Risk of Transvaginal Mesh Complications Leads Australian Regulator to Ban Devices

Published on December 4, 2017 by Sandy Liebhard

Australia’s Therapeutic Goods Administration (TGA) has banned the use of transvaginal mesh implants in pelvic organ prolapse repair, after a review of the devices indicated that their risks do not outweigh their benefits.

The Australian transvaginal mesh ban also includes devices known as mini-slings, which are used to treat stress urinary incontinence.

The TGA’s decision to ban the implants followed a review of the latest international studies and an examination of the clinical evidence for each transvaginal mesh product sold in Australia.

“Based on this new information, and since the publication by the TGA of the Results of review into urogynaecological surgical mesh implants, the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients,” the agency said in a statement dated November 28^th.

Since the TGA began its review in 2013, 45 transvaginal mesh implants have been removed from use by the agency. Another 43 have been canceled from Australia’s Registry of Therapeutic Goods, while two others have been limited to non-urogynaecological procedures. Additional devices have been removed from the Registry by their manufacturers.

The TGA’s transvaginal mesh ban will take effect on January 4, 2018.

Transvaginal Mesh and the FDA

The U.S. Food & Drug Administration (FDA) launched a safety review of transvaginal mesh in 2008, after the devices had been linked to more than 1,000 reports of complications, including:

• Mesh erosion through vaginal epithelium
• Infection
• Pain
• Urinary problems
• Recurrence of prolapse and/or incontinence
• Bowel, bladder, and blood vessel perforation
• Vaginal scarring
• Chronic pain
• Pain during sexual intercourse

The FDA published an update in 2011, after the number of transvaginal mesh complications reported to its database tripled. More than 1,500 of the new reports involved implants used for prolapse repair, while over 1,370 were associated with stress urinary incontinence repair.

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” the agency said. “This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

Last year, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the implants ineligible for the agency’s 510(k) clearance program. That program allows a medical device to come to market without undergoing human clinical trials as long as a manufacturer can show that the product is “substantially equivalent” to a device that has already been subject to the FDA’s stricter premarket approval protocols.

Transvaginal Mesh Litigation

Since 2008, hundreds of thousands of U.S. women have filed transvaginal mesh lawsuits  accusing device manufacturers of failing to adequately test their implants or provide doctors and patients with adequate warnings of their risks.

Numerous transvaginal mesh trials have been convened in the ensuing years, with juries delivering verdicts for both plaintiffs and defendants. A significant percentage of claims have also been settled, though thousands remain pending in federal and state courts throughout the country.