Since the advent of the first FDA approved laser hair-removal system in 1995, its popularity has made laser hair removal a financial cornerstone for many dermatologists and plastic surgeons. The original laser hair-removal machine was The Soft Light Hair Removal System developed by the Thermolase Corporation. Since then the growing popularity of this treatment has prompted many laser manufacturers to seek FDA clearance for their laser hair-removal machines.
The market is growing so quickly that the FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal. However, to learn if a specific manufacturer has received FDA clearance, you can check the FDA Web site, www.fda.gov. You will need to know the manufacturer or device name of the laser. You can also call FDA's Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or (301) 827-3990, or fax your request to (301) 443-9535 (source: FDA Center for Devices and Radiological Health, Laser Facts, May 2001, online).
One of the most significant FDA regulations regarding companies that promote approved laser hair-removal systems is that "…manufacturers may not claim that laser hair removal is either painless or permanent. The specific claim granted is "intended to effect stable, long-term, or permanent reduction." Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time?greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area." That is a very convoluted way of saying that laser hair removal is not permanent and there are no studies showing it to be so. Unfortunately, the FDA's regulation is usually not what the consumer is told.
When laser hair removal arrived on the scene, many exaggerated, unsubstantiated claims about its efficacy, risks, side effects, and long-term effects were asserted (Source: Journal of Cutaneous Laser Therapy, March 2000, pages 49–50). More research has taken place since then and there's more data (both clearer and more precise) regarding statistical analysis of performance and adverse outcomes. For example, a study reported in the November 2001 issue of Dermatologic Surgery, pages 920–924, used a "755 [nanometer] alexandrite laser equipped with a cryogen cooling…. Eighty-nine untanned patients… in the study underwent a minimum of three treatment sessions spaced 4-6 weeks apart [each patient had an average of 5 treatments]. Treatment sites included the [armpit], bikini, extremities, face, and trunk. RESULTS: The patients had a mean 74% hair reduction.… The best results are achieved in untanned patients." Several studies have looked at various other laser systems, including some showing more promise for darker skin tones (Source: Annals of Plastic Surgery, October 2001, pages 404–411).
The risks in laser hair removal can include skin discoloration (either darkening or lightening of skin); swelling; inflammation; and infected hair follicles. Laser hair removal is particularly problematic for those with tans or darker skin colors (Source: Cosmetic Dermatology, November 2001, pages 45–50). One study found that “Both long-pulsed alexandrite and long-pulsed diode laser systems are effective in the treatment of unwanted hair, and they are more efficacious than [the] Nd:YAG laser” (Source: Dermatologic Surgery, April 2004, 498-502).
More recent research confirms early information that laser hair removal, while superior to other forms of hair removal, is still not permanent and there can be complications (Source: Journal of Dermatologic Treatment, April 2004, 72-83).
Because of the potential for complications and the plethora of hair-removal machines available, it is essential to have this procedure performed by a physician who is familiar with the research and able to make the correct choice about which procedure is best for you.
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