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Hysterectomy

HysterectomyHysterectomy

Each year, 600,000 women in the United States undergo hysterectomies to treat a range of conditions. It used to be that total abdominal hysterectomy (removal of the uterus and cervix through a large abdominal incision) was the only type of hysterectomy offered to women. But today, the development of improved surgical devices and innovative techniques allows for less invasive procedures that can remove the uterus but can sometimes allow patients to keep their cervix, ovaries, and fallopian tubes.

Ethicon Gynecare has developed the GYNECARE MORCELLEX™ Tissue Morcellator which enables a minimally invasive solution for hysterectomy.  Furthermore, the company offers other minimally invasive solutions for uterine surgery including the GYNECARE THERMACHOICE® III Uterine Balloon Therapy System, the GYNECARE VERSASCOPE™ Hysteroscopy System, and the GYNECARE VERSAPOINT™ Bipolar Electrosurgery System

In addition, the Biosurgery franchise of Ethicon offers a variety of hemostatic products: EVICEL® Fibrin Sealant (Human), SURGIFOAM® Family of Products, SURGIFLO® Hemostatic Matrix, SURGICEL® Family of Absorbable Hemostats and EVITHROM® Thrombin, Topical (Human).

Ethicon also supplies a wide range of high-performing needles and sutures in a variety of materials. Antibacterial Plus sutures and a DERMABOND ADVANCED™ Topical Skin Adhesive for surgical incisions are also available.

To learn more, please click on the product(s) in the adjacent list of offerings for hysterectomies.
 


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.

For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse.

EVITHROM® Thrombin, Tropical (Human)

Indication

EVITHROM® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM® may be used in conjunction with an Absorbable Gelatin Sponge, USP.1

Important Safety Information

For topical use only. Do not inject EVITHROM® directly into the circulatory system.

Do not use for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

There is a potential risk of thrombosis if absorbed systemically.1

Anaphylactic reactions may occur.

The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM®) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM® or bovine thrombin group) 1

References:
1. EVITHROM® Thrombin, Topical (Human) Full Prescribing Information.

 

Distributed by:
Johnson & Johnson Wound Management
P.O. Box 151, Somervile, NJ 08876-0151
USA
 

Manufactured by:
OMRIX biopharmaceuticals Ltd.
MDA Blood Bank,
Sheba Hospital, Ramar-Gan
POB 888, Kiryat Ono 55000
ISRAEL

EVICEL™ Fibrin Sealant (Human)

Indication:

EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Important Safety Information:

For topical use only. Do not inject directly into the circulatory system.

Not indicated for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of air or gas embolism.

Because this product is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Anaphylactic reactions may occur.

Most common adverse events reported in clinical trials (≥5%) are bradycardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, oedema peripheral, constipation.

See sales representative for Full Prescribing Information

 

Distributed by:
Johnson & Johnson Wound Management
P.O. Box 151, Somervile, NJ 08876-0151
USA
 

Manufactured by:
OMRIX biopharmaceuticals Ltd.
MDA Blood Bank,
Sheba Hospital, Ramar-Gan
POB 888, Kiryat Ono 55000
ISRAEL