FDA bans sales of transvaginal mesh


The US Food and Drug Administration has ordered the sales of transvaginal mesh to be halted due to safety concerns.

The FDA said it’s “determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse.

That’s a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis.

The FDA has advised women who have had transvaginal mesh surgically implanted to “continue with routine check-ups.”

Patients who have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, should notify their health care professionals.

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