Breast Implants — Protection or Paternalism?

Abstract

IN this issue of the Journal, Dr. David A. Kessler, the commissioner of the Food and Drug Administration, presents his rationale for removing silicone-gel breast implants from the market.¹ Each year about 150,000 women receive these implants — 80 percent for the purpose of breast augmentation and almost all the others for reconstruction after mastectomy for cancer. Kessler reminds us that under the 1976 Medical Device Amendments to the federal Food, Drug and Cosmetic Act, manufacturers are required to demonstrate the safety and effectiveness of drugs and devices. Since breast implants were already on the market in 1976, their . . .