I would want to undergo a breast augmentation and the doctor wants to use silicon gel implants. I am a bit worried about the longevity of the implants and about autoimmunity issues which might occur after surgery. Could you please answer my queries? Thanks.
Do Silicone Breast Implants Cause Autoimmune Disorders?
Doctor Answers 16
Silicone Implants and Their Effects on Autoimmune Disorders
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.
Silicone Implants Don't Cause Autoimmune Disorders But:
The short answer to your question is no! Silicone implants have never been associated with autoimmune disorders by a proper study published in a reputable journal.
In fact many studies have now been done by investigators who were looking for an association and none has been found. Many of these investigators probably had a bias toward proving there was an association, but could find none.
So don't worry about autoimmune disorders. They just aren't going to happen, at least because of your silicone implants.
On the other hand silicone implants can and often do eventually leak after many years. The operation to replace them when they do leak is more involved and requires some additional recovery time. Sometimes leaks can go unnoticed and the FDA has recommended MRI every 5 years to check them.
What this really means is there is more maintenance and responsibility that goes with having silicone implants.
I use these implants frequently, especially in thinner patients as I feel they give a superior result. I avoid them in patients who are worried about the idea of having a silicone implant. My patients who have them are quite please with their results and note they feel more life like.
For those who are worried or never want to deal with the above maintenance issues, saline implants remain an excellent choice and give a good result in all but the thinnest of patients.
The safety of silicone gel breast implants
Let's cut through it all: no study published in a proper medical journal has shown any association - let alone causation - between silicone gel filled breast implants and any systemic disease. None. Period.
BUT, as some skpetics would argue, the study sizes were never large enough to prove the absence of any risk. Of course, that argument could be levied against any study...if something happens 1 in 100,000 times and you only studied 10,000 people, you wouldn't expected to see it...even if you studied 100,000 or 200,000, you might not see it. Simply put, it takes huge numbers to prove something can't ever happen.
As of today, you won't find a respected study in any legitimate medical journal that shows an association between today's breast implants and any disease. All you can find that is negative is anecdote, unreferenced articles in non-medical journals, or studies based upon surveys of women. None of these pass scientific muster.
In the worst case scenario, if there were a risk, it would be extremely small. But how small is small? To those who thinkt here is no benefit to implants, then on a risk benefit ratio, since there is no benefit, then any risk would be too great.
When I discuss this with patients, I basically say this: There is no evidence that shows a link between silicone implants and any disease. But that doesn't mean there couldn't be a tiny risk. If you are worried about that very unlikely risk, or if you are the type to worry about it, or you are going to get freaked out by a non-scientific article you read in a holistic yoga magazine or teh like, then you quite simply can't put them in your body. If you have doubt, just use saline...or get nothing at all. But if you are comfortable with the fact that after having been the most studied medical device in history no evidence of a problem with autoimmune diseases have been shown, then you can consider proceeding.
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Silicone Breast Implants and Autoimmune Disorders
After 14 years of studies it has very well been proven that silicone implants do not cause autoimmune disorders. So you may rest assured, as the FDA released the use of silicone implants to the public in 2006.
Longevity of silicone breast implants
Silicone implants can last a lifetime! However, the current rupture rate is about 1%/year cumulative. So, you will most likely need to replace them at one point in the future. Also, three very well run studies have proven that your risk of getting an autoimmune disease with silicone implants is the same as the general population. The FDA also approved the use of silicone implants for cosmetic surgery several years ago, so you can feel safe in your decision to get silicone breast augmentation. Good luck!
In 1992 the implants were pulled from the market due to health concerns including autoimmune. They were re-released for use in the general public in 2006 after extensive study. The results are that they do not cause autoimmune disease.
Silicone implants and autoimmune disorders
NO, there has been extensive prospective randomized studies showing that there is no increased risk of developing autoimmune disorders when you have silicone gel implants.
The institute of medicine report and the peace of mind concept
One of the main issues that the institute of medicine report addressed in 1999 is the relationship between silicone implants and autoimmune diseases.
This is the actual language of the report published by the National Academies Press” The committee concludes that there is insufficient evidence to support an association of silicone breast implants with defined connective tissue disease. That is, given the repeated finding of no elevated risk, the evidence supports the conclusion that there is no association and therefore no justification for the use of resources in further epidemiological exploration of such an association."
However, if a patient comes to my office and they are convinced that there is a relationship, i simply ask them not to use silicone implants and shift to saline. Peace of mind is extremely important! Hope that helps!
Silicone breast implants causing autoimmune disorders
Had you asked this question in 1991 - we would not have had a good answer for you. But, in the almost 20 years that followed, hundreds of studies have proven the silicone gel implants do NOT cause autoimmune disease. Period. No more so than any other implant does. (Personally, I think it is a national embarrassment that breast implants have been the MOST studied and scrutinized device in medical history; more than pacemakers, defibrillators, hip and knee joints etc. Are breast implants REALLY that more important? You can thank our trusty American lawyers for this huge waste of research funds)
The problem that we Plastic surgeons have is that there is no doubt that a small number of women come down with autoimmune disease. BUT - every scientific study done to date has failed to show a causality or even an association with silicone gel implants.
This has been recognized by the FDA. This has been recognized by the European Common Market and even by the Judge in Birmingham,Alabama who was overseeing the distribution of extortion funds in the Dow Silicone gel lawsuits - he gave specific instructions that the pejorative terminology "silicone disease" etc could not be used in his court room.
Silicone gel implants, like all implants, have their pluses and minuses. Autoimmune disease is NOT a consideration these days.
I hope this was helpful.
SIlicone Gel Does Not cause Autoimmune Disease
Women with silicone implants have developed autoimmune disease, but an equal number of women with the same age and health status without implants also develop the disease. So, as mentioned already, there is no proven link between silicone and the development of autoimmune diseases.
Silicone is used in a wide variety of implanted medical devices and has proven safe over many years.
The breast implant crisis of the early 1990s was a legal fiasco, not a medical one.