Published on September 5th, 20180
Among the more than a dozen “treatable conditions” listed in the brochure were neuropathy, a disorder resulting from nerve damage, and multiple sclerosis (MS). The two-page brochure also featured a testimonial for fibromyalgia from a Vietnam War veteran, and a testimonial for post-traumatic stress disorder (PTSD), a disease that disproportionately affects military members. It referred readers to the product website, where it was marketed as “FDA approved.”
The PTSD testimonial read:
I injured my right shoulder March of 2011 which led to a more recent diagnosis of arthrop[a]thy of the AC joint along with PTSD, after years of physical therapy and pain medications I finally found a real solution for my pain. With in [sic] a few treatments my pain levels went from an 8 to a 2! My PTSD symptoms have also drastically improved! With my physicians [sic] help I went from 11 different medications to now just 3! My quality of life has drastically improved, I am actually able to sleep at night and play with my children.
The name of the miracle medical device that made it all possible: Neurolumen.
So that’s the story of the brochure. Here’s the reality: Neurolumen — which consists of a control unit that sends laser- and light-emitting diodes and electrical impulses to wraps that are applied to different areas of the body, costs $1,995, and is only available by prescription — has not been approved by the FDA for the treatment of any disease, making claims in the brochure to treat neuropathy, fibromyalgia, MS, and PTSD illegal.
While Neurolumen, as a Class II device, has something called FDA clearance, that only means that the makers of the device were able to show the FDA that Neurolumen is “substantially equivalent” to another product with the same indications for use that the FDA has already cleared to market. As we’ve noted before, it’s not all that impressive (one of the devices that Neurolumen claims equivalence to is an earlier model of its current device), and “FDA cleared” is certainly not to be confused with “FDA approved,” which means the product has been subjected to a rigorous review process by the FDA.
Moreover, the indications for use for the current Neurolumen PN-1000 model, as described in the company’s application for FDA clearance, are mum on treating diseases:
The Neurolumen is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated. The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
In response to an inquiry, Neurolumen founder Shelly Henry said: “Neurolumen is a pain management device which is stated throughout the brochure and website. It is used as a treatment for pain associated with those diseases and disorders (neuropathy, fibromyalgia, MS, PTSD), not to treat or cure the disease or disorder.”
Henry said she would make that distinction clearer in the brochure, a copy of which was provided to TINA.org by a reader whose account of the disabled veterans event is shared above. However, even claiming to treat the symptoms of a disease is a no-no without FDA approval.
Speaking of which, after TINA.org pointed out to Henry that this is something Neurolumen lacks, she had the claim on the product website changed from “FDA approved” to “FDA cleared.” The problem is that multiple news articles, including this 2016 story in Reader’s Digest, describe the device as FDA approved. Hopefully, the next time Neurolumen is asked to comment on its FDA status, it gives a clear answer.
Find more of our coverage on medical devices here.