The sensational media and lawsuit publicity about breast implants has not made it any easier to find out the facts. In the 1980s, a few anecdotes about women with silicone gel breast implants and connective tissue disease began appearing, and the first multimillion dollar suit against implant manufacturers was filed. The issue snowballed, with more women claiming problems and more lawsuits, public outcry, fear, and distrust. Women with implants reported feeling like walking time bombs and as if any ache or pain, whatever its cause, must be related to their implants. In 1992, after impassioned public hearings, FDA Commissioner David Kessler banned silicone gel implants altogether for the time being, except for use in clinical trials of breast reconstruction after breast cancer.
Breast implants filled with saline remain available, although they faced new safety tests also.
What got lost in the shouting was Kessler's clear statement that the ban was imposed not because there was any clear scientific evidence that the implants were unsafe, but because they had not yet been proven safe. Now the manufacturers would have to carry out clinical research under very strict conditions to see whether the implants were indeed safe, something that should have been done years before. Women making personal decisions about implants need to look at the quality of the evidence, pro and con. Some animal studies and immunological investigations have been reported, but many questions remain about the quality of the research. The most believable research on implants would be epidemiological studies, which compare two otherwise similar groups of women, one group with and one group without implants.