Johnson & Johnson is facing a new Ethicon mesh lawsuit from a Virginia woman alleging  that their hernia mesh product is defective. The Ethicon mesh lawsuit alleges the defective nature of the product caused the woman to undergo multiple hernia repair procedures due to the medical device failing.

Plaintiff Linda A. first had the Physiomesh hernia mesh implanted in August 2014, which was a typical treatment purpose for the device. However, Linda opted to file an Ethicon mesh lawsuit after being forced to undergo multiple hernia mesh repair surgeries. She alleges other patients have suffered similar experiences.

Linda opted for the Physiomesh product after reviewing the company’s marketing materials which described the medical device as a “sterile, low profile, flexible composite mesh designed for repair of hernias and other fascial deficiencies.”

The medical device is composed of a macroporous polypropylene held together by two undyed polygelcaprone-25 films. However, these components may be allegedly contributing to the device’s high failure rate.

According to the Ethicon mesh lawsuit, Linda had hernia mesh repair surgery at least two other times and will have to contend with continuous medical treatment.

Linda underwent hernia mesh repair again on Aug. 24, 2015, due to the initial procedure failing. However this hernia repair surgery also failed, with Linda needing revision surgery on Oct. 21, 2016. Her Ethicon mesh lawsuit indicates Linda will most likely need additional hernia repair procedures.

Linda opted to file the Ethicon mesh lawsuit soon after her last hernia repair surgery, alleging the company either knew or should of known of the medical device’s defective nature.

Overview of Physiomesh Hernia Mesh Complications

Surgical mesh has been used for hernia mesh repair for over 50 years, with manufacturing companies offering a variety of hernia mesh products to patients. Johnson & Johnson is one of these companies, marketing Physiomesh to patients needing a treatment option for hernia mesh.

The Physiomesh device entered the market in March 2010, through the FDA’s 510(k) fast track approval program. Under this process, medical products proved to work at an equivalent level to a similar already released product, it can bypass rigorous pre-clinical testing requirements.

However, recent injury reports suggest the Physiomesh hernia mesh product may be defective in nature, as many patients have reported mesh complications and needing revision surgery. In fact, several reports of Physiomesh complications eventually led to the company initiating a market recall of the device in May 2016.

In addition to the injury reports, several studies had found that the Physiomemsh hernia mesh product had higher revision surgery rates than expected. Plaintiffs say Ethicon reportedly failed to sufficiently describe the potential causes of the failure in the market withdrawal.

Ethicon stated the high failure rate may be due to several possibilities including hernia mesh design, physician’s instructions and patient selection. The injuries reported in Physiomesh hernia mesh reports include, but are not limited to:

• Pain
• Swelling
• Adhesions
• Obstructions
• Mesh migration
• Bacterial infections
• Hernia recurrence
• Need for revision surgery

Linda states she never would have opted for the Physiomesh hernia mesh product if she had known about potential hernia mesh complications.

This Ethicon Mesh Lawsuit is Case No. 3:17-cv-00058, in the U.S. District Court for the Western District of Virginia.