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FDA TVM Safety Communication

Safety Communication Background

Transvaginal mesh is a common treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In 2010, more than 550,000 women had surgery for POP and SUI, many receiving transvaginal mesh implants.

 
A number of adverse event reports detailing often serious medical complications have been associated with the use of transvaginal mesh. According to a 2008 FDA Public Health Notification, the administration received over 1,000 reports of complications over the course of a three year period between 2005 and 2007. Additional reports, as well as numerous transvaginal mesh lawsuits, followed.
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July 13, 2011 Food and Drug Administration Safety Communication

The purpose of the 2011 FDA safety communication was to provide an updated report on the potential for serious medical complications arising from transvaginal mesh surgery. The FDA stated that "serious complications associated with surgical mesh for transvaginal repair of POP are not rare." Additionally, the FDA noted that their review of transvaginal mesh showed that the product did “not improve symptomatic results or quality of life over traditional non-mesh repair.”

In the 2011 safety update the FDA stated that it had received an additional 2,874 reports of transvaginal mesh complications between 2008 and 2010, in addition to the over 1,000 reports that it received between 2005 and 2007. These reports included incidents of mesh erosion and mesh contraction, both of which "may lead to severe pelvic pain, [and] painful sexual intercourse." In many instances additional surgeries were required to remove or repair the transvaginal mesh implant. The FDA established a committee to evaluate the risks and benefits of transvaginal mesh in light of these findings.

No Evidence of Greater Clinical Benefit

The FDA news release that accompanied the July 13, 2011 Safety Communication made it clear that "with the exposure to greater risk comes no evidence of greater clinical benefit such as improved quality of life." The new release cited an increasing number of adverse event reports associated with the mesh, "five times as many as the agency received from 2005 to 2007" related to the use of transvaginal mesh to treat POP.

Injured by Transvaginal Mesh? Free Consultation.

Our transvaginal mesh lawyers represent women nationwide who have suffered injuries from vaginal mesh implants. If you or a loved one suffered vaginal mesh injuries, you may have a legal right to financial compensation. For a free and confidential consultation about your possible transvaginal mesh lawsuit, please fill out the form to the right or call (866) 981-4800.

Women Representing Women

Ms. A. J. De Bartolomeo, a partner at Girard Gibbs, represents women injured after using transvaginal mesh as well as Mirena and NuvaRing birth control products, and serves on the Plaintiffs' Steering Committees for the Yaz and Yasmin Birth Control and Pradaxa lawsuits. Our personal injury attorneys have also represented those injured by Medtronic medical devicesSprint Fidelis leads, SSRIs, Actos, and GranuFlo. We have recovered settlements worth hundreds of millions for our clients.

Our law firm has decades of experience successfully representing people injured by some of the nation’s largest and most powerful corporations. Our attorneys pride themselves on being there for our clients at every stage of the litigation from intake through verdict or settlement.

Why Girard Gibbs?

Girard Gibbs represents consumers, investors, whistleblowers, employees, and businesses in cases involving consumer protection, personal injury, securities, antitrust, employment litigation and arbitration. The firm’s senior partners, Daniel Girard and Eric Gibbs, have been selected for inclusion in The Best Lawyers in America® 2012 and Northern California Super Lawyers, and have earned AV-Preeminent ratings from Martindale-Hubbell, recognizing them in the highest class of attorneys for professional ethics and legal skills.

Transvaginal Mesh Attorneys
  • Eric
    Gibbs
    Eric Gibbs is a founding partner of Girard Gibbs LLP. MORE >
  • A. J.
    De Bartolomeo
    A. J. De Bartolomeo is a partner at Girard Gibbs LLP. She has more than twenty years of experience in complex... MORE >
  • Kristine
    Meredith
    Kristine Meredith is a partner at the Danko Law Firm. She represents victims of defective medical devices,... MORE >
  • Amy
    Zeman
    Amy Zeman is an attorney at Girard Gibbs LLP. She represents plaintiffs in complex litigation cases against... MORE >
  • Kristen
    Boffi
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