Transvaginal Mesh May Increase Exposure to Significant Risks

In a recent safety communication, the U.S. Food and Drug Administration (FDA) proceeded to warn the healthcare community that surgical placement of mesh through the vagina to repair pelvic organ prolapse (POP) may coincide with catastrophic and unnecessary side effects.

On July 13, 2011, an official FDA News Release acknowledged the risks associated with the use of transvaginal mesh in the treatment of pelvic organ prolapse. More specifically, the warning suggested that the use of such a method may expose patients to greater risks than many alternative surgical procedures. Accordingly, the safety communication also states that while the procedure may increase the exposure to significant risks, there is no substantial evidence of clinical benefit. Due to the severity of these risks, women may seek compensation for their pain and suffering by filing a transvaginal mesh lawsuit.

Pelvic Organ Prolapse may occur when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. Though it is not life-threatening, women who develop POP may experience chronic pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and a significant reduction in their quality of life.

While surgery to fix POP may be preformed via the abdomen or vagina, roughly 75 percent of women choose the transvaginal approach. In 2010, there were at least 100,000 POP repairs that used surgical mesh methods. About 75,000 of these were transvaginal procedures.

Unfortunately, William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health has acknowledged that “there are clear risks associated with the transvaginal placement of mesh to treat POP.” Proof resides in the number of adverse events that have been reported in recent years. From 2008 to 2010, the FDA received 1503 reports of adverse events associated with mesh used in the treatment of POP, five times the original number that the agency received from 2005 to 2007.

Statistics indicate that one of the most frequently reported complications of a transvaginal mesh surgery is mesh becoming exposed or protruding out of the vaginal tissue (erosion). As a result, patients may experience pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. In severe circumstances, patients required additional revision surgeries or prolonged hospitalization. Due to the severity of these complications, women may seek compensation for their pain and suffering by filing a transvaginal mesh lawsuit.

Due to the severity of the previously mentioned side effects, the FDA is imploring healthcare providers to carefully consider all other treatment options and to make sure that their patients are fully informed of any potential complication that may come from a surgical mesh procedure. Due to the severity of these complications, women may seek compensation for their pain and suffering by filing a transvaginal mesh lawsuit.

Do I Have a Transvaginal Mesh Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in transvaginal mesh lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by a transvaginal mesh, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.