Chaffin Luhana Applauds FDA’s Order for Transvaginal Mesh Manufacturers to Conduct Safety Studies

New York, New York—January 9, 2012— On January 3, 2011, the FDA ordered manufacturers of vaginal mesh to conduct further studies on the risk of vaginal mesh side effects like organ damage, painful sexual intercourse, and urinary problems.  Vaginal mesh is used to repair conditions like pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  Many women with vaginal mesh side effects have filed vaginal mesh lawsuits in the hopes of recovering damages.

What is Vaginal Mesh?

Similar to the surgical mesh used to treat hernias, vaginal mesh is a synthetic netting used to help support pelvic organs like the bladder, uterus, and intestines.  Women with POP or SUI often have weak pelvic muscles that cannot support these organs.  Treatment may include surgery with vaginal mesh to help restore and maintain the organ’s original position in the body.

2011 Vaginal Mesh FDA Warning

In 2008, the FDA released a vaginal mesh FDA warning, alerting healthcare professionals to vaginal mesh side effects like erosion and bleeding.  On July 13, 2011, the FDA released a vaginal mesh warning.  The FDA warning stated that serious vaginal mesh side effects were not rare, and that the agency was no longer clear whether treatment with vaginal mesh was more effective than traditional treatment methods. 

At the time of the second vaginal mesh FDA warning, the agency also announced that it planned to conduct an advisory panel meeting to determine whether vaginal mesh products should remain on the market.  In September, the FDA panel recommended reclassifying vaginal mesh products as high-risk devices that require human testing before approval.  The panel also suggested the FDA require additional studies on those mesh products already on the market.

Manufacturers of Vaginal Mesh Under Fire for Vaginal Mesh Side Effects

Vaginal mesh manufacturers like Johnson & Johnson (J&J), C. R. Bard, Ethicon Inc., Boston Scientific Corp., American Medical Systems, and others were among those who received letters from the FDA that detailed the request for additional studies.  All of these companies are currently involved in vaginal mesh lawsuits that allege responsibility for failing to warn of serious vaginal mesh side effects.

The FDA letter requested a total of 33 manufacturers to conduct three years of trials on vaginal mesh safety and effectiveness.  The FDA also asked for data on the results and potential complications of vaginal mesh procedures.  All companies are required to submit study plans to the FDA in the near future.

A Vaginal Mesh Lawyer May be Able to Help

Chaffin Luhana LLP has a long and successful history of protecting the rights of those affected by the serious side effects of pharmaceutical drugs and medical devices. Partners Eric Chaffin and Roopal Luhana represent clients in high-profile cases in federal and state courts across the country and have recovered millions in compensation for injured consumers. Though unable to guarantee results, the firm has a distinguished track record of success and is highly committed to each case.

If you or a loved one has been injured by vaginal mesh or has suffered from vaginal mesh side effects, you may be eligible for compensation.  Contact Chaffin Luhana LLP today and speak with a vaginal mesh lawyer for a free confidential case evaluation at 1-888-480-1123.