What are the TransVaginal Mesh Products?
Many different medical manufacturers produce vaginal mesh and gynecologic mesh used in transvaginal repair procedures. The complications associated with the use of transvaginal mesh in pelvic organ prolapse repairs involve many of the brands of available surgical mesh. In 2012, the Food and Drug Administration ordered some of them to conduct studies to evaluate the safety and effectiveness of transvaginal mesh products:
- American Medical Systems, which manufactures large-pore polypropylene mesh, the Apogee system, the Elevate prolapse repair system and the Miniarc® single incision sling system.
- Boston Scientific Corp., which manufactures the Pinnacle Duet™ pelvic floor repair kit, Pinnacle® posterior pelvic floor repair kit, Pinnacle® anterior-apical pelvic floor repair kit, Lite pelvic floor repair kit, and surgical mesh.
- C.R. Bard, Inc., which makes the Avaulta® Solo, Avaulta® Plus and Avaulta® Biosynthetic surgical mesh kits that are implanted in the front or back vaginal compartments to support pelvic organs that have fallen or shifted.
- Ethicon, Inc., which manufactures the Gynecare TVT Secure™ system, Gynecare Proflift +M™ pelvic floor repair systems, Gynecare Prosima pelvic floor repair systems, Gynecare Gynemesh M™, and Gynemesh prolene soft nonabsorbable synthetic surgical mesh for pelvic floor repairs.
- Organogenesis, Inc., which manufactures Fortaflex surgical mesh.
- Pegasus Biologics, which manufactures Orthadapt surgical mesh and Orthadapt Bioimplant.
- Prosurg, Inc., which manufactures the Easy Lift™ pelvic organ repair system and the Minisling™, a single incision urethral sling for treatment of stress urinary incontinence.
- Proxy Biomedical, Ltd., which manufactures Polyform synthetic mesh, a product distributed by Boston Scientific to repair pelvic organ prolapse.
- RTI Biologics, Inc., which produces Tutopatch Tutomesh®, which is intended for repair of soft tissue weakness, including vaginal prolapse and reconstruction of the pelvic floor.
- Tyco Healthcare, which developed IVS Tunneller® product, which treats both pelvic organ prolapse and stress urinary incontinence in women.