Since 2005, the U.S. Food and Drug Administration has fielded over 1,000 complaints of potentially serious, sometimes life-threatening problems linked to mesh devices used to treat Pelvic Organ Prolapse (POP) and the related issue of Stress Urinary Incontinence (SUI) in women whose pelvic muscles have weakened.
According to the FDA, the most frequently reported complications include:
Studies on the rate of complications with TVM devices vary in their findings. However, according to a review of studies which was conducted by D. Barski and D.Y. Deng of BioMed Research International, the complication rate for transvaginal mesh repair of POP ranges from 15 to 25 percent. Vaginal mesh erosion is the most commonly reported complication, experienced by 10.3 percent of patients, according to a 2013 study.
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TVM Timeline and Recent Updates
Since the 1970s, gynecologists have used surgical mesh to treat pelvic organ prolapse. In 1976, the FDA received authority to regulate medical devices through the federal Food, Drug, and Cosmetic Act. Surgical mesh was classified as a Class II device, not requiring premarket approval.
In 2005, the FDA began studying reports of complications with surgical mesh.
October of 2008
October of 2008 saw the FDA issue a public health notification about the more than 1,000 reports that had come in related to the devices.
In July of 2011
In July of 2011, the FDA issued a safety communication update warning doctors and consumers that utilizing mesh in transvaginal surgical procedures to treat pelvic organ prolapse could pose an unnecessary risk and that other alternatives may be preferable.
In May of 2014
In May of 2014, the FDA proposed an order that would require premarket approval for using transvaginal mesh to repair pelvic organ prolapse.
In 2016, the FDA reclassified TVM from a Class II to a Class III device, formalizing the premarket approval requirement.
As of April 2018
As of April 2018, the FDA has effectively banned using surgical mesh to repair pelvic organ prolapse, and ordered the devices withdrawn from the market.
Frequently Asked Questions About Transvaginal Mesh
A: Vaginal mesh is a device that is surgically implanted in the pelvis order to help support weakened pelvic muscles that are no longer able to hold pelvic organs. Mesh devices have been linked to a number of dangerous side effects and complications, including infections and nerve damage.
A: There are several noninvasive options used to strengthen the pelvic floor and address urinary incontinence, including physical therapies, as well as silicone devices known as pessaries, which are placed into the vagina to keep organs in place. Women are able to manage the pessaries themselves as needed, removing the need for follow-up surgeries.
A: If you have had surgical mesh implanted, you should receive annual checkups to ensure that there are no signs of adverse reaction. You may not experience any problems. If you do begin to experience complications, however, such as bleeding, discharge, or pain, you should consult with your doctor as soon as possible. You may wish to speak with an experienced medical device attorney to pursue a claim for negligence.
A: Although TVM devices have been removed from the market, the following companies are facing product liability claims for transvaginal mesh:
- Endo Pharmaceuticals/American Medical Systems, Inc.
- Boston Scientific
- C.R. Bard, Inc.
- Ethicon, a division of Johnson & Johnson
More than 100,000 lawsuits have been filed against the makers of TVM products.