Bogus medical devices make their way into trade shows

Counterfeit medical products, including skin-tightening devices, are appearing at trade shows and pose risk and liabilities, according to a letter in a recent issue of Lasers in Surgery and Medicine.

The letter to the editor sounds a warning to physicians on the prevalence of counterfeit medical devices - and the consequences of using them.

Brian S. Biesman, M.D., of the Nashville Center for Laser and Facial Surgery, Nashville, Tennessee; and Neelam Patel, of Vanderbilt University School of Medicine, Nashville, Tennessee; authored the letter. They noted that many of the counterfeit medical devices are knockoffs of legitimate devices manufactured by Zeltiq and Ulthera (One author disclosed financial ties to Zeltiq and Ulthera).

The authors wrote that though both companies’ devices are protected by patents and feature integrated safety features, the counterfeits are not certified as safe and have contributed to many documented injuries. The companies that sell the counterfeits deceive physicians by using phony marketing materials that resemble those that legitimate companies distribute.

“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,” the authors wrote. “However … any apparent economic advantages are grossly outweighed by the real risks and liabilities associated with using technology that is not FDA (Food and Drug Administration) approved and has not been proven to be safe and effective.”

Those consequences include lack of clinical efficacy, failure of devices to perform as expected with resultant patient injury, medicolegal liability, loss of medical license, and civil - or even criminal - prosecution.

Dr. Biesman says the FDA is “aware of and concerned about” the counterfeit devices.

“This problem is a complex one with many facets,” he says. “It stands to reason that a simple solution offered by the FDA or other federal agencies may not be available immediately. By raising awareness among individuals who are targeted as potential customers by manufacturers of counterfeit devices, I hope to educate those who are unaware of the problem.”

According to the letter, there are 29 counterfeit versions of a Zeltiq device and at least five bogus Ulthera devices, all of which can be purchased on the Internet and some of which are even displayed at legitimate trade shows. The authors noted that while the prevalence of counterfeit devices is lower in the United States than abroad, there is evidence that the U.S. counterfeit market is growing.

“It does seem to be a more recent trend that these devices are appearing at U.S. trade shows,” Dr. Biesman tells Dermatology Times. “Speaking personally, it is only recently that I have begun receiving frequent solicitation emails from ex-U.S. manufacturers of counterfeit devices.”

Jeremy B. Green, M.D., a dermatologist in Coral Gables, Florida, says physicians bear the responsibility of becoming aware of the problem if they aren’t already.

“The FDA does an excellent job regulating medical devices,” he tells Dermatology Times. “Ultimately, in my opinion, the onus falls on physicians to perform extensive due diligence and only purchase devices that are FDA-cleared. Counterfeit technologies at best provide inferior results and at worst jeopardize both the credibility of aesthetic medicine practitioners and, more importantly, the safety of our patients.”

The letter was published online July 20 in Lasers in Surgery and Medicine.