Transvaginal Mesh

Transvaginal Mesh is a mesh support implant used for treatment of Pelvic Floor Repair, Stress Urinary Incontinence ("SUI"), and a common type of Pelvic Organ Prolapse ("POP"), which occurs when pelvic organs fall out of place. In order to treat these conditions, transvaginal mesh is surgically attached to or implanted in the vaginal wall. However, the transvaginal mesh exposes women to an increased risk of serious and life-threatening complications. Several manufacturers of vaginal mesh received clearance from the U.S. Food and Drug Administration ("FDA") between 1996 and 2008. Approval was based on their prior history of use in other parts of the body (e.g. to repair hernias). However, the vaginal mesh products were never tested for safety for use in transvaginal procedures. As early as 1999, complications stemming from the vaginal mesh implants were reported. That year, Boston Scientific voluntarily issued a transvaginal mesh recall of 20,000 implants. Notwithstanding the recall, the FDA continued to approve vaginal mesh implants that were substantially similar to the recalled implants.

In October 2008, the FDA issued a health alert cautioning doctors about the risks associated with transvaginal mesh. At that time, the FDA stated that vaginal mesh complications were "rare." However, the FDA advisory was followed by a rise in transvaginal mesh lawsuits stemming from the health problems caused by vaginal mesh. In July 2011, the Food and Drug Administration issued a public notice to doctors and Transvaginal Mesh (TVM) patients after 2,875 injuries were reported between 2008 and 2010. The FDA specified that these complications are not limited to a single brand of vaginal mesh. In September 2011, an advisory panel recommended that transvaginal mesh be reclassified as high risk so that manufacturers would be forced to undergo rigorous testing in order to receive FDA approval. As part of its ongoing safety review, in January 2012, the FDA reached out to 35 vaginal mesh manufacturers and requested data on the safety and effectiveness of vaginal mesh implants. The FDA also mandated that manufacturers conduct safety studies on transvaginal surgical mesh implants. Given these developments, there is a growing consensus that a transvaginal mesh recall should be issued.

The reported complications include transvaginal mesh devices from nine different manufacturers.

Transvaginal Mesh has been linked to many side effects and complications such as:

· Erosion through the vaginal epithelium

· Infection

· Pain

· Painful sexual intercourse

· Urinary problems

· Bowel, bladder, or blood-vessel perforations

· Recurrence of POP and SUI

Some patients have also reported recurrences of the prolapse and the need for more surgeries to attempt to remove surgical mesh that had eroded into the vagina.

The dangerous side effects surfaced two years ago when a clinical trial was stopped early after 15% of the women implanted with the mesh suffered vaginal mesh erosion within a period of only three months.

If you or a loved one experienced complications as a result of being implanted with transvaginal mesh, you may be able to file a vaginal mesh lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more.

Contact us today to find out how we can help with your transvaginal mesh issues.

Research more information about Transvaginal Mesh at Wikipedia.