Transvaginal Mesh: Is the Jury Still Out?

October 25, 2014, 8:00AM. By Jane Mundy

Washington, DCAlthough more than 50,000 transvaginal mesh claims have been filed against several mesh manufacturers, recent research indicates that vaginal mesh to treat urinary incontinence and pelvic organ prolapse is considered safe.

Researchers from Cedars-Sinai Medical Center said in BMJ (2014; 349():1-11) that “Despite controversy surrounding vaginal mesh for prolapse, synthetic slings for the treatment of stress urinary incontinence are considered safe and minimally invasive.” And in May of 2014, findings from the American Urological Association’s annual meeting concluded that it is unclear whether a woman’s symptoms, i.e., pelvic pain, discomfort during sex, and problems with urination and defecation, are caused by the device, or that surgically removing the mesh will help.

One study presented at the meeting showed that 67 percent of the women were pain-free after the transvaginal mesh was removed. In the second study, which followed implant removal, about one-third of the women reported moderate to severe pain and urine leakage at least once a day, while half the women reported pain during sex.

Women's Health Weekly reported that Georgetown University Hospital researchers were seeing a rise in synthetic vaginal mesh removal, however. The researchers concluded: “Reconstructive pelvic surgeons advising patients with TVM complications should report that surgical intervention is often necessary, improvement rates of pain-related symptoms after surgery are high, and up to a third may require multiple interventions.”

NICE (the National Institute for Health and Care Excellence) reported that mesh erosion occurred in 11 percent of women treated for uterine prolapse repair. Fourteen percent of women treated for the same condition combined with hysterectomy reported mesh erosion. The time it took for the mesh to erode was not reported.

If the rate of mesh removal surgery is high, why risk having synthetic mesh implanted in the first place?

Lastly, Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, reported the following in 2011:

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.” At that time, the FDA was “asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.”

At that time, Maisel said that transvaginal mesh “is a permanent implant - complete removal may not be possible and may not result in complete resolution of complications.”

Linda can verify Dr. Maisel’s statement: complete mesh removal may not be possible. She has been in constant pain for more than 10 years and has undergone two surgeries in an attempt to remove the transvaginal mesh.

“It took me two years to even find a surgeon who could remove this mesh because it was way beyond my doctor’s scope,” Linda says. She is furious with her doctor for not warning her of mesh complications, but at the same time, she thinks he was also sold a bill of goods by the mesh makers. “My doctor definitely feels my pain but he should have done a helluva lot more research before recommending that I have this procedure. My current surgeon told me that he could remove the mesh but that didn’t happen. Now I am scheduled for another surgery next month and my incontinence problem is worse than ever.”

And to make matters even worse, Linda says she’s addicted to painkillers and her husband is miserable because they can’t have “normal” sex. “I’ve been told that the transvaginal mesh lawsuits should reach settlements soon, but the jury is still out on how much more pain and suffering I have to endure,” she says. “What if this mesh never comes out?”

(To find out more about synthetic mesh, read the FDA recommendations.)