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Posts Tagged ‘silicone breast implants’

Silicone Breast Implant Rupture Is A Misnomer

Thursday, January 29th, 2015


Now that silicone breast implants have been back in clinical use for almost a decade (since 2006), they have rapidly become more commonly used than saline breast implants.  Their more natural feel and the ability to last longer are amongst several important considerations for their favor over saline filled devices.

But the most compelling feature that silicone breast implants have which make them preferred is that they will never suffer spontaneous deflation. Saline implants are essentially bags filled with water which, should a small hole or tear develop in the bag, will allow its liquid contents to come out. Thus the implant will deflate and the overlying breast will become flatter.

Conversely, silicone can not suffer deflation because its contents are not a flowing liquid but a cohesive silicone gel. Silicone implants can fail and that is often called a rupture from a hole or tear in its lining. But the term ‘rupture’ should actually never be used because that is not what actually happens to a silicone breast implant when it fails.

Silicone Breast implant Disruption Dr Barry Eppley IndianapolisThe term rupture is defined and perceived as a forcible disruption or bursting effect. And that is not what happens to a silicone implant at all. Rather even a larger tear in the implant shell is only associated with an intermittent bulge of material when pressure is applied. (squeezed) When the pressure is removed, the gel material returns back into the confines of the implant shell. Even when a  silicone implant is cut it off, it still keep its form.

Due to the highly cohesive nature of today’s silicone breast implants, its failure should no longer be termed a rupture. Rather it is better described as a shell disruption or loss of integrity. This indicates the more benign event and outcome that results from this eventual expected event for many women after years of implantation. Rupture suggests breast implant contents that are lost when the current gel cohesivity no longer permits that to happen.

Dr. Barry Eppley

Indianapolis, Indiana

Plastic Surgery Case Study – Hispanic Breast Augmentation Using Silicone Implants

Thursday, December 25th, 2014


Background: Breast augmentation continues to be popular amongst women of all ages and ethnicities. Amongst certain female patients that have more pigment in their skin, the risk of hypertrophic scarring or hyperpigmentation of the surrounding skin is a legitimate patient concern that may mar an otherwise excellent breast size enhancement.

In the Hispanic female, their intermediate skin pigment raises these scarring concerns. While I have done many Hispanic breast augmentations through the more ‘visible’ inframammary incision, most do not develop any adverse scarring. But the possibility exists and no one can predict whether any Hispanic women will develop an aesthetic scar issue or not from breast augmentation surgery.

Breast implants are well known to be capable of being inserted through a remote incision off the breast, of which the most common is the armpit or transaxillary incision. This is most commonly done using saline implants which are inserted in a folded fashion and filled with saline after insertion through a filler tube. Historically silicone implants have not been placed through the armpit due to insertion difficulties with a fully filled implant.

Case Study: This 26 year-old Hispanic female male wanted breast enlargement using silicone implants. She did not want any visible insertion scars and wanted to lessen teh space between her breasts. (sternal gap) While a ‘non-scar’ approach could be used to place her implants, it was pointed out that the wide spacing between her breasts could not be significantly reduced.

Hispanic Breast Augmentation result front view Dr Barry Eppley IndianapolisUnder general anesthesia, 3 cm long high transaxillary incisions were made. Subpectoral pockets were developed with long instruments. High profile smooth round silicone gel breast implants of 350cc size were then inserted using a silicone funnel insertion device. The armpit incisions were closed with small dissolveable sutures.

Hispanic Breast Augmentationresult oblique view Dr Barry Eppley IndianapolisHispanic Breast Augmentation result side view Dr Barry Eppley IndianapolisTransaxillary Silicone Breast Augmentation Scar Dr Barry Eppley IndianapolisRecovery after her breast augmentation surgery was fairly quick due to a rapid recovery exercise program. Within ten days she was back to all activities including exercise and running. (albeit lightly) Her result showed symmetric implant placement, her desired size, lack of sternal gap reduction (as was counseled before surgery) and excellent appearing axillary scars.

Case Highlights:

1) Breast augmentation in Hispanic females can raise the concern of visible scarring if an inframammary or periareolar incisional approach is used.

2) To avoid a visible scar, a transaxillary approach for even silicone breast implants can be used.

3) Silicone breast implants can be placed through the armpit which is significantly aided through the use of a funnel device technique.

Dr. Barry Eppley

Indianapolis, Indiana

Silicone Breast Implants Under 22 Years Of Age

Monday, December 15th, 2014


Since silicone implants were re-introduced eight years ago in 2006, they have gradually returned to their dominance over saline breast implants. With a more natural feel, lack of a deflation risk and being longer lasting, they have numerous advantages over saline-filled devices. But despite their commercial availability they are not available to all women who desire breast augmentation. By the manufacturer’s guidelines they are restricted to women who are at least 22 years or older.

Silicone Breast Implants Indianapolis Dr Barry Eppley IndianapolisThis silicone breast implant restriction runs into a frequently posed question by younger patients…why can I not have these type of breast implants if I am younger than 22 years old? What could possibly be the difference between the breasts of a 20 year old vs a 22 year old? Why would saline implant be allowed but not silicone implants.

This is both a frequent and understandable question as human anatomy clearly shows that they are no physical differences. This is not a biologic issue but a regulatory one. It is presumed by many surgeons that the FDA mades this stipulation to the manufacturers because patients under 22 years of age were never included in the clinical trials that served as the basis for their approval. However the clinical data showed that such young females were indeed part of the silicone implant study group for all manufacturers. So the decision by the FDA to restrict silicone implants by age seems a bit perplexing but nonetheless a stated regulation.

While this age restriction exists, some plastic surgeons do provide silicone breast implants to women under 22 years old. They take the position that this merely represents off-label use and within the province of the physician’s discretion and judgment. Conversely, many other plastic surgeons will not place silicone implants in these younger women as a strict adherence to the regulatory stipulations. Which one is right?

The answer is simply unknown. It is ultimately up to the plastic surgeon and what they feel in is the best interest of their patients and what their liability exposure is. At the least, patients under 22 years of age need to know of the manufacturer’s stated age restrictions and whether placing them at this age may affect the manufacturer’s warranties of the implants. (lifelong implant replacements) It is not clear what position the manufacturer’s take on this issue.

Dr. Barry Eppley

Indianapolis, Indiana

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

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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