Concerns with Silicone Breast Implants Safety

If silicone breast implants are safe, why does it need to be removed once ruptured and sometimes with breast tissue? Silicone implants consist of many ingredients. How do I know I will be fine? I am not even considering explantation without replacement once implanted.

Doctor Answers 10

Silicone implants and safety

Thanks for the question. Silicone implants as with saline implants are extremely safe. Extensive clinical research has been conducted on silicone implants with the conclusion that there is no definitive link between connective-tissue disease and silicone implants. Additionally, if one looks at the systemic concentrations of silicone secondary to having breast implants versus the typical day-to-day exposure to silicone found in commonly used products such as deodorants, the latter far surpasses silicone implants in regards to its cumulative systemic concentrations.

If a silicone implant were to rupture, the concern is that if the ruptured silicone may permeate beyond the breast capsule, with subsequent exposure into surrounding tissue, potentially necessitating its removal. The gel implants that are currently available are filled with a "cohesive" gel material which essentially means that the gel is semi-solid as opposed to semi-liquid. Subsequently, in the event of a rupture, the gel inside will tend to remain within the confines of the shell thus minimizing the permeation of silicone into local breast tissue.

If you have further questions or concerns regarding safety issues of silicone gel implants, I recommend you consult with your local plastic surgeon. Best of luck !

Beverly Hills Plastic Surgeon
4.9 out of 5 stars 31 reviews

Are silicone breast implants safe?

When silicone or saline breast implants rupture, we always want to take them out. For saline implants, there is just no reason to leave them in and most people want them out or exchanged. For silicone implants that rupture, the silicone is usually still contained within the capsule that your body normally forms around the implant. Sometimes, the silicone can break through the capsule and into the breast tissue. In those cases (very rare), we try to remove all the silicone since it is an inflammatory component and can cause scarring. I hope this helps to answer your questions. Good luck.

Sirish Maddali, MD
Portland Plastic Surgeon
2.0 out of 5 stars 1 review

Silicone implants and ruptures

Hi, we remove ruptured silicone implants because the gel can cause inflammation and scarring of the breast. This can sometimes become a capsular contracture, in which the tissue contracts and can be painful. The material itself however will not migrate through the body or cause disease. Best wishes, /nsn.

Nina S. Naidu, MD, FACS
New York Plastic Surgeon
4.7 out of 5 stars 14 reviews

Concerns with silicone breast implants safety

Dear Helptoknowplease,

Russia these days has some of the richest men on earth and yet when it comes to regulation of medical implantables and injectibles it is still a bit of a Wild West. (Just speak to Turkish plastic surgeons who are asked to operate on some Russians). This is NOT to say that Russian plastic surgeons are in any way inferior to Americans. It has to do with which implants are used on the market.

So I will be assuming you are having American made implants (Mentor or Allergan) - the implants which we use here.

Since 1991, breast implant s,gel ands saline, were MORE extensively studied in the USA than ANY implant in the history of medical science. Hundreds of millions were spent to find and report all complications all adverse effects. They were studied more than pacemakers, catheters, heart valves, defibrillators, hip and knee joints - EVERYTHING. They were found to be safe and effective.

But - like every man-made device (your roof, car, planes, heart valve, TV etc etc) have a life time. In the case of implants, the shell weakens and they will deflate. With gel implants is is very hard to KNOW WHEN they deflate. Some women have vague symptoms, most do not. The only easy way to tell is to have a MRI (looking for a "spaghetti sign"). Because the gel is so cohesive and sticky the easiest way to get the implant and gel out is to peel the implant just outside the scar that formed around it, the capsule, and shell it out. When the shell is heavily scarred (seen with old models) some breast tissue is removed to allow this EXTRACAPSULAR DISSECTION to be done.

If you are REALLY worried about it - it is not scientifically based - but then just have saline implants.

Do what makes you happy.

I hope this was helpful.

Peter A. Aldea, MD
Memphis Plastic Surgeon
4.9 out of 5 stars 109 reviews

Issues related to silicone implant safety

The previous posts have done a good job of emphasizing that silicone is safe and nontoxic, so I will address your other questions more specifically. First, the term "rupture" isn't really accurate since it sounds like the implants are prone to exploding, which of course they do not. In fact, when there is a hole that develops in the outer shell, it is a silent and harmless event. There are actually studies where MRI showed a "rupture" and the patients decided to do nothing, since their breasts still felt and looked OK. On follow-up years later, nothing of consequence happenned. So the advice to remove them in the case of rupture is just that: advice.

Secondly, there really aren't that many ingredients in silicone implants: just silicone. Since it is a polymer molecule, it can be in either a liquid, gel, or rubber, like the outer shell. The gel used in implants today is cohesive, meaning that it is a semisolid which is not prone to migrating if the shell ruptures.

Richard Baxter, MD
Seattle Plastic Surgeon
4.9 out of 5 stars 54 reviews

Let's see

Studies have indicated what most plastic surgeons have known all along- silicone breast implants are not linked with health issues. Basically, you want toget saline and silicone implants out when a rupture is detected. Sometimes in either case it is required to remove the capsule (contracture, sub-optimal appearance, or in the case of silicone implants, to try to keep the silicone localized within the capusle). A small amount of breast tissue usually is removed with the capsule, can't help that.

As the others have indicated, your comfort with the implant is key. None of us is here to convince you of anything. Remember, you don't "need" implants, you want them. You don't have to have silicone. Go with what you feel comfortable with, or none at all. Any way you go, it is fine.

Scott E. Kasden, MD, FACS
Dallas Plastic Surgeon
4.8 out of 5 stars 106 reviews

Risks of Silicone.

If you have anxiety regarding these implants, no amount of reassurance may ease your mind. Furthermore, you may experience anxiety if you have lingering questions. In this event you may want to consider saline but even these implants have an outer shell made of silicone. However, this has been reviewed multiple times and no serious medical concerns have been discovered. Why remove the silicone? It is a viscous material that people generally prefer to have removed but some experts have claimed that leaving it alone will have few serious consequences.

I am providing a link to the executive summary of the Institute of Medicine report. This is an abstract of a 400 page report if you would like to read it. It was originally published in 1999 and ongoing studies have not demonstrated any serious adverse health consequences.

Removing a ruptured silicone implant is a matter of surgical preference to remove the implant and the involved tissues.This is my recommendation to patients.

Otto Joseph Placik, MD
Chicago Plastic Surgeon
4.9 out of 5 stars 82 reviews

Silicone breast implants are safe

Unequivocally, silicone breast implants are safe. Over the past 15 years, many large and rigorous studies have been performed investigating whether silicone breast implants are associated with autoimmune diseases or any types of cancer. All studies performed reached the same conclusion; there is no conclusive data supporting any link between silicone implants and these diseases. Only after carefully considering these scientific studies did the U.S. Food and Drug Administration approve the use of silicone breast implants in all women for breast reconstruction and in women over the age of 22 years for cosmetic breast augmentation.

A breast implant rupture is easy to detect when the implant is filled with saline; the breast tends to deflate rapidly, in the span of a few days. A silicone breast implant rupture is much more subtle to detect. For that reason, the Food and Drug Administration recommends an MRI to monitor for rupture, the first one 3 years after surgery, and then every 2 years thereafter. If an implant were to rupture, the likelihood of developing a capsular contracture, or pathologic scar tissue around the implant, goes up tremendously. A thick capsule tends to make the breast hard and overly round, not to mention can cause pain. If that develops, the implant and the capsule around the implant needs to be removed.

Hope this helps. Best of luck.

Sam Jejurikar, MD
Dallas Plastic Surgeon
4.9 out of 5 stars 95 reviews

Are Ruptured Silicone Breast Implants Safe?

In general, ruptured silicone implants should be removed and replaced and this is the standard of care among most plastic surgeons. However, the silicone gel contained within the implants is not toxic. Imlants prior to 2006 are less cohesive which means that the contents are more like honey or molasses and more likely to get into the lymph nodes or with trauma that can cause a capsule (the body lining around your implants) into your bodies soft tissues. Newer implants are more like jello or "gummy bears" meaning that it stays more together.

Here is some general information about medical grade silicone used in breast implants: 
Despite three decades of safety testing and monitoring of silicone breast implants, there is still a public perception that silicone breast implants are more toxic or dangerous than saline implants. The truth is that there has no known toxicity from silicone gel breast implants. In fact, silicone is one of the most common materials used in medical devices and implants. There is no known toxicity from silicone gel breast implants. It has been studied by the FDA for more than three decades to establish its safety. Silicone is the most common material used in medical devices/implants. Examples include shunts that go from the brain to the abdomen (for hydrocephalus) which are left in for a lifetime, artificial finger joints, syringes, IVs, catheters (including ones that go next to the heart), surrounding pacemakers, and even oral anti-gas tablets.
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.

Larry S. Nichter, MD, MS, FACS
Orange County Plastic Surgeon
4.9 out of 5 stars 159 reviews

Silicone implants

Silicone breast implants are very safe. If the implant ruptures, it is best to remove the contents and replace them with implants protected by the shell.  The shape will better and the material will not migrate.

Steven Wallach, MD
New York Plastic Surgeon
4.1 out of 5 stars 29 reviews

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.