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July 1995

Performance Standards for Medical Device Approvals

Author Affiliations

From the Department of Pathology, University of Medicine and Dentistry of New Jersey—Robert Wood Johnson Medical School, Piscataway, NJ (Dr Silver), and the Department of Otolaryngology, Robert Wood Johnson University Hospital and St Peter's Medical Center, New Brunswick, NJ (Dr Glasgold).

Arch Otolaryngol Head Neck Surg. 1995;121(7):719-721. doi:10.1001/archotol.1995.01890070007003

As a result of the controversy concerning the safety of silicone and other permanent implants, the Food and Drug Administration's Center for Drug Evaluation and Research has conducted a rereview of a small sample of applications by manufacturers. The Food and Drug Administration's "Final Report of the Committee for Clinical Review" found that clinical trials were carried out with little planning or attention to the purpose of the study. It is urged that the medical profession assist in the establishment of complication rates associated with each type of implant and surgical procedure and that surgeons and professional societies need to be more critically involved in the setting up of performance standards for implants prior to their approval by the Food and Drug Administration. To avoid a repeat of the silicone gel—filled breast implant problem, scientists and clinicians are urged to take a more proactive position on the development of performance standards for implants currently being used.

(Arch Otolaryngol Head Neck Surg. 1995;121:719-721)