In a not unexpected conclusion, yesterday the United States Food & Drug Administration re-affirmed their 2006 decision to reintroduce silicone gel breast implants into the United States market for cosmetic indications. In statements from the FDA, they explained that no new information has arisen to question the safety or efficacy of the devices for intended use. As has been discussed on Plastic Surgery 101 a number of times, this is not really news and has been accepted world-wide for a number of years now. Hopefully this statement from FDA heralds the availability of the new form stable "gummy bear" silicone implants here in the United States which have been available everywhere else for almost 15+ years.
Breast augmentation remains the most popular cosmetic surgery in the U.S., with nearly 300,000 women undergoing it last year. According to the American Society of Plastic Surgeons (ASPS), more than 70,000 others received implants for breast reconstruction.

The most disappointing finding was that only ~60% percent of women enrolled in a 1,000-patient study of one manufacturers implants are still accounted for after eight years. A larger study of 40,000 women conducted has lost nearly 80 percent of its patients after just three years. Diana Zuckerman of the National Research Center for Women and Families, one of the most prominent (and persistent) anti-implant activists, cried foul and suggested that most medical journals would not publish the studies cited by the FDA because of the missing data. I'd agree with her, but for different reasons. She's implying safety issues exist (which they don't by and large), while I'm more interested in outcome data to understand how to reduce re-operations.

Why the relatively poor follow up in the FDA trials?

Dr. Phillip Haeck, president of the American Society of Plastic Surgeons (ASPS)sums it up saying that, "When women are happy with their implants they tend to feel that a regular follow-up is pointless - it becomes a nuisance and an unnecessary expense". I'd agree 100% with that.

It also begs the question of what exactly are we trying to demonstrate with the FDA follow up studies. There is overwhelming world-wide information that suggests safety at this point. It would be nice to have a little more data on longevity so as to better counsel patients on when to consider routine exchange with prior devices, but as we're on the cusp of a major design change in the polymers that make the implant almost impossible to rupture (the "gummy bear" form stable devices) we're going to quickly lose interest in exhaustively studying older devices. This kind of technology advance has always created problems about making conclusions with medical devices, as you end up comparing apples to implants :) (bad pun alert).

Rob

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Rob

I am typically one of the biggest buzzkills for technology in plastic surgery and aesthetic medicine, particularly when it involves body contouring. As I've written about before, the whole laser liposuction (SmartLipo, et al.)thing has been very underwhelming on the results side (compared to traditional liposuction)for most practitioners willing to speak candidly on this. Recently, I decided to purchase a machine which is a little different kind of liposuction strategy. The technology, technically called Nutational Infrasonic Liposculpture (N.I.L), involves a novel hand piece with a tip that rotates in multiple dimensions while emitting low frequency vibrations.

In the Unites States, the technology is being marketed with the label "Tickle Lipo".

What's impressed me about the Tickle Lipo is the efficiency of the device for fat removal and the decrease in pain as compared to the gold-standard of traditional lipo. The decrease in pain is presumably from the fact that you can be much more gentle with the manual movement of the cannula while the vibratory effect is supposed to down regulate local pain receptors. When done awake or under light sedation, patient's describe the vibration as a "tickling" sensation, hence the name. SmartLipo and related devices hurt just as much as traditional liposuction (despite what's being marketed) because you still have to go back and remove the fatty tissue with a traditional suction devices, so you're really not doing anything different on that end. To my mind, Tickle Lipo is kind of a hybrid between power-assisted devices (PAL) and ultrasonic (UAL)without the heat generated by higher frequency ultrasound. The heat from UAL and SmartLipo can have severe complications with external or internal burns created.

At the recent meeting of the American Society of Aesthetic Plastic Surgery (ASAPS), (the premier cosmetic surgery meeting annually in the United States), members were surveyed on their feelings and practices re. liposuction. This survey group would be a representative of the most experienced and accomplished body contouring surgeons in the world. Standard liposuction was the preferred method of fat removal for 51% of them. Power-assisted liposuction (PAL) was second, preferred by 23% of respondents. Only 10% of ASAPS members surveyed employ laser-assisted liposuction (SmartLipo and others) in their practice. When these ASAPS members were asked why they used a laser liposuction platform, the main answer was that it gave them a marketing advantage (68%) rather then any clinical result. Ultrasonic liposuction (UAL) was the most likely method to have been abandoned by the respondents.

With regard to complications after liposuction, ASAPS members felt that ultrasonic and laser liposuction were the techniques most commonly associated with complications (35% and 23%, respectively).Of the respondents, almost 40% have taken care of a patient with significant complications secondary to laser liposuction. Contour deformity was the most common complication reported by respondents (71%), followed by unsatisfactory results (59%), burns (44%), and scarring (38%).

This has been my experience as well. We're seeing more issues from these laser devices, most of which are being performed by non plastic surgeons. I think that has to do with the fact that it's more frequently non plastic surgeons buying these platforms rather then the fact that we'd produce less complications with them (although I think we would). After trialing a number of these technologies, we were just impressed with both the effectiveness and safety of Tickle Lipo.


Rob

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Breast reduction surgery presents an interesting issue when we're getting into an era where every health care cost is going to be scrutinized. As a society, is this a procedure we're going to be willing to commit major funding to? Currently there is a patchwork of indications that vary between different insurance companies as to what meets medical necessity for this operation.

In general, most insurers make you do extensive documentation of "conservative therapy" before even considering approval. I'm not sure what conservative management of big breast is exactly anyway! There are differing weight requirements for the tissue to be removed as well. Blue Cross of Alabama for instance requires a minimum of 500 grams (~1.1 lbs) per breast to be removed. Others use a sliding scale called the "Schnur Scale" to correlate appropriate weight removal to a calculation of your total body surface area (TBSA). The Schnur scale came from a paper by a plastic surgeon who was trying to quantify symptoms in his breast reduction patients.

The recommendations from that study by Dr. Schnur were perverted by insurers, written into policy guidelines, and are now used to exclude many patients from having breast reduction surgery. There now exists a great deal of literature showing that reductions much less then prescribed by insurance companies is effective in patients suffering from neck, back, and shoulder pain. In fact, a Finnish study suggests breast reduction surgery seems to improve the health-related quality of life indicators as much or more then surgeries for hip or knee joint replacement.These studies are dismissed by insurers as observational,flawed, or biased by greedy doctors, but if they could speak honestly they would explain that they don't want to open eligibility for the procedure to a whole new class of patients and cost themselves a great deal of money.

Apparently we're not the only country that is having issues on whether to cover breast reduction surgery. Hat tip!

A court in the German state of Hessen has ruled that insurance companies do not need to cover the cost of breast reduction surgery as having a large bust is not a medical problem. The decision means that insurers will only have to pay to correct breasts which are deformed.

The case was brought by a 38-year-old woman who suffered orthopaedic and physical problems due to the weight of her boobs. She had been advised by doctors to have breast reduction surgery.

But her insurance company didn’t see it as a necessity and therefore refused to cover the costs of the operation. It claimed she was suffering from back problems because she was overweight and that her physical discomforts would be reduced if she trimmed down weight and built some muscle up.

The court agreed with the insurance company and the big-breasted woman lost her case.

Two and a half years ago, the court in Hessen rejected the case of a woman who thought her breasts were too small. She wanted her medical insurance to cover a breast enlargement operation and claimed that she was physically harassed for her small boobs. The court declared then that small breasts are not an illness

Rob

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There is an overwhelming amount of skin care products on the market, and it can get kind of confusing to patients and doctors about sorting out hype from substance. At the end of the day I think you've got to keep it simple and try to minimize the number of steps and products that people use.

At a basic level you need to consider 3 things to be essential

• a gentle daily cleanser (which can be something cheap)
• a restorative agent(s) to improve or maintain your skin
• protection from the sun

There's a whole bunch of peripheral products addressing pigmentation (toners, hydroquinone products, etc...) that serve niche roles as well.

I've become a fan of the Neo Cutis line of products for two reasons
1. it's reasonably priced for medical grade skin products
2. you can do a lot with a very simplified regimen

The gimmick with NeoCutis is a substance called "PSP" which is a proprietary protein derivative of sorts derived from fetal skin cells. This PSP ingredient is common to their different product lines in different concentrations and with some other additives. For men, their gel-based, "Biogel"
is a very easy single product that men can use without overwhelming our simple brain or making us feel overly metrosexual. Highly recommended and one tube will last 3 months or so, pretty reasonable for $120-150 dollars. Neocutis makes a more concentrated PSP product eye cream which is also great. As I understand it, a lot of people just use it for their whole face. It seems to work well and be very tolerant to people even with sensitive skin.

I'm not here to pimp for that particular company, but I think they make a value-based product line that is very simple. If you combine one of their PSP products with an OTC gentle cleanser, Retin A (or another retinoid-like product), and some sunscreen you suddenly have a fairly formidable combination for less then $200-250.

rob

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Just like when your wife or girlfriend asks "Do I look fat in this?", it is surely the deadliest of traps when a cosmetic surgery patient asks you the open-ended "What do YOU think I need done?". Most Plastic Surgeons know not to take the bait with this question, but rather tease more out of the patient about what is concerning them.

A careless phrase or suggestion can produce both anger and anguish to a patient. I still think I'm getting pain from a voodoo doll for my inadvertent pointing out a "witch's chin" deformity to a patient (Long story, read here to get up to speed).

Vanity Fair magazine put this to the test when they had a writer go "undercover" on three consults for cosmetic surgery. (The article can be viewed here). One with a Manhattan Plastic Surgeon (whom I've actually heard of), one with an ENT trained "cosmetic surgeon" (who notably was sanctioned for defrauding Medicare in 2003 - Don't these people use Google?), and one osteopathic (a DO as opposed to an MD degree) surgeon who'd trained in an osteopathic plastic surgery residency.

Note: There is really nothing about Plastic Surgery as a discipline that is related to osteopathic tenants. As the mystical snake-oil aspects of osteopathic medicine, like manipulation, have largely been shed from their curriculum, a DO and MD education is now practically similar. As there are only a handful of DO plastic surgery programs, I'm assuming this guy would have been an intelligent guy and good resident to get a position. End of editorial!

The writer's first consult was with the Plastic Surgeon, who came off really, really, really cheesy.

"Now the doctor and I stand in front of the floor-length mirror while he deconstructs the “before” me. “As a Caucasian woman, you probably—if you were doing lipo—would want this brought down,” he says, pointing to my “banana rolls”—his clever name for the part of my rear end that peeks from beneath my underwear lining. “And again, you know, in jeans, to most people … on white women, you guys like to get this down. And we like to see it down.” I gulp, realizing that I’ll never be able to eat my favorite fruit again without thinking of my own ass....

Back in the Upper East Side exam room, Dr. R******* pinches me from shoulders to knees before concluding: “You look absolutely nice, but, even if I were a blind guy and put my hands here”—he seizes my sides—“there are little lumps. This could be brought down just to give you a little bit better of a curve.” These lumps, I learn, are my “waist wads.” To his credit, Dr. R******* does note that my “waist wads” are “borderline.” But, he says, “I’ve done supermodels with much less than this. To them it was important. To each his own.”

He prefaces his conclusion with a hypothetical scenario: “I think if I were a single plastic surgeon, which I’m not, riding around in my Corvette, which I don’t, my license plate would read full c. O.K.? That would be my license plate. So that’s what I would think, in general, is the Promised Land of Breasts for most people.”

OMFG. Is this guy for real? I'll give him the benefit of the doubt that some of his comments were selectively edited, but I cannot imagine most of his peers would consider that language and tone very professional. Pushing services, as opposed to passive advice, is not how most experienced surgeons would teach their residents to act. I know we weren't. There was a well known surgeon in Louisville who was notorious for telling women at social events that that they needed a face lift. The funny thing was that on a number of occasions this surgeon had actually already done a face lift on that patient and just failed to recognize both the patient and his work. Open mouth, insert foot!

The other two consults described were actually much tamer and more professional IMO except for the part where the ENT's office manager offers to show off her implants to the prospective client. Chez tacky! Props to young Dr. Joseph A. Racanelli D.O., who despite being the least experienced, gave the most appropriate response to the honey trap offered by Vanity Fair.

Rob

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There's an article on MSN.com today "Way to go, grad! Here's a check for a new nose - Is cosmetic surgery an appropriate commencement gift for teens?" that's kind of interesting. It's a brief synopsis over the increasing trickle-down of Plastic Surgery procedures to teens which ballooned to 244,000+ procedures in 2006 (data form the Amer. Society of Plastic Surgeons (ASPS)), including about 47,000 nose jobs and 9,000 breast augmentations. The discussion mostly centers around teenage girls and breast surgery. The few teenage boys you see in a Plastic Surgeon's office usually have gynecomastia (excess male breast tissue).

The story of one of the the teens featured caught my eye,

When Courtney Powers graduated from high school last year, she didn’t receive a new computer or a trip to Europe. The North Carolina teen got a pair of D-cup breast implants.

“My breasts hadn’t grown since I was 16,” says Powers, who underwent cosmetic surgery two days after her 18th birthday. “I was a 36AA and my mom and dad knew I was very self-conscious.”

Not to beat a dead horse, but in general, I'd consider the implant size (425-500+ cc) required to go from an A-cup to a D-cup to be a very,very poor choice for long term results in most women. Larger implants are both heavier and wider which dramatically accelerate "aging" of the breast tissue and skin. Ms. Powers' native horizontal and vertical boundaries and tissue attachments likely had to be violated to accommodate her implants, which is something best avoided when you can help it. Avoiding over-sized implants (particularly saline, as they're heavier) is the single most-effective thing you can do in breast surgery to minimize reoperation rates. Last year the perceived problem breast augmentation in teens by a prudish politician caused a mild political controversy in Australia, which I touched upon here.

Issues about the propriety of doing surgery on adolescents or young adults come up a good deal in our field as almost all these procedures are elective rather then absolutely necessary. It's a little patronizing to make blanket statements about older teens like Ms. Powers, as many of them are old enough to vote, marry, or serve in the military. With younger teens it becomes something to consider on an individual basis and becomes invested with a lot of gray area.

Is it appropriate to do teen surgery for breast reductions or reconstruction of congenital breast deformities (which often require implants)? Many feminists who decry cosmetic surgery in teens (or adults) would probably make exceptions for those patients despite the fact that those operations are often cosmetic (rather then functional). The ASPS position paper on elective breast surgery and other procedures recommends using 18 years old as a relative (but not absolute) guide for practice guidelines.

There's a little of the PC sentiment about inner beauty proffered in the article on MSN by Courtney Macavinta, author of “Respect: A Girl’s Guide to Getting Respect and Dealing When Your Line Is Crossed.”

"By giving teen girls, in particular, surgery we’re just sending this message to them that they can be anything they want to be — they can go to any school or do anything in life — as long as they look a certain way on the outside.

I’m all for taking a shower, combing your hair and getting a cute outfit, but there is only a tiny percentage of people whose profession and success rely on appearance,” says Macavinta. “The girls who thrive and prosper in life very quickly invest their energy other places — like their brains, compassion and humor."

This is quickly squashed with a cold,hard dose of reality by Dr. David Sarwer, Associate Professor of Psychiatry at the Hospital of the University of Pennsylvania, and probably the world's authority on issues of body image and psychological outcomes in Plastic Surgery

“From a societal perspective, the reality is that whether we like it or not, our appearance does seem to matter.Studies show that attractive people are treated more favorably and that a positive body image can account for up to one-third of self-esteem....Body image improves after surgery. Self-esteem and quality of life can improve as well. However, more studies are needed before we can say that kids benefit the same way adults do.” "

Rob Oliver Jr. MD

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