Are Silicone Implants Safe?
I think you have to answer this question in two ways -First, to address the perceived silicone safety by the public/patients which has not been substantiated by scientific studies and would be rare if any at all. Secondly you have to address if they have ever been proven to be not safe. The first question is most easy to answer. Breast Implants are safe. There is no know toxicity from silicone gel breast implants. It has been studied by the FDA for more than 3 decades to establish its safety. Silicone is the most common material used in medical devices/implants such as shunts that go from the brain to the abdomen for hydrocephalus and left in a life time, artificial finger joints,syringes, IV's catheters including ones that go next to the heart, surrounding pacemakers and other purposes such as in anti-gas tablets people swallow. The one possible exception may by the PIP implant made in France and generally not available in the USA - and most of the concerns are around use of non-medical silicone, manufacturing problems and do not relate to implants used in the USA by board certified plastic surgeons. This is not to say that breast implants like any implant can have problems and may have to be removed and they 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 or Safety concerns
To answer the perceived safety and toxicity issues of Silicone by the general public; this is quite a different matter. Breast implants have been around since the 1960’s. About 15 years ago Connie Chung ran an expose,"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 don’t cause cancer, lupus, scleroderma, other connective tissue diseases,or a host of other problems.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, part of the National Academy of Sciences is the nation's most prestigious scientific organization. In 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 although may be responsible for localized problems such as hardening or scarring of breast tissue, they do not cause any major diseases such as lupus or rheumatoid arthritis. 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 re-introduction of silicone implants years ago and their approval by the FDA. Interestingly enough, most of the rest of the world re-introduced them many years prior to the USA doing so.
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.