Transvaginal Mesh

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
infection
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.

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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.

2005

In 2005, the FDA began studying reports of complications with surgical mesh.

2005

2008

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.

2008

2011

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.

2011

2014

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.

2014

2016

In 2016, the FDA reclassified TVM from a Class II to a Class III device, formalizing the premarket approval requirement.

2016

2018

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.

2018

Transvaginal Mesh Frequently Asked Questions

How does transvaginal mesh treat pelvic organ prolapse?

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.

Are there other options for treating pelvic organ prolapse?

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.

What should I do if I’ve had a TVM implant?

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.

Who manufactures transvaginal mesh devices?

Although TVM devices have been removed from the market, the following companies are facing product liability claims for transvaginal mesh:

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.

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Transvaginal Mesh

Contact Us Today.

TVM Timeline and Recent Updates

2005

October of 2008

In July of 2011

In May of 2014

2016

As of April 2018

Transvaginal Mesh Frequently Asked Questions

How does transvaginal mesh treat pelvic organ prolapse?

Are there other options for treating pelvic organ prolapse?

What should I do if I’ve had a TVM implant?

Who manufactures transvaginal mesh devices?

Speak With A Medical Product Liability Attorney Today

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