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FDA WARNINGS AFTER INSUFFICIENT TESTING
Under the agency's 510(k) program, transvaginal mesh devices were initially categorized as Class II products. These "fast-track" guidelines simply required manufacturers to show that a new product was similar to one previously approved for sale. As a result, clearance was expedited for the following:
Transvaginal Mesh Device Recalls
Despite ongoing reports of serious complications related to mesh devices, the FDA has not issued a recall. Some of the manufacturers, however, withdrew some of their own products from the marketplace. Listed below are some of these examples to better help you understand your case:
Contact Transvaginal Mesh Lawyers for a Free, Confidential Legal Consultation
Did you suffer complications after a mesh implantation for POP or SUI? Are you furious because manufacturers did not inform surgeons and patients about all of the potential risks? Contact transvaginal mesh lawyers for a free, confidential consultation.