Has Transvaginal Mesh Been Recalled?

With all the news and lawsuits alleging that transvaginal mesh – a medical device used in certain pelvic prolapse surgeries – is dangerous, many might assume that the product’s been recalled by the FDA. This administration, responsible for the monitoring and regulation of drugs and medical devices used in the U.S., has a tiered system of legally enforceable recalls. Surely, then, a product so commonly cited as harmful has been taken out of common use?

The long and the short of it is – no, it hasn’t. What’s more, there’s no sign that TVM will be recalled anytime soon.

We really feel that the best decision making is left between the patient and her physician without outside interference.

Ongoing lawsuits allege that mesh products have caused painful and long-lasting injury to hundreds of women, and that the products are not the ideal treatment method for women suffering from pelvic organ prolapse and stress urinary incontinence. However, many doctors defend the use of mesh and argue that any across the board regulation would be too heavy-handed and would remove individual patients’ choice.

This does not mean, however, that no action has been taken over specific mesh products.

It seems unlikely an enforced ban on mesh products is on the horizon. As lawsuits against TVM manufacturers continue to mount, medical opinion is anything but united. Dr. Anthony G. Visco, president of the American Urogynecologic Society, tells ObGyn News that “we really feel that the best decision making is left between the patient and her physician without outside interference. Instead of a ban on mesh, I think hospitals and health systems should adopt strict credentialing guidelines so that qualified surgeons are performing these procedures.”

Although the FDA has investigated transvaginal mesh products, their stance seems to be one of cautious approval, recognizing that TVM problems exist in some instances while acknowledging that the products are not universally flawed. TVM continues to be used to treat women with pelvic organ prolapse and stress urinary incontinence. Anyone faced with the possibility of TVM surgery should make sure they speak to their doctors and fully understand the product's use and the risks involved.