I think you have to answer this question in two ways:
- First, to address the perceived silicone toxicity by the public/patients which has not been substantiated by scientific studies and would be rare if it occurred at all.
- Secondly you have to address if they have ever been proven to be toxic.
The first question is easy to answer: there is no known toxicity from silicone gel breast implants. It has been studied by the FDA for more than three decades to establish its safety. Silicone is the most common material used in medical devices/implants. Examples include shunts that go from the brain to the abdomen (for hydrocephalus) which are left in for a lifetime, artificial finger joints, syringes, IVs, catheters (including ones that go next to the heart), surrounding pacemakers, and even oral anti-gas tablets.
The one possible exception may by the PIP implant made in France (generally not available in the USA). Most of the concerns about the PIP implant were about the use of non-medical silicone and manufacturing problems, and do not relate to implants used in the United States by board-certified plastic surgeons. This is not to say that breast implants, like any implant, can have problems; they may have to be removed and are not meant to last a life time. Common reasons for replacement include: capsular contracture, rupture, infection, change in breast size, and pain—but not for toxicity.
To answer the perceived toxicity of Silicone by the general public—this is quite a different matter.
Breast implants have been around since the 1960s. About 15 years ago Connie Chung ran an exposé, Face to Face with Connie Chung, claiming silicone implants were responsible for different health problems. This led to lawsuits, a huge windfall for lawyers, and the subsequent ban on silicone implants for first-time breast augmentation patients went into effect. They were always available for breast reconstruction (e.g. after mastectomy) and replacement of existing silicone breasts. Also, please note that saline implants are still covered by a silicone envelope.
Soon after, a ban on silicone implant use became worldwide. This lasted for years until more than 100 clinical studies showed that breast implants aren’t related to cancer, lupus, scleroderma, other connective tissue diseases, or the host of other problems they were accused of causing.
June 1999, The Institute of Medicine released a 400-page report prepared by an independent committee of 13 scientists. They concluded that although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause any major diseases such as depression, chronic fatigue syndrome, lupus or rheumatoid arthritis, etc.
The Institute of Medicine is part of the National Academy of Sciences, the nation’s most prestigious scientific organization.
Eventually, a federal judge dismissed/rejected the lawsuits, declaring them junk science and ended for the most part the barrage of lawsuits. This led to the present reintroduction of silicone implants years ago and their approval by the FDA. Interestingly enough, most of the rest of the world reintroduced them many years prior to the United States.
I happened to be in private practice in Orange County, California during this time of confusion by the public and media. My office was deluged with patients, mostly new ones having had surgery elsewhere, believing they were being poisoned by their breast implants. Most of my consults lasted about an hour and were spent trying to convince patients that they did not need surgery. In fact, I told them that they would not even have to pay for the consultation if they decided to not have surgery. Most of the patients had no problems but were simply gripped with general panic, mass hysteria, and fear from all the media hype and false information. Despite my strong advice to not remove their implants, many insisted upon that action. As a footnote, the vast majority of these patients that I removed implants eventually returned to my office for silicone gel replacement.
—Larry S. Nichter, MD FACS