Contraceptive coil catching on

A new, incision-free method of permanent contraception for women aims to replace the most frequently used U.S. method of birth control -- tubal ligation, also known as having one's "tubes tied." From Our Advertiser The Essure device, approved in November by the Food and Drug Administration, is a small coil fed through the vagina and cervix into each fallopian tube, where it opens on the uterus. During three months, scar tissue grows over the coil and seals off the tubes, blocking sperm and eggs from meeting. No surgery and no total anesthetic are needed, unlike most tubal ligations performed in the United States. "It was much easier to do than I expected," said Lisa Williams, a Portland resident who had the procedure last month instead of a tubal ligation. "Otherwise, it would be something where I had to go to the operating room and go to sleep, and I didn't want to do that." Access to the device is limited because doctors are just starting to learn the procedure, and not all health insurers cover it. But "tubal occlusion," as it is called, soon could become faster, cheaper and more widely available than tubal ligations, said Dr. Mark Nichols, an Oregon Health & Science University obstetrician and gynecologist. He has implanted Essure in three patients, including Williams. The Essure procedure can be done outside of operating rooms, in doctors offices and women's health clinics -- including Portland-area Planned Parenthood clinics, said Nichols, who also serves as medical director of Planned Parenthood of the Columbia/Willamette. "We here in Portland have been identified as the first site for Planned Parenthood in the country" to offer the Essure procedure, Nichols said. "I'm really excited about . . . being able to do this in a clinic." Tubal ligations are conducted in operating rooms because they involve making small cuts in the stomach and abdomen to reach the fallopian tubes, the small tubes that conduct eggs from the ovaries into the uterus. Despite the surgery and scars, the operation "is the most common method of contraception used in the United States," according to the national Centers for Disease Control and Prevention. More than 10 million U.S. women have their tubes tied, according to the agency, and an additional 700,000 women get the operation each year. That compares with about 400,000 men who get sterilized by vasectomy each year. To perform a tubal ligation, doctors generally use a laparoscope, an illuminated tubelike tool, that lets them make only small incisions, Nichols said. Women getting their tubes tied can generally go home the same day the operation occurs. Tubal ligation surgery tends to be quite successful, too, though roughly one of every 200 women who have the procedure will later get pregnant. But most tubal ligations in Oregon are done under total anesthetic, Nichols said, adding some cost and risk to the operation. Moreover, doctors often use clips or other devices to clamp off the fallopian tubes. Putting any device in the abdomen like that also carries risks, such as nicking the bladder or an intestine, Nichols said. Local anesthetic Tubal occlusion cuts time and cost from the operation by ending the need for an operating room and total anesthetic. Patients just get a local anesthetic to numb the cervix region and, if they want, a mild sedative, what Nichols called "two-martini kind of sedation." The device that gets implanted looks like a simple, metal spring, as thin as a pencil lead and almost two inches long. It actually contains two coils. The outer coil expands to hug the sides of the fallopian tube and holds the device in place at the mouth of the tube. It is made of a nickel-titanium metal similar to those used in the stents that hold blood vessels open, Nichols said. "Dick Cheney's heart vessels are being held open now by something very similar to this," he said. The inner coil is what separates the implant from heart stents and makes it effective birth control. That coil is made of stainless steel, woven through with polyethylene fibers. The body recognizes those fibers as foreign matter and naturally grows scar tissue over them. In about 12 weeks -- during which patients must use other birth control -- the tissue entirely covers the device and closes off the fallopian tube. An X-ray after three months ensures the tube is closed. Implanting both coils takes only about 15 minutes, Nichols said. The entire procedure, from entering the clinic room to going home, takes roughly an hour. Williams said she felt "zero" discomfort during the procedure, adding that she did get a sedative injection in addition to the local anesthetic. "The IV stick was the worst part of the procedure," she said. The procedure didn't limit her activity, Williams said. A health care worker and mother of two, she saw patients just after having the Essure implant and "went to a Chuck E. Cheese birthday party for my kid after that." In use elsewhere The novelty of Essure didn't bother her, Williams said. The device has been FDA approved, she said, and when she read research studies about its use, "it didn't seem like a big risk." The device has been used for several years in Australia, Canada, Singapore and some European countries. The studies submitted to win FDA approval for Essure showed that some women getting the procedure had unpleasant side effects, but few serious ones. Nearly 30 percent of women reported cramping, and nearly 13 percent reported some pain. Researchers followed 632 women for a year after they had the Essure implant, and none became pregnant. The company and Nichols both warned that there is a small chance a woman can get pregnant after this procedure or a tubal ligation. In either case, a pregnancy is a potentially serious health risk that should spur women to see a doctor, Nichols said. Nichols said he thinks the main problem with Essure is that, in two studies, doctors got the devices implanted in both fallopian tubes on the first try 86 percent of the time. Unsuccessful attempts generally meant doctors had to try the procedure again, not any serious harm to the patient. Still, "that's, in my mind, a very real issue," Nichols said. Engineers at Conceptus, the California company that makes Essure, are trying to improve the design to make successful use easier, Nichols said. He expects other companies to develop competing implants, which could generate easier-to-use designs and create competition that lowers Essure's costs. A pair of the implants costs about $900 now, Nichols said. According to Conceptus, the cost for implanting Essure is about $1,500 total, compared with about $2,000 for a tubal ligation. Nichols said several insurers, including the Oregon Health Plan, now pay for the procedure in Oregon. He expects that almost all insurers, except Catholic-affiliated plans, eventually will cover the procedure, as they do tubal ligations. Andy Dworkin: 503-221-8239; andydworkin@news.oregonian.com