The pain began almost immediately after Cheryl Sorrels had pelvic surgery to correct a bulging
three years ago. There was also a lot more
than she expected.
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
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
, menopause or a
, 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,
, 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
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
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
"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
, 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.
That was an issue for Ann, an Illinois woman whose OB-GYN kept dismissing her symptoms — intense pain, bleeding — after Ann underwent surgery in 2009 to deal with a bulging bladder. "One time she told me I wasn't a spring chicken and that was why I wasn't healing," said Ann, 63, who asked to be identified with her middle name only. "I couldn't convince her anything was wrong."
Last year, it took a specialist less than two hours to diagnose what the OB-GYN had failed to pick up on in 16 months and two follow-up surgeries, Ann said: Mesh had bunched up along her bowel and broken through her vaginal wall.
Beverly Pennington, 63, who lives just outside Atlanta, also turned to multiple doctors to fix complications that followed a March 2009 vaginal mesh surgery to shore up her bladder and rectum.
Three months after that surgery, Pennington had to undergo another procedure to treat an abscess at the surgical site. Over the next two years, she had three more surgeries to remove mesh that had protruded painfully into her bladder and rectum, including one at UCLA Medical Center last week.
"To be quite honest, I think it's taken 10 years off my life," said Pennington, a wedding planner who said she's suffered complications including profound exhaustion, emotional anguish and pain during sex. She is suing the company that made the mesh, C.R. Bard Inc., in U.S. District Court in the Northern District of Georgia.
In an interview, Dr. William Maisel, chief scientist of the FDA's Center for Devices and Radiological Health, said the FDA's warning applies broadly to mesh used in vaginal pelvic organ prolapse surgeries, not any single type manufactured by a single company. Bard did not respond to a request for comment.
In addition to the risk of complications, Maisel said "there is not proof that using mesh for transvaginal repair of pelvic organ prolapse actually improves clinical outcomes" compared with other surgical options.
Asked for comment, the largest manufacturer of "mesh kits" used in vaginal prolapse surgeries, Ethicon Inc., issued a statement saying: "Numerous clinical studies suggest that when combined with proper surgical technique, the use of mesh kits is efficacious and has an acceptable post-operative complication rate." Ethicon is a wholly owned subsidiary of Johnson & Johnson.
Mesh products first came on the market in the 1950s for use in
repairs. Though the FDA didn't approve the material for use in prolapse surgeries until 2002, physicians began using it "off label" for abdominal procedures in the 1970s and for vaginal procedures in the mid-'90s.
The FDA considers surgical mesh to be a "Class II" medical device, posing an intermediate risk of harm to patients. With mesh products already in widespread use, the agency granted approval for their use in prolapse procedures without requiring new studies demonstrating their safety or effectiveness. Under the agency's controversial 510(k) approval process, that's permitted if devices are believed to be "substantially equivalent" to those already on the market.
Maisel said the agency is considering several regulatory options related to mesh, including reassigning products used in vaginal prolapse surgeries to Class III, the most tightly regulated type of device. Should that occur, companies would have to provide much more data about the products' effectiveness both before and after they come out on the market. An FDA advisory panel is scheduled to consider the evidence and make recommendations in September.
Women harmed after vaginal mesh prolapse surgeries say they plan to turn out at the FDA's public forum in force to have their voices heard. Pennington, still recovering from surgery, puts her message this way: "These products have done a lot of damage, and something has to be done about that."