Transvaginal Mesh Devices
The transvaginal mesh is a type of medical device used to treat Pelvic Organ Prolapse and Stress Urinary Incontinence, conditions that may occur after childbirth and pregnancy. The vaginal mesh products are manufactured by several companies, including Ethicon/Gynecare/Johnson & Johnson, C.R.Bard, Inc., Boston Scientific Corporation, American Medical Systems, and Caldera Medical.
Bard Avaulta Mesh vaginal sling product is marketed as the Avaulta Anterior and
Posterior Biosynthetic Support System.
Since 2005, more than 1,000 patients have suffered from serious complications following the placement of a transvaginal mesh device. Recipients of transvaginal mesh/sling products may suffer from complications, including:
- erosion of vaginal tissue
- perforations of the bowel, bladder or blood vessels
- mesh erosion
- recurrence of Pelvic Organ Prolapse and Stress Urinary Incontinence
- urinary problems
- vaginal scarring
On October 20, 2008, the FDA issued a public health notification alerting healthcare providers and the public about the increasing number of serious health issues associated with the transvaginal mesh. Complications reported arose from mesh products from nine different manufacturers.
In an article published in an August 2010 issue of the journal Obstetrics & Gynecology, researchers reported that scientists had to stop a transvaginal mesh clinical trial early because women implanted with the mesh experienced too many complications. In the trial, which began in 2007, 65 women with prolapse underwent either surgery using the vaginal mesh or a procedure known as colpopexy that uses ligaments to help support the muscles. The trial was cut short in 2009 after researchers found that over 15 percent of women implanted with the mesh, within a period of only three months, suffered from erosion, a potentially serious complication involving the protrusion of the mesh when the skin splits.
A 2011 study on released by the Journal of Obstetrics and Gynecology Canada procedures stated, “Until adequate effectiveness and safety evidence is available, the use of new [transvaginal mesh] devices for prolapse repair should be considered experimental and restricted to use in investigative trials.”
If you or someone you love has suffered complications after taking implant of a transvaginal mesh device, you should contact the Plymale Law Firm for a free consultation by filling out the form on this page or by calling us at (877) 328-7670.