Johnson & Johnson Moves to Settle Transvaginal Mesh Injury Claims

What’s the latest news on transvaginal mesh injury lawsuits?

New Jersey-based medical device maker Johnson & Johnson has been facing thousands of lawsuits by women who claim the company’s vaginal mesh inserts caused a variety of injuries. Now, J&J has agreed to pay more than $120 million to resolve about 3,000 suits. The claims arose from organ damage and pain caused by mesh that eroded within the women’s bodies.

What are the dangers of transvaginal mesh?

These medical devices were designed to replace suture surgery to correct pelvic organ prolapse and stress urinary incontinence. The transvaginal mesh patch implant (also known as a “pelvic sling,” “bladder mesh,” and “vaginal mesh”) manufactured by Johnson & Johnson and other medical  device manufacturers have caused injuries due to vaginal mesh erosion, including perforation or puncture of the bladder and other organs, pain and infections. These injuries often require additional surgery and long-term medical treatment.

FDA Action

In 2012, the U.S. Food and Drug Administration ordered J&J, Boston Scientific, C.R. Bard and other device manufacturers to conduct studies of injuries and complications in the wake of the initial round of lawsuits. More recently, the agency has tightened regulations and requires these implants to be classified as “higher-risk” products. The FDA also will require makers of pelvic mesh to submit new applications demonstrating the safety and effectiveness of their products.

What is Johnson & Johnson’s potential liability?

Although the company is moving to settle 3,000 claims, this is only the tip of the iceberg as Johnson & Johnson faces more than 42,000 of these cases — according to the company’s recent regulatory filing with the Securities Exchange Commission. The extent of J&J’s exposure is unknown at this time and depends upon the outcome of those cases. While this is the first settlement agreement involving J&J and its Ethicon unit responsible for manufacturing the implants, the company said in the SEC filing that the financial risk would not be “material.”

The cases facing J&J started five years ago and now there are about 100,000 suits against a number of device makers including Boston Scientific Corp and C.R. Bard — these companies have also reportedly settled some cases and have set aside more than $1 billion in reserves against future claims.  If you have suffered an injury from a pelvic mesh implant or any other medical device, you should consult with a personal injury attorney in order to ensure that you will receive the compensation you deserve.

Posted in: Personal Injury