiomesh off the market worldwide. Patients who were already implanted with Physiomesh should follow up with their doctors as usual, unless they are experiencing symptoms of hernia recurrence or other complications.
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