FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes

Abstract

James H. Liu, Paul D. Blumenthal, Paula M. Castano, Scott C. Chudnoff, Lori M. Gawron, Erica B. Johnstone and Kathy Lee-Sepsick

Objective: To assess pregnancy outcomes following non-surgical tubal occlusion using the FemBloc® system in a population of women seeking permanent contraception.

Methods: Three prospective, multi-center clinical trials (Clinicaltrials.gov NCT03067272, NCT03433911, and NCT04273594) of females aged 21-45 years desiring permanent contraception, who underwent non-surgical, in-office procedure with the FemBloc system, conducted collectively at twenty-five academic and private medical centers in the United States. An ultrasound-based confirmation test for tubal occlusion with the FemChec® device was performed prior to subject reliance and contraceptive effectiveness assessment of FemBloc through one year. Follow-up continued annually through five years for safety.

Results: The pregnancy rate for FemBloc non-surgical permanent contraception subjects, who met trial eligibility and, three months post-FemBloc, were determined bilaterally occluded by investigator after a properly performed ultrasound- based confirmation test with FemChec was 0% (95%UCB: 0.057; n=0/51), which was significantly lower than the performance goal of 6% based on the historical control (one-sided P=0.0426). The safety reports were consistent with those typically observed for intrauterine transcervical procedures, with no on-going safety concerns through five years. There were no reports of serious adverse events, no ectopic pregnancies and no uterine perforations (n=0/228) for subjects that underwent a FemBloc procedure.

Conclusion: No pregnancies occurred among eligible subjects who relied on the FemBloc permanent contraceptive system after receiving a properly conducted confirmation test. The FemBloc system involves minimally invasive delivery of a proprietary synthetic tissue adhesive to occlude the fallopian tubes, fully degrading and producing nonfunctional scar tissue. It has the potential to offer safe, effective, accessible, non-surgical permanent contraception as an option to surgical sterilization with fewer risks, contraindications, and a substantially lower cost.

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