Manufacturers of surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday. The FDA said it “has ...

October 21, 2008 — Clinicians should receive specialized training for the transvaginal placement of mesh products and be vigilant for adverse events, the US Food and Drug Administration (FDA) warned ...

The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) ...

The U.S. Food and Drug Administration has issued a proposed rule to reclassify surgical mesh for transvaginal repair of pelvic organ prolapse as a Class III “high-risk device.” The mesh is currently ...

After issuing safety warnings, the FDA may revoke its approvals of transvaginal mesh devices made by Boston Scientific and Johnson & Johnson, according to a Mass Device report. The devices, used to ...

The U.S. Food and Drug Administration has issued an update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse (POP), indicating these ...

GAITHERSBURG, MD — Instrumentation used to place surgical mesh during urogynecological procedures should be subject to stricter manufacturing requirements and more detailed labeling, according to US ...

Microscopic particles left behind by vaginal mesh could continue to trigger the immune system to attack healthy tissue even after the material has been removed, according to researchers. Experts ...

Matthew Johnson, a spokesman for J&J's Ethicon unit that makes the devices, said the company was reviewing the correspondence from the FDA. “Ethicon's transvaginal mesh devices are already among the ...

Have you ever thought about how medical devices designed to improve lives can sometimes cause harm instead? This became evident in August 2024, when a landmark settlement in England saw 140 women ...