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.
Pelvic organ prolapse is a condition in which the muscles and tissues around the pelvis that support the bladder, the uterus, and the rectum weaken, allowing these organs to move around or press into the vagina.
Thousands of women have filed lawsuits against transvaginal mesh (TVM) manufacturers, and many have been successful, some culminating in millions of dollars in compensation for complications as well as damages for pain and suffering.
According to the FDA, the most frequently reported complications include:
- vaginal mesh erosion
- pelvic pain
- urinary problems
- prolapse and/or incontinence recurrence
- perforation of the bowels, bladder, and blood vessels during insertion
- vaginal scarring
- pain during intercourse
- other potentially serious and life-threatening side effects.
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.
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.
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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.
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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.
Speak With A Medical Product Liability Attorney Today
The attorneys at Heninger Garrison Davis are accepting clients who have been injured by a transvaginal mesh device. Even if you feel you are not ready to file a suit, consult with one of our experienced lawyers as soon as possible so that you will know your options. We do not charge any fees up front. In fact, we will only charge attorney’s fees if we obtain a financial settlement for you. If you don’t win, we won’t get paid a legal fee.