Removal of Faulty Mesh for Incontinence
Experts say there's still no clear-cut answer as to whether or not to have surgery
By Amy Norton
MONDAY, May 19, 2014 (HealthDay News) -- Removal of vaginal mesh -- a device implanted to help support a woman's pelvic organs -- won't necessarily improve side effects such as pain and incontinence related to the device, suggests the mixed results from a pair of new studies.
The findings, reported Monday at the American Urological Association's annual meeting, come at a time of growing safety concerns over vaginal mesh devices. Last month, the U.S. Food and Drug Administration (FDA) said it will require stricter oversight of the products -- specifically, as they are used to treat pelvic organ prolapse. The FDA now classifies these devices as "high-risk."
In pelvic organ prolapse, the structures supporting the bladder, uterus and rectum weaken and stretch. The organs may drop from their normal position and protrude into the vagina, which can cause pelvic pain, discomfort during sex, and problems with urination and defecation.
Some women with pelvic organ prolapse eventually need surgery to reposition and secure the pelvic organs. In the 1990s, doctors started using vaginal mesh implants to give extra support to the organs after surgery.
But over time, the FDA began receiving reports of problems linked to the devices. There were cases where the mesh eroded, and women suffered infections, bleeding or pain; some women developed new or worsening urinary problems or pain during sex.
It's not always clear, though, that a woman's symptoms are caused by the device, or that surgically removing it will help.
"In the worst-case scenario, you have a recurrence of the [pelvic organ prolapse symptoms] and the patient still has the pain" attributed to the device, said Dr. Philippe Zimmern, a urologist at the University of Texas Southwestern Medical Center in Dallas, who worked on one of the new studies.
That study followed 123 women who had surgery to remove either a mesh device or another synthetic device called suburethral tape.
And the news from this study was good. Most of the women -- including 67 percent of those with the mesh device -- became pain-free after surgery. And on average, patients' pain ratings were much lower two to three years after surgery versus before the surgery.
A big caveat, however, is that pain had been the sole issue for all of the women before surgery.
The second study, by researchers at the University of California, Los Angeles, had less-positive results. It surveyed 214 women about three years after they'd had their mesh implants removed; these patients had opted for surgery due to a range of symptoms, not only pain.
Post-surgery, many women continued to have problems, the study found. Although two-thirds of the women said they had no pain or only mild symptoms, the rest had moderate to severe pain. Twenty-eight percent said they had urine leakage at least once a day, and half had pain during sex, according to the study.