FDA approves new female sterilization device.(Essure System from Conceptus Inc. )

2002 DEC 5 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration has approved a small metallic implant that is 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 is the Essure System manufactured by Conceptus, Inc., of San Carlos, California. FDA expedited review of the product because of its potential benefit to couples seeking 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 works by inducing scar tissue to form over the implant, blocking the fallopian tube and preventing fertilization of the egg by the sperm.

During the first 3 months, women cannot rely on the Essure implants and must use alternate contraception. At the 3-month point, women must undergo a final x-ray procedure in which dye is placed in the uterus and an x-ray is taken to confirm proper device placement. Once placement is confirmed, the alternate contraception can be discontinued.

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 the Obstetrics and Gynecological Devices Panel of FDA's Medical Devices Advisory Committee. No serious adverse events were reported from either clinical study.

In one clinical study, placement of the Essure implants in both fallopian tubes (bilateral placement) was achieved in 200 of 227 women. Following confirmation of placement after 3 months, 194 women began relying exclusively on the device to prevent pregnancy. Of those, 181 women have relied on the device for at ...