FDA bans sales of transvaginal mesh amid safety concerns

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

FDA bans sales of transvaginal mesh amid safety concerns
Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias, according to the FDA. (Source: KIRO, COX)

(CNN) - 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.

Women who have had transvaginal mesh surgically implanted should “continue with their annual and other routine check-ups and follow-up care,” the FDA advised. “There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms.”

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.

"Patients around the world have become unwitting test subjects for new medical technology," the International Consortium of Investigative Journalists, stated. "Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants."

The Consortium included more than 250 journalists based in 36 countries and examined more than 8 million device-related health records.

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