Dr. Epstein's Blog

Patients often ask me if they can avoid a face lift and just focus on the neck. The question is also asked the other way around: is it possible to have a facelift without a neck lift? This is my response:

With the advent of techniques that permit greater facial rejuvenation with less operating time and less risk of nerve injury (such as with the MACS lift), I believe that the neck should be treated with the face for a variety of reasons.

Aesthetic reason: The neck ages with the face. For example, they are both exposed to the sun in equal amounts (this assumes you don’t wear a turtleneck every day of the year!). It is a very rare case indeed (I’ve actually never had one) where the neck couldn’t benefit from surgical rejuvenation at the same time as the face. As I am already there, why leave it out of the equation when there is benefit to be gained?

Technical reason: If you are having the face lifted, then you need the neck skin to come up and re-drape over the jawline. It takes only a few minutes to undermine (elevate) the neck skin (I like using power-assisted liposuction with or without suction as needed). When elevating the cheek skin (I prefer the MACS lift) it is a simple extension of the surgical plane to enter the neck. After lipo undermining, this is very easy and quick. As the MACS lift is a pure vertical lift, it is a natural extension to bring the neck skin up to the jawline and at the same time elevate and tighten the platysma (the thin, flat muscle in the neck). I see little to gain by treating the neck without the face and vice-versa. Doing them together gives a much more natural look, which is what you want, right?

Give a jingle to our Stony Brook plastic surgery office if you’re thinking it might be the right time for some neck and/or facial rejuvenation. I promise we’ll guide you to the right decision for you.

To your health and wellness,

Dr. Mark Epstein

Silicone is material that has a rubbery texture. A breast implant consists of a solid silicone shell (bag) filled with either saline (salt water) or silicone gel. All breast implants are made by spraying a mold with or dipping a mold into liquid silicone. When the silicone dries, the implant is then peeled off the mold. When the implant is removed from the mold, there is a small opening on the back (underside) of the implant where the mold was attached to its supporting pole. A silicone patch is then applied to seal the implant. To make a silicone gel filled implant, a needle is inserted through the patch to inject the silicone gel. To make a saline implant, a separate valve is attached to the front of the implant. Silicone gel filled implants are inserted pre-filled with silicone gel, but saline implants are inserted deflated. First, a fill tube is attached to the implant and then the implant is rolled up like a cigar. Once inside the breast, saline is inserted into the implant via the fill tube. The fill tube is then removed when the implant is fully inflated, and the valve plug is pressed into the valve to seal it.

Silicone gel filled implants were re-released by the FDA in November 2006 after fifteen years of extensive study. Silicone implants have become extremely popular.

THE FILLER: Silicone gel is “cohesive” filler where saline is not. This means that the silicone gel holds together and does not disperse should there be a disruption in the silicone envelope that contains the gel filler. The more “cross-linking” of the silicone, the more the gel tends to retain its shape, a term called “form-stable”.

SHAPE: Saline implants are available in either a round or a teardrop shape. The advantage to a saline teardrop implant is that the overall breast shape is more natural in most cases. Use of saline teardrop implants requires greater attention to detail in placement than a round implant. A common criticism of teardrop implants from my colleagues is that they turn once inside the breast (not true for a first time augmentation) and that later on they look the same as round implants. When I look at my own results with saline teardrop versus round implants, I believe that the shape of the breasts with the teardrop saline implants is clearly superior to those with the round saline implants. If you view the cases on my web site, www.epsteinplasticsurgery.com, I think that you will come to the same conclusion.

Silicone gel filled implants are available in a round shape only. However, due to the cohesive nature of the gel filler, the round implant tends to give a more natural appearance of the breast than a round saline implant. When reviewing my own cases, (again, you can see them on my website), I think that you will agree that the appearance of the round silicone gel implants is similar to those of the teardrop saline implants.

EASE OF USE: The advantage of saline round implants are that they are much easier to use and less expensive than teardrop saline implants. There is a definite “learning curve” to using teardrop implants. If you are placing saline implants, I do agree that the teardrop implants should be highly considered. As of this writing, silicone gel implants are only available in a round shape, and thus easy to place, but because they are prefilled and cannot be rolled up, require a slightly longer incision than saline implants do, but not enough to warrant a choice of one or the other.

FEEL: Due to the cohesive nature of the silicone gel filled implants, in my experience (and my patients agree) the breasts augmented with silicone gel implants feel much softer and more natural than those with saline implants do. Breasts with saline implants feel much more firm and unnatural. The more soft tissue that you have to cover the implant (muscle and particularly breast tissue, the less palpable a saline implant will be. However, understand that as the breast ages, and then undergoes changes caused by pregnancy and lactation, it will atrophy (the tissue thins out). As atrophy occurs, a previously less palpable saline implant may not be noticeably visible and easily palpable. I have seen this happen in a few patients who underwent augmentation prior to pregnancy and then returning a year or so after childbirth.

RIPPLING/WRINKING: There is far less visible and palpable rippling and wrinkling with silicone gel implants over saline implants (14 times less!).

SAFETY: 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. On November 17, 2006, the FDA approved the use of silicone breast implants for breast augmentation and reconstruction. Breast implants are the most studied medical devices in history.

Silicone is biologically inert. This means that there is no reaction between silicone and the body. You cannot reject silicone nor be allergic to it. There is absolutely no connection between breast cancer and breast implants. Studies have shown that the incidence of breast cancer is the same in women with breast implants as those who do not have them. Furthermore, in those that do develop breast cancer, the stage of breast cancer at detection is the same for within with and without breast 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. These carefully designed medical studies have proven that there is no connection between breast implants and any other disease processes.

LEAKAGE/TEARS: Both saline and silicone gel filled implants are safe. Should a saline implant develop a tear or even a pinhole leak, the implant will deflate in about 48 hours. Leaks can also occur at the fill valve, which is not an issue with silicone gel implants which do not have a fill valve. When the implant deflates, the breast will be noticeably smaller and feel much different than it was a few days before. Should a silicone implant develop a pinhole, the gel will most likely stay inside the implant due to the cohesive nature of the gel? Should a larger tear occur, there may be some movement of the gel out of the implant. However, the gel would be contained by the normal scar tissue “capsule” that forms around all breast implants shortly after implantation. If a problem occurs with a gel implant, you may notice a change in the shape or feel of the breast, or experience some mild discomfort. An ultrasound of the breast is an excellent way to detect the presence of a problem with a breast implant. Actual rupture rates are extremely low, approximately 1% per year.

PATIENT SATISFACTION: 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.

RESTRICTIONS: Saline implants are approved by the FDA for use in women 18 years and older. Silicone gel filled implants are approved for women age 22 years and older.

COST: Silicone gel implants do cost a little more than saline implants, but it is my opinion that the difference should not be enough to be a factor in selecting which type of implant you which to have.

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.

Breast implants are placed into a pocket under the breast. The terms “above the muscle” and “below the muscle” are frequently bandied about. Which is better? Patients have opinions, surgeons have opinions. Certainly, I, a plastic surgeon who has performed a fair number of breast augmentations, have an opinion. Before I render than opinion, let’s review the pertinent anatomy.

Below the breast is the pectoralis major muscle. It is attached to the chest wall along the lower, inner portion of the breast, then along the entire side of the breast bone. The muscle spans across the chest like a triangle, and attached to the upper arm bone called the humerus. Below the muscle lies the chest wall, essentially the rib cage.

To place the implant under the muscle, a pocket is created by lifting the muscle off the underlying rib cage. The attachment of the muscle to the overlying breast remains undisturbed. To place the implant above the muscle, the breast is lifted off the underlying muscle. The attachment of the muscle to the underlying rib cage is undisturbed.

So, which is better? In either case, you have a pocket, and in that pocket you increase the size of the breast by inserting an implant. Theoretically, it should not make much difference. Theoretically yes, but in practice, quite the opposite. Consider the following:

1. The more soft tissue (breast and muscle are both examples of “soft tissue”) that is placed over the implant, the less visible and palpable the implant will be. If the patient has nice, thick, firm breast tissue, then it may not make too much difference which route you take. Certainly, if the tissue is naturally thin, or thinned out by atrophy after pregnancy and lactation, if will matter greatly which route of placement is utilized. Also, consider that with time, everyone (unfortunately) ages and that results in thinning (atrophy) of tissue.

2. The muscle is subject to less stretching that the skin and breast tissue. It acts like a stabilizer to prevent overstretching of the breast pocket (to some extent).

3. There is (according to my friends who are radiologists specializing in breast imaging) less interference with interpreting mammography when the implant is below the muscle. This statement is purely anecdotal and not based on any personal experience as I do not interpret mammograms.

4. It is no easier to place the implant above the muscle than below it, and probably requires a little more surgical effort, although not enough to make any difference to persuade the surgeon to choose below the muscle placement.

5. Despite the fact that the muscle is being partially cut with placement below the muscle, I do not believe that there is any more discomfort or downtime in using below the muscle placement. I utilize a rapid recovery method with below the muscle placement and my patients require no more than Advil for discomfort and are driving the next day.

So then, what is the reason surgeons choose to place implants above the muscle? There are a few reasons. The first may seem silly, but is in fact a reason surgeons choose to do what they do. The answer is “because that is what I was taught to do”, or “because that is how I have always done it and it works for me”. That is fine, but you cannot advance as a surgeon if you don’t keep yourself open to advances. Personally, I am always on the lookout for better ways to do things. It may take some getting used to when changing up to another technique, but if it is for the betterment of my patients, then why not? If I wasn’t progressive, then I would still be writing prescriptions for narcotics like Vicodin instead of just Advil after surgery, wrapping my patients is straps and bandages instead of just a small paper Steri-Strip and telling my patients they cannot raise their arms or drive for days or weeks instead of raising their arms high above their head while still on the recovery room stretcher and driving to their first follow up visit in my office the next day. That is a whole different story; my point is that a surgeon must be up to date on the latest techniques and methods.

There is one compelling reason why many surgeons place implants above the muscle. If you have a breast that has lactated, lost fullness in the upper portion and the glandular tissue is bottoming out (some of the breast tissue lies below the lower crease of the breast), then you have a special situation, one which is also very common. If you place an implant below the muscle, then the breast mound from the implant will lie up high, but the breast tissue will slide off the front of the implant and sag over the implant. From the side, this resembles the side view of the dog “Snoopy” from the Charlie Brown cartoons. The reason for this is that the muscle is preventing the implant from moving lower into the breast where there is some sagging. If you place the implant on top of the muscle, then you no longer have this problem. However, placing the implant above the muscle will result in some other potential problems: there is now much thinner tissue over the implant, so the implant will be more palpable and visible. Also, there will be less support of the shape of the breast without the muscle. Lastly, mammography may be more difficult.

A better solution is to place the implant under the muscle using a dual plane technique. In this technique, the muscle is repositioned superiorly in the breast pocket. There is a little less muscle coverage of the implant, but there still is muscle coverage of the upper portion of the implant nonetheless. The implant can now move into the lower pole (portion) of the breast and fill it out properly. All this with no need for a breast lift.

The dual plane technique will be the subject of a future blog on this website.

Many of my patients have asked about how VASER (internal ultrasound ‘VASER’ assisted lipoplasty) is different from Smart Lipo and Slim Lipo (Internal Laser-Assisted Lipoplasty). This article, written by a biomedical engineer compares these and several other technologies to reduce subcutaneous fat. I think that the article is well written and informative. When I was looking for a technology, I compared both laser technologies and VASER and came to the same conclusions as the suthor of this paper. In summary, the article describes the superiority of the VASER technology over the other technologies. – Mark D. Epstein, M.D., F.A.C.S.

Body Sculpting Surgery: Technologies and Techniques

by William W. Cimino, Ph.D.

‘Lipoplasty’ is the all-encompassing term that refers to body contouring by sculpting or removal of fatty tissue. The major groups of different technologies and techniques for lipoplasty are described below, along with a short assessment of their respective advantages and applicable volume considerations.

Suction-Based Technologies

Liposuction or Suction-Assisted Lipoplasty (SAL)

• Power-Assisted Lipoplasty (PAL) Ultrasound-Based Technologies
• 
  Internal Ultrasound-Assisted Lipoplasty (IUAL)
• 
  VASER-Assisted Lipoplasty (VAL)
• 
  External Ultrasound-Assisted Lipoplasty (EUAL)

• Transdermal Ultrasound-Assisted Lipoplasty (TUAL) Laser-Based Technologies
• External Laser-Assisted Lipoplasty (ELAL)
• Internal Laser-Assisted Lipoplasty (ILAL) Chemical-Based Technologies

Mesotherapy

Suction-Based Technologies

Liposuction/Suction-Assisted Lipoplasty (SAL)

Liposuction, with all of its many variations, is the predominant form of body contouring surgery today. These variations include liposculpture, tumescent liposuction, suction lipectomy, syringe lipoplasty, and micro-cannula technique. All of these suction-based techniques can be included in a general category commonly referred to as Suction-Assisted Lipoplasty, or ‘SAL’.

SAL is a two-step process that requires the infusion of a wetting solution into the fatty tissues followed by the insertion of a suction cannula that is attached to a suction source. The cannula avulses (tears) and aspirates the fatty tissue fragments which are deposited into a waste canister.

This technology has been around in basic form for more than 30 years and has undergone improvement and refinement during that period. Major advances for the SAL technique include the introduction of the side-ported cannula, the introduction of wetting solutions with drugs for pain and control of bleeding, and overall reduction in cannula size.

Suction-based technologies are not tissue selective. Any tissues, such as nerves, vessels, or collagen structures in the fatty layer that get pulled into the ports on the suction cannula will be torn or avulsed. The technology is reliable, and has been used and studied extensively.

SAL has been used for small to very large volumes of fat removal in lipoplasty.

Power-Assisted Lipoplasty (PAL)

Power-Assisted Lipoplasty (PAL) is essentially a liposuction cannula (SAL) with the addition of a motor-driven reciprocating handle. The primary advantage of this technology is that it makes passage of the suction cannula through the tissues easier for the surgeon but represents no clinical improvement in outcomes or safety relative to SAL for the patient¹.

Surgeons may develop arthritis, ulnar palsy, or carpal tunnel syndrome as a result of the motor-induced vibration². Like SAL, PAL is not tissue selective – any tissues, such as nerves, vessels, or collagen structures, in the fatty layer that get pulled into the ports on the suction cannula will be torn or avulsed.

PAL is generally used for medium to large volumes of fat removal in lipoplasty as it may be too aggressive for smaller, more delicate areas.

Ultrasound-Based Technologies

Internal Ultrasound-Assisted Lipoplasty (IUAL)

Internal Ultrasound-Assisted Lipoplasty (IUAL) uses an ultrasonically vibrating cannula to emulsify (liquefy) adipose tissue during the aspiration process. IUAL technology was introduced with the promise that the ultrasonic technology would provide a level of tissue selectivity due to the emulsification process and thereby improve outcomes relative to those obtained using SAL. However, clinical experience and outcomes with IUAL vary considerably. Some surgeons report no significant clinical change in outcomes^5,6. Some surgeons report an improvement in outcomes^3,4. Others report increased complications or tissue damage relative to SAL⁷. This wide variation in results is in large part explained by the design of the technology which aspirates protective fluids/ tissue while the ultrasonic energy is active, by application of excess power to the tissues, and by the initial insufficient clinical understanding of the technology, all of which prevented consistent and uniform effectiveness⁹.

IUAL is called internal UAL to differentiate it from external UAL (EUAL, explained below). Most IUAL is a two-step process similar to SAL: infusion of a wetting solution into the fatty tissues followed by a combined emulsification and aspiration phase using a hollow ultrasonically powered cannula.

IUAL has been used generally for medium to very large volumes of fat removal in lipoplasty as it may be too aggressive for smaller, more delicate areas.

VASER^®-Assisted Lipoplasty (VAL)

VASER-Assisted Lipoplasty (VAL) represents a third-generation internal ultrasound system that incorporates significant design improvements over the previous two generations of internal ultrasound devices.

VASER technology is the ultrasonic component of an integrated lipoplasty system. The VASER System uses small-diameter, solid, multi-ringed probes to deliver a minimal level of ultrasonic vibrating energy to specifically target and emulsify fatty tissues. Smaller diameter probes and pulsed delivery of the ultrasonic vibratory energy further reduce delivered energy by as much as 50% compared to continuous wave ultrasound used in first and second generations of internal ultrasound-assisted lipoplasty⁸.

By emulsifying the fatty tissue prior to extraction, aspiration can be performed with less avulsion, and hence less tearing of the tissues. The VAL procedure does not utilize standard SAL to remove the emulsified tissues and fluids -rather, specially designed aspiration cannulae, call VentX^® Cannulae, are used to remove the emulsified fluids and minimize avulsion and other tissue trauma associated with standard SAL aspiration devices.

This third-generation ultrasound technology was specifically designed to preserve and spare as much of the tissue matrix as possible, yet still remove the desired amount of fatty tissue. This approach helps minimize post-operative pain and bruising and also addresses the limitations inherent in earlier generation IUAL devices^10,11. VAL was compared to IUAL in a clinical study and found to significantly reduce potential complications relative to the earlier generations of IUAL⁹.

VAL has been used on volumes from the very smallest (face/neck) to very large volumes.

External Ultrasound-Assisted Lipoplasty (EUAL)

External Ultrasound-Assisted Lipoplasty (EUAL) is the application of non-focused ultrasonic energy in the 1-3 MHz range to the skin of the patient prior to the use of standard SAL techniques. The theory is that the externally applied ultrasonic waves disrupt or soften the fatty tissue so that subsequent suction aspiration is easier. However, there has been no scientific substantiation that this additional step, prior to SAL, improves outcomes or safety.

Because SAL is used to remove any fat targeted by the EUAL technique, the outcomes are generally consistent with SAL outcomes. EUAL surgery may involve significantly more time if larger volumes are to be pre-treated with the EUAL device. This technology is not in widespread use today, primarily because the combination of EUAL and SAL has not been shown to be clinically superior to SAL alone.

Because SAL must be used in conjunction with the EUAL device, addressable volumes are the same as SAL, from small to very large, strictly a function of the SAL step.

Transdermal Ultrasound-Assisted Lipoplasty (TUAL)

Transdermal Ultrasound-Assisted Lipoplasty (TUAL) is the application of focused ultrasonic energy directly to the skin of the patient to disrupt the fatty tissue below the skin and does not require removal of the ruptured cells with a suction cannula (SAL). This technology is not currently available for use in the United States, as it has not yet gained Food and Drug Administration (FDA) clearance.

Transdermal ultrasound is a single-step process which involves application of the ultrasonic energy directly to the skin without the prior infusion of wetting solution as required in all other techniques. The body’s natural processes remove the damaged tissues over a period of time after the ultrasound application.

This technology is used to treat only small volumes in a single patient visit, on the order of 250–300 milliliters (cc’s) per treatment. The treatable volume is limited because this approach requires that the patient’s body remove or process the dead or damaged tissue. Because the treated fatty tissues are not removed at the time of surgery, results are not seen until several months after the procedure. Many treatments are required over an extended period of time if more significant volumes are to be addressed.

Laser-Based Technologies

External Laser-Assisted Lipoplasty (ELAL)

External Laser-Assisted Lipoplasty, also called Low-Level Laser-Assisted Lipoplasty, is the application of low-level laser energy to the skin of the patient prior to the use of standard SAL techniques. The theory is that the application of the low-level laser energy causes the fatty cells to produce a transitory pore in their cell membranes, which allows the fat inside the cells to pass to the outside of the cells¹². This claim was subsequently studied for validation, and results showed that the ELAL therapy did not influence the fat cell structure as reported¹³. This technology is not in widespread use today, primarily because the combination of ELAL and SAL has not been shown to be clinically superior to SAL alone¹³.

Because SAL is used to remove any fat targeted by the ELAL technique, the outcomes are generally consistent with SAL outcomes, as are addressable volumes, from small to large, strictly a function of the SAL step.

Internal Laser-Assisted Lipoplasty (ILAL)

Internal Laser-Assisted Lipoplasty (ILAL) uses a small-diameter laser fiber to deliver laser energy directly to

the fatty tissues through an incision in the skin. The laser is reported to operate through photomechanical and photothermal effects¹⁵. In short, these processes cause destruction of cells via coagulation and vaporization due to localized heating and rapid thermal expansion. ILAL was first introduced in the mid to late 1990′s¹⁵ and did not gain wide adoption or use. It has been reintroduced and is marketed as SmartLipo™ and Cool Lipo™.

A contra-lateral study comparing SAL on one side of the patient to ILAL (SmartLipo) on the other side of the patient showed no significant difference in outcomes¹⁴. The American Society for Aesthetic Plastic Surgery issued a guidance statement for this technology stating “Although SmartLipo received FDA clearance in late 2006, alarm bells rang for many experts when discussing this procedure based on the recent publication of data showing that this procedure was no better than traditional liposuction, and that it may present some risks to the liver and kidneys due to the way it releases free fatty acids when destroying the fat cells”¹⁶. The surgical technique for ILAL is a three-step process: (1) infusion of wetting solution followed by (2)application of the laser energy to the fatty tissue then (3) aspiration of the emulsified tissues using SAL. It has been proposed that the suction phase is not required for ILAL but surgeons are generally not willing to risk leaving the laser-affected volumes of damaged or dead tissue in the body. ILAL is therefore applicable only to small volumes as a standalone technology if no SAL step is used. If ILAL is combined with SAL to remove larger volumes, then outcomes consistent with SAL can be expected¹⁴. In this case (ILAL with SAL) the laser is used to treat only a small percentage of the removed tissues.

Chemical-Based Technologies

Mesotherapy

Mesotherapy is the use of a large number of injections of non-FDA approved drug mixtures, most often including phosphatidylcholine. The drug mixture is injected directly through the skin and into the fatty layer using several hundred needle injections to distribute the drugs throughout the fatty layer.

The mesotherapy theory provides that the drug mixture causes the breakdown (cell rupture and cell death) of the fat cells, which are then absorbed by the body. The American Society of Aesthetic Plastic Surgery recently released a position statement on mesotherapy which warns patients, stating: “efficacy and safety are not known, the procedure and the drug mixtures are not approved by the FDA, and that the procedure is often offered by unqualified personnel”¹⁷. Mesotherapy is marketed as LipoDissolve^®, LipoStabil^®, and LipoShape^®.

1. Fodor PB, Vogt PA. Power-assisted lipoplasty (PAL): A clinical pilot study comparing PAL to traditional lipoplasty (TL). Aesthetic Plast Surg., Nov.-Dec.,23(6):379-85, 1999.
2. Shiffman, MA. Editor’s Commentary in Liposuction: Principles and Practice. Editors M.A. Shiffman M.D., and A. DiGiuseppe M.D. Springer-Verlag, Berlin, Germany, 2006; p 405.
3. Kloehn RA. Liposuction with “sonic sculpture”: six years experience with more than 600 patients. Aesth Surg. J. 1996;16:123-8.
4. Zocchi ML. Ultrasonic assisted lipoplasty: Technical refinements and clinical evaluations. Clin. Plast. Surg. 1996;23(4) 575-598.
5. Fodor PB, Watson J. Personal experience with ultrasound-assisted lipoplasty: A pilot study comparing ultrasound-assisted lipoplasty with traditional lipoplasty. Plast. Reconstr. Surg. April 1998;101(4):1103-1116;discussion 1117-9.
6. Karmo FR, Milan MF, Silbergleit A. Blood loss in major liposuction procedures: a comparison study using suction-assisted versus ultrasonically assisted lipoplasty. Plast. Reconstr. Surg. 2001;108(1):241-7; (discussion 248-9).
7. Cardenas-Camarena L, Andino-Ulloa R, Mora RC, Fajardo-Barajas D. Laboratory and histopathologic comparative study of internal ultrasound-assisted lipoplasty and tumescent lipoplasty. Plastic & Reconstructive Surgery. Sep. 2002;110(4):1158-1164.
8. Cimino WW. Ultrasonic Surgery: Power Quantification and Efficiency Optimization. Aesth Surg. J. 2001;21: 233-240.
9. Jewell ML, Fodor PB, De Souza Pinto EB, Al Shammari MA. Clinical application of VASER-assisted lipoplasty: A pilot clinical study. Aesth. Surg. J. 2002;22:131-146.
10. Cimino W.W. “Ultrasound-Assisted Lipoplasty: Past, Present, and Future”, Liposuction: Principles and Practice, Editors M.A. Shiffman, M.D. and A. Di Giuseppe, M.D., Springer-Verlag, Berlin, Germany, 2006, p 225-228.
11. Cimino WW. VASER-Assisted Lipoplasty: Technology and Technique. Liposuction: Principles and Practice, Editors M.A. Shiffman,

M.D. and A. Di Giuseppe, M.D., Springer-Verlag, Berlin, Germany, 2006, p 239-244.

1. Neira R, Arroyave J, Ramirez H, Ortiz CL, Solarte E, Sequeda F,Gutierrez MI. Fat liquefaction: effect of low-level laser energy on adipose tissue. Plast Reconstr Surg. 2002 Sep 1;110(3):912-22; discussion 923-5.
1. Brown SA, Rohrich RJ, Kenkel J, Young VL, Hoopman J, Coimbra M. Effect of low-level laser therapy on abdominal adipocytes
2. before lipoplasty procedures. Plast Reconstr Surg. 2004 May;113(6):1796-804; discussion 1805-6.
2. Prado A, Andrades P, Danilla S, Leniz P, Castillo P, Gaete F. A Prospective, Randomized, Double-Blind, Controlled Clinical Trial Comparing Laser-Assisted Lipoplasty with Suction-Assisted Lipoplasty. Plast. Reconstr. Surg. 118(4):1032-1045, September 15, 2006.
3. Schavelzon, D., Blugerman, G., Chomyszyn, A., “Laserlipolysis”, Liposuction: Principles and Practice, Editors M.A. Shiffman, M.D. and A. Di Giuseppe, M.D., Springer-Verlag, Berlin, Germany, 2006, p 321-325.
4. ASAPS website commentary: http://www.surgery.org/press/news-print.php?iid=476&section=news-lipoplasty

5. http://www.surgery.org/press/news-release.php?iid=475

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.