An influx of adverse transvaginal mesh reports have become the subject of intense scrutiny in the healthcare community. The past two years have witnessed an exponential growth in complications associated with the surgical application of transvaginal mesh products. Due to the frequency and severity in which these adverse events are being reported, a public advisory committee to the U.S. Food and Drug Administration (FDA) has announced that they will hold a meeting to discuss safety and effectiveness concerns regarding the use of transvaginal mesh in the treatment of pelvic organ prolapse (POP).
On September 8-9, 2011, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will attempt to present the FDA with a better understanding of transvaginal mesh products. Doing so will provide the FDA with important information that will help the agency determine the safety and effectiveness of these devices. Subsequently, any new data revealed to the FDA may have overwhelming implications on future restrictions and regulations of transvaginal mesh products.
Gary Duerhring, Ph.D., a retired Woodland Health Center physician, has been granted a position on the panel roster for his professional knowledge on the subject in question. Duerhring, acting as the Consumer Representative, will attempt to present the FDA with substantial evidence that the surgical application of transvaginal mesh products coincides with frequent and severe complications. Medical device reports obtained from the Manufacturer and User Facility Device Experience (MAUDE) database indicate that frequent risks include: organ perforation, bleeding, pain, infection, dyspareunia, mesh exposure, mesh erosion, revision surgery. Duerhring, in association with Patient Representative Barbara Berney, will attempt to convince the FDA that these risks greatly outweigh the benefits of transvaginal mesh products.
Industry Representative Sergio Gadaleta Ph.D., will attempt to refute accusations made by Duerhring and Berney. By presenting the FDA with evidence that supports the use of transvaginal mesh, Gadaleta hopes to convince the agency that benefits of these products demonstrate a favorable risk/benefit profile.
The rest of the panel roster consists of 15 non-voting members, each of whom are considered experts in the medical community. Each of these members will present the FDA with evidence that will help determine the safety and effectiveness of transvaginal mesh products.
The final chair on the panel roster was given to Shanika Craig, a figurehead at the FDA. Craig’s responsibilities include those of the Designated Federal Officer.
Do I Have a Transvaginal Mesh Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in transvaginal mesh lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by transvaginal mesh, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.