Are Silicone Breast Implants Safe?

There is a question on RealSelf from 4yrs ago about safety of implants & doctor were sure, however the FDA's updated report in 2011 shows uncertainty: "The FDA believes that silicone breast implants have a reasonable assurance of safety" "There is no apparent association between connective tissue disease & silicone gel-filled breast implants, although most of the available studies have limitations" 'Reasonable assurance' and 'apparent association' doesn't sound SAFE. What is the truth?

Doctor Answers 8

Silicone Implants Are Safe

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.

Orange County Plastic Surgeon
4.9 out of 5 stars 159 reviews

Silicone Implant Safety

There have been numerous studies demonstrating the safety of breast implants.  Since the moratorium the implant manufacturing process is better and the implants are more stable. The FDA's legal ease is to keep them from getting involved in litigation.  The biggest problems with silicone is local implant problems such as encapsulation and hardening. If you use a small implant and have a significant amount of breast tissue to cover it there is little difference between the two implants. They look exactly the same.

Robert Kearney, MD, FACS
La Jolla Plastic Surgeon
5.0 out of 5 stars 32 reviews

Safety and Breast Implants

There are inherent risks with any medical procedure, especially major surgery.  Breast Implant surgery is no exception to this.  In my experience, silicone breast implants pose no greater risk than saline implants, and during our patient consultations we discuss both options, including risks and rewards, to determine the right implant for that specific person.  The most important thing is to pay attention to your body.  If you experience any problems with either type of implant at any time after your surgery, make sure to speak with your doctor.

Norman M. Rowe, MD
New York Plastic Surgeon
4.9 out of 5 stars 58 reviews

Safety of silicone implants

Silicone implants are safe. There have been numerous studies performed over the last 15 years that support this statement.

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

Silicone breast implants are safe, at least according to the FDA

In 2006 the FDA gave approval to silicone gel-filled breast implants.  Interestingly, saline filled breast implants were only FDA approved in 2000. these decisions were not reached without a huge amount of discussion, review of study data, and controversy.  My personal opinion is that breast implants, saline or a silicone, are "safe," and I offer them to my patients.  As you noticed, words like "reasonable assurance" and "apparent association" are generally use when talking about breast implants, although you should understand that those words should be applied to ANY other medical device. Breast implants are mechanical devices and therefore, like any other mechanical devices, are at risk for failure.  A thorough discussion is held with every single patient who is having breast augmentation surgery where these issues are discussed.  That is the truth.

James E. Chappell, MD
Annapolis Plastic Surgeon
5.0 out of 5 stars 18 reviews

Are Silicone Breast Implants Safe?

It's my personal opinion from practicing this profession for thirty years and seeing all the various studies, that silicone implants do not pose any significant increased health risk. But that doesn't mean you may feel that way. We also have saline implants available. I like to go over the pros and cons of both types with my patients and leave it to them to choose. My feeling is that you should not have something placed in your body that is going to give you constant concern. Life is too short to worry everyday if you are going to get sick from some choice you made. Both type of implants can give attractive results. Our job as surgeons is to help educate you to risks before you choose a surgical procedure, it is never to sell you some specific operation.

Ronald V. DeMars, MD
Portland Plastic Surgeon
5.0 out of 5 stars 27 reviews

Silicone Implants Are Safe

All surgical procedures carrt some risk including having a mole removed.  There is no way the FDA would allow silicone implants to return to the market if they had any significant concerns.  The one exception is a particular brand of implants used in Europe, etc., but these were never approved for use in this country.

John Whitt, MD (retired)
Louisville Plastic Surgeon
5.0 out of 5 stars 2 reviews

Silicone Breast Implants Safe

Gel implants are safe. The FDA website has a detailed summary of risks. To summarize, as the entirety is too large for the website.

"Breast implants are not lifetime devices. The longer a woman has implants, the more likely it is that she will need to have surgery to remove them.

The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. . . .There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems."

These complications are consistent with what many surgeons including myself have written on this site.

Kris M. Reddy, MD, FACS
West Palm Beach Plastic Surgeon
4.5 out of 5 stars 45 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.