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July 5, 2012
Transvaginal Mesh Complications
In 2011, the United States Food and Drug Administration (FDA), have issued a warning to inform patients and healthcare providers of serious complications associated with implantation of surgical mesh for transvaginal repair of Pelvic Organ Prolapse.
Surgical implantation of a vaginal sling is meant to strengthen internal organs, preventing them from coming in contact with each other with the use of mesh tape. The synthetic mesh is implanted transvaginally to repair Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP). The mesh integrates with surrounding tissues, anchoring it to the muscles and ligaments. This allows for more support surrounding the pelvic floor and organs above it. This mesh patch is a permanent implant.
The FDA reports that mesh kits of all brands have a higher than expected incidence of failure. Complications include the following:
- Erosion of mesh into surrounding organs including the bladder
- Extrusion or erosion of the mesh into the vagina
- Dyspareunia (pain during intercourse)
- Recurrence of Pelvic Organ Prolapse
- Various other complications
Revisionary surgery is often required in some of the above listed complications, but because this implantation is meant to be permanent, it is difficult or impossible for all of the mesh to be removed by the surgeons, even with multiple surgeries.
According to the FDA, complications associated with transvaginal mesh implantation can be serious and permanent. Many organs can be damaged including most commonly, the vagina, bladder and bowel. Patients may develop continuous severe discomfort worsened with intercourse. Correcting these problems can be difficult, dangerous and expensive, without guaranteeing any particular results.
If you or a loved one have been implanted with a transvaginal mesh and have had complications, call Rudolph F.X. Migliore, P.C. for a free case evaluation at 631-543-3663 or visit MiglioreLaw.com .