Healthy Skepticism Library item: 11023

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Ostergard DR.
Lessons from the past: directions for the future? Do new marketed surgical procedures and grafts produce ethical, personal liability, and legal concerns for physicians
Int Urogynecol J Pelvic Floor Dysfunct. 2007 June; 18:(6):591-8 Epub 2007 Mar 16
http://www.springerlink.com/content/j38417833325m526/

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.

Keywords:
MeSH Terms: Device Approval/standards Ethics, Medical Evidence-Based Medicine/ethics* Evidence-Based Medicine/legislation & jurisprudence Female Human Experimentation/ethics Human Experimentation/legislation & jurisprudence* Humans Informed Consent/ethics Informed Consent/standards Liability, Legal Malpractice Marketing of Health Services/ethics* Marketing of Health Services/legislation & jurisprudence* Middle Aged Patient Rights/legislation & jurisprudence Suburethral Slings* United States United States Food and Drug Administration Urinary Incontinence/surgery* Urogenital Surgical Procedures/adverse effects Urogenital Surgical Procedures/economics Urogenital Surgical Procedures/ethics* Urogenital Surgical Procedures/legislation & jurisprudence Uterine Prolapse/surgery*