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FDA Update on Transvaginal Mesh Side Effects

On July 13, 2011, the FDA issued a press release updating information about serious complications associated with transvaginal mesh treatment for pelvic organ prolapse (POP).

On July 13, 2011, the U.S. Food & Drug Administration (FDA) issued a press release updating information about serious complications associated with transvaginal mesh treatment for pelvic organ prolapse (POP). The FDA issued the update to inform the public that adverse side effects associated with transvaginal mesh are not rare, which is a change from what the administration originally reported in October 2008. The transvaginal mesh lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits nationwide on behalf of victims injured by vaginal mesh side effects.

Transvaginal Mesh Lawsuit Update 8/1/12: According to a plaintiff’s attorney in what appears to be the latest in a string of transvaginal mesh (TVM) lawsuits filed around the country over the past several months, Boston Scientific Corporation knew – or should have known – about the health risks associated with its products. The plaintiff, from Tennessee, was reportedly implanted with a Boston Scientific Obtryx Tansobturator Mid-Urethral Sling System, and subsequently suffered debilitating personal injuries. Click here to learn more.

Vaginal Mesh Lawsuit Update 7/26/12: Last Friday, a jury ruled that medical technology giant C.R. Bard and a doctor must pay a total of $5.5 million in damages over a vaginal mesh implant that left a woman with persistent pain and potentially irreversible injuries.The landmark case is the first to go to trial among hundreds of lawsuits alleging that vaginal mesh implants made by Bard, Johnson & Johnson, and Boston Scientific caused severe organ damage and other serious injuries. Click here to learn more.

Transvaginal Mesh Lawsuit Update 6/21/12: A judge has lifted the discovery stay in the federal transvaginal mesh (TVM) litigation, as scores of new cases continue to be filed on behalf of women in courthouses around the country. All discovery was stayed earlier this year in federal lawsuits involving transvaginal mesh products used for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Click here to learn more.

Transvaginal Mesh Update 3/22/12: Multi-national pharmaceutical and biotech giant Johnson & Johnson sold a transvaginal mesh implant for three years before the device was officially approved by the U.S. Food & Drug Administration (FDA). The product, known as the Gynecare Prolift, is currently the subject of more than 550 lawsuits filed on behalf of women who claim it injured them. Click here to learn more.

Free Vaginal Mesh Lawsuit Case Evaluation: If you or a loved one has been injured by vaginal mesh side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

In its October 2008 Public Health Notification, the FDA stated that the number of adverse event reports it had received concerning vaginal mesh devices used to repair POP and SUI between 2005 and 2007 was ‘over 1000.’ In the intervening period from January 2008 to December 31, 2010, the administration received an additional 2,874 reports of complications associated with transvaginal mesh devices. 1,503 of these reports were associated with POP repair and 1,371 were associated with SUI.

Side Effects of Vaginal Mesh

The side effects most frequently reported to the FDA included:

  • mesh erosion through the vagina (also called exposure, extrusion or protrusion)
  • pain
  • infection
  • bleeding
  • pain during sexual intercourse (dyspareunia)
  • organ perforation
  • urinary problems
  • recurrent prolapse
  • neuro-muscular problems
  • vaginal scarring/shrinkage
  • emotional problems

Sadly, many of these side effects require additional intervention including medical or surgical treatment and hospitalization. The complications associated with the use of vaginal mesh for POP repair have not been definitively linked to a single product or manufacturer.

FDA Review of Vaginal Mesh Scientific Literature

To better understand the risks posed by transvaginal mesh products, the FDA conducted a systematic review of scientific literature published between 1996 – 2011. The review found that vaginal mesh for POP repair does not improve symptomatic results or quality of life over more conventional treatment methods that do not involve surgical mesh. Additionally, the FDA’s literature review found that erosion of mesh through the vagina was the most common and consistently reported mesh-related complication. Mesh erosion can require additional revision surgeries to repair and can be permanently debilitating for some recipients. In certain cases, even multiple surgeries will not resolve the issue.

Additionally, the FDA review uncovered a previously unknown risk of transvaginal mesh known as mesh contraction (shrinkage). Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening, and vaginal pain. Mesh contraction may lead to severe pelvic pain, pain during sex, and an inability to engage in sexual intercourse. Men may also experience irritation and pain to the penis during sex when the mesh is exposed in mesh shrinkage.

Click here to learn more about vaginal mesh side effects from Schmidt & Clark, LLP.

Do You Have a Transvaginal Mesh Lawsuit?

The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in vaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new vaginal mesh injury cases in all 50 states.

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