Mesh used in pelvic surgeries under scrutiny
10% of women have problems with mesh protrusion; FDA warns of risks
Surgical technician Zully Ysatuirre prepares the mesh material for Dr. Gregory Bales to perform a pelvic organ prolapse repair Wednesday, July 20, at University of Chicago Medical Center. (Brian Cassella/Chicago Tribune)
Sorrels chalked that up to a difficult recovery. It wasn't until the 58-year-old began a new relationship that she realized she had a bigger problem: When she and her partner were intimate, a piece of thin, porous material stuck in her vagina made them both very uncomfortable.
No one had told her that mesh used in her pelvic surgery could break through or scar that part of her body. "I'd never heard of that happening," said Sorrels, of Munster, Ind.
The U.S. Food and Drug Administration recently highlighted the problem in a new advisory about vaginal surgeries that use mesh to repair pelvic organ prolapse, warning that the procedures are no more effective than other options while complications are common.
As many as half of all women experience some type of pelvic prolapse — a condition in which the bladder or other organs begin slipping out of place — after childbirth, menopause or a hysterectomy, or with age. Symptoms are mild most of the time but can entail significant pain or discomfort. Yet scientific studies are scarce and little is known about which prolapse treatments are most effective for which patients.
Of special concern are procedures that involve inserting mesh through the vagina to help hold up a woman's sagging bladder, bowel, uterus, intestines or rectum. Some experts are concerned that physicians are performing these surgeries without sufficient training. Others worry that patients without serious symptoms may be getting the procedures unnecessarily. Meanwhile, the FDA hasn't required companies selling mesh products to prove they're safe or effective when used in the pelvis, even though the potential harm can be substantial.
U.S. physicians perform about 75,000 such surgeries each year, and complications can include pain during intercourse, infection, bleeding, perforations of the bowel or bladder and, most frequently, erosions — the protrusion of a piece of mesh through the vaginal wall.
The FDA's new review says erosions occur in about 10 percent of women undergoing vaginal prolapse repairs using mesh. Sometimes the piece of the material involved can easily be removed. But sometimes tissue has grown in and around the mesh and multiple medical interventions are required, the FDA noted.
Because of the risks, some physicians won't perform the procedures.
"We think there are other, better alternatives," said Dr. Kimberly Kenton, director of the female pelvic medicine fellowship program at Loyola University Medical Center in Maywood.
"We don't do them. No one at the Mayo Clinic feels there is added benefit," said Dr. Daniel Elliott, an assistant professor of urology at the clinic in Rochester, Minn.
Alternatives include vaginal repairs that don't involve mesh and repairing prolapse through an abdominal incision, with or without mesh. The FDA warning doesn't apply to these alternatives.
Some physicians are advocates of vaginal mesh surgeries.
The procedures are generally quicker, call for less anesthesia and involve less recovery time than abdominal surgery.
They're an important option for women who have had previous abdominal surgeries or recurrence of prolapse and for older women who may react poorly to anesthesia, said Dr. Gregory Bales, an expert in female urology and reconstructive surgery at the University of Chicago Medical Center.
"Ninety percent of patients end up with successful outcomes and without significant complications," he said.
The real issue here is the surgeon's skill, said Dr. Vincent Lucente, a urogynecologist at the Institute of Female Pelvic Medicine & Reconstructive Surgery in Allentown, Pa., who consults widely for industry. Many urologists and gynecologists haven't received much training in these procedures, don't perform many of them and don't have good outcomes, he said.
"You have surgeons entering into this arena almost as novices," said Dr. Mickey Karram, a urogynecologist and pelvic surgeon at The Christ Hospital in Cincinnati, and also an industry consultant. Karram added that too many patients with mild prolapse that doesn't need surgical intervention are getting repairs by doctors eager to operate — a concern voiced by other physicians.
Still another problem is physicians not knowing how to correct complications when they occur.