Do I have a Transvaginal Mesh case?
Vaginal mesh complications recently gained widespread media attention after the FDA announced that the likelihood of an adverse incident was not as rare as originally thought in the medical industry. The agency further concluded that insufficient evidence existed to support earlier theories that the devices improve pelvic organ prolapse at all.
Several manufacturers were able to gain FDA clearance of similar mesh models on a theory of “substantial equivalence” under the agency’s 510K procedure. In light of the recent safety communication, the agency’s latest announcement certainly casts a measure of doubt on the wisdom of that clearance process as it pertains to vaginal mesh devices.
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