January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
Bloomberg News reports that the manufacturers of transvaginal surgical mesh implants face more than 600 lawsuits. The lawsuits allege that the transvaginal surgical mesh manufacturers, like Johnson & Johnson, Boston Scientific, Bard and AMS, were negligent in designing the mesh implant and failed to warn patients and physicians of the risks. The surgical mesh implants cause serious injury to women. Many of the women suffer from pain and need additional surgery because the surgical mesh implant eroded into their pelvic organs.
The FDA approved the various transvaginal surgical mesh implants through its 510(k) process. This process allowed for approval without scientific review and testing. Ironically, the transvaginal surgical mesh implants’ 510(k) approval was based on a similar implant which was recalled from the market because of safety concerns. This calls into question the current approval process of substantially similar devices. To learn more about how the transvaginal surgical mesh implants were approved click to read, The Rapid Evolution of Vaginal Mesh Delivery Systems for the Correction of Pelvic Organ Prolapse, Part I: Clinical Data.