Ethicon’s Physiomesh used in hernia repair linked to complications, higher incidence of surgical recurrence

posted on:
December 9, 2016

author:
Jennifer Walker-Journey

Johnson & Johnson subsidiary Ethicon has been plagued in recent years with litigation over its transvaginal mesh used to resolve symptoms of pelvic organ prolapse and stress urinary incontinence in women. The women allege that transvaginal mesh, made from a fibrous plastic product called polypropylene, can migrate within or erode inside the body, and perforate or puncture organs, causing chronic pain, infections and even death.

Now the company’s hernia repair device, Physiomesh, also made from polypropylene, is under scrutiny from reported similar complications. Physiomesh is a flexible polypropylene mesh designed to reinforce the abdominal wall, preventing future hernias from occurring.

Ethicon continues to deny that polypropylene implanted in the body can cause life-threatening complications. Yet, in May 2016, the company issued a market withdrawal of the products, a Food and Drug Administration (FDA) designation for products with a “minor violation” during which “the firm removes the product from the market or corrects the violation.” The withdrawal came in response to independent studies that revealed high rates of complications associated with the Physiomesh.

When Ethicon withdrew Physiomesh from the U.S. market, it also issued recalls of Physiomesh in Europe and Australia – actions that are more serious than market withdrawals and issued when a product has the possibility of causing adverse health consequences.

Meanwhile, complaints continue to mount against Ethicon’s hernia mesh. Studies in Germany and Denmark found higher rates of hernia recurrence and re-operation in patients who were implanted with Physiomesh compared to similar devices.

At least two lawsuits have been filed against Ethicon over alleged Physiomesh side effects. A Florida woman alleges she was seriously injured when the hernia mesh migrated and blocked her intestines. The mesh could not be removed because it had embedded into her abdominal wall. An Illinois man is suing Ethicon alleging his Physiomesh caused him to develop infections, abscesses and an intestinal fistula. His case is set for trial in January 2018.

Source: Record Reform

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