http://www.jcadonline.com/aesthetic-upd ... #more-2217
Michael H. Gold, MD
Dr. Gold is the founder and medical director of Gold Skin Care Center, Advanced Aesthetics Medical Spa, The Laser and Rejuvenation Center, and Tennessee Clinical Research Center located in Nashville, Tennessee. He is also Clinical Assistant Professor at Vanderbilt University School of Medicine and School of Nursing in Nashville, Tennessee; Visiting Professor of Dermatology, Huashan Hospital, Fudan University, Shanghai, China; and Visiting Professor of Dermatology, No. 1 Hospital of China Medical University, Shenyang, China.
It is crucial to state at the onset that all FT devices are not the same, and even though almost every laser company produces an FT device, research endeavors, presentations at major medical meetings, and, most importantly, scientific publications in peer-reviewed medical journals are needed for the legitimacy of FT devices. As clinicians, we should demand the science behind medical devices and not rely on the so-called “white” papers laser companies are eager to make available. Although the majority of laser company papers are sponsored clinical studies, those that have credence will have an institutional review board (IRB) approval for safety concerns and a peer-reviewed manuscript, which helps provide the legitimacy laser companies are so eager to achieve.
Numerous FT devices are available and all differ somewhat in energy delivery, injury patterns created, and intensity. They also differ in their clinical work as not all of the devices have peer-reviewed papers to support their treatment claims and successes, and rely on clinicians to “speak” on their devices or to be part of company-promoted “white papers,” which many laser surgeons do not endorse. The companies, as noted, need to perform IRB-approved clinical research and have the results published in peer-reviewed medical journals.
With the Fraxel RePair, most patients require some sort of sedation for the procedure to be performed. This seems to be in deference to the majority of other ablative fractionated laser systems, which usually only require topical anesthesia in the majority of cases. Because this is a deep dermal FT system and produces some of the highest energies of all the ablative systems, several reports of adverse events (i.e., scarring) have recently been documented. We will likely continue to see an increase in adverse events with these machines, as more of them enter the market and are utilized by those who are not skilled laser surgeons.