Abstract
This review examines the peer-reviewed literature describing prospective studies that report amenorrhea rates, patient satisfaction, and surgical reintervention rates following the NovaSure® endometrial ablation procedure. A search of the English-language literature published from 2000 to 2011 was conducted using PubMed. Ten prospective studies, six single-arm NovaSure trials, and four randomized controlled trials comparing the NovaSure procedure with other global endometrial ablation modalities met the inclusion criteria and were reviewed. The follow-up periods ranged from 6 to 60 months. Amenorrhea rates for the NovaSure procedure ranged from 30.0% to 75.0%. Patients who reported being satisfied with the NovaSure procedure ranged from 85.0% to 94.0%. In randomized controlled trials with other global endometrial ablation modalities, amenorrhea rates at 12 months with the NovaSure procedure ranged from 43.0% to 56.0%, while other modalities ranged from 8% to 24%. In addition, this manuscript reviews the following: the NovaSure technology; use of the NovaSure procedure in the office setting; intraoperative and postoperative pain; effects on premenstrual syndrome (PMS); dysmenorrhea; special circumstances, including presence of uterine disease, history of cesarean delivery, coagulopathy, or use of anticoagulant medication; post-procedure uterine cavity assessment and cancer risk; contraception and pregnancy; and safety.
Acknowledgments
Dr Gimpelson would like to thank Hologic, Inc, for providing editorial and indirect financial support for this publication.
Disclosure
Dr Gimpelson is a consultant to Hologic, Inc, the manufacturer of the NovaSure endometrial ablation device, and Boston Scientific, the manufacturer of the Genesys HTA device. Dr Gimpelson was an investigator in the Phase III trial for the NovaSure device and an investigator in the Phase III trial for the Genesys HTA device. Dr Gimpelson has received royalties from Cooper Surgical, the manufacturer of the Her Option device, and a research grant from Ethicon, a subsidiary of Johnson and Johnson Ethicon (Gyneclamp), the manufacturer of the ThermaChoice Uterine Balloon system. Dr Gimpelson did not receive any compensation for this project.