INDICATIONS:

The GYNECARE THERMACHOICE^® 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: 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; or who is pregnant or who wants to become pregnant in the future.

POTENTIAL ADVERSE EFFECTS that may occur 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); 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 a perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur if the heater is activated.

CAUTION:

Endometrial ablation procedures using the GYNECARE THERMACHOICE^® 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^® System. Rx Only.

INDICATIONS:

The GYNECARE TVT™ Family of Products: GYNECARE TVT SECUR™, GYNECARE TVT™, GYNECARE TVT™ with Abdominal Guides, and GYNECARE TVT™ Obturator System are intended to be used in women as suburethral slings for the treatment of stress urinary incontinence (SUI).

CONTRAINDICATIONS:

As with any suspension surgery, these procedures should not be performed in pregnant patients.Additionally, because the PROLENE* Polypropylene Mesh will not stretch significantly, it should not be performed in patients with future growth potential including women with plans for future pregnancy.

WARNINGS & PRECAUTIONS:

ADVERSE REACTIONS:

GYNECARE PROLIFT^® Total Pelvic Floor Repair System
GYNECARE PROLIFT^® Anterior Pelvic Floor Repair System
GYNECARE PROLIFT^® Posterior Pelvic Floor Repair System
GYNECARE PROLIFT+M™ Total Pelvic Floor Repair System
GYNECARE PROLIFT+M™ Anterior Pelvic Floor Repair System
GYNECARE PROLIFT+M™ Posterior Pelvic Floor Repair System

GYNECARE PROLIFT^® and GYNECARE PROLIFT+M™ are intended for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect. GYNECARE PROLIFT^® and GYNECARE PROLIFT+M™ should not be used in infants, children, pregnant women, or women planning future pregnancies. GYNECARE PROLIFT^® and GYNECARE PROLIFT+M™ should not be used in the presence of active or latent infections or cancers of the vagina, cervix, or uterus. All surgical procedures present risks. Complications associated with the procedure include injury to blood vessels or nerves of the pelvis, difficulty urinating, pain, scarring, bladder and bowel injury. There is also a risk of the mesh material becoming exposed into the vaginal canal. Mesh exposure can be associated with pain during intercourse for the patient and her partner. Exposure may require treatment such as vaginal medication or removal of the exposed mesh.

Synthetic mesh is a permanent medical device implant. Therefore, you should carefully discuss with your doctor and understand the benefits and risks of mesh implant surgery before deciding how to treat your condition.

INDICATIONS:

GYNECARE INTERCEED^® Absorbable Adhesion Barrier is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles.

CONTRAINDICATIONS:

The use of GYNECARE INTERCEED^® Absorbable Adhesion Barrier is contraindicated in the presence of frank infection. GYNECARE INTERCEED^® is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.

WARNINGS:

The safety and effectiveness of GYNECARE INTERCEED^® in laparoscopic surgery or any procedures other than open (laparotomy) gynecologic microsurgical procedures have not been established.

Postoperative adhesions may be induced by GYNECARE INTERCEED^® application if adjacent tissues (eg, ovary and tube) and structures are coapted or conjoined by the device, or if GYNECARE INTERCEED^® is folded, wadded or layered. Postoperative adhesions may occur in the presence of GYNECARE INTERCEED^® if meticulous hemostasis is not achieved prior to application. As with all foreign substances, GYNECARE INTERCEED^® should not be placed in a contaminated surgical site.

PRECAUTIONS:

Use only a single layer of GYNECARE INTERCEED^®, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of GYNECARE INTERCEED^®. Care should be exercised in applying GYNECARE INTERCEED^® to a pelvic organ not to constrict or restrict it. If the product comes in contact with blood prior to completing the procedure, it should be discarded, as fibrin deposition cannot be removed by irrigation and may promote adhesions formation. Ectopic pregnancies have been associated with fertility surgery of the female reproductive tract. No data exist to establish the effect, if any, of GYNECARE INTERCEED^® on the occurrence of ectopic pregnancies. No adequate studies have been conducted in women who have become pregnant within the first month after exposure to GYNECARE INTERCEED^®. No teratogenic studies have been performed. Therefore, avoidance of conception should be considered during the first complete menstrual cycle after use of GYNECARE INTERCEED^®. The safety and effectiveness of using GYNECARE INTERCEED^® in combination with other adhesion prevention treatments have not been clinically established. GYNECARE INTERCEED^® is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNECARE INTERCEED^® must not be resterilized. Foreign body reactions may occur in some patients. Interactions may occur between GYNECARE INTERCEED^® and some drugs used at the surgical site. Pathologists examining sites of GYNECARE INTERCEED^® placement should be made aware of its usage and of the normal cellular response to GYNECARE INTERCEED^® ‘to facilitate proper evaluation of specimens'.

ADVERSE REACTIONS:

The type and frequency of adverse events reported are consistent with events typically seen following surgery. Postsurgical adhesions may occur in the presence of GYNECARE INTERCEED^®.