Published On: Thu, Jun 1st, 2017

Johnson & Johnson Under Fire Again for Defective Hernia Mesh Product

Johnson & Johnson’s subsidiary Ethicon is under fire once again for its defective hernia mesh product Physiomesh. A man from Illinois has filed a lawsuit against the company after he experienced serious complications after ventral incisional hernia repair.

The complaint – filed on May 22nd with the U.S. District Court, Southern District of Illinois by Gary Goodson – alleges that the Physiomesh received by the plaintiff was defective and not reasonably safe for hernia repair.

Goodson claims he now requires revision surgery due to complications with the device. He alleges that the mesh’s coating, designed to help the body absorb the  mesh, creates a breeding ground for bacteria.

The lawsuit states: “The multi-layer coating prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response resulting in an adverse tissue reaction including migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic tissue and improper healing.”

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The lawsuit is not the first for Ethicon, which withdrew its Physiomesh Flexible Composite Mesh in 2016. The company made the decision to remove the product from the market after two hernia registries in Europe alleged that the product was associated with high revision and recurrence rates compared to other meshes.

While the withdrawal was not deemed an official recall in the U.S., hospitals were advised to return unused hernia patches.

Lawsuits related to Ethicon’s other mesh product, Prolift, has cost the company $120 million. More than 40,000 lawsuits over Prolift are still pending.

Physiomesh and Prolift are two more examples of dangerous medical products that made it to market thanks to the FDA’s 510(k) Pre-Market Approval process, a controversial program. Ethicon’s mesh products were able to make it to the market without safety testing because it could demonstrate that its products were “substantially similar” to another product on the market.

When Ethicon removed its Physiomesh product from the market last year, the company stated that it believed the higher rates of failure were “a multifactorial issue” and they were unable to “fully characterize these factors.”

Plaintiffs allege that Johnson & Johnson and Ethicon were aware of the problems with the meshes, but failed to disclose this information to medical providers and patients.

In addition to the thousands of lawsuits filed in the U.S. over Ethicon’s defective hernia products, Canada is joining a class action suit against the company.

The Canadian plaintiffs joining the suit allege that they experienced severe pain and had to undergo surgery to repair the mesh. Plaintiffs had their hernias return with “greater severity.”

Ethicon says it plans to defend against the lawsuits, which now amount to nearly two dozen in Canada.

Another manufacturer, Atrium, is at the center of many suits in Canada. Atrium’s mesh has a fish oil coating that is designed to prevent it from adhering to the bowel. Plaintiffs allege that coating does just the opposite, sticking to the bowels and organs. Some plaintiffs experienced ulcers, bowel obstructions, infections and other serious complications.

Author: Jacob Maslow

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