Nov. 5, 2002 -- Women will soon have the option of sterilization without surgery. The FDA has approved a device that is implanted into the fallopian tubes without the use of an incision or general anesthesia. It's the first nonsurgical alternative to "getting your tubes tied," or tubal ligation.
The FDA said it expedited its review of the Essure System because of the product's potential benefit to those who want an alternative means of sterilization. Researchers with Essure's manufacturer, Conceptus Inc., say the procedure will cost less to perform than a tubal ligation and the recovery time is much quicker.
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.
Conceptus says the device should be available nationwide by March of 2003 but could be available sooner as doctors are trained in its use.
During the implantation procedure, a doctor uses a special catheter to insert one of the devices into each of a woman's two fallopian tubes. The device works by causing scar tissue to form over the implant, blocking the fallopian tube and preventing fertilization of the egg by the sperm. It is an irreversible procedure.
During the first three months, women cannot rely on the Essure implants and must use alternate contraception. At the three-month point, women must undergo a final X-ray procedure to confirm the device is in the right place.
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. But women with a history of tubal or uterine disease or who have enlarged fallopian tubes may not be good candidates for the procedure.
In the studies, 643 women who were implanted with Essure reported no pregnancies over either one or two years. No serious side effects were reported from either clinical study. Mild side effects include short-term cramps, pain, and nausea.
In the second study, doctors failed to implant the device successfully in 14% of the patients. So the FDA is requiring Conceptus to conduct a post-approval study to document how well the devices are being implanted by newly trained physicians and to identify factors associated with placement failure.
Because women will rely on this device for permanent sterilization for many years after placement, Conceptus also will be required to follow all study participants from both clinical studies for at least five years to evaluate long-term contraceptive effectiveness.
Amy Allina, program and policy director at the National Women's Health Network, testified before an 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."
About 700,000 women in the U.S. undergo tubal ligation each year, which makes it one of the most common methods of contraception. The procedure requires general anesthesia and two incisions in the abdominal area. A four- to six-day recovery period is recommended before the patient can return to normal activities.