The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on July 22, 2002, in an open session.
A report was provided to the panel by the Office of Surveillance and Biometrics/ Epidemiology Branch on a post-market surveillance study of vacuum-assisted delivery devices.
The panel discussed the pre-market approval application (PMA P020014) from Conceptus, Inc. for their Essure® Micro-Insert System. The Essure® System is indicated for permanent birth control (female sterilization) by occlusion of the fallopian tubes.
The panel considered the sponsor’s prospective, single arm clinical trial in which 464 women received bilateral placement of the Essure® Micro-Insert using a hysteroscope. With 408 patients having relied on the Essure® System for one year or more, there have been no pregnancies. In an earlier single arm clinical trial, there were no pregnancies among 194 patients relying on the Essure® System for one year or among 149 patients relying on the Essure® System for two years. A Bayesian statistical analysis that combined the one year data from the two studies indicated that the probability was 95% that the cumulative one-year pregnancy rate is between 0 and 0.48%. When the results are adjusted to the age distribution of the CREST study, the one-year pregnancy rate is between 0 and 0.67%.
The panel voted 8-0 with 1 abstention that the PMA was approvable with the following conditions:
- The Sponsor should follow subjects from both clinical studies for five (5) years.
- The Sponsor should conduct further assessment of the placement failure rates as the Essure® System is used by more physicians following approval.
- Hysterosalpingogram (HSG) should continue to be required to confirm the correct placement of the Micro-Inserts and the occlusion of the fallopian tubes, unless the Sponsor demonstrates the effectiveness of pelvic x-rays or other alternatives.
- Physicians trained to use this device must be proficient hysteroscopists, and they must demonstrate competency at using the Essure® System.
- Physician and patient labeling should include the following: failure rates for device placement; recommendation to discuss in advance alternative steps if placement fails; relationship between patient age and later regret, with emphasis that this procedure is irreversible; warnings regarding possible future ectopic pregnancy; further explanation of the pregnancy rates indicated by the studies; information about metal sensitivity; information about how the device limits future medical options for electrocautery or in vitro fertilization. Physician labeling should also include guidelines regarding safe hysteroscopy and recommendation to perform the procedure during the proliferative phase of the menstrual cycle. Patient labeling should also include written, informed consent; multiple methods of presenting information (e.g. CD-rom video and/or written booklet) should be explored.
The panel met on July 23, 2002, in a 3-hour, closed session.
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