PERFORMANCE STANDARDS FOR MEDICAL DEVICE APPROVALS

As a result of the controversy concerning the safety of silicone and o ther permanent implants, the Food and Drug Administration's Center for Drug Evaluation and Research has conducted a rereview of a small samp le of applications by manufacturers. The Food and Drug Administration' s ''Final Report of the Committee for Clinical Review'' found that cli nical 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 o f implant and surgical procedure and that surgeons and professional so cieties need to be more critically involved in the setting up of perfo rmance standards for implants prior to their approval by the Food and Drug Administration. To avoid a repeat of the silicone gel-filled brea st implant problem, scientists and clinicians are urged to take a more proactive position on the development of performance standards for im plants currently being used.