Just when I thought I had reviewed all of the known issues relating to silicone breast implants, from the risk of autoimmune disorders to breast feeding, one appears that I not yet heard of…..the risk of platinum toxicity.

 
The metal, platinum, is used as a catalyst in the cross-linking reaction of the silicone gel and elastomer in silicone gel breast implants and is present in the finished implant at a parts-per-million level. As such, there is the theoretical risk that residual amounts of platinum may diffuse from the breast implant into the surrounding tissues, posing a potential health risk to patients. Dr. Roger Wixtrom of Virginia, a toxicologist, reviews the platinum issue and its risks in the December 2007 Supplement to Plastic and Reconstructive Surgery. Diffusion studies of current manufactured breast implants indicates that only very minute levels of platinum are released and more than 99% of the original platinum is retained in the implant. Also, the platinum that is present is in its most biocompatible form. (zero valence or oxidation) An FDA report on this issue was released on June 16, 2o06 which states..”Based on the existing literature, the FDA believes that the platinum contained in breast implants is in the zero oxidation state, which would pose the lowest risk, and thus the small amounts of platinum that leak through the shell do not represent a significant risk to women with silicone breast implants.”

 
Allergic reactions to plastinum are known, but these are to higher valence forms of platinum which are not present in current silicone breast implants. Furthermore, in unpublished studies, over 100 human volunteers have been exposed to repeated applications of the platinum catalyst in patches without any evidence of sensitization. Current evidence would indicate that this potential platinum toxicity concern in breast implants does not represent a significant health risk.

 
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis

An exhaustive amount of investigations have been done relating to the health of women who have had silicone breast implants. Little work has been published on a more obscure, often not thought about, but very relevant issue…..do silicone breast implants have an any adverse effects on children born to mothers who have had breast implants?
In the December 2007 Supplement in Plastic and Reconstrucive Surgery, Dr Kjoller and others from Denmark examined published findings of epidemiologic studies that have examined that very issue. Based on four epidemiologic studies from Scandinavia where population records and birth registers are historically well tracked, a total of 11,445 women with breast implants and 3,248 children born after the mother’s breast augmentation surgery were examined. Comparisons were made to general population controls. Outcomes evaluated were a variety of birth defects and rheumatic disorders. Their conclusions were that congenital deformities , rheumatic disorders, and perinatal mortality were comparable between children born to motehrs with breast implants and children born to mothers who had under gone other cosmetic surgery.
While these study findings don’t surprise me, I was not aware that this interesting and very relevant issue had actually been studied.
Dr Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medcal Center, Avon, Indiana
Indianapolis

Since silicone breast implants have been re-introduced into the commercial marketplace in the United States in late 2006, most of the women seeking breast augmentation are not aware of the tremendous controversy with their predecessors fifteen years ago due to their age. Generally, only patients over the age of 40 would likely remember the tremendous publicity that surrounded silicone breast implants being banned by the FDA at that time.
Over the past fifteen years, much study has been done on the association of silicone breast implants, particularly ruptured implants, with autoimmune connective tissue disorders. In the December 2007 Supplement of Plastic and Reconstructive Surgery, Drs Holmich et al from Denmark did a large scale literature review of all publications relating to these two topics with emphasis on findings stratified by breast implant rupture status. Numerous comprehensive reviews and updates of large epidemiologic studies have evaluated associations of breast implants and connective tissue diseases. None of them have ever found any credible association between silicone breast implants and any form of connective tissue disease to date. This has been known for some time and continued investigations, such as this one, continue to repeatedly report the same findings. What made this paper so unique was that it focused on those studies where the silicone breast implants were known to be ruptured, exposing the ‘offending agent’ directly to the bodies tissues.
They identified five such publications and reviewed them in detail in the article. In none of the studies were diseases or symptoms related to some form of connective tissue disease associated with breast implant rupture status. No credible evidence can be found that would support the concept of a ’silicone-related disorder’ exists amongst breast implant patients, particularly those whose implants are known to be ruptured.
While this potential rheumatologic issue with silicone breast implants may never completely die in some minds, such a view does not currently hold up to scientific scrutiny. Investigations from around the worldwide on the topic provide overwhelming comfort for all women who have silicone breast implants or those that may be comtemplating breast implant surgery. While they are infrequent stories and internet websites in which patients report their ‘horrific’ experiences and alleged illnesses from breast implants surgery, confirmatory medical information is lacking to know the exact origin of their problems. 

Dr Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis

While not commonly asked, one of the first questions a potential breast augmentation should ask is…does the breast implant interfere with being able to detect breast cancer? Since breast cancer in the United States affects one in 11 women during their lifetime, this is a fairly important question. As breast augmentation procedures continue to be on the rise, this important question should be thoroughly addressed.

 
In a recently published analysis of this topic by Dr. Neal Handel of Santa Barbara, California in the December 2007 Supplement issue of Plastic and Reconstructive Surgery, he does exactly that. Using over 4,000 patients over a 23 year period, he assessed how easily mammography detected breast lesions. Women with breast implants presented more frequently with breast masses, invasive tumors, and axillary node spread. However, there was no significant difference in stage of disease, tumor size, recurrence, or survival between the two groups. Despite the diminished sensitivity of mammograms to detect breast cancer in women with implants, nonaugmented women and augmented women are diagnosed at similar stages of disease and have similar prognoses.

 
In a companion study in the same Supplement, Dr. Dennis Deapen of Los Angeles, California evaluated literature over the past 20 years which examined breast cancer-related risks among breast implant patients. He found that women with breast implants do not experience delayed detection of breast cancer. He summarized that breast implants are not associated with an increased risk of breast cancer incidence or death and these patients do not experience delayed detection or poorer survial after breast cancer treatments.

 
These two published studies should go far to alleviate any concerns in potential and existing breast implant patients about the detection and treatment of breast cancer.

 
Dr Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis

Now that silicone breast implants are back for breast augmentation, they are rapidly becoming the preferred implant over saline for primary breast augmentation. Due to their more natural feel, lack of implant rippling, and lower risk of detectable implant failure, they now represent 90% of implants that I put in for breast augmentation. One of the many ’safety’ questions that arises with the use of silicone breast implants for younger women is……do they interfere with the potential for breast feeding?……and will any silicone ‘leak’ into the breast milk and potentially harm my baby?
First and foremost, the vast majority of implants in breast augmentation are submuscular…meaning that the breast tissue between the nipple and the muscle is undisturbed. Therefore, the breast implant does not impinge on the breast ducts and no interference is possible. Furthermore, the most common incisional approach for silicone breast implants is through the inframmary fold, not the nipple, completely eliminating any potential damage to the breast ducts.
The blood and breast milk chemistries (content) of women with silicone implants has now been studied and published. Dr John Semple from Toronto has published the definite work to date on this subject entitled ‘Breast-Feeding and Silicone Implants’ in the Supplement to Plastic and Reconstructive Surgery, December 2007, Silicone Breast Implants: Outcomes and Safety. In his study, he compared women with silicone breast implants to women without and showed that the mean silicon levels were not different in these two groups in either their breast milk or in their blood. Interestingly, silicon levels in other methods of infant nutrition, such as store-bought cow’s milk and commercially-available infant formulas, were much higher. Cow’s milk had a nearly 10 fold increase in silicon levels and commerecial infant formualas were as high as 50 times greater!
It would be fair to say based on this evidence that silicone breast implants pose no significant known risks to breast feeding. Our clinical experience would back this finding as well.

Dr Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis

Since 2006, silicone breast implants have been approved again for breast augmentation. These are new-generation silicone breast implants that are filled with a new gel formulation of silicone that promises not to leak or bleed and be more durable than the old silicone breast implants that were used from the late 1970s to 1992. The long-term data on these newer silicone breast implants is relatively short, while we have 15 years of long-term data on saline breast implants. How, then, do they compare?
In a recent February 2008 editorial by Dr Rod Rohrich, Editor of Plastic and Reconstructive Surgery journal, he does exactly that….comparing the scientific data of both types of breast implants. Here are the highlights of his analysis:
1) Patient satisfaction is high with either saline or silicone breast implants.
2) Saline breast implants need a smaller incision to be placed and cost less than silicone.
3) For breast cancer imaging, both breast implant types require additional views on
mammography to adequately image the breast.
4) Saline implants have a decreased capsular contracture and rupture rate than
silicone breast implants.
5) Saline breast implant rupture can be seen, silicone breast implant rupture can not be
seen on the outside and requires an MRI to detect.
6) Breast augmentation is not a forever, one-time operation. Many patients will eventually
require revisional surgery at some point in their remaining lifetime, often to replace their
implants.
These findings support what I tell every breast augmentation consult. Neither saline nor silicone breast implants are perfect, each has its own unique set of advantages and disadvantages. Both of them will do the job and do it satisfactorily, make the breasts bigger. Saline breast implants have an exceptional safety history, are less expensive, and can be placed through a small incision that is away from the breast (armpit)…….but one has to accept some implant rippling/wrinkling, less of a natural feel, and the immediate deflation of the breast should the implant rupture. Silicone breast implants are not as well studied, require a bigger incision in the crease of the breast fold to place, and are more expensive…. but with the benefits of a more natural feel, virtually no rippling, and lack of any breast changes (in the short-term) if the implant should rupture.
How does a patient choose? I tell patients make your choice based on which of their disadvantages you can live with the best. Both saline and silicone implants work for breast augmentation…which of their disadvantages is more acceptable to you?

Dr. Barry Eppley

http://www.eppleyplasticsurgery.com

http://www.ologyspa.com

Clarian North Medical Center, Carmel, Indiana

Clarian West Medical Center, Avon, Indiana

Indianapolis

How to Choose between Saline or Silicone Implants in Breast Augmentation

Since silicone breast implants have been re-introduced to the commerical market in late 2006, this has provided women with a choice in breast augmentation. While some plastic surgeons may favor one type of breast implant over another, the reality is that both breast implants have their advantages and disadvantages. Whether one type of breast implant is better than another depends on what implant characteristics the patient can accept. My mission as a plastic surgeon is to educate my potential breast augmentation patients as to the different features of saline vs silicone breast implants. It is up to the patient to decide what breast implant features they desire. Or to put it more simply…..which of the breast implant liabilities (disadvantages) can you live with the best? (the potential health-related issues of silicone breast implants has now been sufficiently refuted and therefore do not enter into any discussion here)

One important concept to grasp…..both saline and silicone breast implants can do the job. Both work and can look equally well. One type of breast implant doesn’t necessarily look better than the other, contrary to the suppositions of some. However, the choice of one implant over the other does control several issues about the breast augmentation procedure……and besides choicing an experienced plastic surgeon is the most important decision about your breast augmentation procedure.

Saline and silicone breast implants differ in the following diametric ways. Saline breast implants are surgically inserted deflated, silicone breast implants are inserted at their listed volume. Therefore, saline breast implants can be put in through a very small incision in the armpit while most silicone breast implants need a larger incision in the lower fold of the breast. Saline breast implants will develop a phenomen of rippling, most of which can be felt at the bottom and sides of the breast (in very thin patients this rippling can be seen), silicone breast implants remain smooth and do not develop this cosmetic rippling issue. If a saline breast implant fails, it is known as deflation as the implant becomes like a flat tire. While this causes no harm, it is dramatically seen and is a cosmetic ‘emergency’ so to speak. If a silicone breast implant fails, it is not called deflation but is known as silent rupture. In other words, there is no visible sign that the implant has ruptured as it does not change shape or deflate. (since what is in it is not water, but a jello-like substance that does not flow) It is possible that a patient may never know that it has ruptured as long as the breast is soft, looks good, and is pain-free. What this suggests is…..the likelihood of the need for breast implant replacement due to ‘failure’ over one’s lifetime is most likely less for silicone than for saline breast implants. The last difference between the two is cost. While surgeon’s fees and other surgical expenses may differ, the purchase cost of a pair of silicone breast implants is higher than for saline. Sinc most plastic surgeon’s merely pass the cost of the breast implants onto to the patient in the overall fee, silicone breast augmentation is more expensive than saline breast augmentation.

In summary….which liability can you live with……..saline breast implants and the issue of rippling and possible deflation……or……silicone breast implants which are more expensive and require a bigger incision to insert.

Dr Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis

Silicone Gel Breast Implants in Breast Augmentation - Scientific Assessment of their Safety

Despite the release of silicone gel breast implants for widespread commerical use in late 2006 and being one of the most (if not the most) studied medical device in history, some patients do question their safety. Any patient over 30 years of age has some recollection of the publicity surrounding the moratorium of silicone gel breast implants back in the early 1990s.

Understanding the science of silicone goes along way in addressing the safety of silicone gel implants for patients when used for both breast augmentation and in breast reconstruction.

First and foremost, silicon as an element is a naturally occurring material (check the Periodic Table) found in sand, quartz and in many types of rocks. It is one of the most common elements that we as humans come into contact with. (oxygen is the most common) When combined with oxygen, carbon, and hydrogen (all naturally occurring elements) in a manufactured process, the polymer silicone is borne. Secondly, silicone has great diversity as a manufactured product and can be made from a liquid form to a solid. It is part of thousands of manufactured products, many of them topical in form for human use. Many of the products used in the beauty industry contain silicone. More relevantly, the use of silicone in medical products is extensive from intravenous catheters to the coatings of joint replacements. As humans, we all have had sufficient exposure to silicone products that most every human alive will test positive for silicone levels.

While silicon is a element and we all have had lots of exposure to it, what does that mean when it is implanted internally in a high volume in one spot? (or in this case, two spots)

The historic conern about the safety of silicone gel breast implants revolves around their potential association with autoimmune diseases. Does a sufficient quantity of silicone, or a long duration of exposure, make the body think it is an immunogen and induce the possibility of autoimmune disease creation?After over 15 years of exhaustive clinical studies, no definitive link between any autoimmune disease (e.g., arthritis, lupus, scleroderma) has yet to be found. The initial link between silicone breast implants and women seemed obvious but the association has turned out to be coincidental as autoimmune diseases have a natural high predilection for women between the ages of 20 and 50, who also are the main recipients of breast implants. The occurrence of autoimmune diseases in women with breast implants is no higher than in women who do not have breast implants. In short, there is no scientific evidence that a silicone gel breast implant increases the risk of autoimmune disease…..or increases the risk of developing breast cancer.

Lastly, it would be hard to imagine that the FDA would re-introduce silicone gel breast implants, and all of the attendant medical-legal risk and liabilities, unless there was absolutely no current evidence of potential harmful effects. As a precaution, the commerical release of silicone gel breast implants comes with a mandate from the FDA…every implanted patient must be enrolled in the Post-Approval Study where further long-term data will be collected over the next ten years. This obligates every implanting plastic surgeon to enroll their patients in this monitored long-term study. The final statement on the safety of silicone gel breast implants will be written in another decade based on hundreds of thousands of implanted women.

Dr Barry Eppley
http://www.eppleyplasticsurgery.com/
http://www.eppleybreastaugmentation.com
http://www.ologyspa.com/
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis

Anatomy of a Breast Implant in Breast Augmentation - What’s It Made Of?

While patients have a major choice between saline or silicone filler materials today in breast implants for breast augmentation, there is another component of a breast implant that is frequently overlooked and can have a big impact on how a breast augmentation feels….and that is the bag or shell which contains the filler material. And occasionally I do have a potential breast augmentation patient ask about the shell, particularly if they have some ‘old fears’ about silicone breast implants.

The shell (containment bag if you will) of a breast implant is made up of silicone oil (technically siloxane), but it is a highly cross-linked formulation giving it a rubbery or rubber consistency. From an elemental standpoint (for you chemistry enthusiasts), silicone does contain some silicon atoms (semimetallic element #14) but it is combined with oxygen and methyl groups which give it characteristics completely different from silicon on the periodic table. When cross-linked together to create a solid, it is known as polysiloxane. And it can be made in any consistency from an oil (what was used in antiquated breast implants and is now still used in ophthalmology for eyeball fluid replacement and in some countries as a soft tissue injectable filler) to any stiffness of a rubber material. As a result, silicone rubber is used in a large number of medical devices and implants. In plastic surgery, for example, many facial implants (cheeks, chins) are made of it. Silicone rubber has been consistently proven to be safe…..which is particularly evident from the intense evaluations done of it from the breast implant issues from the 1990s. It is fair to say, silicone breast implants have been the most studied medical implants in history…and it has now been proven that women with silicone breast implants are no more likely to develop ill health than women without breast implants. Which is why they are now again approved by the FDA and are now widely used in breast augmentation again.

But back to the shell, it is silicone and the shell is the same for either silicone breast implants or saline breast implants. When there is only one shell, it is called a single lumen breast implant, which is by far the most commonly used. In single -umen breast implants, it is only what lies in it that differs. When saline is used, the breast implant is placed ‘deflated’ and filled after it is in place. This is why saline breast implants can be placed through very small incision off of the breast. (through the armpit or bellybutton) It is like inserting a burrito through a small hole. In silicone breast implants, the semi-solid silicone material is placed in the implant at the factory, therefore they are pre-filled. As a result, a larger incision somewhere on the breast (lower fold usually) must be used to get them in place.

As opposed to a single-lumen breast implant, a double-lumen breast implant has a shell within a shell, or a ‘bag within a bag’. There is a smaller bag that floats inside a bigger bag. Usually the big or outer bag (the one you would hold in your hand) contains silicone (for the softness and lack or ripples) and the smaller inner bag contains saline (which can be added to at the time of surgery to offer some adjustability of size.The inner lumen (bag) is filled during surgery through a valve in the implant. This implant type combines the benefits of saline and silicone fillers in one breast implant.

As for filler materials, saline is just salt water. (although this is not entirely accurate, saline is 0.9%, salt water is around a 3% concentration of salt solution) Even if it leaks out, it is as safe as water. Silicone gel (oil is no longer used) is much like jello. It is still silicone, but it is somewhere between oil and rubber in consistency. If you cut a silicone gel implant with a knife and hold it upside down, it will act like meringue pie. The gel is ‘cohesive’ and it stays together. So if you get a hole in your silicone gel breast implant, it is not going to leak out. Increased firmness of the silicone gel is what makes a ‘gummy bear’ implant. It is still silicone but it is firmer or stiffer. Whether differing firmness of the silicone gels is any advantage in breast implants is a cosmetic matter, not any safety issue.

Remember that breast implants are medical devices that are highly regulated by the FDA today and are manufactured with high standards. That being said, I never tell a patient that a breast implant is permanent. They have a lifespan and can always fail and need to ber replaced. What makes a breast implant need to be replaced is failure (tear, rupture) of the shell. This would obviously be kost evident in saline breast implants (i.e., a flat tire) vs a silicone breast implant (which may not even be detectable as it doesn’t change size.

Dr Barry Eppley
http://www.eppleyplasticsurgery.com/
http://www.ologyspa.com/
http://exploreplasticsurgery.com/
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis