Due to the rate and severity of pelvic prolapse mesh complications reported in women implanted transvaginally, the FDA is proposing tougher regulations for these products. Specifically, the FDA is reportedly considering that transvaginal mesh products used in the treatment of pelvic organ prolapse (POP) repair be reclassified into Class III, the highest-risk category in the agency’s regulatory structure for medical devices. If the agency elects to reclassify the mesh, makers of POP vaginal meshes may need to provide additional safety data to regulators to allow their products to remain on the market, while those creating new mesh products could be subject to a premarket review process. To learn more about the pelvic prolapse mesh complications which may prompt this new classification, visit
http://www.classaction.org/transvaginal-mesh.html today.
The FDA report regarding the possible new regulations for surgical mesh products was released prior to an upcoming obstetrics and gynecology devices advisory committee meeting to discuss pelvic prolapse mesh complications. The meeting is said to center on the increasing number of
vaginal mesh complications which have been reported among POP repair patients. In July, the FDA stated that it saw the number of reports of vaginal mesh side effects continue to increase since its first announcement regarding transvaginal mesh products; in this safety announcement, the agency also warned that mesh erosion and other pelvic prolapse mesh complications associated with transvaginal placement are not rare.
If you have suffered from pelvic prolapse mesh complications, you may have legal recourse in light of the increasing number of reports of problems in patients. Potentially, women experiencing vaginal mesh complications may be able to file a claim seeking compensation for medical bills, pain and suffering and other damages. To find out if you qualify for a
transvaginal mesh lawsuit, visit Class Action.org today for a no cost, no obligation evaluation of your claim.
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