After receiving injury reports for years, health officials in the United States have recently stopped the sales of vaginal mesh implants indicated for pelvic organ prolapse.

On April 16, the FDA issued an order to the manufacturers of the last vaginal mesh products on the market, requiring them to cease selling these products. The agency says manufacturers Boston Scientific and Coloplast “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

The FDA classified vaginal mesh products for pelvic organ prolapse as high-risk devices in 2016. The high-risk classification requires manufacturers to submit and premarket approval applications for these devices.

The companies have been reportedly given ten days to submit their plan to recall these vaginal mesh products from the market.

“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

Coloplast and Boston Scientific have marketed their vaginal mesh products for pelvic organ prolapse treatment for years. But the companies allegedly failed to prove that their devices were safe and effective for this application. The companies also allegedly failed to prove that their products had greater benefits than risks.

Boston Scientific has already submitted two applications for premarket approval for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System vaginal mesh products, while Coloplast filed an application for its Restorelle DirectFix Anterior.

In February 2019, the FDA had an advisory panel of experts evaluate the safety and effectiveness of vaginal mesh implants for POP repair. The panel concluded that vaginal mesh was comparable to native tissue repair, but that the documentation and data did not prove that the devices were particularly effective for treating pelvic organ prolapse.

Overview of Vaginal Mesh Complications

Surgical mesh has been commonly used to treat pelvic organ prolapse since the 1990s, and is now commonly used to treat stress urinary incontinence (SUI). Both conditions involve the loss of control of the bladder and other pelvic organs, which can sometimes cause organ prolapse, significant pain, and urinary problems.

The FDA approved the first vaginal mesh implant in 2002, with manufacturers promoting the product as a faster alternative to traditional surgery.

However, the FDA has since received thousands of injury reports indicating that vaginal mesh products could pose serious risks to patients. Complications have been especially problematic for women who had vaginal mesh products implanted for POP repair, which eventually spurred the FDA into classifying the devices as high risk in 2016.

The complications associated with vaginal mesh products include but are not limited to:

• Mesh Erosion
• Exposure
• Extrusion
• Perforation
• Mesh Infection