ShareThisBy JANET MOORE
Minneapolis-St. Paul Star Tribune
Tuesday, May 15, 2007
Sara doesn't want her last name revealed, or where exactly she lives. She is too embarrassed to discuss her condition _ severe menstrual bleeding.
She could barely leave the house. The last straw was a family July Fourth vacation up north when she couldn't swim in the lake.
Earlier this year, she opted for a treatment offered by American Medical Systems that freezes the lining of the uterus. The 20-minute procedure, performed in her gynecologist's office, worked. "I'm delighted," she says.
About 18 million women in the United States suffer from excessive menstrual bleeding, a condition called menorrhagia usually caused by hormonal imbalance or uterine fibroids. Treatments range from birth-control pills to a hysterectomy, in which a woman's uterus is removed.
American Medical Systems' treatment, HerOption cryoablation therapy, uses subzero temperatures delivered by a probe to the inner lining of the uterus, which is responsible for excessive bleeding.
Other devices that target the uterus wall exist, but the company says HerOption is the only one approved by the Food and Drug Administration (FDA) for use in a doctor's office instead of an operating room.
The average cost of HerOption is $2,600, and the procedure is covered by Medicare and most private insurers. Company executives say the market could reach $50 million to $100 million in the next three to five years.
"We've been steadily adding more and more sales people who are working with physicians" to spread the word, said Martin Emerson, president and CEO of Minnetonka, Minn.-based American Medical Systems.
It has taken the company about five years to fully roll out the product, as it wrangled to secure insurance coverage. Now the challenge is to win over physicians, who already have a number of viable options to treat menorrhagia by endometrial ablation, the destruction of the uterus wall.
Since 1997, the FDA has approved five such devices, some of which use heat, radio frequency, balloons filled with saline and microwave energy to treat the condition. All have high levels of success and patient satisfaction, according to a 2005 article in the medical journal OBG Management.
The Mayo Clinic, for example, uses a device powered by ultrasound technology that heats the wall of the uterus, said Dr. Andrew Good, a consultant in the division of gynecology. He's pleased with the results and sees little reason to switch therapies.
"It really depends on physician preference," he said. "They're all pretty much the same as far as effectiveness goes."
Which explains why American Medical Systems is selling HerOption almost exclusively to gynecologists who can use the device in the office. The procedure requires only a local anesthetic in most cases, and patients often drive themselves home afterward.
Common side effects include mild cramping and a watery discharge after the procedure. Women who want to have children should not consider the treatment because the procedure destroys the endometrial lining, which must be intact during a normal pregnancy.
"You're not going to the hospital for a day of surgery," said Dr. James Presthus, an Edina, Minn.-based gynecologist. "There are no incisions or hormones. There's a patient satisfaction rate (with HerOption) of 94 percent."
An office-based procedure is also cheaper than one in a hospital, said Good. "If you go into the OR, you're paying for all the safeguards a neurosurgeon, or cardiac surgeon, may need _ even though you don't need them with these procedures," he said.
"Patients probably don't care where they go (for a procedure), as long as people are competent," Good added. "Obviously, if you have something where you can walk in, where you're not put to sleep, but sedated, and then able to walk out, that's really nice."
(Contact Janet Moore at jmmoore@startribune.com.)
(Distributed by Scripps Howard News Service, www.scrippsnews.com.)
