Reports of complications have led manufacturer Ethicon to issue a hernia mesh market withdrawal of its Physiomesh composite mesh product.

Physiomesh is a surgical implant used to repair abdominal hernias and other fascial problems. It consists of a polyproplylene mesh held together by two films. Mesh products like Physiomesh have been in use for decades.

Physiomesh itself entered the market in 2010 after receiving initial approval from the FDA. The product was approved using an expedited review process known as the 510(k) process.

Medical devices can be approved under the faster 510(k) process if they are substantially similar to another product that’s already on the market. Critics of the process say it fails to put medical devices through the more rigorous testing and clinical studies that other devices go through.

By one estimate, around 300,000 Physiomesh implants have been used since the product was FDA-approved. But after more than six years on the market, Physiomesh was the subject of enough reports of complications that Ethicon elected to initiate a hernia mesh market withdrawal.

Ethicon Issues Hernia Mesh Market Withdrawal

In May 2016, Ethicon issued a Field Safety Notice announcing it was voluntarily withdrawing its Physiomesh composite mesh from the market.

The company decided to implement this hernia mesh market withdrawal after reviewing data from two independent data registries from German and Danish sources.

These registries showed that patients who underwent laparoscopic ventral hernia repair using Ethicon Physiomesh experienced higher rates of recurrence of hernias and need for reoperation.

Ethicon believes these complications are due to “possible product characteristics, operative and patient factors.”

As part of this hernia mesh market withdrawal, Ethicon asked health care providers to immediately search their inventories, remove any Physiomesh products subject to the recall and return them to Ethicon. Products returned by Sept. 16, 2016 would be eligible for a full refund.

The withdrawal does not offer any particular remedy for patients already implanted with Physiomesh composite mesh, who may be at risk for developing future hernia mesh complications. Ethicon only advises physicians to “continue to follow those patients in the usual manner.”

Ethicon says it has no plans to return the affected Physiomesh products to the market.

Hernia Mesh Complications

While Ethicon’s announcement did not specify what complications had been reported, the FDA’s adverse event reporting database has logged hundreds of reports of mesh complications related to Physiomesh.

Problems that can arise following hernia mesh implantation can be severe enough to require further surgery for correction. Mesh repairs that don’t go as planned may lead to excessive adhesions or obstruction.

In some cases, mesh can migrate out of its proper position. Patients may also be vulnerable to bacterial infection around or near the mesh following implantation. Such infections may lead to abdominal abscesses, intestinal fistula or obstruction of the bowels.

If you or someone you know suffered injury from hernia mesh, you may be eligible to file a lawsuit.