There is a sucker born every minute so says the expression. With regards to peripheral neuropathy treatments this saying rings true. Many so-called miracle treatments are touted as being FDA cleared. Any device with a FDA approval is a powerful endorsement for the said treatment device. Yet the categories of approval are vastly different. Take the term “FDA cleared.” One would think that the FDA has stamped their approval of the effectiveness of the device. Nothing is further from the truth. FDA clearance simply means the following:
- be suitable for their intended use
- be adequately packaged and properly labeled
- have establishment registration and device listing forms on file with FDA
- be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)
Breaking it down- FDA cleared simply means that the device is properly packaged and is manufactured under a quality system (whatever that means). FDA says nothing about the effectiveness of the treatment. Approval from the FDA has to only have to be meet manufacturing guidelines. Shyster promoters for their so-called miracle cures, bank on the confusion between FDA approval as opposed to FDA cleared. FDA approval for a drug or therapy has to undergo rigorous scrutiny including lengthy and costly clinical trials.
This is the old ‘bait and switch” con game. Many of the devices that are FDA cleared are light therapies, including laser, infrared and electrical stimulation, including TENS therapy. Don’t get me wrong, some of these therapies can be beneficial-however these are not stand-alone therapies. This means light therapy may be helpful in some instances but IT WILL NOT CURE NEUROPATHY NOR WILL IT RELIEVE NEUROPATHY SYMPTOMS ON A PERMANENT BASIS. I put that in caps because many of disreputable people out there try to convince you that since a device is cleared it will therefore have a remarkable positive effect on neuropathy symptoms-claiming that their FDA cleared device will completely eliminate pain, numbness, burning and tingling, associated with peripheral and diabetic neuropathy. This is simply not true. Relieving neuropathy often takes a combination of therapies and medications. Prevailing approaches for relieving neuropathy symptoms include:
· Mild pain medication such as Tylenol
· Anti-inflammatory medications such a s Motrin or Aleve
· Anti-epileptic medication-Neurontin and Lyrica
· Antidepressant such as Cymbalta
· Nutritional supplement such as Nerve Health Essential Nutrients or Metanx
· Prescription patches such as Lidoderm patches
· Stronger medication proportional to the pain level such as Oxycodone and Oxycontin
· Spinal stimulators
So “let the buyer beware”-please consider the source of the claim before jumping in. Do some research on the internet-Mayo Clinic, Web MD, NIH are excellent credible sources to name just a few.