Laser Hair Removal

Myth: Laser results are permanent

Fact: The U.S. Food and Drug Administration (FDA) has not permitted any manufacturer to claim permanent hair removal; however, FDA did clear a laser hair removal device to claim permanent hair reduction.  AEA regards this new term to be misleading. Suggestions of hair growth reduction are not supported by the submitted clinical data because the reduction refers to a very small percentage of reduction in the number of hairs, typically no better than about twenty (20) percent; and permanent refers to periods of observation as brief as three (3) to six (6) months, and rarely longer than one (1) year after treatment. Such poor results do not justify the high cost of treatment.

Questions regarding claims about specific devices may be telephoned to the FDA's Office of Consumer Affairs: 800-532-4440. Be prepared to provide the device's name, model number and manufacturer.

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Myth: Laser is painless and does not harm the skin

Fact: Despite the claims of many promoters, FDA has not permitted any manufacturer to claim "painless" laser hair removal.  Contrary to claims of minimal sensation and despite the skin-cooling devices built into several hair removal lasers, most manufacturers promote the routine use of local anesthetic prior to treatment, such as EMLA cream, available only by prescription. Patients are still known to complain about the levels of pain involved.

The manufacturer of a popular ruby laser reports that one patient in three experiences hypopigmentation (skin-lightening) or hyperpigmentation (skin-darkening), which takes one to six months to clear (by which time most of the hair will have regrown)! A newer diode laser has reduced these odds to a still poor one in six.
 In order to minimize pain and pigmentation changes, clinics commonly operate hair removal lasers near their lowest energy output, despite several manufacturers' claims that high energy may be more effective.

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Myth: Research by Harvard Medical School proves Laser is permanent

Fact: This commonly heard claim refers to research conducted by the Harvard Medical School's Wellman Laboratories of Photomedicine at the Massachusetts General Hospital (MGH), Boston, MA. It should be noted that MGH has a contractual agreement with a laser hair removal device manufacturer and receives a percentage of all laser hair removal device sales.  Results of MGH's 1994 laser hair removal experiment were published in a scientific paper called Damage of Hair Follicles by Normal-mode Ruby Laser Pulses in the December 1996 issue of the Journal of the American Academy of Dermatology, Volume 35, Number 6, pages 889-894.

The study involved only thirteen human test subjects, each of whom had hair removed from the back or posterior thigh by a laser device. There were eight test areas, each about one square inch. After three months, the average regrowth was about 58 percent. After six months, the average re- growth was about 75 percent. Five of the thirteen patients had one hundred percent regrowth.

The article also stated that the test subjects described the treatments as "moderately to strongly painful" and having a "rotten-egg smell".

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Myth: The Test of Time will prove laser results are permanent

Fact: Clinics promoting laser hair removal frequently claim that their laser was designed to produce permanent results, but that it is still too new to provide proof. They may also misrepresent existing research, such as the above "Harvard Study", falsely claiming that patients have gone as long as five years without any regrowth.  They may also speak optimistically about "new" clinical trial results, again claiming miraculous results. Neither the AEA nor anyone else can verify these claims due to the absence of any documentation proving their statements.

Consumers are advised to demand that clinics provide copies of scientific papers to support their claims, and review the data with their personal physician prior to undergoing such treatment.

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Myth: Regrowth from Laser treatment will be finer and lighter.

Fact: This phenomenon occurs with all non-permanent methods of hair removal, such as waxing and tweezing. However, the regrown hair can be expected to mature to its original texture and color.

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Myth: Our laser is "FDA Approved."

Fact: When a clinic proclaims "FDA approved", the public expects that its laser must be safe and effective. Not necessarily! It helps to know what constitutes "FDA approval".  The FDA has two types of regulatory requirements for manufacturers of medical devices. The most stringent is called "Pre-Market Approval Application" (PMA), which requires manufacturers to submit years of detailed scientific testing to prove safety and effectiveness. It is important to note that no laser hair removal device has been required to submit a PMA to the FDA.

 The second, less stringent, FDA regulatory requirement is a 510K application, also known as "clearance to market." This requires only that the manufacturer gives one-day notice of its intention to market a device, and to show that it is similar to other devices allowed to be marketed by FDA. To claim safety and effectiveness for new uses, manufacturers are required to submit only very limited supporting scientific evidence. All of the lasers currently marketed were cleared to market via this simple route.

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Myth: Laser is safe.

Fact: The long-term safety of laser hair removal has not been established. Only a few, brief clinical trials were conducted prior to their introduction, so no clear determination can be made as to the potential long-term effects of repeated lasing of the skin. Therefore, it is the opinion of the AEA that the real test subjects are those who are now paying for laser hair removal treatments.  Some clinics require patients to sign consent forms prior to laser hair removal treatment. These forms should be read very carefully and caution should be exercised to be sure no legal patient rights have been waived in the event of short or long-term complications. Should there be doubt, get legal advice.

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Myth: Laser hair removal is more cost-effective than Electrolysis.

Fact: Since electrolysis results are permanent and laser results are mostly temporary, it is impossible for laser treatments to be more cost-effective than electrolysis.  Electrolysis remains the GOLD STANDARD against which every other method of hair removal has been measured. And, with very good reason. Since 1875, electrolysis has proven time and again that it achieves a permanent result. Permanence equals cost-effectiveness.

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