"Vaginal Mesh Surgery Poses Greater Risks than Benefits", Warns FDA

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- Brunei FM!

01/04/2012 - Adult women all over the world are familiar with vaginal mesh implantation for the repair of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). Originally, it was considered as the best treatment for these conditions. But recently, vaginal mesh lawsuits have multiplied all over the United States after complaints of deadly complications brought by the implantation of vaginal mesh started to appear and increase at a fast pace.

In 2010, there were over 100,000 procedures involving surgical mesh, and75 percent of these were implanted vaginally.

On October 20, 2008 the U.S. Food and Drug Administration (FDA) first issued safety information on vaginal mesh because of the many adverse effects related to it. 1500 cases of adverse events caused by vaginal mesh were reported to the FDA in a span of two years from 2008 to 2010, five times greater than in 2005 to 2007.

The mostly reported complications related to vaginal mesh surgery include mesh erosion, development of infections, bleeding, recurrence of prolapse, pelvic organ perforation, and voiding difficulties. Out of these, the most common is mesh erosion, and has the tendency to prompt the development of other complications. A study on October 2010 was discontinued since 15 percent of its participants developed mesh erosions during the study. Moreover, mesh erosion is the most difficult to deal with since it requires multiple operations to repair; and most often, mesh erosions are impossible to correct.

According to the FDA, vaginal mesh procedures expose patients to deadly complications. In comparison to other non-mesh procedures, the benefits of vaginal mesh are not well-defined. The agency also asks gynecologists and urologists to consider non-mesh procedures to treat POP and SUI patients, and only administering vaginal mesh procedures to patients who will gain more benefit from it than complications.
The FDA further proposed that special training on vaginal mesh placement should be completed by surgeons, symptoms on possible complications during and after the procedure should be watched carefully, and patients should be well-informed on the potential risks of this procedure.

The number of vaginal-mesh-related complications continue to grow despite the fact that vaginal mesh FDA warning was first announced in 2008. This may be related to the continuous availability of these products in health care facilities; as there are still many manufacturers producing them making more and more physicians use their products and continue practicing vaginal mesh surgeries in hospitals or their own clinics. While it is the doctors’ responsibility to keep their patients safe, it is also important for the patients to make themselves aware about the safety and efficacy of the use of vaginal mesh.

If you or a loved one have suffered or been injured from a defective transvaginal mesh sling you may be entitled to compensation. Contact the vaginal mesh sling attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding your transvaginal mesh sling injury a possible class action lawsuit, or any other type of vaginal mesh litigation. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form at ennislaw.com.

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::

 

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