In November, 2006, silicone gel filled implants were approved by the Food and Drug Administration (FDA) for use in women twenty two years of age and older. Along with this announcement came an interesting recommendation: routine MRI (Magnetic Resonance Imaging) to surveil for implant rupture. Why this new recommendation? Saline implants are prone to device failure just as is a silicone gel implant. After all, the silicone shell of both saline and silicone gel filled implants are identical. Furthermore, saline implants have a valve that silicone implants do not have and this is prone to failure (and leakage) as well. The difference is that if a saline implant leaks, the device will deflate in about 48 hours and there will be a very noticeable difference in breast contour and loss of volume. The saline is absorbed. Saline is nothing more than salt water, a normal component of our bodies. With silicone gel filled implants, on the other hand, should a small defect occur in the implant shell, the silicone will by its cohesive nature most likely remain inside the implant. If a more significant compromise occurs to the implant shell, such as a tear, the silicone gel will be contained by the scar tissue capsule that forms around all breast implants, silicone and saline. There may or may not be any appreciable difference in the breast appearance and feel. There may or may not be some discomfort in the breast. As many of such device failures are asymptomatic, the FDA believes that there should be some type of routine screening for such a situation. MRI’s are ideal for identifying a defect in the breast implant. Although not perfect, they are fairly accurate and do not involve the use of ionizing radiation as is the case with a mammogram and CAT (computerized axial tomography) scan.

The current FDA recommendation is to obtain a MRI examination of the breasts three years after breast augmentation surgery and every two years thereafter. Does this make sense? To put it simply, there will be a certain amount of women who will experience device failure of a silicone gel implant. If you screen everyone every year, then almost all of these problems should be picked up by the MRI scan. If you screen no one, then of course, there will be none of these problems identified. So then, what frequency of examination makes sense? Just like screening for any disease or problem, you have to have an understanding of the actual frequency the problem, the severity of the problem (is it life threatening or a risk to quality of life or the health of the community vs. low health risk) and the costs of the screening program. Most likely, a screening program will not screen everyone each year, which leads to some problems going unrecognized. The other question is: What is the consequence of not recognizing the problem? Will there be a compromise to one’s life, health, livelihood or their family? In the case of breast implants, if a rupture is missed, there is most likely not going to be a significant risk to the patient’s health. Silicone is biologically inert and fifteen years of studying breast implants have demonstrated that they are not a causative factor in the development of any systemic diseases.

The first question is whether or not an MRI, which is an expensive test, is an appropriate first line screening test for breast implant rupture. In screening for cancer, mammogram remains the gold standard for initial screening. If there are any abnormalities seen, then it is ultrasound, not MRI that is used next to investigate further. This is not because MRI is inferior to ultrasound, but rather than ultrasound is a good second screening test and is much more cost effective then proceeding directly to an MRI. Should there still be some question after ultrasound, an MRI may be a good way to go prior to considering surgery in cases where there exists uncertainty as to whether or not a problem exists within the breast. I have found this process to be extremely useful in my cosmetic breast surgery patients (augmentation, lift, reduction) who require routine screening prior to commencing surgery. So why then, is MRI recommended as the initial screening tool for a silicone breast implant rupture? Is it better than less expensive tests?

In an excellent 1998 scientific study at the University of Michigan, Chung found that if ultrasound was the initial screening tool for a breast implant rupture and the ultrasound test was read as normal, the chance of a false negative, in other words, the chance that the normal interpretation of the ultrasound was incorrect and that there really was a rupture which was undetected was only 2.2%. On the other hand, if ultrasound did suggest a rupture, and an MRI was obtained afterwards which also supported a diagnosis of implant rupture, then there was an 86% chance that the implant was in fact truly ruptured. This is a high enough chance of rupture to support the plan of surgical exploration and implant replacement if a true rupture is actually found.

In a separate study in 2001, Cher found that in women with breast implants who have a specific complaint referable to the breast such as pain, capsular contracture or a change in the appearance of the breast, an MRI is better than 80% accurate in predicting an implant rupture. In the absence of such symptoms, the predictive value of MRI is much less, and was not felt to warrant use as a routine screening method for implant rupture in such asymptomatic women. The Royal College of Radiologists in the United Kingdom stated that ultrasound is 91% accurate if it demonstrates an intact implant, not too dissimilar to the results of the University of Michigan study discussed above. Furthermore, they concluded that the initial screening tool should be an ultrasound, followed by MRI (preferably one with a dedicated breast coil and a magnet strength greater than 1.5 Tesla) if the ultrasound suggests a rupture of the implant.

How often does rupture really occur? I use the rough rule of thumb of about 0.5 to 1% per implant, per year. Mentor’s core study of 420 patients demonstrated a 0.5% rupture rate at three years out from surgery, but there have been other studies that don’t show ruptures for even up to seven years (Sharpe and Collis- UK). Does it make sense to have 199 women to undergo MRI to find one rupture (assuming a 0.5% rupture rate)?

So, should one follow the current FDA recommendation and obtain an initial MRI examination of the breasts three years after breast augmentation surgery and again every two years thereafter?

- Consider that as third party payers (your health insurer) have strict clinical guidelines for the authorization of a breast MRI, it is quite possible that these routine MRI’s in an asymptomatic patient may not be paid for by health insurance.
- Consider the fact that a missed implant rupture is highly unlikely to represent a health risk to the individual.

- Consider that a normal ultrasound demonstrating an intact implant is better than 90% accurate

- Consider that the rupture rate is approximately 0.5% after three years.

My personal opinion, based on the information given above, is that the FDA guidelines represent overkill. In other words, I believe that these recomendations are not cost effective, and probably counterproductive. What I mean by stating that the FDA’s recommendations are not cost effective is that less expensive ultrasound is highly effective as a screening tool for implant rupture and given the fact that breast implant rupture occurs with such a low frequency brings into question the relatively frequent intervals that the FDA is recommending for breast surveillance for implant rupture. What I mean by counterproductive is that if the MRI’s are not covered by health insurance (unless there is a clinical problem, and even then possibly only after a mammogram and ultrasound have first been performed) I would not expect most women with breast implants to voluntarily follow these guidelines for cost reasons alone, as they may have to bear the financial burden of these costs. Therefore, less, if not more women will undergo such routine surveillance, which is the opposite of the FDA’s intended goals. I do not know what scientific rationale was used to develop the FDA recommendations, however, based on current scientific data, the FDA recommendations are not supported. The FDA’s recommendations are only just that, “recommendations”, not law and it is up to the individual patient to decide how to use this information. I feel that it is my obligation to present not only the FDA’s position, but my own as well.

The good news for women undergoing breast augmentation with silicone gel implants is is that breast ultrasound, a much less expensive option, is readily available for those women who are interested in routine surveillance of their breast implants. Breast ultrasound is also not “rationed” by third party payers as are breast MRI examinations.

Part III – A comparison of the available systems – one plastic surgeons personal opinion

There are currently two systems available for computerized imaging and simulation of breast augmentation surgery. Portrait 3D manufactured by AxisThree, a company funded by Siemens and started in 2002. AxisThree claims to use technology developed by Siemens in the Portrait 3D product. Other than the Portrait 3D system, I am unaware of any other products that the company produces. The other system, Vectra 3D, is manufactured by Canfield Scientific, a company specializing in medical imaging with a long history of many successful products including imaging software, which has been in existence about twenty or so years. Canfield is known for its work in standardizing medical photography, so that images can be taken with consistent lighting, positioning and exposure parameters. Their systems are well known to the dermatology pharmaceutical industry, which contracts with them to produce imaging systems for various drug studies. Both systems were released very recently in the past year.

Let’s start with the physical capture device itself. They are pictured below:

(Photos of Vectra 3D on the right, Portrait 3D on the left)

The camera system of the Vectra 3D consists of six 12 megapixel cameras arranged into three pods. The pods use mirrors to permit the imaging of subjects from the side without having to have physical extensions to mount the cameras off to the side. The Portrait 3D system has three cameras of 3 megapixels each. The cameras are mounted on extensions out to the side.

The lighting system of the Vectra 3D consists of high powered flash. This permits imaging without the use of additional lighting. The very bright flash emits much more light than the ambient room light, therefore the room light will not affect the exposure and the room lights can be left on during the imaging process. The Portrait 3D uses LED (light emitting diode) technology. On the Portrait 3D, the LED lighting system requires the user to shut off the room lights to prevent interference of the exposure by the room light.
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Part II – How three dimensional imaging is used in my breast augmentation practice

When I see a patient in consultation for breast augmentation, I inquire as to what the patient is looking to achieve. I examine the patient and make recommendations as to what implant I think is best for them. The exact details of how I do this are beyond the scope of this blog, but suffice it to say, I determine what I think is the best implant to fit a particular patient’s tissues. I then have a discussion with the patient about what implant I recommend. The next question is invariably “what will I look like?” I told them that it is very hard for me to answer that question. Due to the nature that the implants conform to the body’s contours, you cannot put an implant in your bra, or a bag of water or rice. In my opinion there really is no way to see how you will look. Maybe you can get a very cursory idea of size, but I caution them that this, too, is highly inaccurate. So it comes down to a matter of trust. The patient just has to trust me that I will take into account the cup size she wishes to be, mindful of the fact that cup size is not a standard volume as “cc’s” are. You don’t buy a container of milk in A, B, C, D, or DD size. You buy a half pint (for your coffee), pint, quart, half gallon or gallon. These all have defined numbers of cc’s in them. For instance, a quart is 948 cc’s. Implants come in cc’s not cup sizes. The actual cup size is the sum total of how much tissue you start with and how many cc’s of implant you add later. The same implant can look very different in three different women.

I have had the opportunity to be the first in Suffolk County, NY to have a computer system capable of three dimensional imaging and surgical simulation. I have since taken the liberty of introducing the system to my breast augmentation patients who have had their surgery performed prior to my having such technology available. I have posed the following question to many of these patients: Prior to your undergoing breast augmentation surgery, did you have any visual image in your mind as to what your surgical result would look like. Having spent a fair amount of time with my patients in consultation prior to surgery, and that included either reviewing photos of similar patients who underwent breast augmentation or having the patients view such patients on my web site, I was very surprised with what they all (and I mean ALL) told me: all of the two dozen or so patients I queried told me that they had absolutely no idea what they were going to look like after surgery. They told me that they just “trusted me”!
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Part I – What three dimensional imaging systems are

I have always enjoyed technology. Since I was a teenager in the early 1970’s, I loved electronics (computing wasn’t even a hobby back then). For my pre-med major in college, I studied Biomedical and Electrical Engineering at Northwestern. It was there that I obtained a strong background in computers and emerging biomedical technologies. During the latter part of my plastic surgical fellowship training, I saw the advantage to know not only how to operate computers and run software programs, but to learn how to develop tem as well. Several of the software applications I developed over ten years ago, are still in use in my practice today.

When I was a surgical resident, I remember visiting a young plastic surgeon that had a computerized imaging system. It consisted of an inexpensive, low resolution video camera, a computer (one of those early PC’s) and a monitor. He took a photo of my face and showed me how the software could change the image. He deftly demonstrated how he could take my nose, remove it from my face and replace it back, this time upside down. Kind of a cool curiosity, but is it worth it? That was about twenty five years ago. Over the years, I have seen a couple of such imaging systems that could take a two dimensional image (two dimensional means a flat image with height and width, but no depth) and manipulate it somewhat. I was pretty unimpressed by what I saw, until recently.

I practice plastic surgery in the same office as dermatologist Dr. Elyse Rafal, who also is my spouse. Dr. Rafal has always been involved in clinical drug trials with various pharmaceutical companies. These studies rely on high quality, consistent, reproducible photographic imaging. Over the thirteen years I know my wife, I cannot remember a single drug study that required imaging that did not have customized photographic equipment developed by Canfield Scientific, in Fairfield, NJ.
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by Mark D. Epstein, M.D., F.A.C.S.

Traditionally, breast augmentation is associated with a considerable amount of pain and down time, but this no longer needs to be the case.
Breast implants may be placed either below or above the pectoralis major muscle (a muscle located just beneath the breast). The advantage to placing the implant below the muscle is that there is much less interference with mammography, as well as more soft tissue to cover the implant, making it less palpable and visible.

Pregnancy/lactation causes stretching of the breast tissue with loss of fullness and bottoming-out of the breast. Often, a decision is made to place the implant above the muscle to better fill out the breast-skin envelope; however, in these cases there is less soft tissue coverage of the implant and less support for it. Using a specially created technique called dual-plane augmentation, women with such breasts can enjoy the benefits of a breast augmentation with implant placement below the muscle.

A breast implant consists of a silicone shell (bag) filled with either saline (salt water) or silicone gel. Silicone gel filled implants were re-released by the FDA in November 2006 after extensive study. They have become increasingly popular. Saline implants are available in either a round or teardrop shape. The advantage of a saline teardrop implant over a round saline implant is that the overall breast shape will be more natural in most cases. Use of saline teardrop implants requires greater attention to detail in placement than a saline round implant. The advantage of saline round implants are that they are easier to use and less expensive. Silicone gel implants are available in a round shape only. As silicone gel round implants are more flexible in shape than a saline round implant, in my experience, I believe that the overall shape of a breast augmented with a silicone gel round implant is more natural than that obtained with a saline round implant.

Breast implants may be placed through incisions in the armpit, around the nipple or under the breast. The advantage to an armpit incision is that the scar is well hidden and there is no scar on the breast itself. Although most surgeons perform this procedure blindly, minimally invasive endoscopic breast augmentation (similar to laparoscopic surgery) provides enhanced visualization of the surgical pocket on a large television monitor, affording greater precision during the surgery.
A periareolar scar (around the nipple) is usually inconspicuous. The disadvantage to the technique is that wound healing varies greatly according to the biology of the individual and thus some women have a more noticeable scar, which would now appear on the most conspicuous part of the breast.

The most common surgical approach to breast augmentation is an inframammary (breast crease) incision. This scar is barely noticeable as the lower portion of the breasts often covers the crease and scar. This surgical approach provides the surgeon with the greatest visualization of the surgical pocket, and the ability to make internal modifications as necessary in a breast that has drooped secondary to pregnancy/lactation. The techniques best suited for you will be discussed at your consultation.

Using techniques specifically designed to reduce post-operative discomfort, the post-operative experience has been dramatically improved. Many patients return to normal activities of living within 24 hours. During the past 3 1/2 years, nearly all our patients have been able to raise their arms up high over their head before they left the recovery room. Some patients have even put on makeup and brushed their own hair before going home. Occasionally, patients have felt good enough after surgery to go out shopping or to dinner later the same day! Rapid recovery after breast augmentation surgery is the culmination of proper preoperative planning, delicate and precise surgical technique, refinements in anesthetic management, and postoperative care designed to promote a quick recovery with minimal discomfort. Average return to work is about five days, and often less. Most patients experience some mild discomfort after surgery, but overall, the average amount of discomfort and downtime after surgery have been significantly reduced while the quality and consistency of the aesthetic results have been greatly improved.

Dr. Mark Epstein is a dual board certified plastic surgeon specializing in breast augmentation, with a special focus on improving the patient experience before and after surgery.

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Investing in yourself - Cosmetic surgery and Botox in Stony Brook, Long Island

There are many things that we invest in. Most of the time when we think “invest” we envision a plan to take an initial financial commitment and place it somewhere so that it enhances in value. Although worthwhile, there are other great ways to invest your money. We do this all the time and not think about it. We invest money and time in our own education or that of our children so that we (they) can have an enhanced earning capacity to hopefully lead a more comfortable and secure life. We invest time to find the right home, car, vacation. We invest our emotions in finding the perfect spouse. I write this on the day of my eleventh anniversary, for instance. Investing all comes down to making oneself happier and more secure.

Cosmetic surgical procedures such as breast implants, breast lifts, tummy tucks, facelifts, rhinoplasty and liposuction are often seen as a luxury, maybe even frivolous. But when you think of it, it really isn’t. It may help you feel more secure and confident about yourself; more comfortable within your own skin, so to say. And unlike a vacation, a car, a boat, a new entertainment system, the results obtained with cosmetic surgery are longer lasting and appreciate with time. How do you place a value on feeling good about yourself, being more self-confident?

Let’s talk about Botox. An average treatment may run $600 for about 40 – 50 units of Botox. If the Botox treatment lasts, conservatively speaking 90 days (sometimes up to 120 days), the cost per day is about six dollars per day to look younger and more refreshed.

Cosmetic surgery is even more of a value. The most common cosmetic surgical procedure is breast augmentation. The approximate cost of breast implant surgery on Long Island is around $7300.00. Although you never need to change a perfectly good breast implant, device failure is about one percent per year. So at twenty years there is a twenty percent chance of needing to replace a breast implant. So let’s say the duration of the breast implant surgery procedure is twenty years. Twenty years is 7300 days. So for just one dollar per day, you can feel better about yourself. Isn’t that worth it?