Health risks of failed silicone gel breast implants: a 30-year clinical experience.

The purpose of this paper is an assessment of clinically evident systemic health problems associated with failed silicone gel breast implants. 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 breast implant procedures by a single surgeon. This allowed determination of the exact integrity status of 681 implants collectively placed in these 200 patients between 1962 and 1992 and followed clinically for a median of 49 months. The common indications for surgical reexploration in these 200 patients were capsulectomy, open capsulotomy, 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) patients, 104 (15 percent) implant failures were found. The patients' medical records were reviewed with specific attention to diagnoses suggesting immune-related disorders, siliconoma, acquired non-breast malignancies, metachronous breast cancer, and recurrent breast carcinomas. In this very select subgroup of 65 patients with silicone gel breast implants which had failed or were deteriorating, no excess of expected immune-related disorders or malignancies was identified. Our 30-year clinical experience with silicone gel breast implants for augmentation mammaplasty or breast reconstruction failed to demonstrate that clinically evident adverse health problems are incurred by those women who subsequently experience a silicone gel breast implant failure.