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.
Thousands of women have this surgery every year, unaware of the risks. If you had transvaginal mesh surgery and are now suffering complications, you may be eligible for compensation. Call (920) 486-9726 to begin discussing your options with our Green Bay defective product lawyers.
Transvaginal mesh complications have been under investigation for several years.
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.
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.
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.
Women who have a transvaginal mesh inserted suffer high rates of serious complications, including
Any of these can lead to a reduced quality of life. Furthermore, these problems can result in additional complications, such as the need for a revision surgery, IV therapy, blood transfusions, and the treatment of hematomas or abscesses.
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.
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 our Fox Cities defective product lawyers today to learn how.
Brian Hodgkiss Injury Lawyers works on a contingency fee basis, which means you never pay us a cent unless we get you compensation. Contact us today to schedule your free consultation.
This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration.