The American Electrology Association (AEA) has been informed that the Food and Drug Administration (FDA) has to-date granted six lasers and one pulsed-light device clearance to market for hair removal. The AEA believes that additional devices will be cleared in the near future.
     The AEA views laser hair removal as a novel concept; however, neither the manufacturers nor the FDA have provided the AEA with the laboratory and clinical studies upon which the clearance to market decision was based. Therefore, the AEA cannot attest to the safety and effectiveness of this laser technology at this time. Some of the concerns that the AEA has raised in the past regarding the use of lasers for hair removal include:

• Safety of the tissue surrounding the follicle.
• High incidence of hyper/hypopigmentation, which may last for months after treatment. Exposure to sun too soon after treatment can cause the skin to heal a darker shade than normal skin.
• Skin anomalies, such as herpes, etc. have been shown to worsen on lasered skin.
• Unknown long-term adverse effects on the skin from potentially many years of repeated irradiation.
• Lack of training required for laser technicians.
• Lack of dermatological knowledge by technicians which would enable them to distinguish between a potential skin cancer and a harmless eruption. In the case of cancerous 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 contains toxic gases and vapors. At high concentration, the smoke may cause ocular and upper respiratory tract irritation in health care personnel; it may also create visual problems for the surgeon.
• Scientific proof regarding lack of permanence. The few studies that are 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.
• Poor cost-to-benefit ratio for patients. Treatment packages often cost as much as a full course of electrolysis, even though electrolysis results are permanent and laser results are temporary.

    Laser hair removal is an experimental therapy and the first generation of patients are unwitting test subjects for the manufacturers. Laser manufacturers are exerting a tremen- dous public relations campaign intended to lead an unknowing public to believe this new technology is the gateway to less painful, faster and permanent hair removal.
    AEA has grave concerns regarding the standards ofpatient care. In this rapidly evolving and entirely unregulated medical specialty, any physician, or his on-the-j ob trained employ- ees, can use a laser on patients the very same day of purchase, with no more training than the instructions offered by the manufacturer's sales representative.
    The AEA will endorse new technology only after a thorough review of laboratory and clinical studies that conclusively demonstrate safety and effectiveness (permanence). We will then work with government regulators and allied health professions to establish the regulations and trainingprograms thatwill ensure that ourmembers canprovide treatments meeting the highest standards of patient care.

AMA SPEAKS TO THE USE OF LASERS:
     The American Medical Association (AMA) has issued a position statement, "H-475.988 and H-475.989 Laser Surgery" which states that the organization "supports the position that revision, destruction, incision or other structural alterations ofhumantissue is surgery".
    The Association "adopts the policy that laser surgery should be performed only by individuals licensed to practice medicine and surgery, or by those categories of practitioners licensed by the state to perform surgical services." The AMA further "encourages state medical associations to support state legislation and rule-making in support of this policy."

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