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According to allegations raised in a product liability complaint filed against Johnson & Johnson and it’s Ethicon subsidiary, complications after Physiomesh hernia surgery resulted in severe injury for a Florida woman, who indicates the hernia mesh adhered to her internal organs and had to be removed.
The complaint (PDF) filed by Sarah Ann Gilman in the U.S. District Court for the Middle District of Florida on December 27, alleging the Ethicon Physiomesh was defectively designed and unreasonably dangerous for hernia repair.
Gilman received a 15 x 20 cm Physiomesh Composite mesh on February 3, 2016, during a laparoscopic procedure to repair a ventral hernia. According to the lawsuit, complications after the hernia surgery resulted in the need for revision surgery on August 17, due to an abdominal bulge, return of the hernia and severe pain associated with adhesion to other organs.
“Defendants’ Physiomesh was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design,” the lawsuit states. “As a result of the defective design and/or manufacture of the Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain, recurrence of hernia, foreign body response, rejection, infection, inadequate or failure of incorporation/ingrowth, migration, scarification, deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complications.”
The case joins a growing number of similar Ethicon Physiomesh lawsuits filed in courts nationwide, each involving individuals who experienced severe complications following hernia repair, with at least one case scheduled for trial to begin as early as January 2018.
Gilman’s case comes after an Ethicon Physiomesh recall was issued by the manufacturer in several countries last year, due to a higher-than-expected rate of problems resulting in recurrent hernias and revision surgery. Although the action was classified as a “Market Withdrawal” by the FDA, Ethicon has required all unexpired products be returned and decided to remove the hernia mesh from the market, after failing to identify the cause of the problems or come up with ways surgeons may be able to reduce the recurrence rate.
Gilman presents charges of defective design, failure to warn, and negligence. She seeks both compensatory and punitive damages.