Some things from my experience...

Hair Removal Methods Laser hair removal
1

Just a little heads up from my own experience.

Just like with electrology, there is a wide variation in the skill, integrity and results that one will see from a particular laser treatment center. There are many things that one needs to research in this area before committing to a course of treatments. Things to think about:

  1. If you have very light hair color, you may want to consider other options. If during a consultation, the tech telly you that no problem, we’ll get rid of you unwanted hair in 6 to 8 treatments and does not mention that light hair colors do not respond well to laser, especially on the faces of M2F.

  2. How long has the place been in business? Do you know anyone who has had work done by them? If so, what were the results. How long has it been since their last appointment/treatment? Were there any problems with getting additional clearances?

  3. Do they actually have a laser or are they using one of the diode type machines?

  4. What does it cost? Can you afford it?

  5. Do they make claims of total permanent hair removal? If so, you may want to go elsewhere. In the U.S. the FDA has not granted laser hair removal practices to claim any more than “hair reduction”. Anyone using the term permanent can not be too trustworthy as they are ignoring this directive to begin with.

I have a lot of friends and acquaintences that have had laser work with good results. I also know some that have used laser and not done so well at all. The ones it didn’t work for didn’t get any money back and are now proceeding with electrology.

I will state up front that I am an electrologist, but I want what’s best for my clients. If they are very fair skinned and have dark hair, laser will most likely be a good option for them. I will usually begin treatments on them about a year later to clean up what the laser doesn’t get. I also treat the areas that are not safe for laser as well (near the eyes!). Either way, I can still earn a good living.

Just a cautionary note as it is your money and I like it when people can get a good result for their hard-earned cash. Just like electrology, there are those in the business of laser who should have gone into other fields.

Joanie

2
  1. Do they actually have a laser or are they using one of the diode type machines?

Thanks Joanie. I agree with all of the above. Just wanted to point out that a diode type is actually a good type of laser (skin types I-IV). I believe this should say “avoid most IPL machines (intense pulsed light)”

3

diode is a real laser and has provided the best results in my case.

4

. . .especially on the faces of M2F.

  1. Do they make claims of total permanent hair removal? If so, you may want to go elsewhere. In the U.S. the FDA has not granted laser hair removal practices to claim any more than “hair reduction”. Anyone using the term permanent can not be too trustworthy as they are ignoring this directive to begin with.

First, what is a “M2F?”

Your #5 is not technically correct. One can get total permanent hair removal with lasers and to say otherwise is wrong. What the FDA has done is to apply a standard that requires a significant amount of effort to prove and so no manufacturer has been willing to make the effort (time and money) to prove complete removal of hair. So the FDA has prohibited the manufacturers from making that claim. That said, this does not apply to anyone providing laser hair removal services but just to manufacturers selling the machines.

So if a laser center says that they can offer permanent hair removal, one has to consider what they mean by that and how they define it. If they have been in business five or more years and make that claim, that says one thing. If they make that claim and they’ve been around less than a year. That says something else.

Any by the way, electrolysis has never had to prove any claims. That’s because electrolysis devices were being sold before the FDA existed. If the manufacturers of electrolysis devices had to prove that their devices offered permanent hair removal, they also would not be able to prove it to the degree demanded by the FDA and would be treated the same as lasers.

5

Could we not start this argument again?

The Grandfather clause argument is patently false, there are studies that prove electrolysis to the standard that LASER has not satisfied the FDA and the biggest problem with LASER meeting the FDA standard is at the very least being able to reliably deliver a predictable result on everyone, or at least be able to state before treatment (and separation of client and money) who it can help, and who it can’t.

6

Hi sslhr:

An M2F is a short form way of saying a male to female transsexual. Transsexuals have a language all of their own which could best be described as transspeak.

Alicia

7

Could we not start this argument again?

The Grandfather clause argument is patently false, there are studies that prove electrolysis to the standard that LASER has not satisfied the FDA and the biggest problem with LASER meeting the FDA standard is at the very least being able to reliably deliver a predictable result on everyone, or at least be able to state before treatment (and separation of client and money) who it can help, and who it can’t.

I was not involved in the “argument” before but I think there is some misinformation here. And I find it disingenious when people promote electrolysis as being permanent and laser hair removal as not, based on what happened at the FDA. Especially by people who don’t know how the FDA works or what happened with laser hair removal.

By the way, I didn’t say anything about being “grandfathered.” But the reality is that needle electrolysis is exempt from the FDA because it was already being used when the FDA was given the mission of regulating “medical” devices. On the other hand, tweezer epilators are not exempt because they are newer. Though I don’t know what their status is.

But reading what you find on the FDA website, electrolysis is considered “permanent removal” because it destroys the hair root. But how does one know that, by histology (biopsies) for one. At the same time, there are plenty of biopsies that show the same thing for laser hair removal.

Now I don’t argue that electrolysis (when performed correctly) can remove a wider range of hair than laser hair removal (when performed correctly). There are limitations to laser hair removal due to its nature. But the final result, once we get past the method of energy delivery is the same in hair that can be treated by lasers. I actually believe that laser and electrolysis are complementary.

But let’s turn to the FDA. I had a conversation with someone from Palomar immediately after they won approval from the FDA to market their Epilaser as permanent reduction, not removal. What is important to understand is that what one reads in an opinion or finished review from the FDA is only the tip of the iceberg. There is a tremendous amount of discussion and argument that goes on below that final report.

There was tremendous discussion within the FDA and their advisory committees as to what “permanent removal” actually meant with respect to hair. In fact, some of that confusion came about because of the AEA (electrologists) who at that time were vehemently opposed to laser hair removal. And they were strongly arguing to the FDA that lasers could not remove hair and that electrolysis was the only “permanent” method.

To make a long story short, ultimately a compromise was hammered out. A big part of the reason was that Palomar did not want to go through the expense and time to provide the data that the FDA was going to require to prove permanent removal. It would have taken Palomar at least another 3- 4 years of study to provide enough research to meet the FDA’s expectations. And all they wanted to do was to market their laser as able to remove hair. And understand also that once one laser company proves something, then it becomes easy for other laser companies to piggyback on their research as long as they can prove that their device is substantially similar (easy to do). So there was no value to Palomar to spend the millions of dollars it would have taken just to let every other company ride their coattails. And so, they took the compromise, which was to call it “permanent reduction.” And if you read what that means, it is a convoluted definition that is truly in keeping with a compromise. But it allowed Palomar to make that claim based on a handful of studies.

And by the way, I don’t doubt that there are studies on electrolysis. But I don’t know of any study that is properly controlled, published in a peer reviewed journal acceptable to the FDA (they don’t accept just any journal, there is a hierarchy of jounals in the medical world), that shows that electrolysis can permanently remove all the hair. I would be happy to see a reference. But this is going to have to be a long term, multicenter trial, properly controlled and not just anecdoctal evidence. And that is the really hard part.

8

FDA’s Center for Devices and Radiological Health allowed electrolysis to claim “permanent hair removal” based on nearly 100 years of clinical data prior to regulation of the devices.

http://www.hairfacts.com/medpubs/electmed.html

FDA is certainly not infallible. In 1989 they allowed two companies to use a 9-week standard to define permanent hair removal, though they no longer use this as the standard. This unfortunate decision has led to a lot of confusion and influenced the laser decisions in 1997/1998.

The reduction/removal distinction stemmed from a lot of problems with electric tweezers at the time, combined with laser manufacturers like Palomar trying to use the 9 week/3 month standard to base their claims. FDA does not approve devices but clears them based on predicate devices, so lasers were comparing themselves to devices already cleared. Since that time there has been a significant body of long-term laser data that suggests consumers (especially those with light skin and dark hair) will often see permanent reduction of hair in treated areas after a course of treatment, but rarely complete removal of all hair. Studies have also shown that some electrology consumers do not respond well to treatment.

Because these are not life-threatening matters, FDA places a pretty low priority on regulating these devices. The agency was gutted in the 1980s under Reagan and can barely keep up with potentially life-threatening matters.

So, which is better? Laser or electrolysis? It’s kind of an apples and oranges question. It depends on the individual consumer’s needs, area treated, time frame, money available, physiological characteristics, etc. etc. The best thing for consumers to do is research the options and ignore most of the hype.

9

I have never seen the FDA’s writeup allowing electrolysis to claim “permanent hair removal.” And I can’t seem to find it anywhere. The only thing I could find was a reference to needle electrolysis being exempt. My understanding of the law that established the FDA (somewhere around the late 50s or so) is that prior devices and a vague grouping of routinely used products around for years were exempt. The most famous is nicotine in tobacco. Most of this was political.

Looking over the articles provided, none of them would pass muster with the FDA as the basis of making a claim. There are good articles there but they aren’t good enough and there aren’t enough of them. They are just not epidemiologically sound. That’s not saying that they aren’t correct, just that they have potential confounding flaws that aren’t controlled. For example, one study quotes treatments for 500 people but then only reports the results on about 75 or so of them? What happened to the other 400 or so? That is an example of uncontrolled confounding. Granted the FDA requires more for drugs than devices, but this is why the average cost to get a drug approved by the FDA is over $500 million dollars, last time I checked.

The point of all of this is that the FDA is a difficult agency to satisfy and the laser companies were not willing to go through the effort. All they wanted was the ability to make a marketing claim. And by the way, the claim that the FDA allows them to make only applies to manufacturers. People who buy those lasers can make any claim they want to make. The FDA has no control on that. So for example, I could claim that prescription strength ibuprofen can cure impotency, baldness, and make your breasts bigger, if you are a woman. No one may believe me but the FDA would have no say in what I am claiming. This is called an off-label use.

Another part of the problem with all of this is that there are many many light based devices on the market that “remove” hair. Unfortunately, only a few of them actually work well and the other problem is that there are many people who don’t really know what they are doing. And finally, removing hair is really not that easy, so it is unfortunately, a “buyer’s beware” market.

So, which is better? Laser or electrolysis? It’s kind of an apples and oranges question. It depends on the individual consumer’s needs, area treated, time frame, money available, physiological characteristics, etc. etc. The best thing for consumers to do is research the options and ignore most of the hype.

I am not sure the “which is the better?” is a fair question. And it is hard to ignore the hype because even on this site, we all have our biases and spin what we write.

The bottom line is that neither is better and that in competent hands they both deliver excellent results. Lasers are a little more problematic because the technology is still quite new and hasn’t shaken itself out yet. There are many systems that aren’t worth using and as the industry matures they will disappear. But it will take some time. And there is no question that certain color hair and thickness of hair (in combination with the background skin color) will not respond effectively or at all to lasers. On the other hand, lasers have advantages over electrolysis. So eventually it comes down to a matter of trust. Can you trust the person who is recommending the electrolysis or laser? And of course, that is the same question one has to ask for any significant purchase (like a car or real estate).

So how do you decide if you can trust someone? If I knew the answer to that . . . But one way is to look at how long they have been in business and how many people they have treated. The longer in business and the more people they have treated, the more I would trust them.

10

I have never seen the FDA’s writeup allowing electrolysis to claim “permanent hair removal.” And I can’t seem to find it anywhere. The only thing I could find was a reference to needle electrolysis being exempt. My understanding of the law that established the FDA (somewhere around the late 50s or so) is that prior devices and a vague grouping of routinely used products around for years were exempt. The most famous is nicotine in tobacco. Most of this was political.

Looking over the articles provided, none of them would pass muster with the FDA as the basis of making a claim.

Needle epilators were first regulated in 1976, 100 years after the first published clinical paper demonstrating permanent hair removal. They were not declared exempt by FDA until 1996 (Docket No. 95N-0139), when FDA determined that premarket notifications are unnecessary for the protection of the public health.

“Needle epilators are used in electrolysis. Because this technique destroys the hair follicle, it is considered a permanent hair removal method. The hair root may persist, however, if the needle misses the mark or if insufficient electricity is delivered to destroy it.”

http://www.fda.gov/fdac/features/796_hair.html

It was determined that unlike lasers, needle electrolysis did not require regulatory evaluation prior to marketing because its effects and results were well-established.

FDA discussed the term “permanent hair removal” when also reclassifying electric tweezers in 1998 (Docket No. 97N-0199):

“Although there is no universally accepted medical definition of what constitutes permanent removal of hair, FDA acknowledges that the phrase “destroying the papilla of a hair” is widely accepted by many to be equivalent to stating the device permanently removes hair. FDA now believes that the use of this phrase in the device identification statement was inaccurate, and in this final rule, is removing this phrase from the device identification.”

FDA does not object to use of the term “permanent hair removal” for electrolysis but has not allowed other devices, notably lasers to make the same claim. Their clearance of the term “permanent hair reduction” made the issue confusing for consumers and effectively deflected the debate so FDA could focus on other issues.