An Emerging and Disturbing Trend in Medical Spas....

For those that follow the medical spa industry, there is always a new product or service that is being touted as the latest and greatest in the industry. Many are little more than marketing hype.

One emerging trend is the hCG diet. Supporters argue that it has allowed many to lose weight. Others maintain that there is no scientific evidence that indicates that it is effective. They further opine that any weight loss is a result of near starvation diet levels of calorie intake (less than 500 calories per day).

hCG is human chorionic gonadotrophin and it is a pregnancy hormone. It is non existent in the male anatomy except for a brief period after birth. It only exists on women during pregnancy. It use is linked to near starvation diets in the weight loss use.

It is important to note that its use is not FDA cleared. By itself, this is not a concern because physicians routinely utilize medical and prescriptive materials "off label" if they believe that it is warranted in a given situation.

However, it is appearing in many non-physician owned medical spas. The HCG dispensed in such settings cannot be medical grade hCG and popular belief is that the non medical grade hCG is non efficacious for weight loss. In fact, in January of 2011, the FDA determined that homeopathic hCG is "fraudulent and illegal" when sold for weight loss. Even in a medical setting, with physicians utilizing medical grade hCG, the product must carry a warning which indicates that there's no proof they accelerate weight loss, redistribute fat, or numb the hunger and discomfort typical of a low-calorie diet.

The bottom line is that there is no scientific evidence to suggest that hCG works.

The disturbing thing is that I have noticed many medical spas that are touting outrageous results from the use of hCG. It appears that many spas are promoting hCG without differentiating between homeopathic grade and medical grade.

In any event, the use of such a product must be carefully watched. Practitioners need to exercise extreme care in providing this service. Extreme caution must be made in marketing the service. From what I have observed, there are a lot of fraudulent claims that may result in severe damage to patients and client...

FDA's New Agressive Policies on Websites and Skin Care

Recently, I have had several clients receive warning letters from the FDA regarding their websites or retail skin care products.

In regard to websites, the FDA makes various claims that the particular sites are making unsubstantiated claims regarding efficacy of products and services. In each cases, I strongly disagree with the FDA. In one instance, the website merely stated that a procedure "lessened the appearance of wrinkles". Those are appropriate words for an appropriate procedures.

In other website issues, the FDA is claiming that the procedure was not cleared for marketing of the respective procedure. This is ludicrous to me beause a physician can claim whatyever they want to - the FDA has no jurisdiction over them and their independent medical judgment. A physician can claim whatever they want, but they cannot claim that it is "FDA approved". This is a misnomer anyway as the FDA does not "approve" anything.

In regard to skin care, the FDA is cracking down on physicians that compound and offer prescription strength products in an over the counter format. They are also concerned with claims about claims made in skin care. In one example, the product merely claimed to "hydrate" the skin. The FDA had a problem with this?? The product contained hyaluronic acid which is agruably nature's best emollient since it binds to water and retains 1000 times its molecular weight in water. It is more than fair to say that it "hydrates" the skin.

In yet another skin care example, the FDA took exception to a clain that the product softened the appearance of wrinkles. What is wrong with that?? If they are going to start enforcing such language, there will be no marketing on any product. Cosmetics make far more medical claims every day in TV and print ads.

The point is that the FDA appears to be embarking on a course to strictly enforce its policies - to the point of over-stepping their bounds...

Off Label Use

The use of prescription drugs and medical devices in an “off label” manner has been prevalent since the Food & Drug Administration (FDA) first began in 1906. The “off label” use is a reference to physician’s utilizing a prescription drug or medical device in a manner that is different from, or inconsistent with, the FDA clearance for the drug or device. The discussion begins with a brief explanation of the FDA process. The FDA requires a manufacturer, distributor or importer of a medical or cosmetic product or device to obtain “marketing clearance” for the item. In the United States, prescription drugs, medical devices and biologics are required to undergo rigorous laboratory, animal, and human clinical testing before they can be put on the market. The Food and Drug Administration (FDA) reviews the results of clinical studies to verify the identity, potency, purity, and stability of the "ingredients," and demonstrate that the drug is safe and effective for its intended use.

Upon acceptance that the device or product performs as claimed the FDA issues marketing clearance for the device or product.

There are many misconceptions about the process and results however. In the area of cosmetic surgery and aesthetic medicine, the misconceptions are vitally important. Recently, I have heard more conjecture that the FDA has “no jurisdiction over me” from physicians. They believe that they are able to do whatever they want and utilize any device, product or drug in any manner that they choose because the FDA does not regulate the behavior of physicians.

Technically, this is true. As I mentioned above, the FDA regulates the device, product or drug and not the individual behavior of physicians. However, from a practical and legal standpoint, there is a trend that is concerning. Physicians engaged in cosmetic surgery and aesthetic medicine are utilizing devices and drugs in an “off label” manner with increasing regularity. There are risks associated with this trend and a discussion of risk management is overdue. 

Examples of “off label” uses are Botox® Cosmetic and Sculptra®. Botox® Cosmetic received FDA approval in 2002 for the temporary treatment of moderate to severe frown lines between the brows in people 18 to 65 years of age. Physicians routinely utilize the product for other areas of the body and in patients older than 65 years of age. Sculptra® gained FDA clearance for lipoatrophy in patients with human immune deficiency virus (HIV). It is safe to conclude that the vast majority of cosmetic patients are receiving such treatments for reasons other than lipoatrophy pursuant to HIV.

Recently, I have been contacted by more than half a dozen patients that have received liquid injectible silicone (LIS) treatments in the lips. They have migration, extrusion, and inflammatory responses to the treatments and have health and aesthetic concerns. This brings up the biggest concern over “off label” use of medical devices and drugs: treatments that are not even tangentially related to the FDA clearance and the FDA has never cleared LIS for any cosmetic indication. LIS is approved only for injection into the vitreous cavity of the eye to treat retinal detachment and/or hemorrhage. LIS is intended to help save a person's eyesight and to be aspirated at a later date, once the eye has healed. It is not intended to be kept inside the body indefinitely. However, physicians utilize LIS “off-label” for cosmetic procedures. The FDA prohibits manufacturers or doctors from marketing or promoting unapproved products such as liquid silicone, meaning they cannot legally advertise or sell this material, but can legally offer them to customers/patients.

The use of Liquid Injectible Silicone is rising and so is the number of complications. The injection of silicone oil, and many other injectible tissue augmentation fillers, triggers a foreign body response by the accumulation of phagocytes, macrophages, and lymphocytes in the body. The resulting inflammation causes your body to respond by trying to either break it down, by engulfing the product and moving it to other organs for excretion, or essentially encapsulating it from the rest of your body to lessen the irritation effect on your body. The body cannot break down LIS. Since our body cannot break down LIS, the macrophage accumulation triggers fibroblasts to begin encapsulating the LIS, to guard the rest of the body against the irritant. Our body then forms collagen layers around the LIS and eventually augmentation is gained in the form of fibrous tissue. Since the body cannot break down the LIS after encapsulation, it will continue to form more and more collagen around the product and eventually a hard nodule will form around the implant. The good thing about encapsulation is that it can help keep the majority of the LIS where it was injected and hinder its migration into the surrounding tissues. The amount of collagen formed is dependent upon and individual’s unique reaction to the LIS implant so it is difficult to know the degree of augmentation since it will vary from patient to patient.

Physicians must utilize care in the delivery of “off label” products. In fact, it would be prudent to utilize MORE care when utilizing “off label” products than in a typical standard of care for a medical product or service. The trend is for physicians to all but deny the practice of “off label” products and services. I have personally seen the absence of medical charts on many patients treated with LIS for example. This is a precursor to a Board of Medicine violation and potentially a loss of license. Physicians tend to believe that an “off label” use is salacious and should be minimally recognized. The opposite is true and physicians need to exercise more care in the delivery of medical products and procedures in an “off label” use and they need to document the disclosure of information more thoroughly to patients.

Accordingly, if you intend to utilize medical products in an “off label” manner, make certain that you have thoroughly documented the procedure in the chart and include appropriate consents. The consent should include a reference to the fact that you are performing a service utilizing a medical product in an “off label” manner. In other words, the consent should include a statement that either the material or the procedure has not received clearance with the FDA. The more information you provide the better. This can be achieved without alarming the patient and losing the sale of the procedure.

It would also be prudent to discourage payment of cash for the “off label” procedure.  If you do accept cash from a patient, make certain that the cash appears on the practice bank deposits for the day. Also be certain to note that on the daily patient logs etc.  It is too frequent that physicians require cash for an “off label” procedure and this can again lead to intervention by a state board of medicine. The requirement that a patient pay cash for a procedure is prima facie evidence that a physician believes that he or she is performing a legally questionable procedure or that the physician is not reporting the income to the Internal Revenue Service.

A physician that is utilizing products in an “off label” manner must also be careful about the advertising of the procedure. You must always recall that the FDA mostly regulates the marketing of medical and cosmetic products.  Even though they do not necessarily have jurisdiction over a practicing physician, they do have jurisdiction over the marketing of the medical product.  You are able to render your opinion about the effectiveness of a medical product and you are able to discuss the benefits of a medical product, but the further you venture from the underlying FDA clearance, the more care you must utilize in advertising. An example is LIS indicated above. It should not be marketed as a procedure at all since it has not been cleared for any cosmetic purpose.