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
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
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
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
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.
The study, however, had its own limits. The researchers sent
surveys to nearly 700 women who'd had surgery at their center, but
only one-third responded. It's possible that women who'd continued
to have problems were more likely to respond.
So what should women do? Zimmern said that despite the good
results in his study, women should not rush into surgery.
"We can only say that in this subset of patients, the outcomes were better than we expected," Zimmern said.
It can't be assumed that the results would extend to women more
generally. For one, Zimmern explained, pain was the only reason for
device removal, and it's not clear that the outcomes would be the
same for women who had pain and other symptoms.
Plus, Zimmern said, the study included no patients who'd gone
with nonsurgical options -- like physical therapy for the pelvic
floor muscles, or "trigger point" injections with medications that
ease pain and inflammation.
"This study might have included a select group of women," Zimmern said.
The issue is complicated, agreed Dr. Tomas Griebling, a
professor of urology at the University of Kansas Medical Center in
"I think most [doctors] would advise patients with no adverse signs or symptoms that they do not need to undergo surgical removal of mesh implants," said Griebling, who was scheduled to moderate a discussion of the studies at the meeting.
But when it comes to women who are having symptoms, the decision
about what to do is not clear-cut.
Zimmern suggested that the safest course is to try nonsurgical
options first. When women do opt for surgery, they need to realize
that some symptoms might improve while others might get worse,
If you had incontinence before the mesh was implanted, then
developed pain because of mesh erosion, removing it might ease your
pain. "But you might experience worse incontinence," Griebling
He and Zimmern both suggested that women read the FDA
recommendations on the devices, available on the agency's
The implants are still in use, and the recent FDA action applies
only to vaginal mesh used for pelvic organ prolapse -- and not the
other uses for mesh implants. They are often used to treat stress
incontinence and as part of abdominal surgery for pelvic organ
prolapse, for example.
Because these studies were presented at a meeting, findings
should be viewed as preliminary until they've been published in a
The FDA has more information on
mesh implants and pelvic organ prolapse.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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