AEA Laser Position Statement
September 19, 2003

FDA Clearance of Laser Hair Removal Devices

Many lasers and several pulsed-light hair removal devices have received clearance to market by the Food and Drug Administration (FDA). The FDA has granted some of these hair removal device clearance to market as "Permanent Hair Reduction."

The AEA believes that this ambiguous term, "Permanent Hair Reduction" has been coined for the sole purpose of getting the word "Permanent" into advertising. Many promoters are emphasizing the word "Permanent" and, in most cases, eliminating the word, "Reduction."

The term is too similar to "permanent hair removal" which electrologists and the public understand to mean, that at the end of a course of treatment none of the treated follicles will ever grow another hair. No laser "manufacturer may claim that laser hair removal is either painless or permanent." http://www.fda.gov/cdrh/consumer/laserfacts.html.

AEA has regularly reviewed the published peer review scientific clinical papers. We question the biases that might be affecting the information contained in these papers: "The most important aspect of any scientific paper is the peer review whereby every theory is intensely scrutinized by those whose motives are not tied to the outcome." To date it is clear to us that we cannot attest to the effectiveness of laser hair removal technology at this time. Among the many concerns of the AEA regarding the use of lasers for hair removal are:

• Unknown long-term adverse effect on the skin from potentially many years of repeated irradiation and safety of the tissue surrounding the follicle.

• Lack of scientific proof regarding permanence. The few studies that have been made available have revealed a very rapid and nearly complete regrowth of hair, typically within 2 to 6 months after a single treatment. Multiple treatments have not been demonstrated to significantly improve results.

• The pain factor involved in laser hair removal requires topical anesthesia prior to treatment.

• High incidence of hyper/hypopigmentation, which may last for months after treatment. A great deal of controversy has appeared in the media regarding this issue. Just two of the burn cases reported may be viewed at http://hairfacts.com/medpubs/lasergen/overtreat2.html and http://hairfacts.com/medpubs/lasergen/overtreat.html

• Lack of dermatological knowledge by technicians which would enable them to distinguish between a potential skin cancer and a harmless lesion. In the case of malignant moles, the cancer may metastasize invisibly once the surface evidence has been removed by the laser. Eradicating a skin lesion and leaving no specimen available for laboratory study makes proper diagnosis after removal impossible.

• Research studies have confirmed that the smoke plume created by laser hair removal contains toxic gases and vapors. At high concentrations, these toxins may cause ocular and upper respiratory tract irritation in health-care personnel.

• Poor cost-to-benefit ratio for patients. Costs of treatment packages often exceed that of a full course of electrolysis. Electrolysis is widely accepted as permanent while clinical laser results are proving to be temporary.

The AEA has grave concerns regarding the standards of laser hair removal patient care. In this rapidly evolving and completely unregulated medical specialty, a technician, practicing in any field can use a laser on patients the very same day of purchase-directed only by the manufacturers' representative's instructions. In some instances a "Rent a Medical Director" is the "physician" overseeing the clinic or tech. State Medical Board rulings are overlooked entirely. Laser hair removal devices are now being sold for dual applications and vascular and pigmented lesions, sun damage and telangiectasias are the latest addition to this unregulated field.

AEA's concern is for that of the public. An adequate training programs that ensure treatments meet the highest standards of patient care is not an option offered by these companies. Adherence to state laws on who may use/purchase these devices is not a criteria. Selling equipment to anyone willing to pay the cost of the device is their only criteria. The health and safety of the unknowing public is at risk.

AEA is dedicated to the consumer of our services. We develop standards to safeguard the public and electrologists in their practice. We have been working with community colleges to provide appropriate training programs that will ensure our members can provide treatments meeting the highest standards of patient care.