GYNECARE PROLIFT+M™ Pelvic Floor Repair System Launched In US For Use In Pelvic Organ Prolapse Surgery

Ethicon Women’s Health & Urology, a division of Ethicon, Inc., a Johnson & Johnson Company, announced that the GYNECARE PROLIFT+M™ Pelvic Floor Repair System is now available in the United States for use in surgery to treat pelvic organ prolapse. GYNECARE PROLIFT+M™ includes a partially absorbable mesh for increased biocompatibility and improved patient comfort.

The GYNECARE PROLIFT+M™ System is indicated for tissue reinforcement and long-lasting stabilization of fascial structures (fibrous organ connective tissues) of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or as a bridging material for defective fascia. The mesh is implanted using the tension-free vaginal mesh (TVM) technique, a procedure involving a small incision in the vaginal wall.

The GYNECARE PROLIFT+M™ System includes anatomical guides, retrieval devices, cannulas, and the new partially absorbable mesh implant. This lightweight polypropylene mesh is less dense and has larger pores than previous meshes, which could lead to decreases in reactive scar formation and a reduction in inflammatory response during healing. This mesh also has properties that help the surgeon place the mesh more easily because it resists wrinkling and folding, and it has increased longitudinal elasticity while maintaining lateral support to ensure pliability after surgery. The new design may improve vaginal wall compliance and allow for better tissue incorporation.

“Thousands of women have been treated successfully with the GYNECARE PROLIFT+M™ System for pelvic organ prolapse. With GYNECARE PROLIFT+M™, surgeons now have an option that is specifically designed to offer patients even higher levels of comfort with improved biocompatibility to work with the body’s natural healing process while correcting the prolapse,” said Salil Khandwala, MD, Clinical Associate Professor, Wayne State University, Michigan.

Pelvic organ prolapse (POP) is characterized by the abnormal descent or herniation of pelvic organs. Forty percent of women aged 40 to 79 are affected by pelvic organ prolapse, a condition in which weak pelvic floor muscles cause the pelvic organs to fall out of place. By age 80, more than one out of every 10 women will have undergone surgery for prolapse or urinary incontinence. Pelvic organ prolapse can affect a woman’s daily life, limiting physical activity and sexual intimacy. Each year approximately 200,000 inpatient procedures are performed in the US to correct POP.

All surgical procedures present some risks. Complications associated with surgical treatment for POP include injury to blood vessels 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.

GYNECARE PROLIFT+M™ was developed by Ethicon Women’s Health & Urology.

Source: Johnson & Johnson

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