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FDA: Conventional Treatment Options Expose Women to Less Risk than Transvaginal Mesh

On July 13, 2011, the FDA issued a press release stating that surgical placement of mesh to repair pelvic organ prolapse poses risks, and that more traditional treatment options may be a safer alternative.

On July 13, 2011, the U.S. Food & Drug Administration (FDA) issued a press release stating that surgical placement of mesh to repair pelvic organ prolapse (POP) poses risks, and that more traditional treatment options may be a safer alternative. The warning also claims that the potentially dangerous vaginal mesh products offer no greater clinical benefit over more conventional forms of transvaginal treatment. The vaginal mesh lawyers at Schmidt & Clark, LLP are now investigating potential lawsuits on behalf of women injured by transvaginal 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 6/6/12: Ethicon, a subsidiary of Johnson & Johnson, has announced plans to recall its Gynecare line of transvaginal mesh devices nationwide in response to a high number of injuries that have been linked to the products. To date, hundreds of Ethicon Gynecare Transvaginal Mesh lawsuits have been filed in courthouses around the country on behalf of women who allegedly suffered mesh erosion, infections, and severe pelvic pain after having the devices surgically implanted. 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?

Pelvic organ prolapse (POP) occurs when one or more pelvic organs – the uterus, vagina, bladder or rectum – shifts downwards and bulges (prolapses) into or even out of the vaginal canal. While not generally considered a life-threatening condition, women with POP often experience a number of severe side effects as well as an overall reduction in their quality of life. Around the country, it is estimated that nearly one-quarter of all women suffer from some variety of POP. The main symptom associated with POP, stress urinary incontinence, costs the U.S. $20 billion in medical expenses annually, and surgeries to correct POP cost more than $1 billion every year.

Procedures to repair pelvic organ prolapse can be performed surgically through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of mesh to repair the anatomy. In 2010 alone, there were at least 100,000 POP procedures utilizing surgical mesh, approximately 75,000 of which were transvaginal procedures.

“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”

Vaginal Mesh Side Effects

According to the FDA, the most frequently reported side effects associated with vaginal mesh used to repair POP include:

  • mesh becoming exposed or protruding out of the vaginal tissue (erosion)
  • pain
  • infection
  • bleeding
  • pain during sexual intercourse
  • organ perforation from surgical tools used in the mesh placement procedure
  • urinary problems
  • additional surgeries or hospitalization to treat complications or to remove the mesh

Vaginal Mesh Products

Manufacturers of transvaginal mesh products include:

Johnson & Johnson:

  • Ethicon TVT
  • Gynecare TVT
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch
  • Secur


  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh

American Medical Systems (AMS):

  • SPARC®

Boston Scientific:

  • Advantage™ Sling System
  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System

Injured by Vaginal Mesh? Contact Us Today.

If you were the recipient of a vaginal mesh product and suffered from any adverse health complications, you may be entitled to compensation. Contact the vaginal mesh lawyers at Schmidt & Clark, LLP today for a free case evaluation. Act now – there is a limited amount of time in which to file your claim.

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

Do You Have a Vaginal 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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