FDA Creates Stricter Rules for Surgical Mesh Products
Posted On behalf of Pfeifer Morgan & Stesiak on Jan 05, 2016 in Product Injury
After years of complaints, the Food and Drug Administration is stepping up regulations for surgical mesh products used on women after childbirth. Also referred to as transvaginal mesh, the products will now be classified as high-risk by the FDA, requiring more testing before being introduced to the market.
Transvaginal mesh is typically used in a surgical procedure following childbirth to prevent pelvic organ prolapse, a condition where internal organs drop and push against the walls of the vagina causing pain and discomfort.
Until this change, most surgical mesh products were classified as moderate-risk, and did not have to demonstrate the safety of the product if they could prove they were substantially similar to other products already on the market.
Surgical mesh products have also been in use to treat hernias and stress urinary incontinence, with fewer reported complications.
Complications Caused by Transvaginal Mesh
Women across the country have reported complications from the mesh, including bleeding and infections. These complications often require additional surgery and multiple procedures to correct.
- Urinary problems
- Pain during sex
Surgical mesh has been in use for decades, but the newer kits were introduced in 2002. The FDA issued its first safety warning in 2008, followed by an order in 2012 for companies to conduct post marketing surveillance studies.
The new requirements will require makers of transvaginal mesh to submit safety testing data before the products go to market, as well as address the existing safety concerns. These requirements only impact mesh used for transvaginal repair of pelvic organ prolapse.
Vaginal Mesh Lawsuits
Thousands of lawsuits have been filed against vaginal mesh companies, including Boston Scientific Corp., Endo International PLC and Johnson & Johnson.
Boston Scientific Corp. has so far paid out $119 million in claims, and Endo International PLC has paid $830 million. Johnson & Johnson discontinued its transvaginal mesh products in 2012, although the company claims it was not related to lawsuits.
The product liability attorneys at Pfeifer, Morgan & Stesiak believe that these companies should be held accountable. If you or a loved one has suffered due to a defective medical device, contact us today for a free consultation. We will work to get you justice.