Incontinence Research Today is a free monthly online journal that collates and summarizes the latest research about Incontinence, including details on urinary incontinence, bladder control, treatment, causes.

Lessons from the past: directions for the future. Do new marketed surgical procedures and grafts produce ethical, personal liability, and legal concerns for physicians?

Ostergard DR

University of California, Irvine, USA. catalinaisland1@cs.com

New procedures and materials for incontinence and prolapse are proliferating rapidly. Surgical procedures were developed by physicians and carried their names, but over the last 15 years, these procedures are developed by industry and bear the trade names of the companies selling the kits needed to perform them. The Food and Drug Administration (FDA) approves devices, not procedures, and does not require submission of efficacy or adverse-event data to gain this approval by the 510-K process. Evidence-based medicine is lacking in the performance of these procedures that may be considered experimental by an insurance company or malpractice carrier with denial of payment or coverage. Physicians and hospitals are exposing themselves to financial, legal, and ethical risks when performing or allowing such procedures to be performed. Informed consent from the patient cannot be obtained. We must not confuse medical marketing with evidence-based medicine.

Published 1 June 2007 in Int Urogynecol J Pelvic Floor Dysfunct, 18(6): 591-8.
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