Is Silicone Really Safe for the Human Body?

I want to get breast implants but fear the safety of silicone. I am confused why in the medical field, FDA, and plastic surgery silicone is treated as safe for the human body but why is silicone injections banned by the FDA then? After working in the special effects industry for movies, silicone IS treated as A TOXIN and prosthetic companies that manufacture silicone based products warn of skin contact and toxicity of silicone with workers and actors? Please help on these thoughts?

Doctor Answers 9

Silicone safety

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Thank you for your question.  Medical grade silicone is an inert substance and safe for the human body.  Silicone implants have been approved by our FDA after extensive research.  Silicone implants are silicone contained in a shell and are carefully placed during surgery.  Silicone injections are typically free silicone, usually not medical grade silicone, and have the risk of injection into a blood vessel which can be extremely dangerous, and thus banned by the FDA.

Salt Lake City Plastic Surgeon
5.0 out of 5 stars 37 reviews

Silicone is safe in the human body.

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The body responds to a silicone breast implant as a foreign body, the same as prosthetic joint, a pacemaker, a piece of glass, or even a bullet.  It is not, however, toxic to the body and there are no antibodies to the material (an immune response).

Surgical grade silicone in an implant is safe

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Silicone got a bad rap back in "92-'93.  They commissioned an Institute of Medicine Study which found NO correlation to silicone implants and all of the diseases they were alleged to have been a factor in.  At least 400 peer-reviewed medical studies have confirmed this.  The new implants are even better now as the leak rate is much decreased and the gel is designed to not leak from the implant, even in the unlikely event an implant may be damaged.

In short, they are safe, or I would not put them in my patients.

Jeffrey J. Roth, MD, FACS
Las Vegas Plastic Surgeon
4.6 out of 5 stars 17 reviews

Silicone Implants

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Thank you for your question. Many early silicone implants were very bad as the shells on the outside of the implants were prone to erosion, and allowed the gel inside to leak out and migrate, getting into the lymphatics and causing issues if not treated early. There were many makers with diverse quality control, and they were left in too loing, sometimes 20 years or more. However, all the studies conducted after the silicone ban to determine if there were connective tissue disorders due to silicone implants was negative, meaning silicone caused no issues when properly placed. The new silicone gel implants are very good, not prone to leaking, and do not have the syrup like gel inside. Most of our patients use silicone gel, and we have never had a leak. They feel like real breast tissue compared to saline. I hope this helps!

Vivek Bansal, MD
Danville Plastic Surgeon
4.9 out of 5 stars 26 reviews

Breast Implant Surgery

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Thank you for your question.

In general, medical grade silicone is widely accepted as safe and is used in many parts of the body besides in breast implants.  

Breast implants have silicone gel that is contained within a silicone elastomer shell.

Injectable silicone is a completely different story and should not be injected into the breasts.

To be sure what is right for you, see two or more experienced, board-certified Plastic Surgeons for a complete evaluation to make sure you are a good candidate and that it is safe for you to have breast implant surgery.

I hope this helps.

J. Jason Wendel, MD, FACS
Nashville Plastic Surgeon
5.0 out of 5 stars 221 reviews

Is silicone safe?

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That is the billion dollar question that still lingers out there.  Personally, I prefer saline.  They feel almost the same in most women and offer better peace of mind.  Also, there is a lower capsular contracture rate.  If you are the least bit worried about the safety of silicone, just go with saline.  You'll have less stress and probably fewer problems in the long run.

Ronald J. Edelson, MD
San Diego Plastic Surgeon
5.0 out of 5 stars 31 reviews

Breast Implants

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There are multiple studies showing that silicone breast implants are safe. They are approved by the FDA.

Aramis Vega, MD
Dominican Republic Plastic Surgeon


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I appreciate your concerns and silicone is in lip stick, toothpaste, deodorants and skin creams and clearly approved for use after arduous studies.  I think your concerns are over reaction but if concerned go with saline implants and/or free fat transfers.  It doesn't pay to worry.

Dr Corbin

Frederic H. Corbin, MD
Los Angeles Plastic Surgeon
4.9 out of 5 stars 65 reviews

Multiple studies have established the safety of medical grade silicone implants

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Despite the fact that multiple studies performed by multiple different investigators and institutions and multiple different specialties have all demonstrated a lack of association between silicone gel and any systemic toxicities or diseases, there is still a lot of fear out there regarding that.  There are a few points contained in your question that should be clarified.  First, the silicone gel used in breast implants is contained within a silicone rubber shell, thus, the gel is generally not in contact with the tissues the same as it would be if free gel were injected into the body.  Additionally, even when that is the case, or in the case of a gel implant rupture, the only thing that has been demonstrated to occur is the formation of fibrous scar tissue, granulomas, and the like.  This is much different than systemic illness or reaction.  Further, one can't compare the silicones used in other industries and applications to the gel used in breast implants, because the silicone gel used in breast implants is a VERY specific, VERY stringently manufactured and monitored form of medical grade silicone gel, and nothing else will compare to it.  In fact, you may have heard about a European implant manufacturer that was recently prosecuted for distributing gel filled implants filled with an industrial grade of silicone.  These other types of silicone preparations very often contain impurities and trace amounts of other things that can be toxic to humans, and this is the culprit, not the pure silicone.  Properly purified and manufactured medical grade silicone, like that used in the implants sold in the US, is vastly different.  I hope this addresses most of your concerns.  I have also included a link below to a website that has been specially built to offer objective, evidence-based truthful information to the public about this issue.  Be sure that if you do decide to go forward with surgery that you select an experienced board certified plastic surgeon who can properly advise you and address all of your concerns.  Good luck.

Joseph L. Grzeskiewicz, MD
San Diego Plastic Surgeon

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.