Plaintiff Ronne W. has filed a lawsuit in Georgia federal court against Johnson & Johnson and Ethicon, Inc.

Ronne is a resident and citizen of Tennessee. And according to the hernia mesh complications lawsuit, he was implanted with the hernia mesh in December 2013.

However, he claims he ended up having  to undergo revision surgery to remove the allegedly defective hernia mesh, due complications that resulted.

According to the hernia mesh complications lawsuit, Ronne will continue to experience “physical pain and mental anguish.”

Hernia Mesh Complications Lawsuit Facts

Although hernia mesh devices have been in place for well over 50 years, not all hernia mesh products are manufactured the same. If a hernia mesh device is defective, it can cause serious complications and adverse effects leading to additional surgeries.

The Physiomesh Flexible Composite Mesh manufactured by J&J and Ethicon Inc. was voluntarily withdrawn from the market in May 2016. It was withdrawn after Ethicon received reports of a higher revision rate than other devices.

Symptoms of a defective hernia mesh that may require revision surgery include mesh migration, bacterial infections, hernia recurrence, obstructions, adhesions, swelling, and pain.

The Phsyiomesh Flexible Composite Mesh was approved by the U.S. Food and Drug Administration in March 2010. However, it received its clearance through the FDA’s fast-track approval program, which allows manufacturers to expedite the approval process by proving that their product is similar or equal to products already approved and being sold on the market.

After the FDA’s approval, the hernia mesh received extensive popularity and approval. However, the product received and was correlated to more complications and issues than was expected. These complications and adverse effects included removal surgery, infections, abdominal pain, and hernia recurrence.

According to Ronne’s hernia mesh complications lawsuit, the manufacturers failed to clearly define why the Physiomesh product had a high failure rate. Ethicon supposedly said that the products high failure rate can be due to a variety of factors including physician instruction, patient selection, and hernia mesh design.

Allegations against the defendants include but are not limited to the following: failure in making a safer mesh product, providing defective instructions for surgeons, providing inaccurate and misleading information about the safety and efficacy of physiomesh, failure to warn of the complications that may result, and failure to perform adequate research prior to the products FDA’s approval.

The defendants face the following counts within the hernia mesh complications lawsuit. These include: Strict Product Liability: Defective Manufacture, Strict Product Liability: Defective Design, Strict Product Liability: Failure to Warn, Negligence, Breach of Warranty, Consumer Protection, and Punitive Damages.

The Hernia Mesh Complications Lawsuit is Case No. 1:17-cv-03511-RWS, in the U.S. District Court for the Northern District of Georgia.