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FDA orders makers of surgical mesh products for pelvic collapse to stop selling immediately
USA Today

The Food and Drug Administration is ordering companies that produce mesh devices for women suffering from pelvic organ prolapse to end the sales of those products immediately.

The companies, “Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” the agency said Tuesday in a statement.

The products are supposed to assist in transvaginal repair as a result of POP, but their ability to stay on the market was put in jeopardy three years ago when the FDA labeled them high-risk. That classification meant the manufacturers had to apply for “premarket approval,” the highest bar to clear to keep selling.