Transvaginal mesh is a procedure used to treat pelvic organ prolapse in women. Pelvic organ prolapse is known to occur after a hysterectomy, childbirth, or menopause. When this condition occurs, the ligaments and muscles supporting the pelvic organs begin to weaken. As a result, the organs prolapse, or slip out of place. A transvaginal mesh is used to support the pelvic muscles and ensure that a woman’s anatomy remains intact.
Transvaginal mesh has benefited patients who suffer from pelvic organ prolapse and hernias. More than 75,000 patients received a transvaginal mesh implant in 2010 alone. However, more than 10 percent of these surgeries resulted in failure. Many patients experienced dangerous and painful side effects such as organ perforation and urinary incontinence. Thousands of patients have filed lawsuits over transvaginal mesh side effects.
What Is Transvaginal Mesh?
A transvaginal mesh implant is made of a fibrous surgical mesh material. For decades, surgical mesh has been used to treat abdominal hernias. Transvaginal mesh is most often used to treat pelvic organ prolapse. Transvaginal mesh can also be used to treat stress urinary incontinence.
In the past, the mesh used for hernias was often made from biological materials such as bovine or human tissue. Today, transvaginal mesh implants are made from a synthetic material called polypropylene. The polypropylene is typically coated with biological materials such as bovine collagen. This coating is meant to reduce the chances of developing side effects .
Transvaginal Mesh Side Effects
Transvaginal mesh patients often experience erosion. Erosion is a dangerous side effect during which the edges of the transvaginal mesh erode the vagina and nearby organs. This condition often causes pain, bleeding, serious infection, and scarring of the vagina.
The FDA reviewed scientific research on transvaginal mesh that was collected between 1996 and 2011. The data revealed that the transvaginal mesh often caused more risks than non-mesh repairs. Additionally, many transvaginal mesh operations did not successfully cure the patient’s pelvic organ prolapse.
Transvaginal Mesh Revision Surgery
Many transvaginal mesh patients sought revision surgery to have the mesh removed due to unexpected complications. Revision surgery can be particularly painful and inconvenient, as internal tissues tend to grow around and in the transvaginal mesh. As a result, transvaginal mesh revision surgery can be expensive and dangerous. The procedure also has a long recovery period coupled with a high risk of infection or further internal damage. In many cases, multiple operations are required in order to fully remove all mesh pieces.
FDA Declines Recall
In September 2011, a review of transvaginal mesh dangers and health risks was conducted. The Obstetrics and Gynecology Devices Advisory Committee of the FDA conducted the review. Evidence showed that the mesh caused serious health problems and failed to significantly improve pelvic organ prolapse.
Despite this evidence, the committee did not remove the device from the market. Instead, the committee called for extensive testing of new transvaginal mesh devices. The FDA now requires manufacturers to conduct three-year studies on each of their mesh products. Additionally, the committee supported the reclassification of transvaginal mesh to Class II. Class III is used to classify the highest-risk medical devices.
Transvaginal Mesh Lawsuits
Thousands of women have filed lawsuits to receive financial compensation for the side effects of their transvaginal mesh implants. Plaintiffs allege that the various transvaginal mesh models share similar defective designs and thus carry similar risks. The lawsuits that were filed in federal court have been consolidated into a multidistrict litigation (MDL) which is overseen in West Virginia’s U.S. District Court.
Five companies are involved in transvaginal mesh lawsuits:
- Boston Scientific Corp.
- American Medical Systems
- C.R. Bard
- Johnson & Johnson’s Ethicon