THE INTRODUCTION OF silicone-gel implants in the early 1960s was a boon for manufacturers who accurately predicted a lucrative market, and for plastic surgeons who sought an effective and safe method to augment and replace breasts. Sales of the devices soared even as complaints of breakage and leakage began to emerge. Reports began surfacing in the mid-1980s that revealed a number of detrimental health effects which appeared to be directly associated with the silicone-gel breast implants.

After a long and heated battle over product safety, in 1992 the Food and Drug Administration (FDA) limited the use of silicone-gel breast implants to women who needed reconstructive surgery after mastectomies because of the high risk of possible health dangers. The debate over the marketing and safety of the ...