$830 million settlement puts new focus on pelvic organ prolapse.
Some women say it feels like they’re sitting on something.
Others develop incontinence. There also are women who can literally see the problem but aren’t sure exactly what to do about it.
It’s called pelvic organ prolapse, a medical condition that happens when the muscles in a woman’s “pelvic floor” weaken due to age or trauma, causing organs such as the bladder, uterus and small bowel to drop into the vagina. Doctors say women are often too embarrassed or uncertain about their symptoms to seek medical help.
But they should. It’s much more common than most women think, a Twin Cities gynecologist said.
“In any given day I probably see one or two patients who could benefit from pelvic floor therapy or some procedure,” said Dr. Kellie Stecher, an OB/GYN physician at Clinic Sofia in Edina and Maple Grove.
One particular procedure has come under fire. In 2010 alone, the FDA said U.S. doctors performed at least 100,000 surgeries using something called vaginal mesh inserts to correct the problem.
Recently, the parent company of a Minnetonka-based manufacturer of the vaginal mesh used in such operations agreed to pay $830 million to settle thousands of lawsuits from patients who said the mesh caused pain and other issues.
Doctors say there are several alternatives to dealing with this pervasive problem. We asked Stecher and another local gynecologist with expertise in diagnosing and treating pelvic organ prolapse for a primer on how best to treat it.
A group of muscles known as the “pelvic floor” forms a hammock across a woman’s pelvic opening — holding in place the bladder, uterus, urethra, vagina, small and large bowel and rectum. Prolapse means sagging or a descent.
“Pelvic organ prolapse occurs when the support of the vagina and/or uterus are lost,” said Dr. Elizabeth Frankman, a urogynecologist at Park Nicollet Women’s Center in St. Louis Park. “Most women become aware of prolapse when tissue comes to or beyond the opening of the vagina.”
The biggest risk factors for prolapse are pregnancy, vaginal births (and the number of births), delivery of large babies, a woman’s age and menopause, Frankman said. Genetics also play a role. “It’s probably a combination of things, not any one thing,” she said. Stecher added: “Over time, or because of different traumas, you can have decreasing strength of those muscles.”
Here’s what you need to know about the condition:
Q How common is pelvic organ prolapse?
A WebMD report estimates about a third of women are affected by prolapse or similar conditions over their lifetime. Stecher said that among patients older than 50, at least half have some sort of prolapse.
Just how many women are affected is difficult to say, Frankman said. “What we do know is about 11 percent of women will undergo surgery for either prolapse or urinary incontinence during their lifetime,” she said. “That’s only the women who have surgery. The number of women out there with this condition is larger than that.”
Q What are the risks with vaginal mesh surgery?
A In some cases the mesh can erode, degrade or become exposed, causing pelvic pain and pain during sexual intercourse. Frankman said some women don’t experience any problems at all. Though not life-threatening, prolapse can greatly hamper a woman’s quality of life. But in some cases, complications from surgery to repair the problem have made it worse.
Q What other treatment options are there?
A “The tide has certainly changed,” Frankman said, since the FDA warned in 2011 that serious problems resulting from vaginal mesh surgeries were not rare. “I no longer use transvaginal mesh myself.”
Other surgical options include using the patient’s own tissue from another part of the body — instead of mesh — to repair the affected area. Another option: using mesh but entering through the abdomen instead of through the vagina. Frankman referred to the abdomiwnal procedure as “the gold standard.” A surgeon can either use “laparoscopic” surgery, or small incisions on the abdomen, or else make a larger abdominal cut to insert the mesh support.
For milder cases, pelvic floor therapy offers women exercises designed to strengthen their pelvic muscles. Another alternative to surgery is a device known as a “pessary.” The little, plastic circle is inserted into the vagina to help hold the pelvic organs in place, Stecher said. “If fitted properly, it can be a great adjunct to keeping the structure where it needs to be,” she said.
Q Why are so many women in the dark about this issue?
A “It’s something that is very embarrassing to a lot of women,” Frankman said. “Often, women feel like these things are just part of what happens when you have a baby.” She added that they may not have even heard of the issue before. She’s seen many patients who did not know that their organs could drop. But once they learn about the condition, Frankman said, they start talking about it with their friends and realize that they’re not alone.
Allie Shah • 612-673-4488