Hysterectomy

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 Women's Health & Urology has developed the GYNECARE MORCELLEX™ Tissue Morcellator which enables minimally invasive hysterectomy.  Furthermore, the company offers other minimally solutions for uterine surgery including the  GYNECARE THERMACHOICE® III Uterine Balloon Therapy System and GYNECARE VERSASCOPE™ Hysteroscopy System, 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 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

INDICATIONS: The GYNECARE THERMACHOICE^® 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; 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^® 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 GYNECARE THERMACHOICE^® UBT System.

PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE^® UBT System. Rx Only

Refer to package insert for complete product information including warnings, precautions, and adverse reactions. RX Only.

Indication
EVITHROM^® Thrombin, Topical (Human) is 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.

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.

Anaphylactic reactions may occur.

Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM^® or bovine thrombin group). The most common adverse event reported was procedural complications and pruritus. None of the adverse events reported was considered casually related to EVITHROM^® administration.

Immunogenicity was evaluated by testing for the development of antibodies to highly purified antigens: human thrombin, human Factor V/Va, bovine thrombin and bovine Factor V/Va. None of the patients treated with EVITHROM^® developed antibodies to human thrombin or to human Factor V/Va.

Direct comparison of incidence of antibody development following administration of EVITHROM^® with incidence of antibody development following administration of other products may be misleading and the clinical significance of these findings is unknown.

Please see Full Prescribing Information.

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.

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

Anaphylactic reactions may occur.

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

*Trademark