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How Safe is Silicone As of March 2012? What is the Statistics of Getting Silicone Toxicity?

I was considering getting silicone as a breast implant, since it is the preferred choice by women over saline. But how safe is it, even if it is FDA approved? Any statistics regarding "getting sick" over time?

Doctor Answers 6

Is there evidence of silicone toxicity and is it safe?

Saline, or natural body fluid implants are my preference. However I have never read a reputable medical article proving silicone toxicity or silicone causing any systemic disease. When I change silicone implants that have been in place for more than twenty years it is rare to find implants that do not show signs of silicone outside the implant shell. Small bits of silicone migrate to the capsule and frequently cause inflammatory contracture and often an egg shell like calcification of the capsule. If more silicone escapes the shell it can often migrate into the breast tissue and has to be investigated to rule out cancer. If a saline implant develops a small or large leak the body absorbs the saline from the implant and it soon goes flat but it can be changed with a quick easy procedure. For several years while the FDA was dithering about the safety of silicone implants I gave each patient a paper with the latest information I had from the FDA and showed my patients both a saline and a silicone implant to hold in each hand. I explained that it was my opinion that both were equally good implants. About 3/4 chose silicone implants and only 1/4 chose saline implants. (I think it was mostly because of the fear of the saline implant suddenly going flat at an embarrassing time.) I was also doing follow up exams on my patients for 5 years at that time and I decided to examine each patient before looking at their chart to see if I could tell by my exam if she had chosen a saline or silicone implant. I quickly found I could not determine if the patient had saline or silicone implants before I looked at their chart. I think it would be very unusual if anyone can tell by exam whether the patient has saline or silicone implants. I personally get the most naturally looking and feeling breasts using saline implants.  

Oklahoma City Plastic Surgeon

Current Silicone Implant Safety Information

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.

Larry S. Nichter, MD, MS, FACS
Orange County Plastic Surgeon
5.0 out of 5 stars 72 reviews

Silicone implants are very safe

Silicone implants are very safe. There have been numerous studies over the past 15 years supporting their safety.

Steven Wallach, MD
New York Plastic Surgeon
4.5 out of 5 stars 20 reviews

Are silicone breast implants safe?

There are now 3 different companies with FDA approval to sell silicone breast implants in the US, (Allergan, Mentor and Sientra). The silicone implants have been extensively studied and there is no good scientific evidence yet that shows a correlation between them and systemic illness. The complications with any breast implant are local, i.e. confined to the breast. I have no personal experience with any patients who have felt they were ill from the currently approved silicone gel implants.

I hope this helps

Dr. Edwards

Silicone gel safety in 2012

First of all silicone gel is not the 'preferred' implant or choice over saline and you will note on this site many still use the saline implant. As of 2012 there were two safety developments concerning implants, the rare form of breast cancer anaplasic lymphoma of which there have been 42 cases worldwide which might be associated with both saline and silicone implants. The second is the PIP implant scare with possible breast cancers and premature ruptures. In the US silicone gel implants remain a safe choice and a good one for those that understand the nature of the implant and requirements for future replacement when worn. There is no current evidence that implants will make you sick over time.

Peter E. Johnson, MD
Chicago Plastic Surgeon
4.0 out of 5 stars 36 reviews

Silicone does not make you 'sick'

You will not get 'sick' over time.

Silicone is probably the most researched implantable material.  Medical grade silicone has been around for years and although in the US it was unavailable for cosmetic use (but was still used for reconstructive surgery) for years, in Europe and Asia it was never taken off the market.  In US after years of thorough research FDA once again approved silicone for cosmetic breast enhancement.  It does not cause breast cancer or other inflammatory diseases.  Recently a report stated that there was a very slight association with a very rare cancer... where only some 64(?) cases have been reported worldwide! 

Martin Jugenburg, MD
Toronto Plastic Surgeon
5.0 out of 5 stars 298 reviews
