Use of vaginal mesh in the face of recent FDA warnings and litigation.
Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of "transvaginal mesh" results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records. The purpose of this commentary is not to deter gynecologic surgeons from using transvaginal mesh when appropriate, but to provide an overview of current medical-legal controversies and stress the importance of documenting informed consent.
Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, TX 77555-0587, USA.
Sara J
SJ
Mucowski
Catalin
C
Jurnalov
John Y
JY
Phelps
D001291:Attitude of Health Personnel; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D007603:Jurisprudence; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D010818:Practice Patterns, Physicians'; D011475:Prosthesis Failure; D018570:Risk Assessment; D053825:Suburethral Slings / Q000009:adverse effects*; D013526:Surgical Mesh / Q000009:adverse effects* / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence; D014550:Urinary Incontinence, Stress / Q000175:diagnosis / Q000601:surgery*; D014596:Uterine Prolapse / Q000175:diagnosis / Q000601:surgery*