FDA Mandates That Surgical Mesh Implants Undergo Extensive Study To Identify Problem Areas

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Parker McDonald, P.C. reports on the latest news coming from the FDA on surgical mesh implants.

Parker McDonald has monitored developments surrounding surgical mesh implants used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The firm supports the Food and Drug Administration’s recent mandate requiring manufacturers to extensively study the impact of surgical mesh implants.

On January 3, 2012, the FDA commanded that all manufacturers of surgical mesh implants conduct post market surveillance studies, also known as 522 studies. In total, the FDA issued 88 post market study orders to 33 manufacturers of surgical mesh for POP and 11 post market study orders to seven manufacturers of single-incision mini-slings for SUI. The FDA is requesting that manufactures perform a three-year market survey to track side effects and the quality of life of patients.

From 2008 to 2010, the FDA received more than 1,500 complaints about surgical mesh implants – a fivefold increase from 2005 to 2007. Some of the complications reported to the FDA include mesh erosion through the vagina, urinary problems, bleeding, and severe pain. In 2010 alone, 75,000 women with POP were repaired with mesh, and 200,000 needed corrective surgery for stress urinary incontinence.

In July of last year, the FDA announced that the surgical placement of mesh through the vagina to repair POP may expose patients to greater risk than other options. Additionally, the FDA stated that there was no greater clinical benefit with the exposure to greater risk.

Thousands of women may experience POP during their lifetime, so the results of these studies potentially have a widespread impact. If the studies confirm the FDA’s thoughts on the use of the device, vaginal mesh could be reclassified in a higher-risk category. Transvaginal Mesh is currently a Class II medical device, meaning no clinical trials were required prior to market availability.Reclassification to a Class III device would force manufacturers, like Johnson & Johnson and Boston Scientific, to do pre-clinical trials before the devices can be approved.

Some information in this release was provided by Reuters. For additional information, visit us online at http://www.parkermcdonaldlaw.com/vaginal-mesh/. Parker McDonald will continue to monitor and report medical and legal developments on surgical vaginal mesh.

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.


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Erin McDonald
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