EDITORIAL, Amy E. Newburger, MD
Cosmetic Medical Devices and Their FDA Regulation
REPRINTED) ARCH DERMATOL/VOL 142, FEB 2006 225

CLINICAL DERMATOLOGY PRACTICE HAS exanded to include the use of many procedures and devices for cosmetic purposes. This is a consequence of not only the rising interest in aesthetic medicine but also the economic pressures on the practitioner participating in managed care plans, as well as increasing regulation and requirements of office practice.

However, the increased reliance on new cosmetic procedures and devices has resulted in confusion over their real benefits and risks. This confusion has arisen, in part, as a result of aggressive marketing by manufacturers. For example, entering the cacophonous technical exhibits hall at the American Academy of Dermatology meeting is an experience similar to walking in the Central Bazaar in Istanbul, where myriad merchants are plying their wares, each exhorting the superiority of his product over that of his neighbor. Many practitioners greet these innovative devices with unbridled enthusiasm, which tempers over time as the disadvantages and risks become apparent.

It is clear that many physicians who use these products to enhance their patients’ appearance do not understand the US Food and Drug Administration (FDA) approval process for devices such as lasers and injectable dermal fillers. Without this knowledge, the physician is limited in understanding the safety and effectiveness of the devices and may not be advising or treating the patient appropriately. To determine what is best for our patients, we must become better informed about the benefits and risks of these devices, rather than relying solely on the sales force of the company entreating us to purchase their “FDA approved” device. Many physicians erroneously seem to believe that FDA approval of a device is paramount to receiving the Good Housekeeping Seal of Approval. Rather, it is more appropriately likened to an Underwriters Laboratories (UL) listing. For example, the electrical socket with the UL label is approved for a particular use, but improper use will give you a nasty shock. Similarly, FDA approval is granted for a specific use with specific indications, and this information is available in the manufacturer’s labeling and instructions for use of the device. The approval does not imply that the device is safe for every use or indication. Physicians are familiar with the FDA requirements for drug approval but much less knowledgeable about the different regulations that apply to medical device approvals for the marketplace. After a drug or device is approved, the adverse cutaneous reactions such as those described in this issue of the ARCHIVES1-4 become known.Careful reporting of such events is far less stringent in the postapproval marketing phase than in the preapproval period. It behooves the physician to understand the data supporting the risks and benefits of a medical device, as well as the limitations of the evaluation of these devices because only then can he or she use the device in a safe and effective manner.......

The following checklist should help physicians use medical devices most effectively:

DO understand the extent and the limitations of the testing. If the product has been approved by a PMA, get a clear understanding of the success/failure statistics. Examine closely the safety issues and contraindications, and check the sex and ethnicity of the test populations.

DO ask to see the safety and effectiveness data if the device has been cleared for marketing by a 510(k) application. (The PMA would have the clinical data in the labeling in the package insert.) Most clinical information you are provided for 510(k)-approved devices consists of a white paper developed for marketing purposes, which would not withstand scrutiny in a good peerreviewed journal. If the manufacturer cannot provide real data, perhaps there is not sufficient evidence to use the technology at this time.

DON’T jump on the bandwagon as a result of marketing pressure. Some adverse effects may take time to manifest. This is particularly important in new technologies. Consider, for example, Thermage (Thermage Inc, Hayward, Calif ) radiofrequency device treatments that were touted on the Oprah Winfrey show.15 Myriad patients rushed to undergo the procedure described there. As of September 2005, there have been 155 adverse events reported on the Manufacturer and User Facility Device Experience (MAUDE) database.16 A substantial proportion of these events were the development of fat atrophy and scarring 3 or more months after the procedure. Subsequently, the manufacturer recognized the problem and changed the treatment algorithm. Hopefully, the new treatment parameters will avoid or mitigate these sequelae.

CONCLUSIONS

Physicians must take more control of the marketplace to adequately protect our patients. We are confronted daily by patients requesting medications and procedures in response to direct-to-consumer marketing. There is powerful enticement in the positioning of these devices on television and in print media, with physicians providing testimonials about the benefit of their use. These physicians are often consultants paid by the device manufacturers. Consumer demand for these procedures is currently market driven. If we do not require documentation on real clinical effectiveness and safety, and if we purchase these devices based on trust rather than on sound science, then there is no incentive for the manufacturers to improve their track record. We can have a powerful impact on the safety of cosmetic procedures and devices for aesthetic uses if we understand how they have been studied and are labeled and if we demand scientific diligence. In this way, we will fulfill our obligation to our patients and to our profession.