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Performance standards for medical device approvals

F H Silver1, A I Glasgold

  • 1Department of Pathology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, Piscataway, USA.

Archives of Otolaryngology--Head & Neck Surgery
|July 1, 1995
PubMed
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The Food and Drug Administration (FDA) reviewed permanent implant safety, finding clinical trials lacked planning. Medical professionals must establish complication rates and performance standards for implants to prevent future safety issues.

Area of Science:

  • Medical Device Safety
  • Regulatory Science
  • Clinical Trial Design

Background:

  • Controversy surrounding the safety of silicone and permanent implants.
  • The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research initiated a review of implant applications.

Purpose of the Study:

  • To evaluate the quality of clinical trials for permanent implants.
  • To recommend improvements in the regulatory process for medical devices.
  • To address concerns raised by the silicone gel-filled breast implant issue.

Main Methods:

  • Rereview of a small sample of manufacturer applications for permanent implants.
  • Analysis of the FDA's "Final Report of the Committee for Clinical Review".

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Main Results:

  • Clinical trials for implants were found to be poorly planned and lacked clear objectives.
  • A need exists for establishing complication rates for various implants and surgical procedures.

Conclusions:

  • The medical profession should actively participate in setting performance standards for implants.
  • Surgeons and professional societies must be more involved in implant approval processes.
  • Proactive development of performance standards is crucial to prevent future implant safety problems.