Vaginal Mesh FDA Warning


With more and more women filing vaginal mesh lawsuits and manufacturers like C.R. Bard Inc. recalling a line of its products last summer, the vaginal mesh FDA warning published on the agency’s website in October may have hopefully shed more light on this pressing issue in women’s health.

Vaginal Mesh FDA Warning

The vaginal mesh FDA warning, which was released about a year after the U.S. Food and Drug Administration (FDA) categorized the risks for side effects as ‘not rare,’ said the agency may reclassify vaginal mesh devices as Class III. If this comes to pass, all manufacturers will be required to get pre-market approval for future products of this nature, according to the alert released Oct. 4, 2012.

The possibility of reclassifying vaginal mesh as Class III was mentioned a year prior to the FDA warning by the agency’s Obstetrics & Gynecology Devices Advisory Committee. In a September 2011 review of transvaginal mesh, a panel of health experts agreed that a more rigorous testing procedure of approving vaginal mesh devices needed to be implemented before they could gain approval.

Vaginal Mesh Makers Asked to Conduct Post-Market Surveillance Studies

As part of its vaginal mesh FDA warning, the agency vowed to continue mandating post-market surveillance studies for vaginal mesh manufacturers. Beginning Jan. 3, 2013, the FDA issued 88 post-market study orders to 33 transvaginal mesh manufacturers.

Perhaps not so coincidentally, C.R. Bard Inc. voluntarily recalled its line of Avaulta vaginal mesh products just a few months later, in July 2012.

Other manufacturers that could be affected by this vaginal mesh FDA warning include American Medical Systems, Johnson & Johnson subsidiary, Ethicon and Boston Scientific.

In 2008, the U.S. Food and Drug Administration issued its first vaginal mesh FDA warning, categorizing the risk of vaginal mesh side effects as ‘rare.’

Between January 2008 and December 31, 2010, it is estimated that the agency received nearly 3,000 adverse event reports of injury from transvaginal mesh.

Considering a Vaginal Mesh Lawsuit? Contact us.

If you were injured by vaginal mesh, contact your doctor for treatment right away. If you plan to pursue a vaginal mesh lawsuit, it is imperative that you keep track of your medical appointments, times absent from work, and save copies of your medical records, which you can ask your doctor to produce. Bernstein Liebhard LLP is offering free confidential legal consultations to vaginal mesh victims. To speak with a vaginal mesh lawyer please call 1-888-217-3033 or submit the free case evaluation form on this page.

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