Elite Electrolysis - the best in permanent hair removal and skin care

According to U.S. Food and Drug Administration, laser does not result in the permanent removal of hair growth. Despite this fact, many remain wooed by lasers, even to the point of placing their health at risk. On television, in the papers, on the radio... ads for lasers are everywhere! Laser clinics use and abuse the media to convince the public to use this technique. In their ads, they promise everyone permanent hair removal. This offer is so appealing that many are seduced without asking questions on the true effectiveness of this technique. Here are some facts.

To date there is no statistical evidence that laser hair removal is permanent. In fact, electrolysis is the only method that has the legal right to advertise permanent hair removal.

Although, with use of the laser, hair may not grow within many months from the time of the treatment, it serves only as a prolonged temporary method. In addition, laser hair removal is very expensive with an initial treatment costing up to hundreds of dollars.

There have also been numerous cases reported of skin discoloring especially among darker skinned individuals as well as scarring. The lighter hair can not be removed with laser, because it cannot be seen by the laser light, only the darker hairs can.

Several laser manufactures received FDA permission to claim "permanent reduction", but NOT "permanent removal".

This means that although laser treatments will reduce the total number of body hairs, they will not result in a permanent removal of all hair.

Laser treatments provide an alternative to other temporary hair removal methods such as waxing and tweezing but at considerably higher cost. So if you don't have money to waste and want to see a return on your investment, then ELECTROLYSIS is for you.

The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. To learn if a specific manufacturer has received FDA clearance, you can check FDA's Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. 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, fax your request to 301-443-9535 or send an e-mail to: DSIMCA@cdrh.fda.gov.

Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing 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.

FDA does not make comparisons between systems or how well or safely they work compared to another company's system. FDA does not recommend one laser system over another.

Doctor Berkow retired several years ago, and your original letter never made it to me. Your letter of April 14, 2003 arrived on my desk today.

I have reviewed your suggested changes with interest. I have also conducted some research on the topic. I agree that we should drop the phrase, "which is tedious" as a modifier of electrolysis. The literature that we have
reviewed (and our text in the new edition of The Home Edition), agrees with your assessment that laser is less effective than electrolysis. Thus, we will change our text to say, "The only safe permanent local treatment is
destruction of individual follicles with electrolysis; multiple treatments may be necessary. Lasers may be used to decrease hair growth but is generally less effective than electrolysis and hair tends to regrow."

Thank you kindly for your interest in The Merck Manuals and for taking the time to contact us. I apologize for the loss of your first letter. These changes will be made on our web site within approximately the next month.

Mark H. Beers, M.D.
Editor-in-Chief, The Merck Manuals
Executive Director of Geriatrics and Clinical Literature

AEA Laser Position Statement

Posted by: AEA board, 9/19/03

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 nay 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:

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.

More troubling to the experts Primetime spoke with is the rise in popularity of laser treatment to remove body hair. Such treatments are becoming available at more and more spas, and more than 1 million Americans had laser hair removal in 2001.

According to Dr. Roy Geronemus, a leading expert in laser treatments, dermatologists are seeing a "dramatic" increase in the number of complications from laser hair removal treatments. "These complications may have lifelong consequences," he said

Primetime met one woman who received first- and second-degree burns on her cheek and neck while undergoing laser hair removal at an upscale spa in New York City. The woman, who is suing the spa, says she has been left with permanent scarring, and now, more than a year later, still does not uncover her face in public.

Geronemus is particularity concerned about training: some operators have only a weekend's worth. And even with much more training, mistakes are made, he said. There are many different lasers for different skin types and too many operators use the wrong laser for the wrong skin, he said.

Furthermore, only 15 states require that only physicians can perform laser hair removal. In 20 states, including New York, there are no regulations at all.

To see if testers would be accurately told what to expect and what risks they might take, Primetime sent employees to spas in New York to document their consultations on hidden camera. The testers were all deemed high risk or poor candidates for laser hair removal by Geronemus.

Experts Primetime consulted say one of the most important things in laser treatment is assessing a customer's suitability. Some lasers can be dangerous for some darker skin types, they add, and are ineffective on blond hairs. Primetime's hidden cameras found that while some laser operators were careful to consider clients' skin and hair type, others were willing to proceed with laser treatments without giving adequate warning of the potential dangers involved.

At one spa in New York City, the operator told a Primetime tester with fair skin and blond hair that she could get rid of unwanted hair and would not face side effects because of her skin and hair color.

The operator promised that after three sessions costing a total of $1,000, the tester's hair would be gone "permanently." But Geronemus said that was misleading: "Lasers just don't work on blond hair at this time.... It simply doesn't work," he said. "There's no point in even attempting this procedure on this patient."

When Primetime told the operator of the doctors' opinion, she said that while the laser won't work on many blonds, it will on some, and that you don't know until you do it.

Laser hair removal works by targeting melanin, the pigment that gives hair and skin its color. The melanin absorbs the laser's heat, thereby damaging the hair follicle. Blond and gray hairs do not have enough melanin for the system to work.

Those with darker skin, and higher melanin, are at a much higher risk for side effects. Some lasers cannot distinguish the dark hair from the dark skin, so the skin may absorb the laser's heat, which can cause burns.

When Primetime sent a black tester to a laser hair center in New York, the operator promised she would be safe and said any reaction would last only a few days. Primetime's experts were shocked to hear the operator's reassurances, explaining that the laser she planned to use on the black tester was the wrong laser and increased the risk of burning and scarring. There are more than 30 models of hair-removal laser on the market, but operators need to choose carefully which laser to use on which skin type, the experts said.

Dr. Elliott Battle, who has studied the effects of lasers on people with darker skin, said that all people of color, not just blacks, are at risk, including those of Mediterranean, Asian or American Indian background.

When contacted by Primetime, the operator insisted she could provide a safe procedure because she is careful and well-trained — though she wouldn't give any details about that training.

Even more risky, many experts say, is having laser treatment with a tan. When Primetime sent out a tester who goes to a tanning salon regularly, the first two laser salons she visited asked about her tan and turned her away, saying a tan was a problem. But at the third salon, the laser operator didn't seem to notice the tester's tan and never asked her about it.

Geronemus said the chance of complications goes up dramatically when a laser customer has a tan, and said spas should tell consumers with tans to come back a few weeks later, after staying out of the sun.

When confronted by Primetime, the laser operator said she had extensive training and can treat tanned people safely. She said her spa has a laser model approved by the FDA for use on tanned people. She had even told the Primetime tester she would use that model on someone which tan skin — but that was not the one she showed the tester.

"The mistakes that were made were fundamental mistakes and should not be made," said Geronemus. "These are fabulous procedures if performed properly, but there can be significant consequences if not performed properly."