FDA Vaginal Mesh Update

According to the FDA, manufacturers have been asked to perform more studies in order to acquire additional information on the safety of transvaginal mesh, a surgical mesh device used in pelvic organ prolapse (POP) treatment.
In July of 2011, the FDA released a safety warning regarding the serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. The warning explained that mesh used in transvaginal POP repair is associated with risks that are not apparent in traditional, non-mesh surgery for POP repair. The FDA also noted that the use of transvaginal mesh may not work better than a traditional POP repair without mesh.
Read more information on the 2011 FDA Vaginal Mesh Safety Alert here.
According to the FDA, the most common and consistently reported complication related to vaginal mesh is the erosion of mesh through the vagina. This type of mesh erosion sometimes requires multiple surgeries to repair. The problems associated with mesh erosion are debilitating for some women, and additional surgeries do not always resolve the problems brought on by the use of mesh.
On January 3, 2012, the FDA mandated a total of nearly 100 post-market studies by sending letters to 35 surgical mesh implant manufacturers. The studies are needed to find additional information regarding the safety and effectiveness of surgical mesh in the treatment of POP.
Pending results of the safety testing, the FDA may be considering moving mesh implants to a riskier medical device category. Surgical mesh products were originally approved without clinical testing, and the use of these products has been linked to complications in the treatment of POP. The use of mesh for the treatment of POP was approved primarily because of the good track record of surgical mesh in the treatment of abdominal hernias.
In 2010 alone, nearly 75,000 women underwent a medical treatment using a product that had never undergone rigorous safety testing. Many of these women are currently suffering because of the use of surgical mesh to treat POP.
If you or someone you love is suffering due to complications related to the use of surgical mesh in the treatment of POP, contact a vaginal mesh lawyer today.


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