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Safety Information

Intended Use

The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

Contraindications

Current pregnancy; active pelvic infection; known or suspected gynecologic malignancy or premalignant disorders such as atypical endometrial hyperplasia; presence of one or more intratubal implants for sterilization; and presence of an intrauterine device (IUD), unless removed prior to the introduction of the Sonata Treatment Device.

Potential Postoperative Events

Anticipated postoperative events include: abdominopelvic pain/cramping; back pain; constipation; dizziness/fatigue; headache; fever; malaise; nausea/vomiting; sloughing and, less commonly, intact expulsion of ablated fibroid tissue per vaginam (particularly after treatment of submucous fibroids), and vaginal spotting/bleeding/ dysmenorrhea.

Potential risks associated with fibroid ablation using the Sonata System include: allergic reactions (including rash) to device materials; bowel or bladder perforation; cervical/vaginal laceration or tear; dysmenorrhea; electrical shock; hematometrium; hemorrhage; infections: major and minor local and systemic infections, including intrauterine infection; retention of device fragment; skin burn from the dispersion of radiofrequency energy; thrombotic events; unintended injury to the uterus, cervix or vaginal vault, adjacent organs or tissue; unknown risk to future pregnancies; and complications including death.

Adenomyosis

Effectiveness in women with clinically significant adenomyosis has not been established.

Pregnancy

Safety and effectiveness with regard to fertility and fecundity after use of the Sonata System have not been established.