FDA Recommends Strict Changes Affecting Transvaginal Mesh Litigation

Last month a Dallas jury ordered Johnson & Johnson ordered to pay $1.2 million in compensatory damages to a woman injured by a transvaginal mesh (TVM) implant.  As a result of a defective design in the product, the Plaintiff suffered severe injuries when the mesh “bladder sling” eroded inside of her.  This verdict is the first mesh case which deals with a “bladder sling” product, rather than a pelvic organ prolapse product.  Many patients with transvaginal mesh slings have been forced to undergo additional surgeries to correct problems with their implants.  Although there have been many problems with the mechanically cut TVT-O mesh, it is still being used along with other products such as the TVT-Secur and TVT-Abrevo.  The Dallas verdict is expected to set a precedent for future transvaginal mesh cases.

Last week, a WFAA-TV report on transvaginal mesh, a plastic mesh product used to treat stress urinary incontinence and pelvic prolapse, was released disclosing details of the Dallas verdict.  The Federal Drug Administration (FDA) has been aware of problems with trans-vaginal mesh products since 2008, when they first released a “Public Health Notification” after receiving “over 1,000” reports of “adverse events” regarding surgical mesh devices.  In 2011, the FDA sent out another warning, alleging “serious complications associated with surgical mesh” “are not rare” and that mesh “may expose patients to greater risk” than traditional procedures.

Since then, women across the country have formed organizations and online support groups trying to get mesh removed from the market.  This week, we heard from the FDA again, when it called for stricter safety rules for transvaginal mesh after receiving literally thousands of reports of serious and sometimes permanent complications from the product.  There are approximately 60,000 transvaginal mesh cases pending against several companies nationwide.  Although some cases include reports of bleeding and infection, other cases include reports of pain and urinary incontinence.  The FDA’s proposed changes include reclassifying transvaginal mesh as a “high-risk” medical device.  Additionally, the FDA wants to require manufacturers to prove the products are safe before releasing them to market.

The FDA released a press release issued by the U.S. Food and Drug Administration this week identifying clear risks of the products and proposing steps to address the risks in order to provide more “safe and effective products”.  According to Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, if the proposals are finalized, manufacturers will be required to provide premarket clinical data to demonstrate a “reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair”.  These changes come after years of work by Joleen Chambers, a patient advocate who started the Failed Implant Device Alliance.  This proposal does not include surgical mesh treatments for hernia repair.

The FDA will allow public comment on the proposal over the next ninety days.  This is a very positive development for women who have suffered injuries as a result of transvaginal mesh complications.  If you or a loved one has been affected by transvaginal mesh or bladder sling complications, please contact an attorney who handles these types of mass tort claims.