Update on Aesthetic Medical Devices

It never ceases to amaze me how many medical products are marketed for use to the non-medical market. There are so many skin care products making outrageous claims and product manufacturers making claims about their devices and all the while, marketing them to people who cannot legally perform services with the device. This problem is more prevalent today than ever before and this is counter intuitive since there has never been more regulation in the health industry and the FDA has stepped up compliance.

I have previously written about skin care products that claim to alter and repair DNA (this is really funny because it is so outrageous); other products that claim to treat rosacea (even though when you read the package insert it refers to treating “redness”) and devices that are marketed to the aesthetic market when they are being offered to treat medical conditions. Sometimes the problem is that the device is a medical device being offered to non-medical markets. Other times the problem is that the device is treating medical conditions or the use of the device is such that it constitutes the practice of medicine.

I was reading Day Spa magazine today and I ran across an advertisement that I have seen for MANY years. It was for the Lamprobe. Interestingly enough, I met the owner about ten years ago and asked how he is marketing the device to the non-medical market. He had an unsatisfactory answer. It is not my intention to malign any particular product, but this one typifies the problem.

The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia. Very interesting. An esthetician can treat NONE of these proposed uses. How can this product be ethically marketed to the non-medical aesthetic market when the user cannot legally perform the treatments? Virtually all of these proposed uses are outside the scope of license of an esthetician and they are clearly and squarely within the parameters of medicine.

Paddy Deighan JD PhD
http://www.medicalandspaconsulting.com

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.