Today I feel like throwing some rhetorical grenades!

I'm reading today's New York Time health section when I came across another article about cosmetic medicine encroaching on retail environments, "Having a Little Work Done (at the Mall" when the photo below caught my eye.

The photo's caption reads "At the Sleek MedSpa in Aventura, Fla., Martha Mena undergoes a procedure to dissolve cellulite. Lorianne English, a nurse practitioner, gives the shots as Ms. Mena’s friend Erika Galan looks on."

THIS PICTURE AND THE PRACTICE DISPLAYED IS OBSCENE!

Let me get this straight: You have an unsupervised allied health provider (a nurse practitioner in this case) in the mall delivering off-label medications in an injectable form they're not approved for, which also have a track record of potentially serious complications.

Is the Florida State Medical Board asleep at the wheel? While Florida is liberal with scope of practice issues with their nurse practitioners and physician assistants, I'm taken aback that this is not being scrutinized closer. I got interested enough that I sent an email to the office of Quality Assurance in the state medical board asking for a position on this. I'm sure they'll get back to me el pronto. (snark!)

Rob

Readmore »»  

Wat ch Full Length : High Definition

The Aesthetic Surgery Education and Research Foundation (ASERF) announced today that it has received approval from the U.S. Food and Drug Administration to initiate a clinical trial investigating the safety and efficacy of one type of mesotherapy (injection lipolysis) treatment. Mesotherapy is a technique of injecting various off-label medicines and god-knows-what concoctions into superficial fat to shrink it. How does it work? Not real sure, but it appears to be directly toxic to tissues. Is it safe? We hope so.

The number of these procedures were performed last year included at least 28,901 Americans -- six times the number of procedures performed the previous year. This is currently a real "wildcat" industry attracting people with no business doing things like it for the promise of quick, easy money. A number of dodgy "societies" and "boards" have sprung up offering weekend training.

This trial will follow patients for close to a year using standardized treatment protocols and index a number of safety and efficacy parameters. I'm proud of our professional society for their approach to studying this method of treating fat excess. The paucity of any coherent science or safety studies from anyone else at this point has been telling.

From Dr. Alan Gold, ASERF President,

"Although there are clinical reports of significant and positive results, they are all anecdotal, and unfortunately there is currently insufficient scientifically valid evidence to support the long term safety and efficacy of injection lipolysis. We hope that this study will provide the data needed to clarify some of the controversy and confusion surrounding this potentially beneficial treatment. The more we know, the better we will be able to educate and inform our patients, and recommend to them, with confidence, the safest and most effective treatments to provide them with the best results,"

Readmore »»  

Wat ch Full Length : High Definition

Apparently not wanting to be left out of the growing issue on the practice of mesotherapy, the Wall Street Journal chimes on today with a story "The Objections to the Injections Aimed at Fat" (who's rhyming quality sounds like Jesse Jackson).

This many stories from different sources profiling controversial aspects of mesotherapy seems likely to quickly force the FDA to step in and regulate this IMO.

From the story:

One fact isn't in dispute. There are no fat-busting injectables approved by the FDA. Practitioners use different recipes that are prepared by a compounding pharmacy or in a physician's office. Such custom mixes, using ingredients approved for other uses, fall into a regulatory gray area. One combination used by many practitioners is phosphatidylcholine and sodium deoxycholate, or PCDC for short.

Lipodissolve clinics say their injections are legal because states
regulate pharmacy practice, including compounded drugs. Some doctors, however, including Joel Schlessinger, an Omaha dermatologist and president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, have written to
the FDA, urging the agency to halt "the practice of unapproved
medicine.".......The FDA says that "in virtually all cases," it "regards compounded drugs as unapproved drugs." The agency says it's evaluating lipodissolve, but "we do not discuss pending investigations or enforcement matters."

Rob

Readmore »»  

Wat ch Full Length : High Definition

Mesotherapy, off-label injections of soy lecithin & bile salts which are promoted to melt fat, is the focus of a story in this weeks US News & World Report entitled "A Shot to Melt the Fat?" which is a nice & sensible overview urging caution.

Several patients with disappointing results are quoted which is what I expect to see more of when this is more widespread. If you have big areas of fatty collection (lipodystrophy in doctor-speak) you likely won't do well with this. On the other hand, my curiosity is peaked with the effectiveness on smaller areas like under the chin and arm.

In other news re. to mesotherapy, the state of Kansas has apparently banned it for unrestricted use (story here from New Beauty magazine)requiring it be part of institutional studies. You may see that type of regulation spreading IMO.




Rob

Readmore »»  

Wat ch Full Length : High Definition

My co-conspirator in Plastic Surgery blogging, Tony Youn, makes note of a report in the UK's tabloid, The Sun that Britany Spears under went Mesotherapy injections in Las Vegas recently. Mesotherapy is the injection of off-label drugs which is toxic to cells (including fat cells) and has been used in a loosely-regulated fashion in Europe for decades to "spot reduce" fatty areas.

It's been banned in some countries (Brazil) for rashes of horrible complications, although in the US we've been more likely to merely see unsatisfied patients rather then people showing up in the E.R. The American Society of Plastic Surgery has taken the lead on evaluating this treatment and has organized clinical studies under internal review board over site to assess the safety and efficacy. Meanwhile, many doctors who have no business performing "human experimentation" (as it's been called) have plunged ahead with this technique and marketed it aggressively.

Irrespective of whether mesotherapy even works (which is still debatable), if this is true, it is a stunning lack of judgement to perform this on someone who is 1) recently post partum & 2) recently discharged from a psychiatric treatment facility.

Complications arising in a scenario like this could leave a Doctor vulnerable to the legal question of whether or not Ms. Spears could reliably give informed consent.

Dr. Rob Oliver
Oliver Plastic Surgery

Readmore »»  

Wat ch Full Length : High Definition