Endo Settles More Mesh Cases (800) 932-0979
Endo International Plc (ENDP) to pay $400 million patients of its vaginal-mesh implants which eroded causing pain and other complications. It is estimated that amounts 48,000 per person for the 10,000 lawsuits.
This adds to the 800 million plus settlement that occurred earlier this year as reported in the New York Times.
The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels .
On May 1, 2014, the FDA proposed reclassifying transvaginal mesh to increase safety requirements in the rule below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2014-N-0297] Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation AGENCY: Food and Drug Administration, HHS. ACTION: Proposed order. ———————————————————————–
SUMMARY: The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device. In addition, FDA is proposing to reclassify urogynecologic surgical mesh instrumentation from class I to class II. The Agency is also proposing to establish special controls for surgical instrumentation for use with urogynecologic surgical mesh. FDA is proposing this action, based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance. The Agency is reclassifying both the surgical mesh for transvaginal repair and the urogynecologic surgical mesh instrumentation on its own initiative based on new information.
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