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FDA Public Advisory Committee to Discuss Vaginal Mesh Complications

On September 8 and 9, 2011, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet to discuss the safety and effectiveness of transvaginal mesh used in the treatment of pelvic organ prolapse.

On September 8 and 9, 2011, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet to discuss the safety and effectiveness of transvaginal mesh used in the treatment of pelvic organ prolapse (POP). The FDA has arranged the meeting to seek expert advice regarding the risks and benefits of vaginal mesh devices, which have recently been linked to a number of adverse events including vaginal erosion leading to pelvic pain and dyspareunia. The transvaginal mesh lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits on behalf of women 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 Update 6/26/12: Healthcare behemoth Johnson & Johnson (J&J) continued to sell its controversial Gynecare Prolift transvaginal mesh patch for nine months after the FDA ordered it to stop, according to court records. In a letter sent Aug. 24, 2007, the administration asked the company to halt sales of the Prolift until it could determine whether the device was ‘substantially equivalent’ to other products on the market. 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.

Free Vaginal Mesh Lawsuit Case Evaluation: If you or a loved one has been injured by transvaginal mesh, 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?

The Public Advisory Committee will be asked to provide scientific and clinical input on the FDA’s proposed regulatory strategies for transvaginal mesh products, including reclassifying the devices into Class III (which requires premarket approval), labeling updates, as well as post-market surveillance studies.

The FDA intends to make background material available to the public no later than September 6. If the administration is unable to post the information on its website prior to the meeting, it will be made public at the location of the advisory committee meeting, which is being held at the Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD 20879.

If you are interested, you may present data, information, or views on issues pending before the committee. Oral presentations from the public will be scheduled between 10 and 11 AM on September 8 and 9. Time allotted for each presentation will be limited. FDA welcomes the attendance of the public at its advisory meeting and will make every effort to accommodate all persons attending the event.

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

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