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T02-41

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November 4, 2002

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FDA APPROVES NEW FEMALE STERILIZATION DEVICE

The Food and Drug Administration today 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 , Calif. 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 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 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 three months, 194 women began relying exclusively on the device to prevent pregnancy. Of those, 181 women have relied on the device for at least 24 months and another 12 women have relied on the device for at least 12 months. To date, none of the women has reported pregnancy.

In the second study, bilateral placement of the Essure implants was attempted in 518 women between ages 21 and 40. All women used an alternate form of contraception for the first three months. Following confirmation of proper placement, 449 women began relying on the device alone to prevent pregnancy. These women were then followed to see if any became pregnant or had any other adverse events. In this study, FDA considered one-year data on 439 women, and two-year data on 16 women. To date, none of these women has reported pregnancy. In this second study, doctors failed to achieve bilateral placement of the Essure implants at first attempt with 14 percent of patients in the study (approx. 1 in 7). 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 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.

Women who choose this device for sterilization should be aware that the procedure is irreversible, and so they should carefully evaluate such issues as their age and the possibility that they could wish to become pregnant in the future. On the other hand, 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, a life-threatening condition.

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