"Is it worth it?" - the 2011 edition

Plastic Surgery advice site RealSelf.com keeps a consumer-generated list of procedures, rated by whether or not the consumer felt they were "worth it" or not. (link) While it's not scientific, it's a good reflection of how consumers feel about things.

Here are the top five plastic surgery procedures (most worth it), as of today:

#1) "mommy make-over" - 94% approval
#2) lower body lift - 93% approval
#3) tummy tuck - 90% approval
#4) breast implant revision - 89% approval
#5) breast reduction - 87% approval

(Editors note: gastric bypass was rated tops overall, but since it's a bariatric surgery operation, I didn't put it on this list.)

List below are some of the "least worth it" procedures, according to the users of Realself.com

#138) "portrait" skin resurfacing - 11% approval
#137) thread lift - 22% approval
#136) blue peel - 25%
#135) ProFractional Laser - 25% approval
#134) silicone injections
#131) VelaShape - 28% approval
#128) Zerona fat reduction - 32% approval

No surprises in this rogues' gallery. Although we used to use the Blue Peel, we now prefer the VI Peel. Works just as well for light to medium strength peeling, and you don't have a blue tinge to your skin for the first few days!

I'm now participating in the discussion panels over at RealSelf.com, answering common patient questions. Hopefully, prospective patients will find these answers helpful, in addition to all the educational material on our own website. Here's the link...

Q & A with Thomas Fiala, MD:

View all answers from Thomas Fiala, MD on RealSelf.com

Image credit: decorativepackagingblog.com

"What the heck is ALCL? Should I be worried?"

If you're like most people, you've never heard of ALCL. Well, you will now, because the FDA has just issued a bulletin, drawing attention to this exceptionally rare disease. ALCL is a subtype of non-Hodgkin's lymphoma. ALCL is NOT breast cancer, but an entirely different disease. It can affect lymph nodes, skin or breast tissue.

About 3 people per 100 million will be diagnosed per year with ALCL of the breast, whether they have breast implants or not. It's really rare. Most plastic surgeons will never see a case of ALCL during their lifetimes. You're more likely to be hit by lightning and win a major lottery on the same day.

Why are we talking about this rare disease? Because there have been some early reports of ALCL occurring in women with breast implants, so the FDA is investigating whether there is any link between the two. There have been between 34 and 60 cases reported worldwide in women that also have breast implants. The FDA isn't saying there is a definite link for sure, just that there might be a "possible association".

So far, we don't know that much from a tested, scientific point of view. Some of the reported cases happened in women after breast reconstruction, some after cosmetic use. Some have happened with saline implants, some with silicone.

Scientists aren't even sure whether these cases really had "classic" ALCL, or whether it represents something new that happens to look like ALCL. Fortunately, the disease seems to respond well to treatment.

Phillip Haeck, MD, President of the American Society of Plastic Surgeons (ASPS) said "ASPS shares the FDA's commitment to patient safety, but we also want to make certain this information does not raise false alarms with our patients. We've been down this path before. For nearly 20 years American women were denied access to their choice of breast implants because of false claims and unfounded science. We are determined this shouldn't happen again."

Women that have implants certainly don't need to panic. There's no need to have your implants removed.

The FDA is setting up a central registry to look at the reports in more detail, which is a good thing. I'll keep my patients informed, as we learn more.

My advice: do what we've always advised our patients. Do your own breast self-examinations. Get mammograms and ultrasounds of the breast, following the normal schedule. If you notice something new, like swelling or a lump in the breast, let a doctor check you over. But otherwise, there's no need to panic. The FDA's actions are out of an extreme abundance of caution.

Back-log at the FDA

We all want the FDA to be the watch-dog it is, and only allow safe and effective products and drugs onto the market. I just wish they moved a little faster. For example, here is a partial list of products that are awaiting FDA approval. All of them could be significant improvements over what we have now. And these are just a few examples...

Fillers: Belotero by Merz, and Aquamid by Contura

Botulinum toxins: PurTox by Mentor

Breast implants: "gummy bear" form-stable implants - both Allergan and Mentor

Fat-grafting: Celution by Cytori for stemcell-assisted fat transfer

Body-contouring: radio-frequency assisted liposuction by Invasix; Focused non-invasive ultrasonic fat melting by Ultrashape.

All of these have been featured at the "Hot Topics" sessions at the various ASPS or ASAPS meetings, and many have been discussed here in our blog. The approval of even two or three of them could significantly change the way things are done here in the U.S.

We've been waiting for a "yes" or "no" answer on the gummy bear implants, for example, since 2007. And yes, these products are all available in Europe...

Smoking causes damage in minutes...not years

As reported here on the BBC Health website, a new U.S. NCI-funded study looks at how fast the body starts making carcinogenic compounds after inhaling cigarette smoke.

The report, published in Chemical Research in Toxicology, shows that cancer-causing chemicals appear in the bloodstream within 15 to 30 minutes after smoking.

Small bit of biochemistry here: Polycyclic aromatic hydrocarbons (PAH) are some of chemicals that cause lung cancer in smokers. PAH's require activation by the body to exert their carcinogenic effects. One activation pathway is the conversion to a nasty compound called a "diol epoxide", which is what then causes DNA mutations and starts the cancer formation.

So, the researchers let 12 subjects light up a cigarette laced with a stable PAH (called phenanthrene), and checked their blood to see when the converted diol epoxide would appear. Bad news: the cancerous compound was seen right away, at high doses, at the very first blood draw, 15-30 minutes after smoking.

Obviously, this should be pretty chilling news for smokers, and even more incentive to quit. Damage from smoking starts immediately.



(image from Yan Zhong, et al., Immediate Consequences of Cigarette Smoking: Rapid Formation of Polycyclic Aromatic Hydrocarbon Diol Epoxides, Chem. Res. Toxicol.)

Non-surgical treatment for the double chin?

In a press release this week, Kythera Biopharmaceuticals and Bayer HealthCare's dermatology business, announced two European Phase III studies evaluating their injectable adipolytic agent, for the reduction of localized fat under the chin. The product, called ATX-101, has sucessfully passed earlier studies.

In layman's terms, this is a shot that makes your double chin go away without surgery! We've talked about ATX-101 before, in earlier editions of this blog. It looks like the product is progressing well towards clinical use.

The two studies will enroll approximately 720 patients total to assess safety, tolerability and efficacy of ATX-101 in the reduction of submental fat. The studies are being conducted in multiple centers in the United Kingdom, France, Germany, Belgium, Spain and Italy.

Jean Paul Ortonne, MD, a dermatologist and ATX-101 clinical investigator in France said, "There is a huge demand for a safe, effective and approved injectable treatment for localized fat reduction. These Phase III studies are positive steps toward providing patients with a well-studied, clinically-proven treatment to reduce localized submental fat without surgery."

Editor's note: ATX-101 is, as far as I know, deoxycholate. This was a part of the infamous "LipoDissolve" formula that received so much press and hype over the last few years. Now, at least, there is some actual science to prove that it can work, and to figure out some of the side effects and limitations of the product. Hopefully, we'll see the results of the study within the next year, or so. What will be interesting is whether people will want 40-70 injections over several sessions, with several months of waiting...or whether they will still go for the proven effective approach of liposuction.

(photo credit: americanhealthandbeauty.com)

FDA announces new limits on acetaminophen in medications

The pain-reliever acetaminophen (also known as paracetamol or APAP) is one of the best-selling over the-counter medications. It is sold under many brand names, including Tylenol, and is an ingredient in nearly 200 medications and preparations. It is often combined in prescription pain medications with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet) and hydrocodone (Vicodin).

The recommended daily limit for acetaminophen is 4,000 mg per day. Yesterday, after years of deliberation, the FDA announced a new rule, limiting manufacturers of prescription combination products that contain acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. They feel this rule should help reduce the number of accidental acetaminophen overdoses. Currently, many popular products have 500 or 650 mg of acetaminophen in each tablet. People who take these extra-strength medications every four hours can easily find themselves taking more than the recommended daily total dose....

When taken in high doses, acetaminophen can actually cause serious liver damage – and even acute liver failure and death. In fact, acetaminophen toxicity is one of the leading causes of liver failure in the United States, accounting for more than 56,000 emergency room visits, 2,600 hospitalizations and an estimated 450 deaths per year. Often the overdose happens inadvertently, when a patient takes one acetaminophen-based medicine for back pain, another for migraines, and perhaps a third for cough and cold symptoms.

Most people are only at risk for liver toxicity if they take significantly more than the normal recommended amount of acetaminophen. Most cases of liver damage occur in people who have taken at least 10-15 grams — more than twice the recommended dose. However, a study by the FDA showed that about 20% of people with acetaminophen-related liver toxicity had taken less than the recommended daily amount. These are usually people who combine acetaminophen with alcohol, or who have pre-existing liver disease.

The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication.

The following tips can help prevent acetaminophen related liver toxicity:
• Do not take more than the recommended dose of 4 grams within a 24-hour period (for example, 12 regular strength or 8 extra strength Tylenol tablets)
• Do not take the full day’s dose at one time; space it out over the course of the day
• Do not take acetaminophen for more than 10 days in a row.
• Avoid drinking alcohol when taking acetaminophen.
• People who do consume 2-3 alcoholic drinks per day should not take more than half the usual recommended dose of acetaminophen (2 grams within 24 hours).
• People with advanced liver fibrosis, cirrhosis, or Hepatitis B or C should speak with their specialist before taking acetaminophen.
• Check the labels of all medications; small doses of acetaminophen in combination remedies can add up to big trouble.

We'll be reviewing our post-operative pain medications to make sure our patients don't get more than the recommended dose.

Palomar starts to market new "at-home" laser treatment

Palomar has received FDA clearance for their latest product, a hand-held, battery-powered laser. It's called the "PaloVia", and is the first unit cleared by the FDA for home use.

The PaloVia uses a fractional method, in which only small "polka-dots" of skin are treated, and is non-ablative - meaning there won't be any raw, oozing areas after the treatment. It uses an established wavelength for treatment, 1410nm.

The company recommends daily treatment to the crow's feet area for one month, and then maintenance treatments twice weekly thereafter.

In their preliminary study, 92% of patients saw an improvement of one step on the Fitzpatrick wrinkle scale (FWS). The FWS is a nine point scale, so one step, while measureable, is a pretty mild change.

Palomar has been pretty secretive about the other parameters of the laser. Obviously, the power of this laser is much, much less than an office-based machine, so the depth of penetration of the laser beam will be less, tissue heating will be less, and so the total effect will be much less. It might be enough to treat the thin skin around the eyes, but probably not enough to treat other facial areas, where the skin is thicker. It will probably be a good addition to retin-A based skin care and Botox, but time will tell.

Nevertheless, the whole concept of "at-home" lasers is newsworthy. Palomar is marketing these through QVC, so you probably start seeing these on television soon.

(Image from PaloVia.com)

Facial bone structure changes with age

It turns out that it's more than just the skin and facial fat that undergoes changes as our faces ages. There are changes in the actual shape of the underlying facial skeleton, too.

The most recent issue of PRS has an article on this topic, in which CT scans of the facial bones in young, middle-aged, and older age groups were compared. The results: there are a number of significant structural changes that occur in all areas of the face as we age. Overall, the facial skeleton loses volume as we age (which we knew), but more so in particular zones: the eye socket, the midface and the mandible (jawbone).

I was amazed by the CT images showing the change in shape of the eye socket. Both the upper rim and the lower outer rim of the orbit seem to melt away over the years, significantly changing the shape of the eye socket, and making it wider, longer and larger in area. Aging also affected the bones of the middle part of the face (maxilla) and the mandible in visually obvious ways.

(Image from AAPS.org. Aging of the Facial Skeleton: Aesthetic Implications and Rejuvenation Strategies. Robert B. Shaw, Jr., et al.)

What does this mean? Plastic surgeons need to remember that the bony framework changes too, as we age. It's not just about tightening up the skin, or adding volume to the face with fat or fillers. To help make someone look more youthful, we should analyze the patient and think about whether or not the facial skeleton needs to be corrected, in addition to looking at skin laxity or the loss of facial fat, like we usually do.

Maybe that blepharoplasty (eyelid tuck) would look even better if we put in a small implant to restore the shape of the bone to its original youthful contour. Dr. Flowers (in Honolulu) has been doing this for years - maybe he's on to something!

Waist lines and New Years Resolutions

Happy New Year, everyone! If you are like me, you've probably made a resolution to try to lose weight and get more fit this year. Good for you!

Most of us do this to lose some of the weight we gained over the Thanksgiving to Christmas season of over-eating. But it turns out, a smaller waistline can have significant health benefits, too.

Here's the science: there's actually a large body (pardon the pun) of scientific evidence linking obesity, especially excess fat around the middle, to cardiovascular diseases, diabetes, and metabolic syndrome.

To figure out if you have too much around your middle, you don't need any fancy body analyzer machines, CT scans, water-displacement testing - all you need is a tape measure. It turns out that waist circumference is a very good way to identify abdominal obesity, even if your overall weight is normal. A waist circumference more than 102 cm (40 inches) in men, or 88 cm (34.5 inches) for women has been scientifically proven to be a good indicator for abdominal obesity and the need for weight management. (Morrison, et al, 1995)

Another study (van den Donk, 2009) showed that amongst people with a waist size above 102 / 88 cm, 15.5% had metabolic syndrome - hypertension, elevated cholesterol and pre-diabetes. Elevated cardiac risk scores have also been found in people with increased waist circumference (Schunkert, et al, 2008).

In the year 2000, in the U.S., the average waist size was 99 cm/39 inches for men and 94 cm/37 for women. Compare this to 1960, when the average waist size was 89 and 77 cm, or 4 inches and 7 inches less respectively. Over the same time period, we're only about one inch taller.

If we look at the percentage of the population with a waist size in the danger zone, back in 1960, just 12.7% of men and 19% of women qualified. Now 38% of men and 59% of women would fall into the abdominal obesity category. So, Americans are more apple-shaped than ever before.

Does this mean we should do some liposuction around the waist on most Americans? Well, not exactly. Even though liposuction might help someone look smaller, it unfortunately doesn't confer any of the health benefits of diet and exercise.

So, hit the gym. Get on the diet bandwagon. I'll help you with the rest with my magic liposuction cannula!

Illustration courtesy of medicineworld.org

The Return of Curves

If a conservative business paper like the Wall Street Journal has noticed, it really must be true!

In their December 30, 2010 edition (link), the style section noted: "Women, everywhere, rejoice. Your curves came in again in 2010. The Prada collection in February celebrated curves, especially bosoms....Meanwhile, Christina Hendricks, of "Mad Men", made news with her curves on television and the red carpet."

And if it's showing on the fashion runways, you can be sure that consumers will follow the trend.

Plastic Surgery Trends for 2011

Here, according to ASAPS, are their predictions for cosmetic surgery trends in 2011. I'll post some follow-up discussion shortly...

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New York, NY (December 20, 2010)—The American Society for Aesthetic Plastic Surgery (ASAPS), the leading national organization of board-certified plastic surgeons who specialize in cosmetic surgery, offers its predictions for cosmetic surgery in 2011. Predictions are based on interviews with leading plastic surgeons around the country, who are actively involved in cutting edge surgical and non surgical aesthetic/cosmetic technology.

As the economy continues to improve, demand for facelifts and other facial rejuvenation surgery will increase. Non-surgical facial rejuvenation procedures will also see some growth, but people who have been putting off surgery for the past few years because of the economy will be ready for the gold standard in facial rejuvenation in 2011.

The growth and popularity of cosmetic injectables (Botox, Dysport, Sculptra, Radiesse, Evolence, Juvederm, Restylane, Perlane etc.) will continue to increase as products continue to evolve and new players enter the market.

As our population increasingly realizes the dangers and health consequences of obesity, the number of patients seeking plastic surgery procedures for body contouring after dramatic weight loss (abdominoplasty, lower body lift, upper arm lift, etc.) will rise in 2011.

As the baby boomer generation continues to age, so do their breast implants. This year many baby boomer women who have aging implants and/or breast ptosis will replace their implants and have breast lifts.

Consumers looking for a bargain on cosmetic procedures will unfortunately lead to an increase in horror stories about “discount injectables” bought offshore and cosmetic medicine and cosmetic surgical procedures performed by untrained or poorly trained practitioners.

While liposuction (lipoplasty) will continue to be the gold-standard in fat reduction, there will be continued interest in experimental techniques for non-invasive fat removal (freezing, zapping, lasering, etc.) as a future alternative or adjunct to liposuction (lipoplasty) surgery.

Aesthetic Medicine has seen a dramatic increase in the diversity of the patients treated over the past decade and this trend is expected to continue to grow stronger than ever, with applications that cater to all people. The appeal of both aesthetic surgery and cosmetic medicine will continue to spread across the spectrum of our population, as plastic surgeons further tailor treatments to meet the sometimes unique needs of that expanding population.

As the popularity of non-surgical and minimally invasive procedures continues to grow, surgeons and manufacturers will develop new techniques and products that advance the science, produce even better results and lessen recovery time.

Celebrities like Kim Kardashian, Beyonce, and Jennifer Lopez have made a shapely rear-end a must have accessory. In the coming year patients will be seeking posterior body lifts, buttock lifts, surgical and nonsurgical buttock augmentations to shape and augment their buttocks.

Following the trend in increased consumer sophistication, patients will increasingly want to know if the latest procedure and device being touted on the internet and TV talk show really works and if it is safe. By incorporating evidence-based medicine into the core specialties of plastic surgery, the Aesthetic Society will make it easier for both doctors and patients to determine fact from fiction.