You never know when the latest chapter in the saga can be called the Last Chapter, but there is a significant development recently that may shed even more light on – if not provide an epitaph to – the Silicone Gel Breast Implant Controversy that started in the early 1990’s. Hindsight may be 20/20, but there is never a substitute for good science. When non-scientific forces overwhelm science, even temporarily, the result can be chaos – like what which for a time swirled around every mention of the word “silicone”.
Once the mainstay of breast enlargement procedures, silicone gel implants were all but eliminated from routine use in the early 1990’s as a result of multiple reports of complications related to their use. These complications include a wide range of signs, from systemic problems like autoimmune phenomena, hair loss, joint pain, and fatigue, to local problems such as extravasation of the silicone gel into surrounding tissues. The central issue rapidly became whether or not the systemic problems were due to the gel in the implants; i.e., essentially, whether they occurred in the “implanted” population more often that in the “non-implanted” population. Eventually, the evidence came to indicate that they do not.
In June, 1999, a report was released by the Institute of Medicine (IOM) of the National Academy of Sciences. Key points from a summary of that report, taken from an article in “plastic and Reconstructive Surgery” by Rod Rohrich, Vol. 104, No. 6, pp 1789-8, November 1999, include the following:
1. There is no evidence that silicone implants are responsible for any major diseases of the whole body. Women are exposed to silicone constantly in their daily lives. 2. There is no plausible evidence of a “novel autoimmune disease” because of silicone gel implants. 3. The report shows no increase in preliminary recurrent breast cancer in women with breast implants. Some studies even suggest lower rates of breast cancer in implanted women, and 4. There is no danger in breast feeding. Cow’s milk and infant formulas have a far higher level of silicon, a silicone component, then mother’s milk. Breast milk is the best food for babies.
It is important to note that, the above not withstanding, there is a range of “local” and surgical problems such as scar tissue formation (capsules) that have been linked to silicone gel breast implants, and that were not the focus of this report. Some of these can be seen with saline-filled implants as well. In terms of the widely-reported systemic effects of silicone gel breast implants, however, this report concludes that the dangers appear to have been overstated. And those conclusions are echoed in a just-released article in The Journal of Medicine (Volume 342, Number 11, 781-790, March 16, 2000), which states that “…there was no evidence of an association between breast implants in general, or silicone-gel-filled breast implants specifically, and any of the individual connective-tissue diseases combined, or other autoimmune or rheumatic conditions… the elimination of implants would not be likely to reduce the incidence of connective-tissue diseases.”
While the final words may not have been written yet, things have changed quite a bit – and some would say they’ve come full circle – in the past decade.