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 who do not intend to bear more children and who experience menorrhagia (excessive uterine bleeding) due to benign causes. It is indicated as a treatment for menorrhagia AND is shown to reduce dysmenorrhea as a secondary quality-of-life end point.
In a pivotal study for GYNECARE THERMACHOICE® III, 1 year outcome data showed that 37% of patients experienced amenorrhea, 81% of patients returned to normal levels of menstrual bleeding or lower, and 89% of patients experienced a reduction in menstrual pain and cramping.129
Unique delivery of time, temperature, and pressure129
GYNECARE THERMACHOICE® III – Results that speak for themselves in terms of reducing heavy bleeding129
GYNECARE THERMACHOICE® III129
NovaSure®162
Her Option®163
HTA System®164
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 – Provides overall relief your patients will be talking about129
GYNECARE THERMACHOICE® III
NovaSure®162
Her Option®163
HTA System®164
Patients experiencing reduction in pain (dysmenorrhea) at 12 months*
89%
63%
76%
n/a
Not based on a head-to-head study.
Risk Information
GYNECARE THERMACHOICE® III Uterine Balloon Therapy System: Essential Product Information – Physician
INDICATIONS: The GYNECARE THERMACHOICE III 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 (pregnancies following ablation can be dangerous for both mother and fetus); with known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic condition (eg, history of previous classical cesarean sections or transmural myomectomy) or pathologic condition (eg, chronic immunosuppressive therapy) that could lead to weakening of the myometrium; with active genital or urinary tract infection at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or with active pelvic inflammatory disease (PID); with an intrauterine device (IUD) currently in place.
ADVERSE EVENTS: include cramping/pelvic pain; nausea and vomiting; complications with pregnancy (Note: pregnancies following ablation can be dangerous for both mother and fetus); endometritis and risks associated with hysteroscopy; post-procedure symptoms such as pain, fever, nausea, vomiting and difficulty with defecation or micturition; hematometra; 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; vesico-uterine fistula formation.
WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious patient injury. The device is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following this procedure. Pregnancies following ablation can be dangerous for both mother and fetus. 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 III 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 III System. Endometrial ablation procedures do not eliminate the potential for endometrial hyperplasia or adenocarcinoma of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such pathology. DO NOT perform same-day GYNECARE THERMACHOICE® III procedure and hysteroscopic tubal occlusion/sterilization. Ablation may cause intrauterine synechiae, which can compromise (ie, prevent) the 3-month confirmation test (HSG) for the tubal occlusion device. Women who have inadequate 3-month confirmation tests cannot rely on the tubal occlusion device for contraception. Bench and clinical studies have been conducted which demonstrate that the GYNECARE THERMACHOICE® III procedure can be safely and effectively performed with nickel titanium tubal micro-inserts in place. However, the GYNECARE THERMACHOICE® III procedure should only be performed after the 3-month tubal occlusion confirmation test.
PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE III System. For the complete list of Precautions associated with the use of this device, consult the GYNECARE THERMACHOICE III System instructions for use. Rx Only.
* Based on intent-to-treat populations from clinical trials in the Instructions for Use for GYNECARE THERMACHOICE® III, NovaSure®, Her Option®, and HTA® 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.
PRODUCT CODE
DESCRIPTION
EA/BX
00825
Controller (comes with Umbilical Cable and Power Cord)
1
01105
Umbilical Cable
1
04995
Power Cord (US and Canada)
1
TC003
Catheter (5 pack)
5
TC013
Catheter (1 pack)
1
XW200595
Controller 2-year extended service contract
1
Risk Information
GYNECARE THERMACHOICE® III Uterine Balloon Therapy System: Essential Product Information – Physician
INDICATIONS: The GYNECARE THERMACHOICE III 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 (pregnancies following ablation can be dangerous for both mother and fetus); with known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic condition (eg, history of previous classical cesarean sections or transmural myomectomy) or pathologic condition (eg, chronic immunosuppressive therapy) that could lead to weakening of the myometrium; with active genital or urinary tract infection at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or with active pelvic inflammatory disease (PID); with an intrauterine device (IUD) currently in place.
ADVERSE EVENTS: include cramping/pelvic pain; nausea and vomiting; complications with pregnancy (Note: pregnancies following ablation can be dangerous for both mother and fetus); endometritis and risks associated with hysteroscopy; post-procedure symptoms such as pain, fever, nausea, vomiting and difficulty with defecation or micturition; hematometra; 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; vesico-uterine fistula formation.
WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious patient injury. The device is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following this procedure. Pregnancies following ablation can be dangerous for both mother and fetus. 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 III 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 III System. Endometrial ablation procedures do not eliminate the potential for endometrial hyperplasia or adenocarcinoma of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such pathology. DO NOT perform same-day GYNECARE THERMACHOICE® III procedure and hysteroscopic tubal occlusion/sterilization. Ablation may cause intrauterine synechiae, which can compromise (ie, prevent) the 3-month confirmation test (HSG) for the tubal occlusion device. Women who have inadequate 3-month confirmation tests cannot rely on the tubal occlusion device for contraception. Bench and clinical studies have been conducted which demonstrate that the GYNECARE THERMACHOICE® III procedure can be safely and effectively performed with nickel titanium tubal micro-inserts in place. However, the GYNECARE THERMACHOICE® III procedure should only be performed after the 3-month tubal occlusion confirmation test.
PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE III System. For the complete list of Precautions associated with the use of this device, consult the GYNECARE THERMACHOICE III System instructions for use. Rx Only.
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