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.
Public Citizen is further calling for a ban on marketing all surgical mesh products made for transvaginal mesh surgery and for any future versions of the mesh to be classified as Class III medical devices. This would provide stricter approval requirements.
Nine companies manufacture transvaginal mesh products, including Boston Scientific, Johnson & Johnson, C.R. Bard, Tyco Covidian and AMS.
On July 13, the FDA issued an urgent public notice on the medical devices after receiving thousands of reports about painful complications. The notice updated a public health notification issued on October 20, 2008.
The agency reported it had received over 2,800 reports of complications between January 2008 and December 2010. It said serious complications associated with surgical mesh for transvaginal repair of POP are not rare. It advised healthcare providers that in most cases, POP can be treated successfully without mesh surgery.
Finally, the FDA said mesh surgery should only be chosen after health care providers and patients carefully weigh out the risks and benefits over other options.
In September, the FDA will convene a panel to make recommendations for transvaginal mesh surgery.
Complications from transvaginal mesh surgery include vaginal mesh erosion, infection, bleeding, pain during sexual intercourse, organ perforation, urinary problems, vaginal scarring and neurovascular muscular problems. Remedies include surgery and hospitalization.
Public Citizen issued the petition along with a professor of obstetrics and gynecology at Washington University in St. Louis and a urologic surgeon specializing in female urology and POP at the Mayo Clinic in Rochester, Minn.
The Boston product liability lawyers at Breakstone, White & Gluck are experienced in handling cases involving defective medical devices and dangerous medications. If you have been injured by transvaginal mesh surgery, contact us today for a free legal consultation. We can be reached at 617-723-7676 or use our contact form.