FDA Warning letter to One Touch (1997)

Hair Removal Methods Do-It-Yourself Electrolysis
#1

On 30 June 1997, FDA sent a warning letter to Inverness, maker of the One Touch device. (97-NWJ-41) FDA cites them for not maintaining Medical Device Reports when consumers were injured. Some complaints were for an at-home ear-piercing device, while others were for the One Touch:

</font><blockquote><font size="1" face="Verdana, Helvetica, sans-serif">quote:</font><hr /><font size="2" face="Verdana, Helvetica, sans-serif">  A. Complainant [edited], dated 4/30/96, who received small burns and permanent scarring on both of her legs, subsequent to using the "One Touch" electrolysis product.

B. Complainant [edited], dated 3/22/96, who suffered irritation and scarring on her shin after utilizing the electrolysis device.

C. Complainant [edited], dated 9/11/95, who suffered scarring on her ankles and abdomen area, subsequent to utilizing your “One ouch” electrolysis kit.</font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>The reason I do not recommend home electrolysis is because the likelihood of scarring outweighs the possible benefit of permanent hair removal, in my opinion. These devices are difficult to use properly and will cause scarring if used incorrectly. To me, that’s worse than having unwanted hair. The risks are even higher with the face, which everyone will see, so consider carefully before attempting this on your face. I’d practice a while elsewhere before doing work on the face.

This is not to say it can’t be done, but to say that for many, it’s worth the money to go to a pro recommended by someone who is done and happy.

Thanks to reader rosefire for the research on this!

[ July 19, 2002, 11:44 AM: Message edited by: Andrea ]

#2

I’d like to see some pictures. I’ve seen pictures of laser treatments gone bad, and they were quite disfiguring.

Like the one touch says, you wanna first do some test hairs to see how your skin will react. Different parts of the body are more sensitive than others. Doing ones own face can be a little disorienting since you are doing it thru a reverse mirror. I can see how you could do some damage doing your own face

#3

There are several easy ways to scar yourself with the one touch unit. Since it does not have a switch, the electric circuit is complete as soon as you contact moist skin and you burn your way into the pore, rather than inserting the probe to the hair root and then applying energy to it. Shallow rooted hairs mean you are treating very close to the surface, so it is needed to use very low power for these hairs. Also the rheostat inside is 0-10k ohms and if you use the highest setting, you can easily burn, and on a shallow hair you could easily also create a surface scar. Experience, practice, and training are needed to avoid these negative experiences and with a home unit, you are the guinea pig for your training period. Attach a switch, use only low power (yes it will always be slow using pure galvanic electrolysis), and practice on medium deep rooted hairs in non-sensitive areas to minimize damage.

#4

pish, it usually looks like acne scarring or chicken pox scars. It’s caused by breaking down the collagen under the skin, or making a scar in the epidermis.

The best photos of electrolysis scarring is in Mike Bono’s book.

Good tips, NoHair!

#5

NoHair:
Yes - I can verify the problems you get without a switch! I’ve been having electrolysis in my salon with a Sterex machine. On one occasion, the foot switch stuck on, and it took my therapist several zaps to figure out what had gone wrong … the needle was sparking as it got near my skin. It scabbed dreadfully, and I’m left with a line of rather deep pits.

Andrea:
Does Mike Bono suggest any remedial action for the scars?

#6

Toni–

You can get mild chemical peels, a heavier phenol peel, or a laser resurfacing to smooth things out.

In some countries, you can also get injectable skin fillers, but there is some controversy about the safety and effectiveness of this porocedure.

I suggest speaking with a dermatologist to determine your best option.

#7

Thanks, Andrea :smile:

I had a quick look at what’s available after your post. One place I looked at takes UV before/after photos of your skin to assess the amount of damage, and help determine which peel is right for you.

I’m probably quite a way off. It’s quite expensive, and I’d kind of like to make sure all of those hairs are finally gone. They have a nasty habit of coming back 3 months after you think you’ve zapped the last one.

I’ll keep you all posted. :wink:

#8

Those UV photos are a very effective marketing tool-- it’s pretty scary to see the photodamage!

Since you have time to decide, be sure to do plenty of research!

#9

Toni, the amperage in the one touch units is far less than the professional units, thus it is much more difficult to scar with the home unit, although certainly possible. This is because the home units use Galvanic electrolysis and the professionals use Thermolysis or Blend to increase the speed of treatment. The home units can still be as effective, they just take a darn long time to get the job done. A stuck switch in a professional unit could be very destructive.

#10

Thanks both … :smile:

I’ll keep a cynical eye on the marketing hype!!
After all, skin has a very good ability to heal itself - it’s what it’s there for really, isn’t it!! I asked my surgeon what he could do about the damage, and he said he’d only consider looking at it seriously after 6 months of quitting electro…

I must admit, I’m getting quite sold on the idea of this One Touch device, though… My chin and top lip are more or less done - I guess I could just about keep them hair free at home.
(And I loved your switch idea, NoHair!! Ingenious!!! - Did I spell that right…?)

Can you point me to a supplier page? And do they sell in the UK, do you know?

#11

The hairs on the top lip are generally somewhat fine and the probe of the One Touch unit is rather thick. You’d probably be better off getting a professional sylus ($29 US), a box of 0.003 probes ($20 for 50) and hooking it up to a 9V (or higher) battery with a 10 or 50k potentiometer ($2) for control (the One Touch comes with a 10k). See www.NoHair.info for more detail. I’m sure these are available in the U.K., but I don’t know how they may be regulated there.

#12

OK, thanks…

It sounds a bit too technical for me though.

#13

Toni, the switch and all that are a little tricky to do, but NoHair’s suggestion of getting some very thin probes (.003 or so) from a different manufacturer can be very helpful for treating fine hairs. Remember that these bend even more easily than the ones you get with the kit, so be careful!

#14

wow, thanks nohair! i done my entire left arm with the power always on. didn’t know i was to make the connection after the needle was inserted… :smile:

#15

The instructions that come with the One Touch are unfortunately a bit too minimal. Maybe they want to imply that the procedure is simpler than it actually is or maybe they just don’t care. It would appall me to watch the probe burn it’s own pathway under the skin when it was always on. This may be less likely on arm hairs that are more perpendicular to the skin. Although I seem to have luckily resulted in no scarring from this, it certainly could do so if done severely enough. Realizing that I had the ability to eliminate this hazard and also benefit by having better sensitivity to guide the probe down the follicle, made a huge difference. The instructions imply that the device won’t complete the circuit until you’ve reached the root, which is dangerously misleading. I am certainly pleased with the results and permanence achieved from this simple and economical device, although I’ve made a few improvements as I learned and eventually replaced every part (as described above).

#16

Yes, you should keep your finger off the metal band on the stylet until you have the probe in place. Takes a little practice, but it can help[ reduce skin damage if done right.

#17

Hi, I was trying to find the letter, but it’s difficult to find. Do you have a copy of this document, as there are more people reporting the same concern in the UK now.

#18

Even if we wanted to, I dont think we could given the letter was issues 26 years ago. A LOT will have changed at FDA in that time.

#19

Hi Iris-- You can contact FDA and request letter 97-NWJ-41. There may be costs associated, as they were not great with releasing documents online least century. Many of the documents I ordered were mailed to me on microfiche!