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Risk Information

GYNECARE PROLIFT® and GYNECARE PROLIFT+M® Pelvic Floor Repair Systems

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.

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

Please read Risk Information for important information about intended uses as well as relevant risks, warnings, precautions, adverse events and contraindications for the Ethicon products featured on this page.

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