Transvaginal Mesh Implants
Surgical mesh is a metallic or polymeric screen used by surgeons since the 1950’s to treat a variety of medical conditions, both in men and women. In the 1970’s, gynecologists began using surgical mesh to treat pelvic organ prolapse (POP) in women. Then, in the 1990’s, the use of surgical mesh progressed to treat stress urinary incontinence (SUI) in women as well. This new treatment for SUI came about as an extension of surgical approaches for treating POP through the implantation of mesh abdominally to surgical implantation of mesh transvaginally. Unfortunately for many women who have had surgical mesh implanted transvaginally, there have been significant reports of postsurgical complications associated with these procedures. Many contend that these complications – which include movement of the mesh from where it was implanted, shrinkage of the mesh, organ perforation, pain, infection, bleeding, and more – are the result of its use in a narrow anatomical area, the involvement of multiple organs, and the general motion of the area.
The big unanswered question surrounding the implantation of surgical mesh transvaginally is safety. The safety of the transvaginal surgical mesh products currently on the market has never been assessed as part of the FDA approval process. Instead, these products came to market through an alternative FDA approval system which simply approved them for marketing based on their similarity to another product whose safety the FDA had assessed (and even that product was quickly pulled from the market because of such complications). The reasonableness of this entire process has been called into question by the complications women have experienced with these mesh products. On July 29, 2011, the Institute of Medicine released a report essentially calling for this alternative approval process to be eliminated. We expect this topic to be an active one over the next several years.
It is important to note that the complications women experience from these surgical mesh products are not necessarily immediate. Some complications do not arise for years. If you have had surgery to treat POP or SUI, please contact The Spencer Law Firm to confidentially discuss the circumstances of your treatment with one of our female attorneys. Even though complications may not reveal themselves for years, the law does limit the time in which legal action may be taken to protect your rights. If you have been fortunate enough not to experience problems from your surgery yet, waiting to see if problems do arise may actually jeopardize your legal rights. We encourage you to contact a lawyer today.