Arkansas Defective Medical Device Lawyer

Defective Product: Transvaginal Mesh

Many women who suffer pelvic organ prolapse (POP) or stress urinary incontinence (SUI), medical conditions that occur when the internal support structure of the vagina fails, undergo a surgical procedure in which a transvaginal mesh (TVM) is inserted to help hold the woman's internal organs in place. Rather than simply stitching tissue of the vaginal wall together, the transvaginal mesh is used to keep the organs—namely the urethra, cervix, and rectum—from falling out of place and "sagging" inside the body cavity.

In 2010, more than 75,000 women had transvaginal mesh surgery to repair pelvic organ prolapse.

Transvaginal Mesh Complications

A recent study regarding vaginal meshes published in the New England Journal of Medicine revealed troubling results with these procedures: women who had a transvaginal mesh inserted suffered higher rates of serious complications, including bladder perforation and pelvic hemorrhage and an increased number of adverse events after the surgery, such as urinary incontinence and pain during intercourse.

The U.S. Food and Drug Administration (FDA) warns, "The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain."

Furthermore, these problems can result in additional complications, such as the need for a second, "revision surgery," IV therapy, blood transfusions, and the treatment of hematomas or abscesses.

Update: The FDA issued an urgent safety communication advising patients and their healthcare providers to consider alternatives to transvaginal mesh. The FDA met to discuss a potential ban on the mesh, after receiving more than 3,875 injury reports associated with the mesh, three of which involved fatalities, from 2005 to 2010.

Is pelvic organ prolapse common?

Some estimates suggest that nearly half of all women between the ages of 50 and 79 have some degree of prolapse. The risk that a woman will need a surgical procedure to correct prolapse is about 11%, and about 33% of these women will need a second surgery to correct problems stemming from the condition or initial surgery.

What causes this condition?

Pelvic organ prolapse is a result of predisposition, race, and injury. Caucasian women are more likely to suffer the condition than African American women, and injury, childbirth, heavy lifting, and even smoking are also contributing factors.

What should I do if I had a problem with a transvaginal mesh?

If you or someone you care about has a transvaginal mesh used to correct pelvic organ prolapse and suffered any of the above symptoms, our law firm may be able to help. Contact us today to learn how.

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