The 30 year long silicon breast implant litigation saga is as upsetting to learn about as it is hard to believe. Considering the scale and the scope of legal awards that exceeded 4.2 billion dollars in total, and the fact that it brought one of Americas largest corporations to the brink of bankruptcy, it is hard to conceive that this all transpired over a voluntary, elective surgical procedure with no medical value whatsoever.
The first anecdotal reporting of breast augmentation comes from Japan after the second world war. Japanese prostitutes were reported to have injected themselves with paraffin, sponges, and non medical grade silicon, believing that American soldiers were attracted to women with larger breasts. It was not until the sixties that the first medical silicon breast implant was developed for plastic surgical use (Angell 1513). Throughout the sixties and early seventies, silicon breast implants were used safely with few reported problems, with the exception of some reports of localized scar tissue hardening in some cases. Silicon was also regularly used (and still is) to lubricate syringes and in many food processing applications. It was generally believed that silicon was safe for the human body, and, by the time that the FDA began to look into it in 1976, there was no clinical data to support or contradict this. Implants were presumed to be safe as they had been on the market for years with few reported problems as had been the many other medical devices containing silicon that were also being used(Angell 1514-1515)(Worthington, Stallard, Price, Goss 163-164)
It was not until the 80's that some anecdotal reports of illness related to the use of silicon in breast augmentations began to trickle in. It was mainly from overseas and regarding the direct injection of silicon, as opposed to the use of implants, but it was the first reporting of any link between silicon and connective tissue disease. This again raised the attention of the FDA which began to require implant manufacturers provide evidence of their safety in order to keep them on the market. It was perhaps with this gap in evidence, along with the first award of damages to plaintiff Maria Stern for the amount of $211,000, that opened the door to the feeding frenzy of litigation that was to follow. A San Francisco jury found her autoimmune disease to have been caused by her silicon breast implants though there was no scientific evidence to support this (Angell 1514)(Worthington, Stallard, Price, Goss 164-165).
In Maria Stern's case, and in the cases to follow, there was little more than anecdotal evidence and questionable science to back up the claims, but the jury in her case, and those to follow in thousands of other cases were convinced to find against the makers of implants. As related in a paper by legal and medical scholars Worthington, Stallard, Price, and Goss:
“Starting with a 1982 case from Japan, a series of reports hypothesized that