Do doctors now recommend getting silicone breast implants?

The modern era in breast augmentation began with the development and surgical implantation of silicone gel breast implants in a woman in 1963. In the 30 years that followed, plastic surgeons worldwide used silicone-gel-filled breast implants for both breast reconstruction and elective breast enlargement in well over one million women. Saline-filled breast implants were also used during this time, but in only about 15% of all patients receiving implants.

Breast implants were developed and utilized for more than a decade before the FDA began regulating medical devices in 1976; the safe and effective use of silicone in these and other medical products such as pacemaker insulation, lubrication for insulin needles, chemotherapy tubing, and artificial joints was well-established before the FDA could evaluate all of them. Because silicone breast implants and many other silicone medical devices were already in use prior to 1976, the ongoing use of these products was “grandfathered” by the FDA without formal evaluation and approval. None of these other silicone medical devices has been made unavailable to patients, but lack of formal FDA evaluation and approval of breast implants came into public awareness in the early 1990s.

The lay media has been responsible for spreading a great deal of information and misinformation regarding breast enlargement in the past two decades. Many women remember tabloid and TV talk shows' focus on the supposed problems claimed to be associated with silicone gel implants. Despite a lack of scientific data supporting these concerns, in 1992 the FDA restricted the use of silicone gel breast implants in women requesting elective breast augmentation.

At no point have silicone gel implants ever been “taken off the market,” but until November 2006 their use required enrollment in the FDA study that allowed only eligible patients and plastic surgeons access to them under strict guidelines. Since the FDA restrictions in 1992, numerous peer-reviewed scientific studies (over 30 in the past decade) have continued to show NO cause-and-effect relationship between silicone gel breast implants and autoimmune-type illnesses (such as rheumatoid arthritis, lupus, scleroderma, or so-called "human adjuvant" diseases). Since 1992, silicone gel implants have been used by plastic surgeons (including myself) involved in FDA-approved studies for patients undergoing breast reconstruction, breast augmentation revision (in certain patients), breast lift, and for those patients with congenital breast deformities.

After exhaustive review of the past nearly four decades of use, the FDA approved the use of saline-filled implants in May 2000.

Late in 2003, the FDA reviewed all of the available scientific data about silicone gel implants, including very detailed information from implant patients over the past decade, and heard testimony from patients, physicians, and researchers. The expert physician advisory panel to the FDA voted to recommend that the FDA approve the use of silicone breast implants for primary elective breast augmentation. However, the FDA deferred its decision, requesting “additional information” before granting approval.

In spring 2005, the FDA again revisited the request by both of the existing implant manufacturers for approval of general use of silicone gel implants; the expert physician advisory panel recommended approval for Mentor Corporation’s gel implants. Late in 2005, Both Mentor and INAMED® (now Allergan) received letters of “[gel implant] product approvable” from the FDA.

On November 17, 2006 the FDA approved the use of silicone gel implants from both companies in patients over the age of 22, with certain restrictions, including involvement in the FDA study that has been ongoing for the past several years.

Opponents of silicone gel implants continue to claim that they cause autoimmune illness or are unsafe, but peer-reviewed scientific studies by many researchers and institutions have shown them to be safe and effective for their intended use. The controversy about silicone gel implants has made them one of the most intensely studied products in the entire medical marketplace.

As part of the 2006 FDA re-approval of silicone gel implant use, each company has an informed consent booklet that you will be asked to read (and sign). The FDA has made a controversial recommendation that patients with silicone gel implants undergo a MRI (magnetic resonance imaging, a non-X-ray study similar to a CAT scan) every two to three years to evaluate their implants (for leakage or rupture). Studies have shown that MRI evaluation of silicone implants has 79% effectiveness in detecting implant rupture or “leak.” Thus, if you have no identifiable problem or concern with your implants and choose to follow this recommendation, you will require an unnecessary re-operation (for entirely normal non-ruptured) implants 21% of the time! The FDA makes this recommendation because physician examination has been shown to be unreliable in detecting silicone implant rupture. Yet, since present silicone implants are cohesive and cannot “leak,” this is a nonsensical recommendation, in my opinion. If you are not having any kind of problem or concern with your implants, it is ridiculous to perform a costly (may not be covered by your insurance) and often-inaccurate test that would require an operation (erroneously) over 20% of the time. Rather, I believe that if you have any issue at all with your implants (size, shape, position, firmness, or concern about possible rupture), return to your surgeon for evaluation. He or she can then do whatever corrective surgery is needed, where they will be able to examine, and replace if necessary, the implants under direct vision. Your surgeon can offer better than 79% accuracy with direct implant examination!

Since 2006, over 99% of my patients choose the newest cohesive silicone gel implants! Best wishes! Dr. Tholen
 

In my practice, I prefer to use FDA-approved Mentor implants. They contain the latest generation of silicone. The gel inside these implants is not liquid. It's a cohesive gel that holds safely to deliver a natural feel that resembles breast tissue. These implants are extremely safe; in the latest research, patients have reported a 97% satisfaction rate. Best wishes.

Hello and thank you for posting your question. Yes they are safe and FDA approved. The "silicone scare" in the 90s was more a product of mis information from the media then actual scientific evidence. In any case, the FDA and all other regulatory agencies around the world have tested silicone implants extensively since then and to this day. Other countries have been using silicone breast implants none stop since they first came into the market. Actually, it is much harder to get saline breast implants in most countries then it is to get silicone. So, they have not only been safe for a long time but the technology keeps getting better and better. The silicone casing is much tougher now and the silicone filling is a cohesive gel. This means they do not leak, not even if you cut them in half. Add that to the fact that they feel and look much more like breast tissue then saline filled implants, makes them the preferred choice around the world.Best of luck,Dr. Miguel Mota

Almost every patient I have placed implants in has chosen to go with silicone.   They have been proven to be safe and look/feel more natural.   

More women tend to choose silicone breast implants due to the natural feel and appearance. #CohesiveSilicone implants are now made of a gel which are anti-leak even when cut. It is often called “gummy-bear like”. #Silicone implants are also the preferred choice for over the muscle placement. Also, silicone implants require a larger incision than saline, because they are pre-filled.Although, the new generation of silicone implants are far superior than those used in the past and have a proven track record of safety, some prefer an alternative. This is where the #IdealImplant comes in. It was created for women who are not comfortable having silicone implants in their body, but desire a more natural feeling implant than traditional saline implants on the market. The unique structure of the Ideal Implant allows for a similar look and feel as silicone with the safety of #saline.Your choice of silicone or saline will also determine the incision site for which the implant is to be placed.

The safety of silicone breast implants has been the
source of significant controversy. This controversy had its origin in 1990 when
concerns arose over the potential for silicone breast implants to cause
connective tissue diseases. In response to these concerns, the FDA made
silicone implants unavailable for breast augmentation surgery. Since that time, silicone breast implants have undergone
extensive testing and have been found to have minimal risks. They are
considered to be extremely safe and for this reason the FDA lifted its
moratorium on silicone implants in 2006. They are now once again available for
breast augmentation surgery.During this period of controversy, significant advances
have been made in implant technology. Current implants have stronger outer
shells that are less likely to leak. In addition form stable gel implants are
now available.Despite these advances and a plethora of studies that
demonstrate the safety of silicone implants, many patients continue to have
anxiety about their use. Under these circumstances saline implants offer a safe
alternative to silicone implants.If you have concerns about the safety of silicone
implants, it’s important to discuss this issue with your plastic surgeon. Your
surgeon should be able to discuss this issue with you and hopefully alleviate
your concerns.

Thanks for your question.  Many patients want to know which breast implant type is safer--silicone or saline.  Short answer is both are safe and both are approved by the FDA.  They do however have different advantages and drawbacks. Depending on the situation one type may be better than the other.  But the bottom line is that both are safe.  The choice of which one is right for a patient is best made between the doctor and the patient after a consultation.

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.

I have no hesitation in recommending silicone implants.  We have so many studies and years of experience in the use of these implants, that we know they are safe from a medical point of view. The majority of my patients desiring breast augmentation are currently asking for silicone gel implants. The rate of leakage is acceptably low so far, and with regular monitoring with an MRI, you can know the status of your implants. The softness and natural feel of gel implants is better than saline for most women which is why they choose them.

Silicone breast implants currently in use are very different from the previous generation of implants. All currently used silicone implants are cohesive. This means the silicone molecules stick together making the implant more like a solid than a liquid. That way if the implant breaks, the implant tends to stay in one piece. 

Studies show that implants do not affect the risk of breast cancer and do not cause systemic disease. This means that implants will not affect your general health in any way. 

So  while complications can rarely occur with breast implant surgery, they do affect the well being of patients. 

There has been much controversy about silicone breast implants over the years, and these devices have been studied extensively by medical experts. At one time in the late 1980s and early 1990s there was a question of whether silicone breast implants might increase the risk of women developing certain diseases and their use for breast augmentation was restricted. After much study it was demonstrated that silicone breast implants did not increase the risk of these diseases, and the restrictions on their use were removed. Furthermore continuous improvements in the breast implants themselves over the past 50 years have made them more durable, longer-lasting, and overall better devices than previous generations of implants.