A man from Wisconsin recently sued Johnson & Johnson and Ethicon Inc. alleging serious hernia mesh implant complications from their Physiomesh product.

The Physiomesh product had reportedly been implanted for typical ventral hernia repair, which the claimant says gave him no reason for the claimant to be wary for any serious device complications.

Plaintiff Jaime L. underwent the surgery on April 28, 2015, with the lawsuit noting that the Physiomesh product had been implanted with no initial complications.

However, Jaime says he developed hernia mesh implant complications soon after and eventually had to undergo revision surgery. The revision surgery allegedly occurred on Feb. 19, 2016, during which the Physiomesh was removed.

According to the hernia mesh lawsuit, the Physiomesh product had shrunken and pulled away from the abdominal wall, which caused scarring in the right side near the umbilicus. Even with the revision surgery, Jaime says he continues to suffer debilitating abdominal pain and interference with his everyday life.

Jaime says he currently requires ongoing physical care and treatment for his injuries and opted to file legal action soon after discovering the allegedly defective nature of the device.

Overview of Physiomesh Complications

The Physiomesh is a unique device consisting of five layers, including at least one coat of polypropylene material. The polypropylene material is meant to minimize adhesion and inflammation to help it adapt to the body’s biological reactions, along with encouraging healing in the surgical site.

However, patients like Jamie have been reporting hernia mesh implant complications including mesh deformation, adhesion, seroma formation, erosion, fistula formation and biological rejection, according to the FDA.

Surgical mesh has been used for hernia repair for decades, used to provide additional support to weakened or damaged tissue. Surgical mesh is made out of synthetic materials that are either absorbable, non absorbable, or a mixture between the materials, with the non-absorbable material meant for permanent placement.

The Physiomesh Flexible Composite Mesh was approved by the FDA in March 2010 through the agency’s 510(k) fast track approval process, which allowed the product to enter the market without thorough pre-market testing. Under this policy, as long as a product proves to work at an equivalent level with a similar already released product, the manufacturers can apply for 510(k) approval.

However, the Physiomesh product has been linked to numerous serious device complications with the company eventually issues a market withdrawal of the device in May 2016. During this market withdrawal announcement, Ethicon reportedly failed to specify the reason behind the high failure rate.

The company stated that the hernia mesh failures could be due to a variety of reasons including the hernia mesh design, the physician’s instructions and patient selection.

Even though these hernia mesh complications can be devastating to patients, Ethicon allegedly failed to disclose this information to the public. At all times relevant, Jaime says he and his physicians relied on the product information and marketing materials provided by the manufacturers.

This Hernia Mesh Lawsuit is Case No. 1:19-cv-00250, in the U.S. District Court of Eastern Wisconsin.