Johnson & Johnson is facing a new hernia mesh lawsuit with the claimant alleging the company’s Ethicon’s Prolene mesh worsened her condition. The California woman alleges the Ethicon Prolene mesh product did not work as expected, allegedly causing her to develop multiple infections.

Plaintiff Cindy S. had the Ethicon Prolene mesh implanted on Sept. 13, 2010, to treat a hernia in her abdominal area. The Ethicon Prolene mesh product is primarily used to treat hernias, pelvic organ prolapse (POP) and stress urinary incontinence (SUI), and is made from a polypropylene material.

Johnson & Johnson marketed the product as a safe and effective product to treat hernias like Cindy’s. However, not long after her hernia mesh procedure, Cindy’s physician noted that abscesses and infection were forming around the product.

Cindy underwent incision drainage procedures to treat the infection which was allegedly caused by Ethicon Prolone mesh. However, Cindy was diagnosed with abscesses and infection once again on Aug. 18, 2015, had the same incision drainage procedure and had the Ethicon Prolene mesh removed.

On October 16, 2015, a CT scan had showed that a small adhesion was on a small portion of the bowel that was allegedly from the failed Ethicon Prolene mesh. Cindy required another procedure, but is still contending with long lasting complications from the hernia mesh product. The complications associated with hernia mesh include:

• Mesh erosion
• Infections
• Pain
• Organ perforation
• Recurrence of urinary problems

Patients who suffer serious mesh complications may have to undergo revision surgery to remove the defective hernia mesh device.

Overview of Hernia Mesh Lawsuit

Due to the repetitive surgeries Cindy underwent, her umbilical hernia has not been able to heal and remained an open abdominal surgical site. This causes her abdominal cavity to be exposed, allowing for the possibility of a life threatening infection.

Cindy’s open surgical wound requires constant maintenance and medical monitoring, and causes her serious abdominal pain. Cindy’s condition will continually be at risk for further complications, and she will constantly need to be vigilant against recurrent infections relating to remaining pieces from the Ethicon Prolene mesh.

Hernia mesh is considered a revolutionary breakthrough in medical technology, with a significant number of them being approved through the FDA’s 510(k) program. If the medical device in question proves to be substantially equivalent to a similar product already on the market, then it qualifies for the FDA 510(k) program.

The medical device can go directly to market without the rigorous pre-market approval process. However, this means that a full safety profile of the medical device may not be immediately available.

Cindy opted to file a hernia mesh lawsuit, alleging Johnson & Johnson and subsidiary Ethicon Inc. either knew or should have known about potential complications relating to the Ethicon Prolene mesh. At all times relevant, Cindy had used the Ethicon Prolene mesh for its intended purpose and did not deviate from medical instructions.

Cindy states that she would not have used the Ethicon Prolene mesh if she had known about the potential hernia mesh complications.

This Hernia Mesh Lawsuit is Case No. 5:17-cv-05662-BLF, in the U.S. District Court of Northern California.