The Sonata System (Gynesonics, Inc. Redwood City, CA) is a minimally invasive, transcervical ablation (TFA) system used for treatment of symptomatic uterine fibroids. An Intrauterine Ultrasound Probe attached to a Radiofrequency Ablation Handpiece is inserted into the uterine cavity, and the ultrasound tip is articulated to provide contact with the myometrium adjacent to the target fibroid. Using graphical mapping, high-frequency radiofrequency energy at 105°C is delivered to a target Ablation Zone up to 5cm in diameter over 1-7 minutes. Safety mechanisms, such as a Thermal Safety Border and incomplete fibroid ablation, prevent the spread of energy to surrounding tissue and organs.1 The device is designed for treatment of any International Federation of Gynecology and Obstetrics (FIGO) type 1, 2, 3, 4, 5, 6, or 2-5 fibroid causing heavy menstrual bleeding. Contraindications include current pregnancy, active uterine infection, known or suspected gynecologic malignancy or pre-malignant condition (such as endometrial hyperplasia), presence of intratubal implants for sterilization, or presence of an intrauterine device. Insufficient evidence exists to demonstrate the effectiveness of Sonata for fertility outcomes, nor the safety of pregnancies conceived after treatment.2

The Sonata procedure was cleared by the United States Food and Drug Administration in 2018 following favorable results from an investigational trial of 140 patients who underwent the procedure.3 Compared to laparoscopic, abdominal, and hysteroscopic myomectomy, the benefits of this device include avoidance of surgical incisions, preservation of the uterus, ability to treat a broad variety of fibroid types, avoidance of general anesthesia, speed of recovery, and potential use in the outpatient setting.4 The results of the SONATA Pivotal trial were published after 12-, 24-, and 36-months of follow-up.4–6 In summary, the SONATA procedure was associated with reduction in fibroid volume and symptom burden, increased health-related quality of life, high rate of patient satisfaction, and low rate of surgical re-intervention. Only two serious adverse events were reported at 12-month follow-up (1.4% of enrolled patients): the first patient developed a deep vein thrombosis 15 days after the procedure and the second was admitted to the hospital for sterile leukorrhea, pelvic pain, and unconfirmed low-grade fever. No device-related adverse events were reported, and no additional adverse events occurred at 24- or 36-month follow-up.

The SAGE Registry is an independent, ongoing, post-market European registry of longer-term outcomes of transcervical fibroid ablation procedures.7 The final database will be completed in 2026, but initial results from the first 160 treated patients continue to demonstrate an excellent safety profile, with only one serious adverse event involving non-infectious endometritis (0.6% of patients). Anticipated side effects are reported in up to 5% of patients, including fever, chills, vomiting, cramping, pelvic pain, vaginal bleeding, vaginal discharge, and expulsion of fibroid fragments – likely due to a self-limited post-ablation syndrome. The characteristics of successfully treated fibroids include 10% submucosal (FIGO 1 or 2), 52% transmural (FIGO 2-5), 28% intramural (FIGO 3 or 4), and 10% subserosal (FIGO 5 or 6). Fibroids ranged in size from <1cm to >10cm in diameter, with more than one-quarter being >5cm in maximum dimension.

Like any surgical procedure, Sonata TFA has theoretical risks which include infection (intrauterine and systemic), damage to vagina, cervix, uterus, bowel, or bladder, hemorrhage, hematometra, burns, electrical shock, retention of device fragments, thrombotic events, unknown risk to future pregnancies, and even death.2 As of publication, only non-infectious endometritis and deep vein thrombosis have been reported in the literature. However, we present the case of a patient who underwent the Sonata procedure, with subsequent development of bacterial sepsis and Asherman's syndrome – serious complications with long-term sequelae and implications for fertility.