Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2007 Jun;18(6):591-8.
doi: 10.1007/s00192-007-0330-z. Epub 2007 Mar 16.

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

Affiliations

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

Donald R Ostergard. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jun.

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.

PubMed Disclaimer

Comment in

References

    1. J Urol. 1994 Dec;152(6 Pt 2):2316-20 - PubMed
    1. Am J Obstet Gynecol. 2006 Dec;195(6):1762-71 - PubMed
    1. J Urol. 1987 Sep;138(3):568-70 - PubMed
    1. Obstet Gynecol. 1967 Oct;30(4):537-46 - PubMed
    1. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(5):328-9 - PubMed

MeSH terms

LinkOut - more resources