Current status of liquid injectable silicone.

Since the inception of the recently concluded formal study, liquid injectable silicone has been both used and abused by many. Reports in both lay and professional literature reflect this experience in the form of a wide range of opinions and judgments regarding the use of this material in corrective surgery. Those intimately involved in the former study agree that, used properly, liquid injectable silicone appears to have redeeming value in at least a limited group of problem situations. These investigators further agree that its general use could lead to many problems unless its limited scope of usefulness and proper use are known, accepted, and abided by those using it. To satisfy the lingering doubts raised by the many negative reports, further controlled study is also indicated. Until there is a method of control over the general clinical use of liquid silicone and until persistent questions on its safety and efficacy, over a protracted period of time, are answered, the investigators are convinced that the substance should not be made generally available. Designed before the complexity required of a proper study was appreciated, the original research protocol lacked sufficient detail and was broad and vague in scope. The Dow-Corning Company and its investigators therefore recommended the termination of the study and set about planning a new research protocol that would supply more complete information in a much more restricted area of clinical need. This was done with the cooperation of the American Society of Plastic and Reconstructive Surgeons and was submitted for approval by the FDA along with an expanded group of clinical investigators selected with the help of the ASPRS, with consideration given to their even geographic distribution. This new research study was submitted to the FDA and approved. Accordingly, on March 1, 1978, a much more vigorous, detailed, and restrictive study, confined to major tissue defects of the head and neck, was resumed by a larger group of investigators representing the ASPRS supervised by a medical monitor acceptable to all. Hopefully, this study, which will occupy a period of 7 years and a limited number of patients, plus the rigorous efforts to trace and document those involved in the earlier study and the tracking down and full documentation of all known complications, will ultimately bring the true status of liquid injectable silicone into proper and generally acceptable perspective.