Kybella: FDA Approves Non-surgical Drug for Double Chin

In a 2014 survey, about 68% of those asked by the American Society for Dermatologic Surgery said they are bothered by submental fullness... welcome Kybella

Submental fullness (double chin: subcutaneous fat that makes a person look older and heavier) has a new FDA approved treatment that gives medical spas who are not performing tumescent liposuction another newly approved treatment. (Liposuction is the current standard to remove submental fullness.) Good news for cosmetic physicians in the US who need FDA approval.

Kybella, (ATX-101 accordig to the Kythera website) is a patented formulation of deoxycholic acid. It is a less-invasive, non-surgical option treatment for submental fullness. It's manufactured by Kythera Biopharmaceuticals in California.

Kybella contours the area under the chin by destroying fat cells when it is injected into the adipose tissue or subcutaneous fat. Injections into the fat are done through a series of treatments, no less than one month apart. A natural healing and elimination process should follow.

The drug has been developed for more than 9 years. More than 2,600 patients were involved and 20 clinical studies were conducted. Noted side effects may include nerve injuries that may lead to a lopsided smile or facial weakness, bruising, redness, swelling, and pain.

The approval by the FDA of Kybella does not carry with it the approval of its use for fats located in other parts of the body.

In a statement made by the deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, Dr. Amy Egan mentioned that the drug is only approved for treatment of fat below the chin and it is not known if Kybella is safe or effective for treatment outside this area.

Download: Product Info & Final Labeling PDF - Indications, Dosage, and Injection Technique Information.

Laser Liposuction & Skin Tightening - Emperor's New Clothes?

Does laser assisted liposuction really provide all of the skin tightening benefits that the manufacturers claim?

We are in pursuit of many Holy Grails in plastic surgery, from scarless post-surgical healing, non-invasive liposuction and implant-free breast augmentation to non-invasive skin tightening. With the advent of laser-assisted liposuction (LAL) came the promise from the manufacturers that we have finally achieved a way of combining "minimally invasive" fat removal with skin tightening, sensationally treating two maladies with one procedure.

I been involved with LAL for many years, and it has been the primary revenue driver in my practice for nearly five years running. I began to perform the procedure when the machines became powerful enough to actually generate enough subdermal heat in a timely fashion to potentially create significant collagen remodeling and hopefully result in skin tightening. My case load quickly became large enough that I was asked to be a national speaker for one of the dominant laser companies educating other physicians on the use of LAL. As such, I delved into every published paper even remotely relating to heat-generated skin tightening and laser assisted liposuction. Over the years, I have been able to merge a huge surgical experience with the science behind the procedure and draw some fairly clear and simple conclusions on the issue of skin tightening.

Setting up a patient for potential skin tightening is fully dependent on generating ample subdermal heat to initiate collagen denaturation and subsequent remodelling. Generally, this temperature is felt to be between 40 to 45 degrees celsius.  At around 47 degrees celsius, skin blistering and burns occur.  With proper time, temperature-monitoring devices, and careful technique, adequate temperatures can be achieved. Getting the skin to this temperature range takes time and significantly prolongs the procedure. Additionally, the risk of seroma escalates the longer you spend with the tissues in this temperature range in my experience.

In about 15% of cases, I see clinically visible skin tightening which I don't feel I would have seen using other techniques. This skin tightening is not the equivalent of excision techniques, but typically limited and subtle. This is obviously purely my subjective opinion to be clear, and I cannot say that these same results may not have occured witht the same frequency had I used other liposuction techniques.

The science of LAL and skin tightening is clear that some tightening does occur and is quantifiable. But this does not predictably translate into clinical relevance. I have now performed nearly 1000 LAL's and no longer educate my patients that LAL is a good method of tightening skin. The limited degree of tightening I credit LAL for is not enough to call it a clinically relevant skin tightening procedure. The majority of new LAL consults in my practice present with the impression that LAL is going to tighten up their loose skin while removing fat. The notion is dominant on the internet and even in print ads. I politely educate them that although there may indeed by some skin tightening, this will be subtle at best. In my opinion, the advantages of LAL lie elsewhere, particularly in a somewhat easier recovery.

I continue to hear from colleagues who also use LAL that they believe in the skin tightening.  I don't know if this is a case of "The Emporers New Clothes" or not. I have pushed the envelope in terms of thoroughly heating up the skin to appropriate temperatures and length of time, but only see minimal tightening and an increase number of seromas. I continue to use LAL heavily but no longer tout skin tightening as being an expected end point.

Learning From Physicians Worldwide: Unhappy Patient? If You're In Mexico Just Call The Cops.

Medical Spa MD's physician community is worldwide. This poses some interesting challenges and some opportunities to learn how medicine is practiced elsewhere.

If you're not already aware, Medical Spa MD has physician members from 70+ countries... meaning that there are a number of differences in the way that medicine is practiced across the community. The map above shows some of the distribution of Members by location. The reason that I bring this up is to highlight that there are differences between where and how members of our community practice medicine. 

Let me tell you a story or two about some of these differences.

In Mexico, plastic surgeons are less worried about being sued.

A few years ago at a major cosmetic medical conference in Las Vegas with very well known physicians presenting. I atteneded a presentation by a plastic surgeon from Mexico discussing one of the new (at that time) suture plication techniques for facelifts. I'll call the presenter Dr. M.

During this surgeons presentation, Dr. M discussed case study after case study in a way that made it apparent to every other doctor in the audience that he was in fact 'experimenting' on patients in order to guage how results would differ with different techniques.

Dr. M was detailing how he had arrived at what he felt was the optimial technique by identifying likely canditate patients, offering them a greatly reduced price, and then basically trying out a different technique to determine an outcome. The clear message was that he was just trying different things out to see what worked and what didn't work, i.e., experimenting on patients.

You could see a lot of slightly raised eyebrows in the room.

As is usual after a conference presentation, a group formed around Dr. M after his presentation to ask follow up questions or make a connection. After a couple of handshakes the questioning started to revolve around a very specific theme. The US physicians (the very clear majority since we were in Vegas) began asking questions that expresed a large amount of skepticism that they could have interpreted the presentation correctly. Namely, that any plastic surgeon could be performing experimental treatments on patients in the way that he'd described. (I should clearly state that Dr. M indicated that he clearly informed all of these patients of what he was doing and got their consent.)

The physicians weren't really challenging this physicians techniques or professionalism as much as questioning Dr. M about his patient practices and wondering how he could actually get away with this with his malpractice insurance and medical regluatory agencys.

The questions started to revolve around patients who were unhappy with their outcomes and how this physician was handling them. Dr. M freely admitted that there had been any number of failures and that some patients had had poor outcomes and were unhappy but expressed the sentiment that that was really not a big deal.

The US physicians were somewhat incredulous and one slightly exaperated physician asked, "What do you do if they come back to your office and complain?"

"We call the police," he said nonplussed.

Raised eyebrows all around.

Now, to be fair, Dr. M's answer was really based on his perception that the question was about a patient raising hell in his clinic and that answer would be the same answer that any physician would give, but the incredulity that prompted the question was really about how any doctor could get away with performing experimental procedures without being sued out of existence.

What's even more eye-opening to a lot of American physicians was that Dr. M had never been sued.

If you're a plastic surgeon in the US and you've been practicing for a while, the odds are good that you've been sued by a patient and if you're practicing new treatments that could be defined as experimental as a plastic surgeon, you're going to be sued... and dropped by your malpractice carrier. It seems that if you're a plastic surgeon in Mexico you don't have the same considerations to deal with. 

Does it mean that plastic surgery outside the US is less safe? Possibly, since there's no other country that regulates the practice of medicine the way that the US does, but it's also the case that many of the 'medical tourism' destinations are staffed by US trained physicians. (If anyone has stats on this I'd be interested to see them.) There are a growing number of hospitals outsourcing xrays to radiologists in India, medical tourisim is increasingly mainstream, and US physicians are traveling outside of the US for trainings.

Medical Spa MD has members around the world. If you're smart, you'll take the opportunity to learn from everyone, no matter where they are.

Read: Plastic Surgery Malpractice Lawsuits In The US & Canada

Read: "Hello Doctor. I Wouldn't Hesitate To Sue You."