Showing posts with label Allergan. Show all posts
Showing posts with label Allergan. Show all posts

Wednesday, April 13, 2011

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....

Thursday, March 24, 2011

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!!