Not Medically related but REALLY Interesting!!!!

We are all a bit if Jurassic history nuts so I had to pass this along.  Dinosaur footprints were uncovered in a beach in Germany.  Accordingly, there are a number of interesting aspects to this:

1). The dinosaur footprints are estimated to be about 140 MILLION years old;
2). It appears that dinosaurs were more social than previously believed;
3). Germany has beaches AHAHHAHAHAHAHA

It is truly astounding to discover footprints that are 140 million years old.  After all of that time, they came to the surface between 2009 and 2011.  Why now? Can you imagine the series of events during the past 140 million years?

Stories such as this are fascinating to us..

Actually, upon closer inspection, maybe this story is about medical spa issues.  It certainly appears that our Jurassic friend needs a mega dose of Botox Cosmetic!!! ahahahahaha


Here is a link to the original story.

http://www.aol.com/article/2015/08/17/footprints-of-dinosaurs-strolling-on-the-beach-found-in-germany/21223733/?icid=maing-grid7%7Cmain5%7Cdl23%7Csec1_lnk3%26pLid%3D175989300

Have a wonderful day, 

Paddy Deighan
http://www.medicalandspaconsulting.com

Nu U Medical Spas Sued by Illinois AG..Many Med Spas Should Pay Attention

The Illinois Attorney General has filed a lawsuit against Nu U Medical Spas in the Chicago area. The issues presented are remarkably similar to many medical spas owned by non-physicians. This case should be a warning to many in the industry.

The suit alleges that Nu U utilized deceptive marketing and that it is performing unsupervised medical treatments. One of the concerns was over the spas’ use of Lipodissolve to “melt” fat. There are many issues with the use of Lipodissolve but the lawsuit focuses upon the fact that it is not FDA cleared and many organizations such as the American Academy of Dermatology, The American Society for Dermatologic Surgery and the American Society for Plastic Surgery do not condone use of the product. There is little evidence to support its use and a lot of evidence that it does little, if anything.

However, the main issue that I want to discuss is one that affects many medical spas, especially the non-physician owned ones. Lipodissolve is an injected treatment, it requires a physician’s order, but Nu U allegedly administers the fat-reducing treatment without a doctor’s order. Many non-physician owned medical spas have non-medical personal injecting dermal fillers such as Botox Cosmetic, Restylane, Juvederm and Collagen without a doctor’s order. In fact, more often than not a doctor does not even see the patient prior to the procedure. In The Nu U matter, the Attorney General found that fact despite its outward claims, Nu U allegedly “fails altogether to monitor and evaluate patients by licensed physicians.”

Another interesting aspect of the case is something that I routinely blog about: The corporate practice of medicine. The Illinois Attorney General argues that the Nu U Medical Spas have violated the Illinois Corporate Practice of Medicine Statute. Forty-five of the fifty states have such statutes and they are violated openly and routinely. These are serious statutes with severe criminal and civil penalties and I am at a loss to figure out why so many violate these statutes on a daily basis. Oops, I do know why…it is called profit!!

Estheticans Cannot Inject Botox Cosmetic or Dermal Fillers

There seems to be a new and disturbing trend in aesthetic medicine. Non-medical providers, and in particular, estheticians, are injecting Botox® Cosmetic in a number of different facilities. In the past month, I have been contacted by three different medical providers in Nevada, Colorado and Texas. They are also injecting dermal fillers such as Restylane and JuveDerm. This is not legally supportable and the activity should stop immediately.

In each scenario, an esthetician was injecting Botox Cosmetic under the loose supervision of a physician (non-core physician, I might add). Apparently, in the respective cases, the physicians maintained that it was lawful for the estheticians to do this under the physician delegation regulations in each state. The rationale was that there was nothing that specifically precluded such practices.

There is nothing in the state regulations that tells estheticians (or physicians) that they cannot perform brain surgery, but we know that they cannot. Injecting Botox Cosmetic is the practice of medicine. There is no question about this and it is not an arguable point. It is not subject to interpretation or subjective beliefs. It is the practice of medicine for several reasons. First, Botox Cosmetic is a prescription drug. Secondly, it is administered via a 30 gauge syringe and it is diluted with saline. An esthetician cannot perform these functions. An esthetician cannot inject anything, including saline. Third, there is no insurance carrier that I am aware of that will provide coverage for an esthetician performing these services. This is clear indication that something is wrong. Fourth, the Board of Cosmetology in the respective states would not permit such conduct. Fifth, the Board of Medicine in the respective states would not permit such activity. There are patient safety, HIPAA and other concerns as well.

In the case of dermal fillers such as Restylane and JuveDerm, these are not prescriptive drugs. However, they are medical devices approved by the FDA and estheticians cannot legally inject them either.

The estheticians in question risk losing their license as well as civil and criminal fines. It is not worth it. The physicians supervising this activity would be subject to reprimand as well.
One of the additional disturbing aspects of this is that Allergan, the manufacturer of Botox Cosmetic, is aware of this and chose to do nothing.

New Jersey Rules Illustrate Why We Need Restrictions on Cosmetic Procedures

The New Jersey State Board of Dentistry promulgated rules that restrict the delivery of cosmetic procedures by dentists in the State.  New Jersey is known as a "bell weather" state - meaning that other states typically follow legal precedent started in New Jersey.

The new rules state that dentists can do injectable pharmacologics only in the perio-oral area — the gums, cheeks, jaws, lips, oral cavity and associated tissues.  This makes sense as these areas are consistent with the training and experience of dentists.  Predictably, many dentists are outraged by this but the bottom line is that the use of injectables is outside the scope of their license and training.  Procedures such as the wrinkle relaxer Botox Cosmetic, and the dermal fillers such as Juvederm and Restlyane are either prescription (Botox Cosmetic) or a medical device and it is arguably appropriate to limit the use to medical professionals and not dentists.

The new rules are a  bit vague and their are categories of "dentists" that are exempt. For example, maxi lo - facial physicians and oral surgeons are technically medical doctors and not dentists. The term "associated tissue" is also vague.

Many dentists consider the forehead to be an "associated tissue," which would make forehead procedures legal for dentists. Some local dentists in New Jersey, citing their aptitude in the workings of the facial muscles and nerves, say they are more than qualified to offer the treatments.  However, this appears to be a stretch. The "associated tissue" area would preclude the forehead, said Jeff Lamm, spokesman for the Division of Consumer Affairs, which oversees the board of dentistry.

"These are practices of medicine and should be performed by physicians," said Dr. Bruce Brod, a dermatologist and member of the American Academy of Dermatology Association. "This isn't just about doing the procedure but also about making sure there are channels to protect patients if there are complications.

I agree with this new rule since a line must be drawn in the delivery of cosmetic medical procedures and dentists are on the wrong side of the line. However, this rule also illustrates that these procedures are cosmetic medical procedures and they should only b e delivered in medical settings and provided by medical providers.

I feel that regulations should go a step further and regulate the manufacturers such as Allergan (Botox Cosmetic).  There needs to be restrictions on who they can SELL the products to....

Disturbing Trend in the Medical Spa Environment

Many medical spas are turning to various medical, quasi medical and even non-medical personnel in the delivery of medical spa services.  Some of the activities are legally supportable but most are not.

One disturbing trend is the use of non physician injectors.  I categorize this in three ways: Botox Cosmetic; fillers and sclerotherapy.  Botox Cosmetic is a drug and available only by prescription. The manufacturer, Allergan, allows physicians to dispense it in their offices. Contrary to popular belief, it is not directly available to non-physicians, including nurses.  Fillers, are not prescription per se, but they are actually medical devices and as such they are delivered pursuant to the practice of medicine and state and federal guidelines limit the  use and application of these products. These include Hylaform, Restylane and others.

Sclerotherpay is the injection of sclerosing material (saline and others) into a blood vessel to thrombose the vessel and destroy its ability to carry blood and produce unsightly leg veins.  Many states allow Certified medical Assistants to issue injections. Historically, this was for vaccines and such.  Doctors offices could not handle the influx of flu vaccines in the '60's, '70's and '80's so states created this exception to medical practice rules.  recently, many medial assistants wrongfully asserted that they are allowed to inject and have been injecting Botox Cosmetic, fillers and performing vein treatments. This is NOT legally supportable!!