Archive for the 'silicone breast implants' Category
Accuracy of MRI for Silicone Breast Implant Rupture in Symptomatic Women
Author: barryeppley
With silicone gel breast implants returning to the forefront of breast augmentation and reconstruction, there are recurrent concerns about their durability and potential rupture. While there has never been any proven link between disease and silicone gel exposure, being able to diagnose silicone breast implant rupture is important. However,sSilicone implant rupture has been associated with local pain and breast hardening. (capsular contracture) Unlike saline breast implants which usually produce an obvious and immediate change in breast size, silicone implants cause silent and externally invisible ruptures.
With the return of silicone gel breast implants in late 2006, the FDA stipulated that patients should be monitored every 3 years by an MRI. An MRI has been shown to be the most accurate method of detecting rupture in women that have no other breast symptoms. Besides not considering who was going to pay for the costs of the MRI (the manufacturers aren’t), the question exists as to whether an MRI is the best way to detect silicone implant rupture in the face of actual symptoms. (breast pain and hardening) Is an MRI better than a mammogram for symptomatic women?
In the March 2010 issue of Plastic and Reconstructive Surgery, a study was reported by Dr. Paetau and others out of Jacksonville Florida and Nashville Tennessee. From a retrospective analysis of 319 capsulectomies, of which about half were assessed prior to surgery with an MRI and the other by physical exam or mammography, the specificity and sensitivity of these tests were compared. Their results showed that MRI was no more accurate than the other less costly tests in predicting implant integrity. (78% vs 76%)
MRI is very accurate in detecting silicone implant rupture, regardless of whether a women has breast symptoms or not. Radiologists use the term, ‘linguini sign’, to make the diagnosis of implant rupture. But in the face of breast pain and capsular contracture, where one has a suspicion that implant integrity is lost, the cost of an MRI appears to be unnecessary. The history and physical exam alone has proven to be fairly accurate.
If a women is concerned about whether an implant rupture exists, the presence of symptoms strongly suggests that surgery will likely to be needed for replacement. This appears to be particularly true if the implant has been in for some time. A low cost test like a mammogram is likely to be just as accurate based on this reported study.
http://www.eppleyplasticsurgery.com
Indianapolis
Since silicone gel breast implants have been re-introduced for patient use in late 2006, they rapidly have become the preferred implant for many breast augmentations. Yet, despite FDA-approval, many patients (even relatively young ones) understandably ask about their safety. In my Indianapolis plastic surgery practice, I routinuely tell patients that they are perfectly safe and would not be FDA-approved if it were not so. However, a more detailed explanation of that general statement is detailed below.
In 1997, the Department of Health and Human Services began one of the most extensive research studies in medical history by appointing the Institute of Medicine of the National Academy of Science (IOM) to examine potential complications during or after breast implant surgery. The committee included members of the medical, scientific and educational communities with experience in radiology, women’s health, neurology, oncology, silicone chemistry, rheumatology, immunology, epidemiology internal medicine and plastic surgery. After reviewing years of evidence and research concerning silicone gel-filled breast implants, the IOM found that health problems such as connective tissue illnesses, cancer, and neurological diseases are no more common in women with breast implants than in women without implants.
Furthermore, reviews of research and medical studies on silicone breast implants shows that breast cancer is no more common in women with silicone breast implants than in those without. The American Academy of Pediatrics concluded in September 2001 that the evidence currently does not justify classifying silicone breast implants as a contraindication to breastfeeding. Epidemiological investigations have not found any increased risk of adverse health outcome in children born to women with silicone breast implants.
Since the early 1990s, a number of independent comprehensive reviews have examined studies concerning links between silicone gel breast implants and systemic diseases. The consensus of these reviews is that there is no clear evidence of a causal link between the implantation of silicone breast implants and systemic disease. In the 1990s, thousands of women claimed that they had become ill from their implants. Some studies around that time have suggested that these health symptoms of women with implants may improve when their implants are removed. As studies have been done which followed women with implants for a longer period of time, more data have become available on the likelihood of these autoimmune symptoms. Several large studies in Denmark found implant recipients no more likely to be diagnosed with an increased incidence of classic auto-immune symptoms as compared to women of the same age in the general population and that musculoskeletal symptoms were generally lower among women with implants compared with women with other cosmetic surgery and women in the general population.
Several studies have established that women who elect to undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. A large study with long-term follow-up of nearly 25,000 Canadian women with implants reported that breast implants do not increase the risk of death in women.
In 2001 a study suggested an increase in fibromyalgia among women with extracapsular silicone gel leakage, compared to women whose implants were not broken or leaking outside the capsule. This association has not been repeated in a number of related studies and the FDA concluded the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants.
In conclusion, every previous medical fear about the dangers of silicone gel breast implants has never been substantiated by further study and review. Over ten years of exhaustive studies has failed to find any reason for women to be concerned about receiving silicone gel breast implants.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Silicone Gel Breast Augmentation and the Inframammary Incision
Author: barryeppley
Breast augmentation today has seen silicone gel implants not only return to availability but become more commonly used than saline implants in most plastic surgery practices. The improved feel, lack of any significant rippling, and no potential for spontaneous deflation have made silicone the preferred implant filler material for many breast augmentation patients despite its higher costs.
Silicone implants, however, require some incision modifications over those used for saline. Because silicone implants are prefilled, they have to be inserted fully inflated unlike saline which is inflated after it is in place. Because these incisions are going to be bigger, using the armpit or nipple locations is usually inadequate. Therefore, the lower breast crease or inframammary fold is most commonly used. This provides direct access to getting under the muscle and the length of the incision is not so critical as it is ‘hidden’ on the underside of the breast. This is also an area that does well from a scar healing standpoint as it runs parallel to the relaxed skin tension lines of the body in this area.
As the silicone implant can only be deformed so much by squeezing it through a hole (incision), the size of the incision is important. While there are no absolute rules as to the size the incision must be, it should generally be about 1/3 of the base diameter of a silicone implant. This permits the implant to not be overly compressed during insertion, protecting the implant’s shell and lessening the long-term likelihood of implant rupture.
While the natural lower breast crease is usually a good place to put an incision on the breast so that it is the least visible, its placement in one’s existing crease may not always be best. In many breast augmentations, the bottom part of the breast must be expanded so that the a new and lower breast crease will actually be established after. Remember breast implants make the overall breast bigger in all dimensions and this includes the lower pole. For this reason, particularly in larger breast implants, the incision must be made lower than the existing lower crease so that it does on the breast itself after.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Now that silicone gel breast implants have been officially back and FDA-approved since 2006, most breast augmentation patients are opting for it. While it is more costly than saline breast implants, silicone breast implants offer a more natural feel, have very little to no implant rippling, and will not deflate in size if they rupture. While most patients prefer silicone over saline, and do eventually opt for it most of the time, there still remains concerns about their historic safety. Even very young patients, who were just young kids at the time of their removal from the market in 1992, will ask about these now near ancient breast implant issues. In listening to what their concerns are, it is apparent and understandable that patients confuse local complications with systemic complications when it comes to silicone breast implants.
Local breast implant complications exist today as well as decades ago….and they are the same whether they are saline or silicone breast implants. Local complications refer to ‘hardening of the breast implant’ or the formal plastic surgery term, capsular contracture. The formation of scar around any implant in the body is normal and is how the body reacts (favorably) to a foreign body that it ‘tolerates’. This scar is usually very thin and is undetectable by feel, making the breast soft and easily moveable. For reasons that are usually unknown (the leaking of silicone material through or out of an implant is a known cause), the scar around a breast implant may overreact and get quite thick. When this happens to a circular scar around a sphere (breast implant), it can start to contract making the breast hard, immobile, and even distorted if severe enough. This is known as capsular contracture and was quite common with old style silicone breast implants, particularly when they were placed above the muscle which was the norm in the 1980s and early 1990s. While troubling, capsular contracture does not have any harmful effects on the body other than the feel and shape of the breast itself. It is a local complication. The occurrence of capsular contracture in breast implants has been dramatically reduced over the past 15 years as the implants are now routinuely placed under the muscle rather than on top of the muscle. Why this works in not well understood but the combination of constant massage from muscle movement and that the tissue surrounding most of the implant is muscle (very vascular) rather than breast tissue are obvious reasons.
Systemic complications from breast implants refer to the potential for creating sickness of the body, specifically autoimmune diseases. While once touted as ‘fact’ by many, careful scientific scrutiny has failed to establish any such link. The old style silicone breast implants have been studied more than any medical implant in the body in the history of medicine and the causation of systemic health risks from them has been debunked. Today’s silicone breast implants are better made and the leeching of any silicone particles is very low compared to implants of old. It is for this reason that the FDA has released them back for commercial use. Patients should not fear today that any such systemic health risks exist. Yes, there will always be a few unfortunate patients who will develop automimmune diseases and other health issues that have breast implants but this association is coincidental, not cause and effect related.
Silicone breast implants, like saline breast implants, are health-wise safe. They have the potential for local complications over one’s lifetime, such as capsular contracture, but the occurtrence of this problem is fortunately low and capable of being successfully treated.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Debunking The Myths Of Silicone Breast Implants for Breast Augmentation
Author: barryeppley
Since silicone gel breast implants have been released back for commercial use in late 2006, nearly 15 years after they were initially pulled from the market, they have rapidly become the breast implant chosen by most women for their breast augmentation. I have seen many women come in for breast augmentation consults that are initially dead set against silicone breast implants and want saline implants, only to change their minds once they have accurate information. In talking to patients over the past two years, here are some of the most common myths surrounding silicone gel breast implants.
1) SILICONE BREAST IMPLANTS CAN CAUSE HEALTH PROBLEMS AND MAKE ME SICK. The extensive human data that has been analysed on hundreds of thouands of women who have had silicone breast implants has failed to ever make the link to any form of autoimmune disease. This potential cause and effect has been thoroughly evaluated and been dispelled. It is the primary reason that silicone breast implants were allowed back on the market by the FDA. Silicone breast implants are one of the most extensively studied medical devices in the history of mankind. Yes it is true that there have been a very small number of women with silicone breast implants that developed autoimmune diseases but the actual rate of this occurrence is no greater than that of women who have never had breast implants. Autoimmune diseases occur in much higher numbers in women and occur mostly in the age ranges where breast augmentation surgery is likely to be performed.(ages 20 -45) So it would not be unexpected that the two will occasionally occur in the same patient. But silicone breast implants do NOT cause autoimmune diseases.
2) SILCONE BREAST IMPLANTS MAKE LEAK OUT AND SPREAD THROUGHOUT MY BODY. Today’s silicone gel implants are much more like jello than any liquid. The silicone particles are gelled together so that they move as sticky mass, not flowing like a liquid. As a result, if the implant suffered a large tear, the mass of silicone simply sits there. If you squeeze on a silicone implant that has been cut with scissors, you will see that it comes bulging out of the tear only to be retracted back into the implant when the pressure is removed. Checmiaclly, we all have silicone particles throughout our bodies in microscopic amounts due to a lifetime of exposure to that element. But women with silicone breast implants today have not been shown to have substantially higher levels than those who don’t have implants.
3) SILICONE BREAST IMPLANTS BECOME HARD OVER TIME. The phenomenon of ‘hardening of a breast implant’ is known as capsular contracture. It is really the natural scar tissue around the implant which, for reasons not completely understood, may start to thicken and get hard over time. In days gone by with old-style silicone implants, which were placed above the chest muscle, capsular contracture was common. The reasons were that small amounts of silicone leaked (known as implant ‘bleed’) through the implant lining and the body reacted by forming more scar tissue. In today’s breast augmentation surgery, the combination of newer silicone implants which have very negligible amounts of bleeding and the implant being typically placed under the muscle, have reduced the lifelong risk of capsular contracture significantly. While that risk always exists, and it is higher when placed above the chest muscle, the occurrence of capsular contracture is not common.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Breast augmentation remains one of the most popular plastic surgery procedures overall and one of the most commonly performed plastic surgery procedures for women under the age of 35. Breast augmentation is a fairly ’standard’ procedure in terms of how it is performed and the time it takes to perform it. In my hands, a primary breast augmentation procedure takes one hour to complete, from entering the operating room to being awake headed to the recovery room. Much of the cost of breast augmentation is, therefore, fixed including the cost of the breast implants themselves (silicone gel breast implants cost more to purchase than saline breast implants) and the use of the operating room and the anesthesiologist’s charges.
Because breast augmentation costs are predictable, many plastic surgeons freely publicize their fees to perform the procedure. When seeing a breast augmentation fee stated, make sure the fee you are seeing is all-inclusive. Often times, touted breast augmentation fees only list the surgeon’s fee and you have to read the fine print to see the additional costs of the breast implants, operating room, and anesthesia. If the fee has an asterik (*) by it, you automatically know that the listed fee is only a tease and misleading.
Because breast augmentation is a very predictable operation in terms of costs and execution, unlike most other plastic surgery procedures such as facelift, liposuction, etc., the listing of breast augmentation costs for any practice is not unreasonable. Also, one of the most common questions that patients have about breast augmentation surgery is the cost. It is often the first and only question they may have when making a phone call to your office or an e-mail inquiry to your website. For these reasons I, like many plastic surgery practices, prefer to publicize my fees for breast augmentation. In my practice, the all-inclusive costs for silicone gel breast augmentation is $5,999 and $4,799 for saline breast augmentation.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
There are two good reasons why patients choose silicone gel breast implants over saline…and one of those is that silicone breast implants have significantly less rippling or wrinkling than saline. This is of great aesthetic importance to those women with very little breast tissue and thin or stretched out skin where the outline of the breast implant can clearly be felt and often even seen. This is most evident in the inferior (lower) and lateral (side) poles of the breast implant where the chest muscle does not provide coverage.
The phenomenon of breast implant rippling is actually present in both saline and silicone filled implants. The exact reason wrinkling of the breast implant occurs has to do with how well the filler material coats the inside of the implant and bonds to it as well as its own viscosity. Water (or saltwater) flows easily and does not ’stick’ well to the inside wall of the breast implant shell, resulting in implant buckling and folding. This is a normal finding with saline breast implants and its presence is not abnormal or the plastic surgeon’s fault. This is why we usually overfill the saline breast implant to generate increased pressure on the inside which lessens the amount of wrinkling that can occur. In the short-term this works but, over time, the plastic bag of the implant stretches a little and relaxes, creating some rebound wrinkling if you will. Silicone gel, a much thicker (viscous) material and with slightly more weight, coats the inside of the implant shell better and is more effective at lessening wrinkling.
The point is….silicone gel breast implants have less wrinkling, usually substantially less, but it may not always be zero. I have had several women who have small amounts of rippling in the lateral (side) pole of the breast. Usually it is only one or two small ripples, which would be less than that which would have been present had they been saline implants instead. I can’t say at this point whether this subtle rippling phenomenon in silicone implants is less evident in high profile (projection) versus medium or low profile style implants. I think it is more reflective of the lack of breast tissue between the overlying skin and the breast implant, an anatomic issue in which no type of breast implant can completely overcome.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
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
The Health of Children Born to Women with Silicone Breast Implants
Author: barryeppley
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

