People are going in to have implants removed due to toxicity. How common is this? Thanks.
How Common is it For People to Get Their Breasts Removed For Toxicity in Silicone?
Doctor Answers 6
Are Silicone Implants Toxic?
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 any at all. Secondly you have to address if they have ever been proven to be toxic. The first question is most easy to answer. 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 !
To answer the perceived toxicity 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.
US Breast Implants Do Not Have Toxicity Risks
The simple answer is none. There is no medical evidence that the silicone gel used in breast implants that are currently approved by the U.S. FDA have any associated 'toxicities' or pose any medical harm to the implanted patient. You may be referring to the PIP breast implants from a French manufacturer that are used in other parts of the world. There were some manufacturing issues which has led to a rush to have those type of breast implants removed, although whether any such toxicity or harmful risks exist with them is undetermined.
Silicone implants and toxicity
The silicone implants were removed from the market for about 15 years because of fears without scientific evidence. After extensive research the fears were not supported by the research and the FDA placed the implants back on the market.
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Toxicity from silicone gel breast implants
Actually there is no know toxicity from silicone gel breast implants, and the implants have been studied over decades to establish the safely and effectiveness for the product. It is very uncommon, and indeed unnecessary to have implants removed for "toxicity". Implants distributed by PIP is a different situation as they were not a 'medical' grade product.
Breast implants and silicone toxicity
Silicone is one of the most common substances used in medical devices such as syringes, IV's catheters and so on for coating and other purposes. I have not heared of anyone having toxicity from silicone. Breast implants are removed for reasons such as capsular contracture, rupture, deflation, infection, increase or decrease in breast size, pain and so on. Some women had them removed due to concerns about possibility of connective tissue dz.(although extensive studies by the implant companies and FDA have found no corolation between the two).
I have never heard of some one having silicone toxicity from breast implants.
Implant removal for silicone toxicity
I have never removed a silicone implant for toxicity in over 20 years in practice. I have removed them for capsular contraction, for rupture, to change size or to switch to saline. I have had patients who wanted them removed for a variety of reasons including fear from what they heard on the media but I have never seen any toxicity that I was aware of. Hope this helps.