FDA Issues Warning About Transvaginal Mesh Surgery
The Food and Drug Administration (FDA) has issued a public notice on transvaginal mesh surgery after receiving thousands of reports about harmful complications. The notice advised patients and healthcare providers to consider alternatives to mesh surgery. The FDA has not issued a product recall, but will convene a panel this fall to make recommendations for the procedure.
Transvaginal mesh is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). These conditions can emerge after childbirth and pregnancy. POP occurs when organs bulge into the vaginal and bladder areas. SUI is a loss of bladder control.
Over 1,000 adverse events involving transvaginal mesh devices were reported to the FDA between 2005 and 2007. On October 20, 2008, the FDA issued a Public Health Notification reporting the figures. From January 2008 to December 31, 2010, there were an additional 2,874 reports of complications.
From 2006 to 2011, the FDA conducted a systematic review of published scientific literature and reported transvaginal POP repair with mesh has no advantage over traditional non-mesh repair. The FDA is advising health care providers to only choose mesh surgery after carefully comparing the risks and benefits with other surgical options.
The most frequent complications associated with transvaginal mesh surgery is erosion throughout the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. There were also reports of emotional problems, vaginal scarring and neurovascular muscular problems.
Many of these conditions involve painful remedies, including medical treatment, several surgeries and hospitalization.
Several companies manufacture transvaginal mesh, including Johnson & Johnson and Boston Scientific, C.R. Bard, Tyco Covidian and AMS. Injuries have not been linked to a single brand of mesh.
If you have been injured by a transvaginal mesh repair, you may be entitled to compensation. It is important to speak to an experienced product liability lawyer as soon as possible so you can obtain the proper medical attention and compensation for your injuries, loss of time at work and pain and suffering.
For a free legal consultation, contact the experienced Boston product liability lawyers at Breakstone, White & Gluck today. Call us at 800-379-1244 or use our contact form.
The Massachusetts product liability lawyers at Breakstone, White & Gluck are experienced in handling cases involving recalled and defective medical devices and pharmaceuticals. Our attorneys are currently representing victims injured in the DePuy hip recall and those who suffered birth defects resulting from the use of Paxil.