Transvaginal Mesh Failure
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.
Despite U.S. Food and Drug Administration (FDA) warnings about the risk of complications from surgical mesh in the transvaginal repair of POP, many thousands of women continue to have the surgery every year.
FDA Orders Manufacturers to Stop Selling and Distributing TVM Products
In April 2019, the FDA issued an order to TVM manufacturers to stop selling their products effective immediately in the U.S. The FDA reached that decision after determining that two manufacturers of TVM products failed to demonstrate “a reasonable assurance of safety and effectiveness” for their devices. Meeting that criteria became a requirement for TVM manufacturers after the products were reclassified to Class III (high risk) devices in 2016.
Transvaginal Mesh Complications
A 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 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.
Transvaginal Mesh Complications
In 2011, the FDA issued an urgent safety communication advising patients and their healthcare providers to consider alternatives to transvaginal mesh. FDA officials 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.
TVM Reclassified as High-Risk Medical Device
In 2016, the FDA reclassified TVM as a class III device—a classification that generally includes high-risk medical devices. TVM manufacturers were also ordered to submit documentation demonstrating the safety and effectiveness of surgical mesh for transvaginal repair of POP.
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 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.
This law firm is not associated with, sponsored by, or affiliated with the New England Journal of Medicine or the U.S. Food and Drug Administration.