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Meshing FDA and Manufacturers Together at Transvaginal Mesh Advisory Committee Hearings

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

On Friday, the U.S. Food and Drug Administration (FDA) Obstetrics & Gynecology Devices Advisory Committee concluded a two-day meeting to review the safety and effectiveness of surgical mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Since 2002, the FDA has cleared more than 100 mesh products for POP repair and 78 mesh devices for SUI…
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Poll Indicates F.D.A. Panel Would Recommend Reclassifying Transvaginal Surgical Mesh to Class III Device

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

On Thursday an informal poll of an F.D.A. advisory panel revealed that the majority of members would favor reclassifying transvaginal surgical mesh products from class II medical devices to class III devices. Though the panel did not formally vote at the Thursday meeting, the poll may be a harbinger of the things to come. Reclassification to class III is significant…
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