BY: Robert B. Sickels | IN: Class Action & Commercial Litigation, Personal Injury
Has your vaginal mesh device failed you? Call us
On January 4th, 2012 the FDA issued an order requiring manufacturers of implantable surgical mesh – used to treat urinary incontinence in women – to research the risks associated with their products. The agency’s action appears to have been prompted from years of complaints of infections, pain, complications, and other injuries. Details of the FDA’s order were reported in the New York Times and elsewhere.
Female urinary incontinence is usually the result of a weakening of the muscles around the bladder and other support organs. Pelvic organ prolapse, one condition of this type, can be treated by surgically implanting a vaginal mesh device. Although the FDA issued a warning in 2008 regarding complications related to the device, it indicated that the occurrence was rare. Over the next two years, however, reports of those complications increased by 500%, and the agency issued an update in July 2011.
It is important to note that surgical mesh, like all-metal artificial hips, are part of a class of implants that manufacturers are not required to study in patients before or even after the products are put on the market. That means that none of the 185,000 or so women in whom vaginal mesh was implanted in 2010 had the benefit of clinical studies or research prior to their procedures.
In 2010, about 185,000 women underwent procedures in which mesh was implanted vaginally to treat urinary incontinence, and roughly 15% of them experienced related problems, according to research published in the journal Obstetrics & Gynecology. The study also advised that the mesh had no greater benefit than using the patient’s own ligaments to reinforce the vaginal wall, the traditional procedure for treating the condition.
The FDA anticipates that manufacturers, including Boston Scientific, CR Bard, Ethicon, and WL Gore & Associates, will track patients for a three-year period to gauge both the quantity and severity of any complications.
We at Sommers Schwartz are currently evaluating cases of vaginal mesh failures. If your vaginal mesh has failed you, give us a call and learn what we can do for you.
View all posts byRobert B. Sickels
For more than 30 years, Robert Sickels has successfully represented plaintiffs involved in complex personal injury, medical negligence, and products liability matters.