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Risk Information

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.

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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