GYNECARE THERMACHOICE® III Uterine Balloon Therapy System
GYNECARE THERMACHOICE® III Uterine Balloon Therapy System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom child-bearing is complete.
Indicated for menorrhagia AND shown to reduce dysmenorrhea as a secondary quality-of-life end point.
In outcome data from the FDA clinical study for GYNECARE THERMACHOICE® III1:
- 81% of patients returned to normal levels of menstrual bleeding or lower
- 37% of patients experienced amenorrhea
- 89% of patients experienced a reduction in menstrual pain and cramping
GYNECARE THERMACHOICE® III
Results that speak for themselves in heavy bleeding
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| GYNECARE THERMACHOICE III1 | NovaSure2 | Her Option3 | HTA System4 | |
| Patients with normal bleeding levels or less at 12 months | 81% | 78% | 67% | 68% |
| Patients experiencing amenorrhea at 12 months | 37% | 36% | 22% | 35% |
| Not based on a head-to-head study | ||||
GYNECARE THERMACHOICE® III |
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| GYNECARE THERMACHOICE III1 | NovaSure2 | Her Option3 | HTA System4 | |
| Patients experiencing reduction in pain (dysmenorrhea) at 12 months* | 89% | 63% | 76% | n/a |
| Not based on a head-to-head study | ||||
PATIENT INFORMATION
Information for patients is available at the links below:
 GYNECARE THERMACHOICE® III Patient Brochure |
 GYNECARE THERMACHOICE® III "Ask Yourself" Exam Poster |
 GYNECARE THERMACHOICE® III Patient Discussion Guide |
 www.PelvicHealthSolutions.com |
* Based on intent-to-treat populations from clinical trials in the Instructions for Use for GYNECARE THERMACHOICE® III, NovaSure®, Her Option®, and HTA® System.
Reference:
1. GYNECARE THERMACHOICE® III [instructions for use]. Somerville, NJ: Ethicon, Inc; 2009.
2. NovaSure® [instructions for use]. Bedford, MA: Hologic, Inc; 2009.
3. Her Option® [package insert]. Minnetonka, MN: American Medical Systems, Inc; 2009.
4. Hydro ThermAblator® [user’s manual]. Natick, MA: Boston Scientific Corporation; 2007.
RISK INFORMATION
INDICATIONS: The GYNECARE THERMACHOICE® System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
CONTRAINDICATIONS: The device is contraindicated for use in a patient: who is pregnant or who wants to become pregnant in the future; with known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic or pathologic condition in which weakness of the myometrium could exist, such as history of previous classical cesarean sections or transmural myomectomy; with active genital or urinary tract infection at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis); with an intrauterine device (IUD) currently in place.
ADVERSE EVENTS include: rupture of the uterus; thermal injury to adjacent tissue; heated liquid escaping into the vascular spaces and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical burn; hemorrhage; infection or sepsis; perforation; post‐ablation tubal sterilization syndrome; complications leading to serious injury or death; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the fetus); vesico‐uterine fistula formation; cramping/pelvic pain; nausea and vomiting; endometritis and risks associated with hysteroscopy.
WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious patient injury. If uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur if the heater is activated. Endometrial ablation is not a sterilization procedure. Patients who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. Endometrial ablation procedures using the GYNECARE THERMACHOICE® System should be performed only by medical professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and curettage (D&C), and who have adequate training and familiarity with GYNECARE THERMACHOICE® System.
PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE® System. Rx Only.