Public Citizen Demands Transvaginal Mesh Recall

Public Citizen is a nonprofit organization dedicated to serving as the people’s voice in the nation’s capitol. Since 1971, they have actively championed citizen interest above government affairs. They are known for successfully challenging the corrupt practices of the pharmaceutical, nuclear and automobile industries. However, Public Citizen has recently issued a press release acknowledging specific dangers in the medical industry. On August 25, 2011, Public Citizen demanded that the U.S. Food and Drug Administration (FDA) take the appropriate steps to have non-absorbable transvaginal mesh products recalled, due to the needless exposure of severe, life-threatening complications.

Significant injuries to vaginal walls may significantly interfere with the quality of life in many women. These injuries may involve a number of adverse circumstances such as childbirth, pelvic organ prolapse (POP), and stress urinary incontinence (SUI), each of which require immediate attention in order to fix the damaged or stretched tissue. Damage sustained by the vaginal wall, due to the occurrence POP and/or SUI, may prove to be extremely painful and irritating.

In the event that a women is diagnosed with POP or SUI, doctors may surgically implant a transvaginal mesh to provide support for the damaged tissue. The operation replaces the damaged or defective tissue with a surgical mesh that provides support for the urethra. Last year, approximately 300,000 women in the U.S. had surgery to repair POP, 75,000 of whom had a transvaginal mesh surgically implanted, according to the FDA. Public Citizen estimates that approximately 67,500 of these procedures used non-absorbable mesh that is believed to offer no significant benefits and high rates of severe complications.

Unfortunately, recent studies suggest that women who receive a non-absorbable mesh may significantly increase their risk of suffering from a number of catastrophic side effects. In many situations, the side effects are linked to the erosion of the surgical mesh, which has an increased tendency to eroded into the vaginal wall, bladder, and bowel tissues. As a result, women who have received a transvaginal mesh may increase their risk of experiencing severe pain and suffering in the form of infection, urinary problems and numerous post-surgical complications. In many cases, the erosion of transvaginal mesh may actually be responsible for the reoccurrence of the injuries it was intended to treat. In the event that erosion occurs, women may be forced to undergo costly and painful revision surgery in an attempt to fix the problem created by the mesh device.

Public Citizen, in association with a number of prestigious healthcare officials, has requested that non-absorbable transvaginal meshes be recalled due to their lack of clinical benefits and an association with severe, life-threatening complications. Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group acknowledged that “surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life.”

According to a study released by the Journal of Obstetrics and Gynecology Canada (JOGC), the surgical application of transvaginal mesh procedures should be considered experimental. The relative effectiveness of vaginal mesh is widely unknown, many healthcare providers believe that there are safer alternatives to treating complications such as pelvic organ prolapse or stress urinary incontinence.
Between 2005 and 2010, an estimated 3,875 injuries were reported to the FDA. Many of which regarded the erosion of a transvaginal mesh device. As a result, the FDA warned patients and the healthcare community of the risks associated with the use of transvaginal mesh products. Contained in the same warning was a recommendation to consider alternative treatments in respect to POP and SUI.

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 Chantix 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.