Articles Tagged with “FDA notice”

Several weeks after the Food and Drug Administration (FDA) issued a public notice about the dangers of transvaginal mesh surgery, a consumer advocacy group is calling for the recall of all surgical mesh products used in the procedure.

Public Citizen of Washington D.C. petitioned the FDA on August 25, calling for the recall of all surgical mesh products made of non-absorbable synthetic material used in transvaginal mesh surgery. This type of mesh is used during transvaginal surgery to repair pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). POP occurs when organs bulge into the vaginal and bladder areas. SUI is a loss of bladder control.

In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, including 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA.

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.
Continue reading