FDA Vaginal Mesh Recall Remains Unknown

0


The U.S. Food and Drug Administration (“FDA”) recently announced that it may reclassify vaginal mesh products as Class III devices, which would require manufacturers to get pre-market approval for future products. But the question of whether the agency will issue a vaginal mesh recall remains unanswered.

Will an FDA Update Lead to a Vaginal Mesh Recall? 

The FDA update was announced on October 4, 2012, a year after the agency issued a public health alert, stating that vaginal mesh side effects were “not rare.” The update came after a September 2011 review from the agency’s Obstetrics & Gynecology Devices Advisory Committee.

During the September meeting, an expert panel agreed that the mesh devices required more rigorous testing. The panel also advised that transvaginal mesh be classified as Class III devices.

In the FDA statement accompanying the update, the agency stated that it would continue to assess the safety of vaginal mesh devices through “epidemiological research on safety and effectiveness of surgical mesh, as a part of [it’s] effort to better understand possible adverse events associated with surgical mesh for stress urinary incontinence (“SUI”) and pelvic organ prolapse (“POP”).”

The agency also plans to continue mandating post-market surveillance studies by vaginal mesh manufacturers, including C.R. Bard Inc., Johnson & Johnson subsidiary, Ethicon, American Medical Systems and Boston Scientific.

On January 3, 2012, the FDA issued 88 post-market study orders to 33 manufacturers of transvaginal mesh for POP and 11 orders to seven mini-slings for SUI.

Between January 2008 and December 31, 2010, the FDA received nearly 3,000 reports of injury, malfunctions and patient deaths from transvaginal mesh devices.

We are hopeful that the FDA’s latest update will help prevent more women from receiving a dangerous transvaginal mesh implant. Vaginal mesh side effects can include erosion, infection, chronic pain, urinary problems and recurrence of stress urinary incontinence (“SUI”) and pelvic organ prolapse (“POP) afterward.

Help for Those Injured by Vaginal Mesh 

Victims of a defective transvaginal mesh product may seek compensation for their injuries and expenses by filing a lawsuit. Call 1-(888)-217-3033.

Leave a Reply

National Law Journal Hot List Legal 500 Award