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FDA orders manufacturers of surgical mesh intended to treat pelvic organ prolapse, to stop distribution immediately

By |2019-05-09T13:29:26+00:00May 7th, 2019|Defective Medical Equipment, Defective Products, Medical Malpractice, Recalls, Uncategorized|

On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard [...]