New Permanent Birth Control Option
Quick, Nonsurgical Technique Awaits FDA Approval
July 26, 2002 -- Women who want a permanent form of birth control without surgery may soon have a new option. An FDA advisory panel has recommended that the agency approve a new device that provides the first alternative to tubal ligation.
Although the FDA is not required to follow the advice of the advisory committee in deciding whether to grant final approval, it usually does. The device, called Essure, uses a tiny insert to create a blockage in the fallopian tube, which prevents a woman's eggs from reaching the uterus and becoming fertilized.
Researchers say that because the Essure procedure doesn't require an incision or general anesthesia, it will cost less to perform. The recovery time is also much quicker than with tubal ligation.
About 700,000 women in the U.S. undergo tubal ligation each year (also known as "having the tubes tied"), which makes it one of the most common methods of contraception. The procedure requires general anesthesia and two incisions in the abdominal area. Afterward, a four- to six-day recovery period is recommended before the patient can return to normal activities.
With Essure, a small catheter is used to place the device in the fallopian tubes though the cervix. The procedure takes about 10-20 minutes and can be performed in a doctor's office using local anesthesia. Most patients can return home in about 45 minutes after the procedure is completed.
David Levine, MD, who participated in the clinical trials of Essure, says the device gives women a much-needed, noninvasive option for permanent birth control.
"We've been waiting for an alternative to tubal ligation," says Levine, who is director of the woman's diagnostic center at St. Luke's Hospital in St. Louis. "There are many patients that do want tubal ligation [but don't get it] because they don't want to go under general anesthesia, and this is a great option for them"
Levine says many of his patients who underwent the procedure during the clinical trials did not require sedation and were able to go out to lunch afterward. Side effects associated with the treatment were considered mild and included cramps, pain, and nausea.
Since insertion of Essure can be performed in doctor's office or on an outpatient basis, he expects the cost will be significantly less than tubal ligation. The device itself consists of a tiny spring that surrounds a Dacron thread, which stimulates the formation of scar tissue within the fallopian tube to create a blockage.
Levine says women with a history of tubal or uterine disease or who have enlarged fallopian tube may not be good candidates for the procedure. In clinical trials, about 10% of women were unable to have the device successfully inserted.
Although Essure may offer some advantages over tubal ligation, experts say it's important to remember that Essure is also a non-reversible form of birth control.
"Doctors have to counsel patients for Essure in the same way as with tubal ligation" says Levine. "This is a permanent procedure, and don't expect it to be reversible."
Amy Allina, program and policy director at the National Women's Health Network, testified before the FDA advisory panel on Essure. She says the device does have the potential to expand contraceptive choice and advance women's health, but there are some concerns about its long-term safety and effectiveness.
"It has not been tested in many women and not for a great extent of time," says Allina. "It's important to convey the limits of what we know about it."