Johnson & Johnson subsidiary Ethicon has announced a voluntary market withdrawal of its product due to reports of hernia mesh failure.

Ethicon’s Physiomesh Flexible Composite Mesh has seen a higher failure rate after laparoscopic ventral hernia repair, but the company does not understand why.

A ventral hernia usually occurs in the abdominal wall where a previous surgical incision was performed. When abdominal muscles have weakened, a bulge or tear can allow a loop of intestines to push out into the newly created sac.

A hernia will not improve over time, and is generally seen as a bulge under the skin. It may or may not cause discomfort or pain, and will seem to “disappear” when you lay down on your back.

Hernia Mesh Failure Means Higher Revision Rates

With a hernia mesh failure, another surgery is needed to remove that mesh and repair the hernia once again.

Symptoms of hernia mesh failure include:

• Pain
• Swelling
• Adhesions
• Obstructions
• Mesh migration
• Bacterial infections
• Hernia recurrence
• Additional surgeries that treat hernia recurrence

Ethicon announced it was withdrawing the Physiomesh product in May 2016.

Ethicon originally sold the product as a “sterile, low profile, flexible composite mesh designed for repair of hernias and other fascial deficiencies.”

Physiomesh was a popular product after it was released on the market in 2010 because its macroporous polypropylene substance was believed to cause fewer strong foreign tissue reactions than standard polypropylene mesh.

While uncertain of the reason for higher revision rates, Ethicon said it could be a “multifactorial issue” that includes “product characteristics, operative and patient factors.”

In a letter regarding the market withdrawal, Ethicon said, “Consequently Ethicon (has) not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and (has) decided to recall Ethicon Physiomesh from the global market.”

Ethicon recommended that patients who have not experienced hernia mesh failureshould continue to be followed.

Ethicon Physiomesh Fast-tracked Through FDA Approval

The Ethicon Physiomesh was approved by the FDA in 2010 through an accelerated process the agency provides to products that show they are “substantially equivalent” to a similar product. When this is proven, the new medical device is allowed to skip the usual requirements of the approval process, including testing and research.

Hernia mesh lawsuits claim that the hernia mesh failure would have come to light before so many patients experienced problems if Ethicon would have performed adequate research prior to Physiomesh’s market release.

Ethicon also is accused of providing insufficient instructions for surgeons, failing to warn about complications linked to the product and failing to withdraw the product from the market as soon as the mesh problems were found.

If you underwent a hernia surgery and suffered hernia mesh failure, you may be suffering complications because an Ethicon Physiomesh was used. You could qualify for compensation through a hernia mesh lawsuit to recover losses due to complications and the costs of the revision surgeries to correct the issues.