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.

by Mark D. Epstein, M.D., F.A.C.S.

On November 17, 2006, the FDA approved the use of silicone breast implants for breast augmentation and reconstruction. All breast implants have a solid silicone shell. Saline implants are filled with saline (salt water) and silicone implants are filled with silicone gel. Up until recently, only saline implants were available for general use in breast augmentation.

Silicone gel implants were used for many years in this country, as well as in many countries around the world, until 1991 when the FDA enacted a moratorium on their use, pending the results of several studies designed to examine the safety of the device.

Based on the research collected in the US and the practical experience gained outside of the US for the past 25 years in over 60 countries, where both silicone and saline have been available to women and 90% of the markets prefer silicone, women generally find silicone breast implants to look and feel
more natural than saline implants.

The safety of silicone-filled breast implants is supported by extensive pre-clinical device testing, their use in approximately 1,000,000 women worldwide and nearly a decade of U.S. clinical experience involving more than 80,000 women.

Women in the United States now have the same options that women in other countries have had for so many years. As a skilled and dual board certified plastic surgeon I now can provide my patients with the newest option in breast aesthetics that provides women with the most natural look that is proportionate and individualized to their body types and aesthetic goals.

There are several myths about silicone gel breast implants which need to be dispelled.

Myth #1: "In general, silicone products are not safe for use in the body". Fact: For many years, silicone has been used in numerous medical devices including pacemakers, artificial joints, and even baby pacifiers.

Myth #2: "Silicone implants rupture due to normal activities or mammography. Fact: It is unlikely that silicone implants would rupture following routine physical activity or mammograms. Today’s breast implants have a thicker shell and an additional barrier layer that makes them stronger. They can withstand more than 25 times the force of a normal mammogram without failure. Breast implants, both saline and silicone are not lifetime devices. It is possible that they may fail at some point in a woman’s lifetime and may require replacement.

Myth #3: "Silicone gel implants cause cancer or diseases like rheumatoid arthritis and lupus". Fact: Silicone breast implants are among the most extensively studies medical devices in history, with thousands of published reports supporting their use. There has been no proven connection between silicone implants and cancer or other diseases.

Myth #4: "Silicone breast implants can adversely affect a mother’s milk and interfere with breast feeding. Fact: Studies found no evidence of elevated silicone in mother’s milk or any other substance harmful to infants. All mothers with silicone breast implants are encouraged to breast feed.

Myth #5: "Breast augmentation surgery often results in unnatural and disproportionate results". Fact: Through proper pre- surgical planning, assessing not only the dimensions of the woman’s chest, but also her tissue dynamics, breast augmentation usually provides a result that is in line with a woman’s expectation of surgery.

The FDA’s decision confirms that silicone gel-filled breast implants are a safe and effective option for women seeking breast implant surgery. Now, with the FDA approval of Silicone-Filled Breast Implants, I am able to offer a broader range of options to all of my patients, many of whom desire to rejuvenate their breasts after child bearing, or enjoy a fuller shape for which nature has otherwise denied them.

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?