A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices.

OBJECTIVE

To evaluate placement efficacy and reliability of a an intratubal occlusion device for permanent contraception and to assess tolerability and overall satisfaction.

METHODS

Seven hundred seventy women with known parity were recruited to participate in a prospective, multicenter study. Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used. Inserts were placed bilaterally in the fallopian tube lumen. Subsequent bilateral occlusion was assessed with hysterosalpingography.

RESULTS

Overall, bilateral placement success was achieved in 611 of 645 women (95%). Bilateral occlusion was confirmed in 570 of 645 (88.4%). The 1-year pregnancy prevention rate as derived with life-table methods was 98.9%.

CONCLUSION

This transcervical sterilization system offers an effective contraceptive method, which was well tolerated and had a high satisfaction rate.

LEVEL OF EVIDENCE: III.