Please show me that discussion. I don’t remember the 10-15 hair “argument”.
How does the list of side effects reported for a drug come about then?
Correction – we were debating about whether or not the person who reported hair growth 10 years after her laser treatment was suffering from induced growth. I was mixed up with something else.
As for drugs side effects, consumers can report, but then after the reporting happens, the drugs are extensively retested. People don’t just submit a report and the FDA looks at it and says “Ok, someone said they had this effect so therefore it must be true”
Dee, again- re-read my statement. I said lasers PERFORM permanent laser hair removal per a stated criteria. I said the FDA does NOT approve lasers for permanent hair removal for a very specific reason.
Most of my contact with consumers occurs at medspas and schools when conversing with regular customers. I also do marketing for medspas, and am involved with acquiring new customers, and stimulating new customer bases. As a servicer and dealer I do partner with medspas. I have reference sites where I field demo units, and some of my customers hold inventory for me while I work on getting it sold. Most of what I do when I am not selling or repairing lasers is contacting my customers, and asking questions about consumer feedback. I often hear feedback like what I’m reading on this page- but when I give my advice, it is taken, and I rarely hear the same complaint twice- unless it is about a machine I originally suspected wouldn’t deliver as promised.
Apart from real world feedback, I compile feedback through various sources- some equipment specific. I am probably on the MAUDE database more than any technician I know, but if you look at when I joined Hairtell, you would also realize I peruse many consumer forums (well I shouldn’t say many… there aren’t many). I am up to date on the last incident reported to the FDA for most lasers and light based devices, as well as warning letters, and recalls (I am responsible for some of them).
I get more feedback from more consumers on more laser types than you could possibly get from your own customers because, well, it is people like you who feed me information on a daily basis… and I have far more than one customer.
And believe me- if no big deal has been made about this issue, I will. I am going to contact every major manufacturer for their statistics on paradoxical hair growth, as well as feedback from all of my customers. I will say, however, that there is a clear trend among those who are making the claims vs. those who are not. Mr. Bono, for example, is cited in an article citing a study that has nothing to do with the claims he makes in the article.
Are you around laser hair removal more than I am, as you think you are???
FDA logs every single report regardless of conclusion in the MAUDE database. Every practitioner who injures a patient with a medical device, or administering a drug is supposed to self report via form 3500A for mandatory reporting. These reports may not translate as drug side effects, but they are logged nonetheless.
Of course, not very many people do this… I am probably the number sumbitter of FDA forms 3500 (voluntary reporting) for all equipment combined.
Consumers are encouraged to report side effects of drugs and medical devices to the FDA.
For the eyelash (glaucoma drug) Latisse, it looks like this:
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full LATISSE® Prescribing Information.
When consumers of laser hair reduction report a negative side effect, the FDA or the physician in charge should be told and these observations should be kept in a data base. Instead, consumers have come here and complained. I have attempted to group those complaints on one thread for scientists, lawyers and such, to consider and for other consumers to peruse before they decide to get lased on certain areas. Researching-type adults can decide for themselves what they want to do after considering the information presented by others. I’m just a by stander trying to organize information.
Yes Dee, I know they are encouraged to report the effects. What I’m saying is that just because people have reported something to occur, it doesn’t make it a scientific reality. I applaud you for grouping this together, but I’m letting you know as a friend that in the science world, simple reports like that hold little to no value. It’s a good way for scientists to say “We should take a look into this effect and see if it’s real” but it’s not safe or valid to say “Induced growth is a real thing” without testing it further. With the reports on here, it definitely warrants a look at in the science world, but the reports here aren’t enough to generate any conclusions. That’s just how science is
Dee, you are absolutely right about reporting… however, complaining about new hair growth isn’t a valid complaint unless the consumer completes the hair removal process with a specific laser type and model based on that manufacturer’s specifications.
You can’t, for example, start with a Cutera Xeo for your back, then go get Lightsheer done, and finish it off with a Palomar Starlux 500 and claim that any one is defective- they all deliver different energies at different wavelengths in different spot sizes!
If you show me a person who had hair removal performed on them in at least 6 intervals with the appropriate treatment parameters on a reliable, efficient laser system- then those complaints begin to look more valid. THAT is how FDA reporting works. If you don’t report treatment parameters, model, spot size, etc.- you are only complaining, not reporting.
This is ALL I’ve been trying to say
BTW Dee, can you please link that forum? Also, have you reported any of these incidents to the FDA? Just curious…
I am beginning to understand you better, CRV. Thank you for your careful explanations.
I am not a laser specialist. I do electrolysis only. I do refer clients to two or three laser specialists that I like if they are a good candidates for successful laser hair reduction. I am so grateful that LHR exists as I am so busy treating hair structures and colors that laser can’t see or I am finishing the job for total hair removal that requires the preciseness that only electrolysis can accomplish. I get feedback on a monthly basis from clients that are disenchanted with their laser experience or are satisfied, but not totally pleased with the amount of hair that is left. I hear less about laser hair stimulation, but will say it is not as rare as the PubMed article says it is.
Thank you Mickey for your patience.
This is ALL I’ve been trying to say [/quote]
VERY few, if any other posters here, have science backgrounds it seems. As of the current posters on here, I think you and I may be the only ones with physical science backgrounds, so I understand what you’re saying with regards to how things work in the science world
Didn’t mean to call you CRV. I drive a CRV. Must have been thinking of my car. Sorry CRC.
No offense taken! It’s not my name And I know it was a typo! I actually thought “probably drives a CRV”
No, since I didn’t perform the treatments, I didn’t report them. I did encourage the consumer to go back to the laser spa and give them feedback though. They would know the laser model, spot size, joules used, etc. Some have gone back to their laser specialists to complain and were told this has never happened to anybody else. So, now if falls back on consumer hair sites like this. We are like a bitching post for disenchanted laser clients.
Ha! ! It’s a real chick car. Good mileage and peppy!
Do you mean www.cosmeticenhancementsforum.com ?
I haven’t been hanging out there for awhile (too busy removing the rest of the finer, lighter hairs that laser can’t see).
You said you were compiling all those complaints in one thread. I want to see those complaints. This issue is going to bug the heck out of me. Sorry, but I get a little OCD with things like this :-/
Dear Brenton,
The medical scientists used the term laser hair stimulation first. I use the words they use. I don’t diagnose the problem. I listen to the words that medical scientists use and listen to the words and description that consumers of laser use. I observe hair structures all day long and into the late evenings on most days and wonder what I am observing . I’m not dumb, I know how the scientific process works. I do think there is something going on. Hopefully, the genius’s like you can bring it altogether in a conclusive type way.