New female sterilization device

FDA Consumer, Jan-Feb, 2003

The FDA has approved a small metallic implant to be placed into the fallopian tubes of women who wish to be permanently sterilized. Unlike other currently available surgical sterilization procedures for women, placement of the device does not require an incision or general anesthesia.

The product, approved in November 2002, is the Essure System manufactured by Conceptus Inc., of San Carlos, Calif. The FDA speeded review of the product because of its potential benefit to women seeking an alternative means of sterilization.

During the implantation procedure, the physician inserts one of the devices into each of the two fallopian tubes. This is done with a special catheter that is inserted through the vagina into the uterus, and then into the fallopian tube. The device, which resembles a tiny spring, works by inducing scar tissue to form over the implant, blocking the fallopian tube and preventing fertilization of the egg by the sperm.

The FDA based its approval of the device primarily on a review of two clinical studies of safety and effectiveness conducted by the manufacturer and on the recommendation of an FDA advisory committee. No serious adverse events were reported from either clinical study.

In the smaller of the two studies, 181 women had the device implanted in both fallopian tubes for at least 24 months; no pregnancies have been reported. In the second study, 439 women between the ages of 21 and 40 who had the device implanted reported no pregnancies after one year. Two-year data on an additional 16 women also showed no pregnancies.

In the clinical studies, doctors failed to place the device in both fallopian tubes at first attempt in about 1 out of 7 women. As a condition of approval, Conceptus will conduct a post-approval study to document the placement failure rate with newly trained physicians and to identify potential reasons for this failure. 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.

Women who choose this device for sterilization should be aware that the procedure is irreversible. Women should also know that pregnancies following sterilization can occur, even many years after the procedure, and that such pregnancies are at increased risk to be ectopic (outside the uterus), a life-threatening condition.