Panel okays tubal occlusion implant. (Hysteroscopic Sterilization).

ROCKVILLE, MD. --An implant delivered via hysteroscopy into the fallopian tubes may become the first transcervical sterilization method available to U.S. women now that a Food and Drug Administration advisory panel has recommended its approval with conditions.

The Essure Micro-Insert System consists of two soft stainless steel coils containing fibers that stimulate a local tissue response, creating a fibrotic response that eventually results in complete tubal occlusion. To date, no pregnancies have been reported in 602 women who relied on the device for 1 year or 149 women who have relied on it for 2 years in studies done by the manufacturer, San Francisco--based Conceptus.

At a meeting last month, the FDA's Obstetrics-Gynecology Devices Panel voted 8-0, with one abstention, to recommend the device for approval, "with conditions." The FDA usually follows its advisory panels' non-binding recommendations.

Among the conditions set by the panelists was that physicians who train to do the procedure are "knowledgeable hysteroscopists" and that Conceptus follow patients for 5 years to determine longer-term efficacy rates, which the company had planned to do. Considering that the landmark U.S. Collaborative Review of Sterilization (CREST) study, published in 1996, found that sterilization failures can occur years after the procedure, depending on the method and patient age, the panel considered 5 years adequate. The panel also said patient and physician labeling should point out that reversal may be more difficult to achieve after the Essure method than with other sterilization methods, a consideration for younger patients who are more likely to regret their decision and seek a reversal in the future.

The Essure Micro-Insert System consists of the two microinserts and a transcervical tubal access catheter to deploy them into the proximal fallopian tubes, ideally leaving from three to eight coils visible in the uterine cavity. Once in place, the outer coil expands, anchoring it to the tubes. Polyethelene terephthalate fibers laced through the inner coil begin to stimulate the growth of fibrotic tissue into and around the tubal insert.

In the study, women used another method of contraception for 3 months after the procedure, at which point placement and occlusion were confirmed by hysterosalpingography (HSG). The panel recommended that HSG be used to confirm placement at 3 months once the device is approved.

In a multicenter pivotal safety and efficacy trial, 507 women, aged 21-40, underwent the procedure, which successfully placed both implants in 92% of them on the first (88%) or second (4%) attempt. ...