Summary: Counterfeit medical devices are posing a growing threat in the field of aesthetic medicine, with a particular focus on devices from reputable manufacturers like Zeltiq, Inc. and Ulthera. In an article published in the September 2014 issue of Lasers in Surgery and Medicine, physicians Brian S. Biesman and Neelam Patel highlight the dangers associated with these fake devices. The authors emphasize that counterfeit versions often infringe on patents, falsely claim FDA clearance, and even use clinical photographs of outcomes from legitimate devices to promote their products.
The article outlines the distinctive features of the genuine Zeltiq and Ulthera devices, emphasizing their patented technologies and built-in safety measures. In contrast, counterfeit devices lack assurances of safety, reliability, and reproducibility, leading to documented cases of patient injuries. The prevalence of counterfeit devices is especially alarming in international markets, with China being a significant source for knock-offs.
Physicians are cautioned about the deceptive marketing tactics employed by counterfeit device sellers, who mimic the appearance and materials of legitimate manufacturers. While the economic appeal of cheaper counterfeit devices might be tempting, the authors stress that the risks and liabilities associated with their use far outweigh any perceived advantages. These risks include lack of clinical efficacy, potential patient injury, medicolegal liability, loss of licensure, and even criminal prosecution.
The article concludes with a call for awareness among physicians, urging them to purchase medical technology directly from manufacturers or authorized representatives. The authors emphasize the importance of ensuring the authenticity and FDA approval of the technology to safeguard patients and avoid legal repercussions in the rapidly evolving landscape of aesthetic medicine.