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October 2017 ASLMS FDA Update

ASLMS / ASDSA / FDA Session Summary

OCTOBER 31, 2017

lee-kachiu-c

Dr. Kachiu C. Lee,
Director of Government
Communication and Education

ASLMS has been collaborating with the FDA for years to provide educational meetings at the FDA. The goal of the meetings is to provide an unbiased educational forum and two-way exchange of information about lasers and related technology and the challenges of bringing technology forward.

On October 31, 2017, Dr. Neil Sadick, Dr. Gail Mercurio, and Dr. Lilit Garibyan met with the FDA and members of the ASDSA to discuss vaginal restoration/rejuvenation and tattoo removal.

Vaginal Restoration/Rejuvenation

Dr. Neil Sadick reviewed normal anatomy of the vagina, and current vaginal rejuvenation devices. He discussed that these devices are used externally (labia major/minor) as well as internally (vaginal canal). He noted that from 2013-2014, there was a 49% increase in vaginal surgeries. Functional concerns vastly outnumber aesthetic concerns in regards to driving demand for this procedure. He reviewed how to choose candidates for rejuvenation, contraindications for vaginal rejuvenation, and key differences between RF-based rejuvenation vs. laser based rejuvenation. He reviewed the evidence (including histology, gross anatomical images), pre and post-treatment with these devices. Finally, Dr. Sadick reviewed the minor side effects related to this procedure. After discussing light based devices, Dr. Sadick briefly discussed the role of soft tissue fillers (“G-spot”) and PRP for vaginal rejuvenation (“O-shot”).

Dr. Gail Mercurio reviewed the normal function of the vulva and vagina, and also reviewed the abnormal functions of these organs. She outlined current treatment options for vulvar and vaginal dysfunction, including topical/systemic/localized hormones and energy/thermal treatments. Specifically, she outlined the history of energy-based treatments in dermatology, and related it to its role in vaginal health. For vaginal health, the main target is water, with resulting wound healing causing contracture that benefits urologic symptoms. The proposed mechanism is due to stimulation of epithelial thickening (epidermal injury) and neovascularization (lamina propria injury). She introduced the term “vaginal restoration” over the use of “vaginal rejuvenation” because these treatments specifically target medical conditions, not cosmetic. She also discussed the Vaginal Health Index Score, which has been used for research studies in this field. Finally, Dr. Mercurio discussed the quality of life benefits of vaginal restoration.

Tattoo Removal

Dr.Lilit Garibyan discussed laser tattoo removal, focusing on the background of how lasers are used for laser tattoo removal, and also discussed the current technology used for tattoo removal. She reviewed the concepts of photochemical and photothermal effects, as well as selective photothermolysis. She reviewed the parameters that need to be adjusted for treatment of tattoos (wavelength, fluence, pulse duration). Dr. Garibyan also reviewed where the ink goes once it has been treated, and discussed in length the recent research showing transition of ink particles through the lymphatic system. Finally, she reviewed the types of technology used for tattoo removal, including QS, picosecond lasers, and PFD patches. The audience specifically had a question regarding amateur vs professional tattoos, and Dr. Garibyan reviewed the major differences of why professional tattoos are more difficult to remove.

The American Society for Laser Medicine and Surgery is the world’s largest scientific organization dedicated to promoting research, education and high standards of clinical care in the field of medical laser applications. It provides a forum for the exchange of scientific information and participation in communicating the latest developments in laser medicine and surgery to clinicians, research investigators, government and regulatory agencies, and the public.

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