Plastic surgery is one of the marvels of modern medicine, with a wide range of options for face and body improvements. And today’s media outlets make it easier than ever before to gather information on the latest plastic surgery procedures. But how does this information apply to you and your concerns?
Every person is unique and has his or her own desires. What procedure or combination of treatments is right for you? And what can you really expect? EXPLORE PLASTIC SURGERY with Dr. Barry Eppley, Indianapolis plastic surgeon, who can provide you with a wealth of practical and up-to-date insights into the world of plastic surgery through his regular blog posts. In his writings, Dr. Eppley covers diverse topics on facial and body contouring procedures. You will be sure to find useful information that will help broaden and enrich your plastic surgery education.
Archive for the 'silicone breast implants' Category
Breast augmentation using silicone implants is the most popular method used today by most plastic surgeons. While saline breast implants dominated from 1991 to 2006, since they were the only type of implants available, that changed in 2006. The FDA approved silicone-containing implants in 2006, marking their return after fifteen years of study and evaluation.
As part of the re-approval of silicone breast implants by the FDA was the condition that the manufacturers were required to continue to study the patients long-term that were used to gain the approval. In addition, they were required to conduct post-approval studies on implanted women. A recent FDA panel in meeting with the manufacturers (Allergan and J & J Mentor) has looked at that information. According to reports, about 60% of women that were part of the original approval studies have been followed for eight to ten years. Roughly 80,000 women have been enrolled by both manufacturers since 2006 but followup rates have not been as good at the three year mark after their surgery.
The FDA states that silicone breast implants are safe and effective and will remain available in the U.S. They will work with the manufacturers to increase patient participation in the follow-up studies so that substantial long-term data will be obtained. It is no surprise to me that long-term follow-up of implanted patients is difficult because the motivation for patients and plastic surgeons to do so is very low. If a women is doing fine with no problems, she is not very motivated to come back for future follow-ups. More pertinently, the time and paperwork required for plastic surgeons to record and submit follow-up paperwork to the manufacturers is substantial. In a busy plastic surgery practice that does a high volume of breast augmentations, it takes a fully dedicated person to properly perform this job. This is a substantial expense. The solution to both of these problems is reimbursement. That is the real solution to generating better follow-up data.
One of the findings from the FDA panel was that there is a ‘significant complication rate’ with silicone breast implants. One set of data involving a group of women who were part of the original studies used to gain approval of the implants in 2006 showed 20 percent to 40 percent of women receiving implants for augmentation and 40 percent to 70 percent of women who received implants for reconstruction (usually after breast cancer) had to have another operation in the first eight to ten years after they received their implants. The most common breast implant complications were capsular contracture, implant rupture, scarring, pain and infection.
The complication rate show be neither a surprise or unexpected. Doctors and patients alike must remember that these are medical devices, foreign bodies that are placed inside the body. While the body will tolerate them (not reject them from an immunologic standpoint), they are not natural tissues and some expected complications in a number of patients can eventually be expected. This is true of every medical device ever implanted in humans. What is unique about breast implants is that they are placed in a fairly superficial position (which is why under the muscle is better) and are subject to extreme aesthetic scrutiny. A fair number of revisional surgeries are for aesthetic reasons such as asymmetry, size and shape. If you throw these complications out, the number of revisional surgeries would drop substantially. In addition, many implants for breast reconstruction are placed in the face of radiation and diminished soft tissue coverage, a perfect setup for high complication rates and the need for numerous revisional surgeries.
This FDA panel review is a reminder that breast implants should not be perceived as lifelong devices and that the potential need for revisional surgery after implantation is far from rare.
Dr. Barry Eppley
Indianapolis, Indiana
Feel The Difference - Changing From Saline To Silicone Gel Breast Implants
Author: barryeppley
Breast augmentation can be done with a choice between two implant filler options, saline and silicone gel. Each has their own advantages and disadvantages and neither implant is right for everyone. Silicone gel implants offer a more natural feel (a particular benefit in women with little to no natural breast tissue) and no risk of spontaneous deflation when they fail.
Today’s silicone gel breast implants have only been available for slightly less than five years since they re-released by the FDA in late 2006. This leaves a large number of women who have undergone breast augmentation from 1991 to 2006 when only saline implants were available. This leaves some saline patients who are near the unpredictable end of their implant’s lifespan (10 to 20 years) or may have wanted to switch implants for a more natural feel. (if they suffer from implant rippling) Many women will eventually be forced into an implant decision when their saline implants eventually fail. (deflate)
To address these implant concerns the largest breast implant manufacturer in the U.S., Mentor Corporation, has announced an incentive program for those women that currently have saline implants. For former saline breast augmentation patients who want to change to silicone gel implants, Mentor has a program called Feel The Difference! By switching from saline to silicone breast implants, Mentor offers each patient a special $250 savings incentive. Patients will receive their $250 in the form of an American Express Gift Card that comes directly from Mentor by mail. There is nothing the patient has to do to be enrolled. The implanting plastic surgeon provides the patient’s name and contact information, silicone gel implant numbers and the former saline implant numbers to Mentor.
While this amount of money alone won’t make it possible to undergo breast implant replacement surgery for some, it is a nice manufacturer benefit to those who are motivated to do so anyway.
Dr. Barry Eppley
Indianapolis, Indiana
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


