FDA Transvaginal Mesh Review Process May Result In More Stringent Regulations

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Bernstein Liebhard LLP reports that the U.S. Food and Drug Administration is contemplating whether to reclassify surgical mesh products, which are used to treat pelvic organ prolapse in women. If the FDA determines that the surgical mesh devices pose a high risk to patients warranting reclassification, medical device manufacturers would be prevented from using the fast-track 510(K) process to receive market approval.

On August 31, 2011, the U.S. Food and Drug Administration (“FDA”) released a report* in anticipation of this week’s Obstetrics and Gynecology Devices Advisory Committee meeting. The advisory panel is scheduled to discuss the safety of surgical mesh products for the treatment of pelvic organ prolapse and stress urinary incontinence. Currently, the transvaginal mesh implants are classified as Class II medical devices, which allows manufacturers to receive clearance through the expedited FDA 510(K) process, and thereby circumvent the FDA’s rigorous clinical testing by claiming that products are substantially similar to medical devices currently available on the market. If the panel determines that a reclassification of the transvaginal mesh implants is appropriate, medical device manufacturers will no longer be able to use the 510(K) loophole to receive market clearance. Moreover, such a reclassification would indicate that the transvaginal mesh devices do, in fact, pose a high risk to patients. The lawyers at Bernstein Liebhard LLP are hopeful that the outcome of the committee meeting will result in a FDA reclassification of the transvaginal mesh implants.        

Prior FDA Recommendation: Patients Should Consider Alternatives To Transvaginal Mesh

On July 13, 2011, the U.S. Food and Drug Administration (“FDA”) issued a safety communication** advising patients and doctors to consider alternative treatments to transvaginal mesh. At the time, the FDA also announced that it would convene to discuss whether transvaginal mesh should be removed from the market. The advisory panel’s recommendation is likely to affect that decision. Further, the FDA recommended that women suffering from pelvic organ prolapse refrain from undergoing surgical placement of transvaginal mesh because the implants expose them to an increased risk of sustaining serious and fatal injuries.

In 2008, the FDA issued its first communication regarding the dangers associated with transvaginal mesh, and has since continued to review the safety of the devices. Since that time, Bernstein Liebhard LLP has provided a wealth of consumer information concerning transvaginal mesh on its website, http://www.consumerinjurylawyers.com. If you or a loved one underwent a surgical procedure and have been implanted with transvaginal mesh, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.


** http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

For more information about filing a transvaginal mesh lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at info(at)consumerinjurylawyers(dot)com.

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
(877) 779-1414

ATTORNEY ADVERTISING. © 2011 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. The lawyer responsible for this advertisement in the State of Connecticut is Amy L. Abate. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Contact Information:
Felecia L. Stern, Esq.
Bernstein Liebhard LLP

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