Important Update:

On July 13, 2011, the FDA issued a medical alert to physicians warning that the risk of serious injury outweighed the purported benefits associated with the use of synthetic vaginal mesh devices. The warning came following a review of more than 1500 adverse event reports of serious injuries caused by the implantation of polypropylene transvaginal device/mesh. The FDA counseled that physicians should opt for traditional procedures as the preferred treatment and that implantation of these devices should be considered as a treatment of last resort. You may download a copy of the FDA advisory below.

Usage:

Transvaginal mesh is used in the treatment of stress urinary incontinence (SUI) and in the transvaginal repair of pelvic organ prolapse (POP). The products have been in use since the 1990's. In 1996 the FDA approved the first surgical mesh product designed for the treatment of SUI. In 2002 a product for the treatment of POP was approved. The products have continued to evolve with various kits now being marketed.

According to the FDA, in 2010 approximately 300,000 women underwent surgical procedures in the United States to repair POP and approximately 260,000 underwent surgical procedures to repair SUI. Based upon industry estimates provided to the FDA, approximately one out of three POP surgeries (200,000) used mesh, and three out of four (150,000) of the mesh POP procedures were done transvaginally. For SUI surgeries, over 80 percent (208,000+) were done transvaginally with mesh.

Transvaginal products (mesh, tape and sling devices) are manufactured by several companies, including Ethicon/Gynecare/Johnson & Johnson and C.R.Bard, Inc.

Johnson & Johnson®

• Ethicon® TVT
• Gynecare® TVT
• Gynecare® Prosima
• Gynecare® Prolift
• Gynemesh® PS

Boston Scientific®

• Advantage™ Sling System
• Obtryx® Curved Single
• Obtryx® Mesh Sling
• Prefyx Mid U™ Mesh Sling System
• Prefyx PPS™ System
• Arise®
• Pinnacle®
• Lynx®
• Solyx®

C.R. Bard®

• Avaulta Plus™ BioSynthetic Support
• Avaulta Solo™ Synthetic Support
• Faslata® Allograft
• Pelvicol® Tissue
• PelviSoft® Biomesh
• Pelvitex™ Polypropylene Mesh

American Medical Systems®

• SPARC®
• BioArc®
• MiniArc®
• Elevate®
• Monarc®
• Perigree®
• In-Fast®
• Apogee®

Injuries:

The most frequent complications reported to the FDA included vaginal mesh erosion (also called exposure, extrusion or protrusion), pain (including painful sexual intercourse known as dyspareunia), infection, urinary problems, bleeding, and organ perforation. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems. In many cases further surgery or hospitalizations were required.

The risk of complication is real. Analysis from studies involving 11,785 women, found that approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery. This would equate to approximately 20,000 women per year experiencing this serious complication.

Complications related to Transvaginal Mesh:

• Mesh erosion through vaginal wall or other body parts
• Infection
• Pain
• Urinary problems
• Recurrence of prolapse and/or incontinence
• Bladder, bowel or vessel perforation
• Vaginal scarring
• Pain during sexual intercourse

Litigation:

Actions have been brought on behalf of patients who have suffered complications from these products. Our attorneys have recovered millions of dollars in compensation for victims of defective medical products.

If you or someone you know have suffered complications following the treatment of stress urinary incontinence (SUI) or transvaginal repair of pelvic organ prolapse (POP) you may be entitled to significant compensation. Contact us today today for a free consultation with our team to determine your rights.

Make sure to contact our experienced, compassionate and knowledgeable lawyers by using our contact form or call the number above.