In July 2011, the United States Food and Drug Administration (FDA) issued a national medical alert to doctors warning them of risks for serious injuries associated with the use of synthetic vaginal mesh devices, also known as Transvaginal Mesh (TVM). The FDA also warned that TVM’s health risks outweighed its purported benefits.
The FDA’s warning came following more than 1,500 reports of serious injuries caused by the implantation of polypropylene TVM. It advised that doctors opt for traditional procedures as the preferred treatment pelvic organ prolapse (POP) and similar conditions, only using TVM devices as a last resort treatment. A copy of the FDA TVM advisory can be found on our resources page.
Dangerous Transvaginal Mesh Implanted in Women
TVM is used in the treatment of stress urinary incontinence (SUI) and in transvaginal repair of POP. The first surgical mesh product designed for SUI treatment was approved by the FDA in 1996, and a product for POP treatment was approved in 2002. The products have continued to evolve with various kits now being marketed and sold by several companies, including:
Johnson & Johnson
Government statistics show that in 2010 alone, approximately 300,000 women in the United States underwent surgical procedures in the United States to repair POP, and approximately 260,000 underwent surgical procedures to repair SUI.
Mesh implant manufacturers reported to the FDA that approximately 33% – or 200,000 – POP surgeries used mesh, and 75% – or 150,000 – of these procedures were conducted using TVM implant devices. For SUI surgeries, more than 80%, of over 200,000 procedures were conducted using TVM.
The names and brand names of some of the most widely uses TVM products that caused injuries and are subject to lawsuits for injured women are:
Johnson & Johnson®
Advantage™ Sling System
Obtryx® Curved Single
Obtryx® Mesh Sling
Prefyx Mid U™ Mesh Sling System
Prefyx PPS™ System
Avaulta Plus™ BioSynthetic Support
Avaulta Solo™ Synthetic Support
Pelvitex™ Polypropylene Mesh
American Medical Systems®
How TVM Injures Women – Reports to the FDA
The risk of injuries and complications from medical devices is serious and very real. Analysis from studies involving 11,785 women found that approximately 10 percent of patients who underwent transvaginal POP repair with mesh experienced erosion – one of the most common TVM issues – within 12 months of surgery.
The most frequent TVM injuries reported to the FDA include:
Vaginal mesh erosion (also called extrusion or protrusion)
Painful sexual intercourse (also known as dyspareunia)
There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and related emotional problems. In many cases additional surgery and hospitalization were required for women with TVM implant devices.
Schedule a Free Consultation – Contact Us – How Can We Help You?
Lawsuits have been filed on behalf of patients who suffered complications from TVM Products. Litigation is ongoing, and trials against Johnson & Johnson and other mesh manufacturers are beginning to move ahead.
Have you suffered an injury from a Transvaginal Mesh product? Make sure to contact our experienced, compassionate, and knowledgeable defective drug lawyers at Sugarman Law by using our contact form or calling 866-657-5660. We are ready to speak with you about your medical condition, legal rights to money damages, and how we can help. The consultation is free, and we earn no fee unless we collect a settlement or verdict for you.
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