As anticipated, last week the Food and Drug Administration (FDA) issued an order requiring more studies on the risks of transvaginal mesh by manufacturers. Transvaginal mesh – also referred to as vaginal mesh and pelvic mesh – has come under fire after years of reports linking serious injuries to the devices. In September, an F.D.A. advisory panel recommended that such studies be required.
Transvaginal mesh is a medical device primarily used to treat pelvic organ prolapse and stress urinary incontinence. Over the years, significant problems have been reported to the FDA including:
• Vaginal mesh hardening
• Vaginal pain
• Vaginal mesh erosion, protrusion and extrusion through the vagina
• Organ injury
• Pain during intercourse
If you or a loved one has had surgery utilizing the transvaginal mesh and experienced injuries, it’s important to speak with an experienced New Mexico products liability attorney who is familiar with vaginal mesh complications.
The FDA first reported problems with the mesh in 2008, but stated that such problems were rare. However, in the time span from 2008 to 2010, the increase in adverse events related to the mesh increased 10-fold, leading to the most recent warnings. According to reports, in 2010 about 185,000 women underwent treatments using the medical device and about 15% of those women treated with vaginal mesh experienced complications. A study published in the journal Obstetrics and Gynecology also determined that the mesh did not provide any greater benefits than the traditional method using a patient’s own ligaments.
The recent order to manufacturers is similar to the one issued in May to manufacturers of the defective DePuy Hip to conduct post-market studies of the risks associated with
these dangerous medical devices.
For more information about any defective medical device or if you or a loved one has been injured from surgery utilizing transvaginal mesh, contact the dedicated
Albuquerque personal injury attorneys at the Branch Law Firm for a confidential consultation.