Physiomesh Complications After Hernia Surgery Results in Lawsuit Against Ethicon, J&J
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.
7 comments
I had the hernia surgery over two years ago. It stay sore all the time. Sometime feeling like a bulge
I was in severe pain and had spasms in my lower abdomen, after surgery for a long time… It seems there was a hole in the mesh and it week…… Had another surgery to repair it….
I had this surgery in 2004. In 2006 I had to have the mesh removed and still feel pain in my side due to scarring, I was told it had rubbed my internal organs.
I was told by reps. from the original class action that because my mesh was NOT inserted by a Laproscopic Procedure I did not qualify. I cannot see the difference, if the mesh caused problems and had to be removed it was BAD and should be entitled to some compensation.
Mine was a groin hernia repair. They made me suffer year with shots in the back shots in the stomach. I had lumps where the hernia was and it was pinching a nerve. I had to demand them to take it out. 1992
I had hernia surgery in 2013 then about 1 month later Aug 14 2013 my hernia popped and I ended up having a foot of intestines removed at Barnes Jewish Hospital St. Louis, Mo.
Just had my 4th hernia surgery last month. Hopefully this will be my last.