Risk Information

GYNECARE THERMACHOICE^® III Uterine Balloon Therapy System
Essential Product Information - Patient

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 or pathologic condition in which weakness of the myometrium could exist, such as history of previous classical Cesarean sections or fibroid surgery; 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, rupture of the uterus; post-procedure symptoms such as pain, fever, nausea, vomiting and difficulty with defecation or micturition; hematometra; 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:

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. 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 do not eliminate the potential for endometrial carcinoma (uterine cancer) or premalignant changes of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such conditions. The GYNECARE THERMACHOICE^® III procedure and hysteroscopic tubal occlusion/sterilization cannot be performed on the same day. The GYNECARE THERMACHOICE^® III procedure should only be performed after the 3-month tubal occlusion confirmation test.

PRECAUTIONS:

Certain types of Cesarean section may increase the risk of patient injury. 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. You may also visit www.PelvicHealthSolutions.com.

GYNECARE TVT™ Family of Products Essential Product Information

INDICATION

The GYNECARE TVT™ Family of Products: GYNECARE TVT SECUR™, GYNECARE TVT™, GYNECARE TVT EXACT™ Continence System, GYNECARE TVT™ with Abdominal Guides, GYNECARE TVT™ Obturator System and GYNECARE TVT ABBREVO™ Continence 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

Do not use the GYNECARE TVT™ Family of Products for patients who are on anti-coagulation therapy.
Do not use the GYNECARE TVT™ Family of Products, for patients who have a urinary tract infection.
Bleeding or infection may occur post-operatively.
Transient leg pain lasting 24-48 hours may occur and can usually be managed with mild analgesics after a GYNECARE TVT™ Obturator or GYNECARE TVT ABBREVO™ procedure.
Since no clinical information is available about pregnancy following sub-urethral sling procedure with the GYNECARE TVT™ Family of Products, the patient should be counseled that future pregnancy may negate the effects of the surgical procedure and the patient may again become incontinent.
Since no clinical information is available about vaginal delivery following sub-urethral sling procedure with the GYNECARE TVT™ Family of Products, in case of pregnancy, delivery via cesarean section should be considered.
Post-operatively, refrain from heavy lifting and/or exercise (e.g. cycling, jogging) for at least three to four weeks and to refrain from intercourse for one month. The patients can usually return to other normal activity after one or two weeks.
Contact your surgeon immediately if there is burning sensation during urination, unusual bleeding, problems voiding or other problems.

ADVERSE REACTIONS

Punctures or lacerations or injury to vessels, nerves, bladder, urethra, or bowel may occur during instrument passage and may require surgical repair.
Improper placement of the TVT device may result in incomplete or no relief from urinary incontinence or may cause urinary tract obstruction.
Transitory local irritation at the wound site and a transitory foreign body response may occur. This could result in extrusion, erosion, fistula formation or inflammation.

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

GYNECARE PROLIFT^™ and GYNECARE PROLIFT+M^™ Patient ESSENTIAL PRODUCT INFORMATION

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

INDICATIONS

The GYNECARE PROLIFT™ and GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems, are indicated 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.

CONTRAINDICATIONS

GYNECARE GYNEMESH^™ PS Nonabsorbable PROLENE^™ Soft Mesh and GYNECARE GYNEMESH M^™ Partially Absorbable Mesh should not be used in infants, children, pregnant women, or women planning future pregnancies, as the mesh will not stretch significantly as the patient grows.
The GYNECARE PROLIFT™ and PROLIFT+M™ Systems should not be used in the presence of active or latent infections or cancers of the vagina, cervix, or uterus.

WARNINGS & PRECAUTIONS

Notify your physician if you are on blood thinners or have a vaginal infection.
After surgery, refrain from intercourse, heavy lifting and/or exercise until your physician determines that it is suitable to return to these activities.
Transient leg pain may occur.
Contact your physician immediately if unusual pain, bleeding, or other problems occur.
Prolapse repair may unmask pre-existing incontinence conditions or impair normal voiding.

ADVERSE REACTIONS

All surgical procedures present risks. Complications associated with the procedure include injury to blood vessels or nerves of the pelvis, difficulty urinating, pain, scarring, pain with intercourse, 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.
You should carefully discuss with your doctor and understand the benefits and risks of mesh implant surgery before deciding how to treat your condition. You may also call 1-888-GYNECARE (1-888-496-3227) to speak with a nurse.

GYNECARE INTERCEED^® Absorbable Adhesion Barrier

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^®.

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