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.
20,000 units of ProteGen mesh
Voluntarily recalled due to a high failure rate. Boston Scientific received around 500 complaints in just two years, according to U.S News & World Report.
Class II recall of roughly 540 Pinnacle Surgical Mesh kits.
August 3, 2011
Needle detachment during surgery.
ObTape Vaginal Sling sales discontinued, though not recalled.
A potential design flaw may prevent oxygen and nutrients from circulating correctly, although this has not been proved, and the company has never issued a formal recall. The company claims the product was discontinued because a second generation mesh was introduced.
Johnson & Johnson, Ethicon Division.
Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M
2012, following a June 4 letter from the company to U.S. District Judge Joseph R. Goodwin requesting permission to cease sales
The letter asked for 120 days grace period to end sales, allowing doctors and patients time to prepare alternative treatments. This was not a recall of meshes already sold or implanted. It’s possible the number of complaints and ongoing lawsuits prompted the withdrawals.
C. R. Bard
Avaulta Plus, sales discontinued
July 1, 2012
This was one of the first mesh products to lead to a jury verdict, when a court awarded more than $5.5 million to Christine Scott, who underwent multiple surgeries and reportedly suffered damaged relations with her husband. The mesh was first approved in 2008.
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.