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How Pharma and FDA Loopholes like Physiomesh Put You at Risk

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How Pharma and FDA Loopholes like Physiomesh Put You at Risk
Ethicon’s Physiomesh is a hernia repair coated mesh used to reinforce and strengthen the abdominal wall against recurring herniation. Ethicon, a Johnson & Johnson subsidiary, is one of several companies plagued by lawsuits filed by hernia patients implanted with Physiomesh.

The multi-layered mesh has a protective coating that the company claims will minimize and prevent things like inflammation and adhesions that accompany hernia repair surgery. According to lawsuits filed against Ethicon, the Plantiffs contend Physiomesh actually caused or encouraged post-operative inflammation and adhesions, and even far more devastating physical harm.

Hernia Related Lawsuits Against Ethicon

This certainly isn’t the first Physiomesh product nightmare that Ethicon has faced. According to an article by the Hollis Law Firm that represents the plantiffs, the company has been embattled for years with lawsuits and allegations of its polypropylene transvaginal mesh product failures (1).

Hollis Law Firm reports that as of March 2017, 43 Physiomesh cases had been filed in Federal court with the expectation of more to follow. In June 2017, the Judicial Panel on Multidistric Litigation (JPML) consolidated all the cases into the Nothern District of Georgia.

The law firm points out that in spite of the growing evidence of lawsuits, Ethicon has remained firm in its denial that their product is responsible for “life-threatening complications that polypropylene causes.”

Amid the claims of harm, Ethicon as well as other manufacturers of Physiomesh, such as Atrium have continued to sell these hernia repair meshes without any action by the FDA. This lack of response by the FDA has given rise to speculation that FDA loopholes are the reason the FDA hasn’t taken any action.

Physiomesh Victim Claims

Physiomesh victims claim that the products are defective and pose a health risk, and that Eithicon, Atrium and other companies were aware of these risks, yet never warned patients or their doctors. Some of those risks include:

  • Adhesions
  • Bowel obstruction
  • Inadequate repair
  • Hernia recurrence
  • Infections
  • Sepsis

In addition, there are other complications, such as injuries and even death following hernia surgery, all attributed to Physiomesh.

Hollis Law Firm contends that the Plaintiffs in the lawsuits, “…intend to demonstrate that the multi-layer coating instead prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications.”

This was compounded by the polypropylene mesh being ineffecient and unable to withstand the type of force, albiet normal for abdominal. This weakness actually caused herniation, recurrent hernia formation and even the rupture and deformation within the mesh.

FDA Doesn’t Force Recall

The law firm states that the FDA never forced Ethicon to issue a recall on the defective mesh. Instead, in May 2016, using an FDA loophole, Ethicon was allowed to “voluntarily” withdraw their product from the market.

According to Hollis Law Firm, the Plaintiffs intend to prove that Ethicon’s decision to withdraw its Physiomesh from the market was in response to the frequent and severe “complications experienced with this product worldwide.”

Hollis Law Firm contends it was after several independent studies revealed the issues with Pysiomesh that Ethicon decided on their market withdrawal. “The previous high rates of patient and surgeon complaints were never enough to sway Ethicon or its parent company Johnson & Johnson into removing the Physiomesh from the market.”

Was a Recall Needed?

A recall of Physiomesh would have made Ethicon responsible for the effects of a defective product. By allowing the company to quietly take the product off the market, there were no offical safety alerts sent to patients, doctors, hospitals and other medical professionals.

The question now being asked is “if the FDA was justified in allowing Johnson & Johnson and its subsidiary Ethicon to conduct a market withdrawal instead of a recall.”

References & Image Credits:
(1) Hollis Law Firm

Originally published on

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