HEALTH RISKS OF FAILED SILICONE GEL BREAST IMPLANTS - A 30-YEAR CLINICAL-EXPERIENCE

The purpose of this paper is an assessment of clinically evident syste mic health problems associated with failed silicone gel breast implant s. A computer search of the medical records of 2033 patients receiving implants in the years 1962-1992 revealed that between 1970 and 1992, 200 women 14 to 75 years of age underwent secondary silicone gel breas t implant procedures by a single surgeon. This allowed determination o f the exact integrity status of 681 implants collectively placed in th ese 200 patients between 1962 and 1992 and followed clinically for a m edian of 49 months. The common indications for surgical reexploration in these 200 patients were capsulectomy, open capsulectomy, or implant exchange/removal. All patients had a minimum clinical follow-up of 6 months. Surgical findings revealed that 577 (85 percent) implants were intact in 135 (67.5 percent) patients and that in 65 (32.5 percent) p atients, 104 (15 percent) implant failures were found. The patients' m edical records were reviewed with specific attention to diagnoses sugg esting immune-related disorders, siliconoma, acquired nonbreast malign ancies, metachronous breast cancer, and recurrent breast carcinomas. I n this very select subgroup of 65 patients with silicone gel breast im plants which had failed or were deteriorating, no excess of expected i mmune-related disorders or malignancies was identified. Our 30-year cl inical experience with silicone gel breast implants for augmentation m ammaplasty or breast reconstruction failed to demonstrate that clinica lly evident adverse health problems are incurred by those women who su bsequently experience a silicone gel breast implant failure.