Many women report they did not fully understand the risks of Transvaginal Mesh when they consented to surgery.

Doctors were informed by the FDA in 2008 that serious side effects were possible, including:

• Bleeding
• Infection
• Severe Pelvic Pain
• Problems urinating or having a bowel movement
• Pain during sex
• Pain with movement or sitting

When the FDA released this initial warning, they asked doctors to follow certain steps when suggesting mesh to their patients. Did your surgeon follow these recommendations?

• Receive specialized training before implanting mesh to reduce the risk of complications
• Inform the patient that TVM is permanent
• Explain that if complications arise, additional surgery may be needed, and that surgery may not fix the complication
• Provide a comprehensive list of possible serious side effects from TVM
• Give the patient a copy of the surgical mesh label
• After mesh implantation, monitor closely for any signs of complication

In 2011 the FDA published a second warning. In their words:

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare….Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

Despite these warnings, the manufacturers of mesh continue to market their products to urogynecologists.

The American Urogynecologic Society (AUGS) oversees surgeons who implant women with mesh. In response to the 2011 FDA warning AUGS developed a comprehensive consent and information toolkit for surgeons to use when talking to patients about mesh.

However, this consent and toolkit received funding by some of the top mesh manufacturers including American Medical Systems, Boston Scientific, and Bard Medical Division. AUGS also states “The information should not be construed as dictating an exclusive course of treatment or procedure to be followed, or as dictating the standard of care.” The consent and toolkit may help protect surgeons and the manufacturers from liability if there are mesh related complications.

Greg Vigna MD/JD Commitment to You

The Greg Vigna law firm is primarily concerned about the wellbeing of women injured by mesh. We have partnered with medical specialists who understand the complications caused by TVM. These partnerships enable our clients to receive comprehensive representation throughout the United States.

Please contact us today to talk about your mesh experience, and receive a free case evaluation. There is no cost to you to file a lawsuit against the manufacturer. Your case will be added to a growing body of women confronting mesh makers for the damage caused to their bodies.