The Food and Drug Administration on Tuesday ordered manufacturers of surgical mesh used for repairing a condition called pelvic organ prolapse to immediately stop selling their products, the latest turn in a years-long battle over the safety of the implants.
The agency said the companies, Boston Scientific and Coloplast, had not demonstrated a “reasonable assurance” of safety and effectiveness for the devices for use over the long
The FDA action specifically affects surgical mesh used for the transvaginal repair of pelvic organ prolapse, which occurs when the muscles and tissues supporting the uterus, bladder or rectum become weak or loose. That can allow organs to drop or press into the vagina. The regulatory action does not apply to mesh used for other conditions, such as hernias or stress urinary incontinence.