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INSTRUCTIONS FOR USE
GYNECARE THERMACHOICE* III
Uterine Balloon Therapy System
Thermal Balloon Ablation Silicone Catheter and Syringe (Single-Use)
Read all directions, precautions and warnings prior to use.
This instructions for use provides directions for using the GYNECARE THERMACHOICE* III Uterine Balloon
Therapy (UBT) Catheter.
CAUTION
Federal law (USA) restricts this device to sale by or on the
order of a physician with appropriate training.
DEVICE DESCRIPTION
The GYNECARE THERMACHOICE UBT System is a software-controlled device designed to ablate uterine tissue
by thermal energy. The system is comprised of a single-use silicone balloon catheter, a reusable controller,
umbilical cable, and power cord. The GYNECARE THERMACHOICE III Catheter is designed for use only with the
GYNECARE THERMACHOICE UBT Controller.
The silicone balloon catheter is 1) connected to the controller, 2) inserted through the cervix into the uterus, 3) filled
with sterile, injectable fluid (5% dextrose in water- D5W) carefully stabilizing the pressure to 160-180 mmHg
pressure, and 4) activated to thermally ablate endometrial tissue by maintaining a temperature of approximately
87°C (188°F) for 8 minutes.
INDICATIONS
The GYNECARE THERMACHOICE III UBT 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.
• A patient with known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the
endometrium, such as unresolved adenomatous hyperplasia.
• A patient with any anatomic condition (e.g. history of previous classical cesarean sections or transmural
myomectomy) or pathologic condition (e.g., chronic immunosuppressive therapy) that could lead to
weakening of the myometrium.
• To clarify, patients with low transverse uterine scar from a previous Caesarian section remain candidates for
uterine ablation with the GYNECARE THERMACHOICE III UBT System. If a patient has had multiple
Caesarian sections with low transverse uterine incisions, it may be prudent to evaluate the thickness of the
uterine scar with ultrasound prior to carrying out a uterine ablation procedure with the GYNECARE
THERMACHOICE III UBT System.
• A patient with active genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis,
endometritis, salpingitis, or cystitis) or with active pelvic inflammatory disease (PID).
• A patient with an intrauterine device (IUD) currently in place.
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WARNINGS
Failure to follow all instructions or to heed any warnings or precautions could result in serious patient injury.
GENERAL
• 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. There have been reports of women becoming
pregnant following this procedure. Pregnancies after ablation can be dangerous for both mother and fetus.
• Endometrial ablation using the GYNECARE THERMACHOICE III UBT System is not a sterilization
procedure. The patient should be advised of appropriate birth control methods.
• Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation are at
increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. This
can occur as late as 10 years post-procedure.
• Endometrial ablation procedures using the GYNECARE THERMACHOICE III UBT 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 the GYNECARE THERMACHOICE III UBT 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.
UTERINE PERFORATION
o Uterine perforation can occur during any procedure in which the uterus is instrumented. Use
caution not to perforate the uterine wall when sounding the uterus, dilating the cervix or inserting
the catheter.
o Any of the following indicates possible uterine perforation.
1. If the catheter can be inserted to a greater depth than was determined by the uterine
sound
2. If the pressure cannot be stabilized at 160 – 180 mmHg with up to 35ml of fluid (35ml of
fluid in the THERMACHOICE III device is approximately equal to the 30ml used in the
THERMACHOICE I clinical study) and there is no evidence of a balloon leak
If the pressure drops precipitously at any point during the procedure
o If a perforation is suspected, THE PROCEDURE SHOULD BE TERMINATED IMMEDIATELY.
o For patients in whom the procedure was aborted due to a suspected uterine wall perforation, a
work-up for perforation should be considered prior to discharge.
If a perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue
may occur if the heater is activated.
TECHNICAL
• The GYNECARE THERMACHOICE III UBT Balloon Catheter is for single use only - do not reuse or
resterilize.
• Do not treat patients for more than one therapy cycle in a given treatment session because of the potential for
transmural injury to the uterus or injury to adjacent viscera.
• Hold the catheter so it does not rest on the vaginal wall during treatment and cool down periods to prevent
possible burns.
• Allow the catheter to complete the cool down cycle prior to removal of the fluid. Remove the fluid and then
the catheter.
• After completing the procedure it is important not to touch the GYNECARE THERMACHOICE III Uterine
Balloon for the following reasons:
o The balloon is covered with blood and body fluids
o There are mechanical and electrical parts that could puncture the balloon
• Proper care should be taken in disposing of the catheter.
PRECAUTIONS
• The GYNECARE THERMACHOICE III UBT catheter, controller, and umbilical cable are designed as a
system. To ensure proper function, never use other components with the GYNECARE THERMACHOICE
UBT System.
• A starting pressure of 160 – 180 mmHg is recommended and typically requires 6 – 15 cc of fluid and may
require as much as 35 cc. Titration to achieve a stable pressure (no fluctuations greater that ±10 mmHg
for at least 30 seconds) prior to activating the heating element is critical to proper functioning of the
device. When inserting fluid, do not exceed a pressure of 200 mmHg. Typically, pressure levels decline
slowly during the course of the procedure as the uterus relaxes. If a pressure of 160 – 180 mmHg cannot be
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reached with up to 35 cc or less of fluid, or if there is a rapid drop in pressure, it is likely there is a uterine
perforation.
• Rapid loss of pressure during a therapy cycle may indicate a uterine wall defect. Adding additional
fluid to the balloon may create (or exacerbate if already present) a uterine wall defect such as a
perforation.
• Never add additional fluid during a therapy cycle.
• Those patients who have undergone endometrial ablation and are later placed on hormone replacement
therapy should have progestin included in their regimen in order to avoid the increased risk of endometrial
adenocarcinoma associated with unopposed estrogen replacement therapy.
• The safety and effectiveness of the GYNECARE THERMACHOICE III UBT System has not been fully
evaluated in patients:
o with submucosal myomas greater than 3cm**
o bicornuate or septate uteri or previous endometrial resection/ablation
o with large uterine cavities (>35 ml in volume or uterine sound > 12 cm)
o with small uterine cavities (<2 ml in volume or uterine sound <4 cm)
o undergoing repeat endometrial ablation procedures
o who are post-menopausal
**Assuming a margin of equivalence delta of 25%.
• It has been reported that patients with a severe anteverted retroflexed or laterally displaced uterus are at an
increased risk of uterine wall perforation during any intrauterine manipulation. The clinician should use
discretion in patient selection.
• A false passage can occur during any procedure in which the uterus is instrumented, especially in cases of
severe anteverted retroflexed or a laterally displaced uterus. Use caution to insure that the device is properly
positioned in the uterine cavity.
ADVERSE EVENTS
In a study of 134 women, performed with a previous generation balloon catheter (version 1.2) [without the fluid
circulation mechanism inside the balloon] the most frequent events reported during or after the procedure
include:
• Cramping/pelvic pain – Post-treatment cramping was reported in 91.8% of the patients. The cramps/pain
ranged from mild to severe as reported during the intra-operative and immediate post-operative period. This
cramping typically lasted a few hours and rarely continues beyond the first day following ablation. The use of
non-steroidal anti-inflammatory drugs (NSAIDs) prior to and following GYNECARE THERMACHOICE UBT is
usually sufficient to manage cramping and pelvic pain.
• Nausea and Vomiting – Nausea and vomiting were reported in 23.9% of the patients in the immediate hours
following the procedure. This may be attributed to general anesthesia, and was usually managed with
medication.
• Endometritis was reported in 2.1% of patients. All patients responded to a course of oral antibiotics.
• Post-procedure symptoms such as pain, fever, nausea, vomiting and difficulty with defecation or micturition
were reported. Failure of such symptoms to resolve over a reasonable period of time warrants evaluation by
appropriate medical personnel.
• Pregnancy was reported in one patient (0.8%) resulting in a 2-month premature live infant. Pregnancy
following endometrial ablation may be dangerous to both mother and fetus.
• Hematometra was reported in 0.6% of patients treated in clinical studies conducted outside of the United
States. In all patients in this trial, the hematometra was resolved with insertion of a uterine sound, however,
there have been reports of hysterectomy due to hematoma or hematosalpinx.
• A single perforation of the uterus was reported in one controlled clinical study.
In a multi-center study of 250 women, performed with GYNECARE THERMACHOICE III (version 3.0), in which
patients were randomized to receive either treatment with Thermachoice III with an additional post-procedure
curettage (PPC Group) or treatment with Thermachoice III alone (NPPC Group), the following adverse events
were reported during the first one year of follow-up: These events may or may not be related to the procedure.
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Table 1a. Adverse Events- Day of Procedure†
Adverse Event
NPPC Group
N=124
PPC Group
N=126
Endometritis
3 (2.4%)
2 (1.6%)
Vaginal burn
0
2 (1.6%)
Other abdominal or pelvic
pain/cramping
1 (0.8%)
1 (0.8%)
Uterine perforation
1 (0.8%)
0
Post –op Nausea
0
1 (0.8%)
Endometrial polyp removal
0
1 (0.8%)
Injury to tongue (bitten)
1 (0.8%)
0
Swollen hand
1 (0.8%)
0
Knot on wrist
1 (0.8%)
0
TOTAL
8 (6.5%)
7 (5.6%)
†
One subject in the NPPC group experienced 3 adverse events.
Table 1b. Adverse Events- ≥1 Day -2 weeks†
Adverse Event
NPPC Group
N=124
PPC Group
N=126
Bleeding or abdominal or back or
pelvic pain/cramping
3 (2.4%)
2 (1.6%)
Discharge and/ or vaginal infection
3 (2.4%)
2 (1.6%)
Endometritis
0
2 (1.6%)
UTI 0 1 (0.8%)
Fever 0 1 (0.8%)
Fainting 0 1 (0.8%)
Migraine headache
0
3 (2.4%)
Worsening carpel tunnel syndrome
0
2 (1.6%)
TOTAL
6 (4.8%)
14 (11.1%)
†
Three subjects in the PPC group experienced multiple adverse events.
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Table 1c. Adverse Events >2 Weeks - 1 year†‡
Adverse Event
NPPC Group
PPC Group
Abdominal or back or pelvic
pain/cramping
9 (7.3%)
8 (6.3%)
Discharge and/ or vaginal infection
9 (7.3%)
6 (4.8%)
Bleeding
6 (4.8%)
4 (3.2%)
UTI or Cystitis or Urinary
incontinence
5 (4.0%)
3 (2.4%)
Uterine fibroid or cervical polyp or
vulva warty lesion removal
2 (1.6%)
1 (0.8%)
Abnormal Pap (ASCUS)
2 (1.6%)
0
Endometritis
1 (0.8%)
1 (0.8%)
Sinus congestion or infection or
polyp
2 (1.6%)
5 (4.0%)
Ear infection or tooth ache
0
2 (1.6%)
Asthma or bronchitis
1 (0.8%)
1 (0.8%)
Hot flush
0
1 (0.8%)
Hypothyroidism
0
1 (0.8%)
Depression
0
1 (0.8%)
Migraine headache
0
1 (0.8%)
Exacerbation of multiple sclerosis
0
1 (0.8%)
Cholecsytolithiasis
0
1 (0.8%)
Hernia
1 (0.8%)
0
Bloody stool
1 (0.8%)
0
Cracked distal fibula
1 (0.8%)
0
Plantar fasciitis
1 (0.8%)
0
TOTAL
41 (33.1%)
37 (29.4%)
†
This table includes data from patients (5 NPPC, 3 PPC) who had their “12-month” visit at more than 1 year
post-procedure. NOTE: There was one additional adverse event (pelvic pain) reported in the PPC Group,
but the time interval was unknown.
‡
Six subjects in NPPC group experienced multiple adverse events. Five subjects in PPC group experienced
multiple adverse events.
OTHER ADVERSE EVENTS
As with all endometrial ablation procedures, serious injury or death can occur. The following adverse events could
occur or have been reported in association with the use of the GYNECARE THERMACHOICE III UBT System:
1. Rupture of the Uterus
2. Thermal Injury to Adjacent Tissue
3. Heated Liquid Escaping Into the Vascular Spaces and/or Cervix, Vagina, Fallopian Tubes, and
Abdominal Cavity
4. Electrical Burn
5. Hemorrhage
6. Infection or Sepsis
7. Perforation
8. Post-ablation-tubal sterilization syndrome – This is a complication following endometrial ablation in
women who have also previously undergone tubal ligation. The pathophysiology of this condition is believed
to be related to the regeneration of endometrium in the cornual areas of the uterus. Blood from these glands
can flow back into the proximal fallopian tubes in cases where the lower uterine segment is extensively
scarred. The proximal oviduct becomes filled with blood and fluid causing symptoms similar to those of an
ectopic pregnancy.
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9. Vesico-uterine fistula formation
10. Complications leading to serious injury or death.
CLINICAL STUDIES
Two studies that have evaluated the safety and effectiveness of the GYNECARE THERMACHOICE UBT System in
treating menorrhagia in premenopausal women are presented in this labeling. The first was conducted in support of
the initial product approval, and was done using the first generation balloon catheter for GYNECARE
THERMACHOICE I UBT. In 2006, a more recent study completed 12-month follow up on subjects treated with the
third generation device, GYNCECARE THERMACHOICE III UBT. Results from both studies are summarized below.
GYNECARE THERMACHOICE I
The pivotal clinical trial conducted to support the original approval of GYNECARE THERMACHOICE I,
Which was completed in 1997, is summarized below.
Conclusions: The GYNECARE THERMACHOICE I (version 1.2) [without the fluid circulation mechanism, inside
the balloon], at twelve, twenty-four, and thirty-six months of follow-up, balloon ablation was demonstrated to be at
least as safe (with fewer intra-operative complications and shorter procedure times) and as effective as
hysteroscopic rollerball ablation in reducing menstrual bleeding to a clinically acceptable level in menorrhagic
women who had completed their childbearing. Furthermore, statistically equivalent and significant reductions in
patient-reported dysmenorrhea (mild, moderate, severe menstrual cramps), PMS symptoms (mild, moderate, severe
common PMS symptoms), and overall impact of menses on lifestyle (scale of 1-10; 1=none, 10=severe) were
experienced by both groups.
Purpose: The use of balloon thermal ablation for the treatment of menorrhagia for benign causes in an anatomically
normal uterine cavity was compared with rollerball electrosurgical endometrial ablation with regard to safety and
effectiveness. The primary effectiveness measure was a validated diary scoring system (adapted from Higham JM,
O’Brien PMS, Shaw RW, Assessment of menstrual blood loss using a pictorial chart, Br J Obstet Gynaecol
1990;97:734-9). Success was defined as the reduction of excessive menstrual bleeding to normal flow or less.
Secondary endpoints evaluated were overall percent decrease in diary scores and responses from a quality-of-life
questionnaire. The endpoints for safety were based on the evaluation of adverse events associated with each
procedure, including device-related complications, time of procedure, and type of anesthesia use.
Methods: This randomized, prospective multicenter clinical investigation using the previous generation noncirculating balloon catheter was conducted at 14 sites using investigators highly experienced with hysteroscopic
rollerball endometrial ablation. All patients were ≥30 years old, premenopausal, and had completed childbearing. All
had an anatomically normal uterine cavity ≥4cm and ≤10cm.
Three months of documented menorrhagia for benign causes was a requirement for inclusion and was confirmed with
an average diary score of at least 150 points. Endometrial biopsy and pap smear were required to rule out
premalignant or malignant cervical uterine disease. No endometrial thinning medications could be used for three
months prior to treatment and all patients underwent a three-minute suction curettage just prior to suction treatment.
Selection of anesthesia regimen was left to the individual investigators. Treatment success was defined as reduction
menses to a diary score less than or equal to 75 reflecting eumenorrhea. In the original Higham study, a diary score
of 100 had 86% sensitivity and 81% specificity for true menorrhagia for benign causes as determined by chemical
analysis of the saturated pads.
Patient Population
• 260 patients in Intent to Treat (134 GYNECARE THERMACHOICE I; 126 RB)
o 1 aborted RB for uterine perforation
o 2 aborted (1 GYNECARE THERMACHOICE I; 1 RB) for submucous fibroid
o 2 aborted GYNECARE THERMACHOICE I for inability to maintain device pressure
• 255 patients treated with test or control device (131 GYNECARE THERMACHOICE I; 124 RB)
Baseline demographic, physical exam and gynecological variables were statistically equivalent between the test and
control groups with regard to age (GYNECARE THERMACHOICE I 40.2 years, RB 40.9 years), race, body mass
index, mean baseline diary score (GYNECARE THERMACHOICE I 552.5, RB 570) and other criteria.
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Table 2. Subject Withdrawals
Subjects:
GYNECARE
THERMACHOICE I
ROLLERBALL
Entered into study (Intent to Treat
Population)
134
126
Procedure aborted
3
2
Receiving complete treatment
131
124
For whom 12-month data not available:
Hysterectomy
Withdrew
Lost to follow-up
6
2
1
3
• 1 diary score 14
• 1 amenorrhea @ 3 mo.
10
3
4
• 1 daughter’s death
• 1 menorrhagia
• 1 depression
• 1 amenorrhea @ 3 mo.
3
• 1 amenorrhea @ 3 mo.
• 1 6-mo. diary score 32
• 1 6-mo. diary score 77
For whom 12-month data available
125
114
For whom 24-month data not available
Hysterectomy
Lost to follow-up
3
2
1
• 1 yr. hypomenorrhea
9
6
3
For whom 24-month data available
122
105
For whom 36-month data not available
Repeat Ablation
Hysterectomy
Lost to follow-up
Withdrew
8
1
4
2
• both hypomenorrhea @ 2 yr.
1
5
For whom 36-month data available
114
100
RESULTS
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