Are you seeking a less invasive treatment for uterine fibroids? Have you been told you need a hysterectomy and there are no other options? Magnolia Gynecology offers the innovative incisionless Transcervical Fibroid Ablation (TFA) with the Sonata® System in office or hospital.
Who are the Ideal Patients for this incisionless procedure?
This procedure can be used to treat all non-pedunculated uterine fibroid types including
submucosal, intramural, subserosal, and transmural fibroids. It is contraindicated for
women who are currently pregnant, have intratubal implants for sterilization, known or
suspected gynecologic malignancy or premalignant disorders, or an active pelvic
infection.
What is Transcervical Fibroid Ablation (TFA)?
As an alternative to hysterectomy and myomectomy, TFA avoids incisions, does not
require general anesthesia, and preserves the uterus. The procedure is typically brief averaging 30-60 minutes. Most side effects are typically minor and temporary. Ibuprofen only is used postoperatively, and activity returns to normal within 24 hours. For women suffering from heavy menstrual bleeding and other symptoms associated with uterine fibroids, TFA with the Sonata System uses radiofrequency energy to ablate fibroids transcervically. The Sonata System is FDA-cleared and intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids,
including those associated with heavy menstrual bleeding.
It is well-studied in multiple clinical trials. Three prospective, multicenter clinical trials were completed, including a 147-patient trial for FDA clearance. Ten clinical and health economic outcomes research studies and sub-analyses were also completed. TFA with the Sonata System has been clinically demonstrated to be safe and effective. Women were surveyed 12 months after TFA and reported the following results in the SONATA Clinical Trial:
✓ 95% of patients reported a reduction in menstrual bleeding
✓ 50% of the women returned to normal activity the next day
✓ 97% would recommend Sonata to a friend or family member
✓ Most side effects are typically minor and temporary
✓ Significant improvements in mean Symptom Severity Scores (SSS) and Health-Related Quality of Life
(HR-QoL)scores realized at 3 months and were sustained through 3 years(p<0.001)
TFA with the Sonata System may be a viable therapeutic option for you.
