Acclarent, Inc., a business unit of Ethicon, Inc., is a medical device
company located in Menlo Park, CA. Its singular focus is improving patient
care in all...
Catheter-Related Blood Stream Infections (CRBSI) are the 10th leading
cause of death in the United States
BIOPATCH® Disk is the only dressing clinically proven for use
in reducing CRBSI...
Precision engineered to deliver SURGIFLO® Hemostatic Matrix
Lightweight design for optimal control and ease of use
Single expression can deliver nearly 5 times more SURGIFLO® than
the competitors¹
Disposable,...
Designed Specifically for Vascular Reconstruction Procedures
ETHICON™ OMNEX™ is a 100% synthetic sealant which forms a
strong, flexible, physical seal preventing leakage of blood along suture
lines in...
Complex Problem. Simple Solution.
EVICEL® Fibrin Sealant (Human), once thawed, is ready on-demand to
meet your critical bleeding challenges by working independently of your
patient’s clotting factors.
The first...
Experience the Human Alternative
EVITHROM® Thrombin, Topical (Human) the only ready to use1
all human thrombin
Time to hemostasis equivalent to bovine thrombin at 3, 6,
and 10 minutes,...
INSTAT® MCH
Microfibrillar Collagen Hemostat
Utilizing Collagen to Achieve Superior Hemostasis
Microfibrillar structure allows convenient control of the amount of
product and better coherence of collagen fibers
Applicable for irregularly...
Introducing SURGICEL® SNoW™ Absorbable Hemostat
43% FASTERTime to Hemostasis than SURGICEL® Original Hemostat¹
FOUR Proven Performers
The first and only absorbable hemostats proven bactericidal against a
broad range of...
ADAPTABILITY
Speed Handling Performance...SURGICEL® SNoW™ Absorbable Hemostat
43% Faster time to hemostasis than SURGICEL® Original Hemostat1
Enhanced conformability and adherence to the bleeding site compared to
SURGICEL® Original Hemostat2
Structured...
Stop your bleeding.Not your procedure.
SURGIFLO® Hemostatic Matrix Family provides a variety of hemostatic
flowable options to manage bleeding challenges.
Stops bleeding in 2 minutes or less when...
The #1 Gelatin Family of Products in the US
SURGIFOAM® Absorbable Gelatin Powder
Complete coverage, rapid hemostasis on rough or uneven
surfaces
Add thrombin or saline to achieve desired...
Ethicon synthetic absorbable sutures exhibit a range of different
characteristics and capabilities. From VICRYL RAPIDE* (polyglactin 910)
Suture for effective short-term wound support, to PDS* II (polydioxanone)
Suture...
BLAKE® Silicone Drains
The BLAKE® Drains are white, radiopaque silicone drains with 4
channels along the sides with a solid core center. The other components
consist of a...
DERMABOND ADVANCED™ Topical Skin Adhesive
Wound Strength and Protection
DERMABOND ADVANCED™ provides a secure wound closure and a protective
microbial barrier over the wound.1
DERMABOND ADVANCED™ enhances wound closure...
DERMABOND™ PRINEO™ Skin Closure System
Supports wound with strength equivalent to 3-0 sutures1
Demonstrates equivalent wound healing and cosmesis compared to
original DERMABOND® Topical Skin Adhesive at 30...
Physiologically designed to complement your patient's every Twist and
Turn.1-5
Handling Characteristics
The handling characteristics of ETHICON PHYSIOMESH™ deliver
outstanding ease of use.5
Anatomy of abdominal wall can be viewed...
Unique, absorbable "strap" design uses 2 points of fixation to
straddle mesh pores and fibers, including large-pore constructions.4
Straddling a mesh pore.
Straddling a mesh fiber.
Delivers secure mesh...
FlexHD® Acellular Hydrated Dermis, a matrix derived from human skin, is
available through a strategic alliance between Ethicon and the
Musculoskeletal Transplant Foundation (MTF). FlexHD® Acellular Hydrated
Dermis...
Ethicon Hernia Solutions is pleased to offer a complete line of mesh
products for hernia repair. Further details are provided on the individual
hernia repair product pages...
Ethicon Nonabsorbable Sutures
Nonabsorbable materials are used to suture tissues requiring long-term or
permanent support in which the product strength is critical. They are
classified as monofilament or...
GYNECARE GYNEMESH® PS
for Vaginal Wall Prolapse Surgical Treatment
GYNECARE GYNEMESH® PS is indicated for tissue reinforcement and
long-lasting stabilization of fascial structures of the pelvic floor in
vaginal...
GYNECARE INTERCEED® Absorbable Adhesion Barrier
Safely and effectively reduces the formation of adhesions in a range
of open gynecologic pelvic procedures1
Reduces adhesion formation by forming a continuous...
To order GYNECARE MORCELLEX™ Tissue Morcellator:
Contact your local Ethicon Women's Health & Urology Sales
Representative or call 1-800-255-2500. GYNECARE MORCELLEX™ Tissue
Morcellator delivers an optimal combination of...
GYNECARE PROLIFT+M™complements your surgical abilities and helps you
meet the demands of symptomatic pelvic organ prolapse.¹
Coverage
GYNECARE PROLIFT+M™ offers proven apical and
mid-vagina support²
GYNECARE PROLIFT+M™ also provides lateral...
GYNECARE PROLIFT®
Total, Anterior and Posterior Pelvic Floor Repair Systems
The GYNECARE PROLIFT® Total, Anterior and Posterior Pelvic Floor
Repair Systems are indicated for tissue reinforcement and...
To order GYNECARE PROSIMA™ Contact your local Ethicon Women's Health
& Urology Sales Representative or call 1-800-255-2500. Only GYNECARE
PROSIMA™ delivers a truly tension-free repair of pelvic...
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...
Introducing the next evolution in treatment for stress urinary
incontinence
The retropubic sling with tactilefeedback for
enhanced control
Confidence that you can achieveconsistent results with
less mesh
Prescribing Information
Prescribing Information
From...
GYNECARE VERSAPOINT™ Bipolar Electrosurgery System
GYNECARE VERSAPOINT™ Bipolar Electrosurgery System is an innovative
instrument with the potential to transform the way operative hysteroscopy
is performed. This advanced technology...
GYNECARE PROLIFT® Pelvic Floor Repair System
combines a unique delivery system with a specifically designed mesh implant
to allow surgeons to treat symptomatic prolapse patients.
GYNECARE PROLIFT+M™ Pelvic...
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 a pivotal 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
Reference:
1. Gynecare Thermachoice III [instructions for use]. Somerville, NJ: Ethicon, Inc; 2009.
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.
GYNECARE THERMACHOICE® III—
Results that speak for themselves in heavy bleeding¹
GYNECARE THERMACHOICE® III—
Provides overall relief your patients will be talking about¹
‡Based on intent-to-treat populations from clinical trials in the Instructions for Use for GYNECARE THERMACHOICE® III, NovaSure®, Her Option®, and HTA® System.
References:
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.
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.
Reimbursement
To view the Facility and Physician Billing Guide for GYNECARE THERMACHOICE® III Uterine Balloon Therapy System is available at the link below:
If offering in the office, ensure utilization of Site of Service Code 11
For reimbursement support, please call the Ethicon Reimbursement Hotline at 1-800-964-8496.
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.
Patient Information
Information for patients is available at the links below:
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.
Archived webinar featuring Dr. Hector Chapa, MD, FACOG
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.
Related Information
For additional information about this product and related female pelvic health conditions and solutions, click on the links below:
A source of online training, resources and information focused exclusively on the indications and application of our medical devices for surgical repair. Specifically designed for physicians, surgeons and other medical professionals, our self-paced curricula provide you the background you need for advanced or hands-on training as well as information about our innovative medical devices, techniques and services that can transform your practice.
Comprehensive resource for patients to learn about common pelvic health conditions. This site features information about conditions, treatment options, a symptom assessment tool and find-a-physician locator.
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.