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FDA Focuses on New Studies to Determine Safety of Surgical Mesh Implants

The FDA has continued to further pursue research and studies concerning the safety of all urogynecologic surgical mesh implants due to the increased number of complaints and litigations. Filed complaints continue to increase across the U.S. as the FDA looks more closely into research. Complaints began several years ago as women were experiencing severe side effects after having vaginal mesh surgically implanted to help treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Vaginal mesh has been on the market since 2002, having several pharmaceutical companies provide it. Within only two years, the FDA had received over 1,500 complaints filed by patients and doctors. Several women’s procedures resulted in multiple revision surgeries that still left them with unsatisfying results. In October 2008, the FDA issued the first Public Health Notification, warning patients about the possibility of the device failing and the potential side effects that they were not informed about. As complaints continued to pile up, in July 2011, the FDA issued their second safety warning to patients stating that, “serious complications associated with surgical mesh for transvaginal repair of POP are not rare, and it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.” (read full article)

January 2012, the FDA met again to review new studies and undergo new measures of research. Based on Medical Device Reports, published literature and the 2011 Obstetrics-Gynecology Device Panel meeting, the FDA is debating whether or not urogynecologic surgical mesh used for transvaginal repair of POP be reclassified from Class II to Class III. They administration is going to continue to evaluate the safety and success of urogynecologic surgical mesh devices through new procedures and continue to inform the public of any safety warnings. (view full list of new procedures)

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As of today, vaginal mesh is still on the market but the FDA continues to warn doctors and patients of the probable side effects that could severely affect long term health. If you or a loved one have received surgical mesh and it has failed or led to further health problems that you were not properly warned about don’t hesitate to contact an attorney. At Borchardt Law Firm, we have seen and dealt with several failed medical device cases and feel the work we do will continue to better protect future generations of Texans. Feel free to give us a call.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
1300 South University Drive, Suite 500
Fort Worth, Texas 76107
Sources:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

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

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