One of the most important problems in the area of biomaterials is the issue of safety and what methods should be used for determining degrees of safety. No device is entirely risk-free for all patients at all times, so the relationship between risk and safety is important for both FDA and industry. And the agency's approach to these questions has changed dramatically over the years. An example of that is the use of silicone in breast implants. Not only by the scientific community but by many different industries.
Silicone continues to be used ubiquitously in foods and many other products.
But in the medical industry, class action suits have allowed junk science to determine the risk of using this material. When a doctor testifies that three out of four breast implant patients he has examined show signs of autoimmune disease, that implies that three out of four women with breast implants will develop this disease. But no matter how many such stories are told, the plural of anecdote is not data. Unfortunately, people sometimes get sick and encounter health problems. And it is human nature in those situations to look for something to blame other than aging or some naturally occurring disease process.