Physician alert: Beware of counterfeit medical devices

It is well known that copycat versions of designer clothing, watches, and other consumer goods are readily available through street vendors and/or the Internet. Amore serious counterfeiting problem has recently arisen in the realm of aesthetic medical devices. As opposed to legitimate, legal devices, the counterfeit versions infringe on patent rights, falsely claim to have clearance by the US Food and Drug Administration (FDA), and infringe on branding of wellrecognized, FDA cleared products [1]. In many cases, clinical photographs of outcomes produced with an FDA cleared product are used to promote knockoff devices. The counterfeit devices enter the US and are cleared through customsunder false pretenses, only to be sold to potentially unsuspecting (or unscrupulous) buyers. While most all FDA approved technologies in the aesthetic device space are illegally copied, perhaps themost alarming numbers of devices target legitimate devices manufactured by Zeltiq, Inc. (Pleasanton, CA) and Ulthera (Mesa, AZ). The legitimate Zeltiq device uses a patented process referred to via the trademarked term “cryolipolysis” to produce selective injury to adipocytes via an external, noninvasive process. Zeltiq currently holds at least 5 US and 48 foreign patents with another 19 US and 80 foreign patents pending. Zeltiq’s device is FDA cleared in the US, holds a CE mark, and other medical approvals worldwide [2]. Zeltiq’s technology utilizes controlled coolingwith built in thermal-feedback safety measures designed to prevent overcooling of tissue. Ulthera’s device uses focused ultrasound delivered at various depths beneath the skin to produce focal thermal lesions that, when delivered appropriately, produce noninvasive lifting of skin, injury to sweat glands, and other clinical effects. This technology, too, is heavily protected by both US and foreign patents and has built in safety measures. Like the Zeltiq device, the Ulthera platform produces safe, reliable, reproducible tissue effects. In contrast, the counterfeit devices offer no assurance of safety, reliability, or reproducibility. In fact, numerous patient injuries are documented to have been produced by these copycat systems (Figs. 1 and 2). Unfortunately, details of the treatments that led to the injuries demonstrated in these clinical photographs are not available. Based on the clinical photographs, these appear to be freeze injuries whichmay have occurred due to lack of a temperature monitoring and feedback mechanism or failure to protect the skin via other means. Such injuries have not been reported in over 1 million treatment cycles performed with Zeltiq’s technology. Physicians can be misled and tempted to purchase counterfeit devices in several ways. Marketing, graphics, and othermaterials offered in support of counterfeit devices canappearvery similar to thoseproducedbymanufacturers ofthelegitimateproduct.Insomecases,clinicalphotographs of patients treated with FDA approved, legitimate devices are used without permission from by foreign companies sellingcopycatdevices.This is trueofat leastonecounterfeit Ulthera device manufactured in South Korea [3]. At first glance there appears to be a significant economic incentive for purchasing counterfeit devices as they may be acquired for only a small fraction of the cost of the legitimate technologies they imitate. However, upon more careful analysis, any apparent economic advantages are grossly outweighed by the real risks and liabilities associated with using technology that is notFDAapproved andhasnot been proven to be safe and effective. Potential adverse consequences associated with using counterfeit technology include lack of clinical efficacy, failure of devices to perform as expected with resultant patient injury or unanticipated adverse events, medicolegal liability, loss of medical licensure, civil prosecution, and even criminal prosecution. It is worth noting that many medical malpractice insurance carriersmaynot provide coverage for litigation arising from the use of devices that are not approved for use by the FDA. Another noteworthy fact is that the FDAhas a little-known division knownas theOffice of Criminal Investigations that has the same type of arrest authority as other federal law enforcement agents and which focuses its efforts on threats to the public health “particularly in the area of counterfeit and unapprovedmedical products” [4]. Violation of statutes governedby theFDAcanalso result inmandatory exclusion from participation in federal healthcare programs [5]. The prevalence of counterfeit devices is lower in the US than internationally, but numerous knock-off devices have been identified domestically. These devices have been purchased by both core and non-core physicians as well as bymedspas. It isnot clearwhetheraphysicianwas involved in instances where med spas purchased devices [6]. This problem of counterfeit medical devices is more prevalent than most physicians (and consumers) might imagine. Currently, there are approximately 29 knock-offs