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Posts Tagged ‘silicone breast implants’

Silicone Breast Implants: Past, Present and Future

Friday, July 4th, 2014

 

silicone breast implant history dr barry eppley indianapolisSilicone breast implants have been around since 1962, encompassing a complicated and  interesting history of device development that now spans over five decades. Between three U.S. manufacturers, a wide array of commercially available breast implant devices exist today. Saline-filled devices have not really changed over these years but silicone-based implants have undergone a significant evolution that has been described as having gone through five generations.

First generation silicone implants spanned the time period of 1962 to 1970. They had a very dense and viscous gel that was encased in a thick two-piece silicone elastomer shell held together with a seam. They were of a teardrop shape (not round) and had a patch on its back to try and hold it into place.The main complaints with their use was that they were too stiff and unnatural feeling and had high capsular contracture rates.

Second generation silicone implants spanned the time period of 1970 to 1982. The silicone gel was less viscous to produce a more natural feel. The outer implant shell was thinner, slightly permeable and had no seam. It also was round in shape and not tear drop. The thinner shells and less viscous silicone gels, however, lead to diffusion or bleeding of the gel outside of the implant shell leading to high rupture and capsular contracture rates.

Third generation silicone implants spanned the time from 1982 to 1992. A return to a more viscous gel with thicker multilayered shells was done to reduce the problem of silicone gel bleed and the device shell rupture rates. This also was the generation where the textured implant shell was introduced to help reduce the high rate of capsular contractures.

silicone breast implant ripplingWith a moratorium on breast implants imposed by the FDA in 1992, fourth generation silicone implants spanned the time period of 1993 to 2006. During this period, rigorous clinical studies and follow-up were done to produce a more cohesive silicone gel with an improved manufacturing and quality control process. This is what was finally approved by the FDA for the return of silicone gel breast implants to all plastic surgeons and any women older then 22 years of age.

Sientra Ultra Strong Cohesive Gel Breast Implants Dr Barry Eppley IndianapolisFifth generation silicone implants spanned the time period of 2006 to present day. The implant shells are essentially the same as before but the cohesive gel has a greater cohesiveness that retains it shape better in different positions. Such implants have become known as form stable and the urban term ‘gummy bear’ breast implant. Also, new textured anatomically shaped implants have become available to be used in a wider array of breast forms and chest dimensions. (2012)

Silicone breast implants have undergone consideration evolution over fifty years of clinical use. Today’s implant options are undoubtably the best they have ever been with more options the ever before. The concerns about the induction of autoimmune diseases by breast implants has been largely quelled by numerous studies that have demonstrated their safety. Outside of the U.S., no other industrialized country even uses saline breast implants and use silicone gel implants exclusively for breast augmentation.

Are today’s breast implants the best they will ever be? Undoubtably not if history is any indicator of how progress is made. A decade from now I would anticipate a whole new generation of silicone breast implants that offer new features and improved durability.

Dr. Barry Eppley

Indianapolis, Indiana

Case Study: Breast Implant Replacement After 20 Years

Wednesday, June 13th, 2012

Background:Breast augmentation is entering its fifth decade of human use. In fact, the first breast augmentation patient is still alive and is 82 years old. Over that time, much has been learned about the procedure and the implants themselves have undergone a lot of design and structural changes. With each passing decade of use, breast augmentation continues to be an improved and more predictable procedure.

But at the heart of breast enhancement is the implant. The procedure is not possible (with the exception of fat injection breast augmentation which is still in its infancy and is but for a limited number of women) without the implant and both its immediate and long-term success depends on it. But breast implants are not forever. These are medical devices with limited lifespans. While there is the euphoria of the initial operation and the immediate change, the future reality is that one will eventually be having more surgery to replaced a failed or failing breast implant. Best estimates place that occurrence of somewhere between 10 and 20 years, on average, after the initial implantation.

But even when the implant does not fail, most breasts will still undergo some physical changes in appearance and shape. Just like the breast that does not have an implant, time and gravity work to pull the breast downward.While an implant does provide support and helps keep the breast tissue higher on the chest wall over time, some women will still develop sagging of their breasts off of the implant. I have seen lots of women who are now 15 to 20 years after their breast augmentation (without failed implants) and I have been amazed at how much breast sagging that they have developed. While this is not true for all implanted women, it seems to be particularly for those women who have gained a lot of weight over the years.

While an implant pushes outward on the breast tissue, how long it will be supported in an upright and sometimes uplifted position depends on numerous factors.A major factor is the quantity of breast tissue one has to start with or acquires over time. The more tissue that sits in front of the implant will have a definitive tendency to fall or sag 10 to 20 years later.

Case Study: This 53 year-old woman desired to replace her breast implants. She originally had silicone implants placed under the muscle 26 years ago. This is a long time to have such indwelling implants given that most of these type implants has been removed and replaced in the 1990s due to leaks or concerns that they might leak. She had no specific problems with these implants other than they felt a little firm and not soft like they used to. In addition, she did not like the sagging that had occurred and made her feel that her breasts had actually gotten smaller over the years. She was unsure of her original breast implant volume but thought they might be in the 300cc range.

Under general anesthesia, she had her original implants removed which were silicone and 350cc in size. One implant was intact and the other implant had a small tear in the implant shell with limited extrusion of the silicone material. She did have thick and hardened capsules but with minimal calcifications. Her implants were replaced with 550cc high profile silicone gel breast implants.

When replacing old implants with age-related breast sagging, considerations must be given to management of the breast shape. Larger implants will help fill out loose skin and the size increase must be at least 50% to give an effective filling effect. Thus with 350cc implants, for example, the increase must be to at least 500cc. The loose breast skin will engulf much of the implant’s volume so one shouldn’t be afraid to go significantly bigger.

Depending on the amount of breast sagging and the nipple position, an implant alone regardless of size increase may still not provide enough of an adequate lifting effect. Consideration should be at least given to a superior nipple lift. While this should not be confused with what a true breast lift can obtain, it in combination with a larger implant may be just enough for the ‘older’ patient to achieve a satisfactory breast shaping that hopefully will last her the rest of her life.

Case Highlights:

· Due to age and gravity, the implanted breast will lose shape and position over time Usually the breast tissue that sat in front of the implant goes south.

· Most women will undergo elective or forced replacement of their implants due to failure after 15 to 20 years of implantation.

· To restore breast volume or shape with implant replacement, a larger implant size is needed.

Dr. Barry Eppley

Indianapolis, Indiana

Plastic Surgery’s Did You Know? The Silicone in Breast Implants

Monday, April 16th, 2012

Silicone breast implants are composed of both a silicone gel (filler) and a more solid silicone containment bag. But this silicone should not be confused with silicon, number 14 on the Periodic Table, a crystalline metalloid element. While silicone does contain some silicon atoms, it has many more carbon, hydrogen and oxygen molecules which give it very different physical properties. Silicone was developed over 100 years ago and is a polymer with a silicon-oxygen backbone. By cross-linking chains and side groups, it can be made in compositions from a liquid gel to a solid material. Hence the development of the breast implant, a medical device containing different phases of the same material.

Silicone Breast Implants Are Safe And Effective

Friday, September 2nd, 2011

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. Inaddition, 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

Accuracy of MRI for Silicone Breast Implant Rupture

Sunday, March 14th, 2010

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 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.

Dr. Barry Eppley

Indianapolis, Indiana

A Review of the Safety of Silicone Gel Breast Implants

Sunday, April 12th, 2009

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

Indianapolis, Indiana

    

  

 

 

 

 

 

 

 

 

 

 

 

 

Silicone Breast Implants: Fast Forward 20 Years

Tuesday, July 29th, 2008

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

Indianapolis, Indiana

Debunking The Myths Of Silicone Breast Implants for Breast Augmentation

Tuesday, June 24th, 2008

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

Indianapolis, Indiana

Silicone Breast Implants and Risk of Platinum Toxicity

Monday, March 3rd, 2008

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. A review of this platinum issue and its risks was published in the December 2007 Supplement to the journal 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

Indianapolis, Indiana

The Health of Children Born to Women with Silicone Breast Implants

Sunday, March 2nd, 2008

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 the journal Plastic and Reconstrucive Surgery, published findings of epidemiologic studies 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 silicone breast implant issue had actually been studied.
Dr Barry Eppley

Indianapolis, Indiana


Dr. Barry EppleyDr. Barry Eppley

Dr. Barry Eppley is an extensively trained plastic and cosmetic surgeon with more than 20 years of surgical experience. He is both a licensed physician and dentist as well as double board-certified in both Plastic and Reconstructive Surgery and Oral and Maxillofacial Surgery. This training allows him to perform the most complex surgical procedures from cosmetic changes to the face and body to craniofacial surgery. Dr. Eppley has made extensive contributions to plastic surgery starting with the development of several advanced surgical techniques. He is a revered author, lecturer and educator in the field of plastic and cosmetic surgery.

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