title: Lessons from the past: directions for the future. Do new marketed surgical procedures and grafts produce ethical, personal liability, and legal concerns for physicians?
abstract: 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.
authors.affiliation: University of California, Irvine, USA. catalinaisland1@cs.com
authors.forename: Donald R
authors.initials: DR
authors.lastname: Ostergard
mesh_terms: D018795:Device Approval / Q000592:standards; D004992:Ethics, Medical; D019317:Evidence-Based Medicine / Q000941:ethics* / Q000331:legislation & jurisprudence; D005260:Female; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards; D016365:Liability, Legal; D008318:Malpractice; D008389:Marketing of Health Services / Q000941:ethics* / Q000331:legislation & jurisprudence*; D008875:Middle Aged; D028701:Patient Rights / Q000331:legislation & jurisprudence; D053825:Suburethral Slings; D014481:United States; D014486:United States Food and Drug Administration; D014549:Urinary Incontinence / Q000601:surgery*; D013519:Urogenital Surgical Procedures / Q000009:adverse effects / Q000191:economics / Q000941:ethics* / Q000331:legislation & jurisprudence; D014596:Uterine Prolapse / Q000601:surgery*