Abnormal uterine bleeding (AUB) from benign causes effects 20-25% of premenopausal women. 1 It is one of the most common presenting symptoms for gynecology patients, accounting for 15% of gynecology clinic patients, and is the major indication for 25% of gynecologic operations. 2 Menstrual disorders is listed as the second most common indication for hysterectomy (15-20%) and, together with uterine fibroids, accounts for up to 70% of all hysterectomies. 3-6
First-line treatment for dysfunctional uterine bleeding (DUB) consists of medical management with non-steroidal anti-inflammatory drugs (NSAIDs), 2,7-9 antifibrinolytics, 9-11 progestins, 12-14 combined estrogens and progestins, 15,16 androgens, 17 or antiprogestational agents. 18 If a patient fails or has a contraindication to medical therapy, surgical therapy is utilized. Up until the 1980s, dilatation and curettage (D&C) had been widely used as a treatment for DUB. However, D&C has since been shown to have diagnostic value and no therapeutic effect on DUB. Hysterectomy was the definitive surgical standard for the treatment of menorrhagia and was associated with a high rate of satisfaction. Hysterectomy can be associated with many potential adverse events, such as death, significant blood loss requiring transfusion, deep venous thrombosis, pulmonary embolism or infarction, myocardial infarction, abscess formation, sepsis, injury to bowel, bladder, or major blood vessels, longer postoperative recovery times, potentially long-term implications, 19-24 and high direct and indirect costs. 25 – 27 Over the last few decades, the trend in gynecology has been towards minimally invasive therapies for the treatment of common gynecologic conditions such as menorrhagia. Endometrial ablation has been developed as an alternative to hysterectomy for the management of menorrhagia. The gold standard for ablation of the endometrium is hysteroscopically directed rollerball ablation or resection. It is safe, effective, and durable but requires significant technical skill. In addition, endometrial ablation is more cost-effective than hysterectomy as therapy for menorrhagia. 25-27 Global endometrial ablation
or second-generation endometrial ablation technologies (SEATs) were introduced as equally safe and effective as hysteroscopically directed ablation, but are less skillintensive. 28 –30
Endometrial ablation with hot liquid balloons was investigated in the early 1990s and was introduced into clinical practice in the mid 1990s. Three hot liquid balloons were available: ThermaChoice (Gynecare, Division of Ethicon, Somerville, NJ), Cavaterm (Wallsten, Medical SA, Morges, Switzerland), and MenoTreat (Atos, Medical AB, Horby, Sweden). After 10 years of clinical practice, a review concluded that balloon endometrial ablation may be the preferred first-time surgical treatment in appropriate candidates who have failed or have refused pharmacologic therapy for chronic AUB. 31
Garside et al. conducted a systematic review and economic cost-effectiveness of microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBEA) for heavy menstrual bleeding. 32 They reported that satisfaction and effectiveness were high for both MEA and TBEA. The economic model suggested that MEA and TBEA are more cost-effective than hysteroscopic endometrial ablation (HEA) techniques for heavy menstrual bleeding (HMB). 32
Although the hot liquid balloon devices were shown to be safe, efficacious, and cost-effective, several shortcomings were identified with each existing product. Examples included problems with heating of the liquid used by the ThermaChoice balloon, resulting in non-uniform treatment of the endometrium, and poor control of both intraballoon inflation pressure and the length of treatment time (8-15 minutes). Another concern expressed by clinicians and healthcare providers was the relatively high costs for both reusable and disposable components of the existing balloon devices.