The Essure device is a new, permanent birth control method that does not require an incision or general anesthesia.
WebMD Health News
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
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
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
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
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
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
"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.