Thursday, January 16, 2020

Is a Greenville, SC, chiropractor/social media star using patients to test an experimental medical device? I've asked the state to review [UPDATES: 1) Vendor of the "Y-Strap" wrote me that the device is not marketed to be used for any medical treatment; 2) The FDA's taking a look]


Click here to direct download a copy of my letter today to South Carolina's licensing agency requesting of review of chiropractor Joseph Cipriano's use of the "Y-Strap decompression tool."

The Y-Strap is a black, mostly fabric harness that looks like something from an S&M dungeon. In Joseph Cipriano’s YouTube videos, it's placed behind the necks of prone patients who, in the moment before the crack, typically tense as if bracing for a crash.

Cipriano, a chiropractor based in Greenville, South Carolina, has become a YouTube sensation in the past 18 months, taking his channel from inception last March to more than 850,000 subscribers ...“I literally watched every video I could find on the Y-Strap first,” says Xavier, a patient of Cipriano’s. “It’s pretty daunting to think you’re allowing someone to pull apart your spine like a Lego.”

“Coowaa,” goes the sound as Cipriano yanks the Y-Strap and patient's skull away from their body: a mix of them being dragged and cracks that ricochet down the spine, caused by bubbles forming in the synovial fluid around joints. The noise is followed by either laughter, a grimace, or an emotional release that can include crying. “I feel like I just grew two inches,” says one woman.
Via my letter (which includes links and text from the WiredUK article and another article recently published in Vice):
As a result of research by my wife and me into my father's bizarre career, I developed an interest in experimental medical treatments/devices, medical ethics (including the use of human subjects in unsupervised medical research), and oversight responsibility of public health authorities. The following situation in your state appears to include all of those topics.

...This is to request that your office review the following information and provide me with a determination if (Greenville, SC, chiropractor Joseph) Cipriano’s treatment of his patients using a device called the “Y-Strap decompression tool” is in compliance with your agency’s guidelines.
Superior Balance SL is a company in Seville, Spain, that markets the "Y-Strap" in the US and other countries. Via my letter (on which I courtesy-copied Jeffery Shuren MD JD who heads the US Food & Drug Administration's medical devices division):
I searched https://y-strap.com and https://www.drjosephcipriano.com and the FDA’s database of registered devices and failed to locate any information regarding whether the “Y-Strap” is registered with that agency, so yesterday I phoned Superior Balance SL in Seville and a company representative informed me that the device is not registered with the FDA.

When I asked if the device has been the subject of any published studies, the representative replied, “The Y-Strap hasn’t been the subject of any clinical trials. Because there is no clinical proof that it works, we don’t sell it as a medical product.”

Therefore, Mr. Cipriano appears to be using his patients to test the medical benefits of the “Y-Strap.” In your review, would you please determine which if any Institutional Review Board is overseeing his research?
Big hat tip to Myles Power for tweets that introduced me to this story. He also steered me to videos from which I made these clips of Cipriano using the "Y-Strap" to aggressively yank the necks of his patients. (I included the videos in my letter to the state agency that licenses him to practice in the Palmetto State.)








UPDATE: On January 20, Tomas Lopez, president of the Seville, Spain company that markets the "Y-Strap" sent me a complaint email requesting I change this blog item. In a same-day reply, I declined and sent him some questions. I haven't received a reply.

Via his email:
(We) do not market (marketing) [sic] our product as a medical product...

We never say they are intended to diagnose, treat, cure, nor prevent any disease or health condition.
Click here for both emails which I'm sharing shared with South Carolina's licensing agency and the FDA.

UPDATE: On January 27, the FDA wrote me that they're taking a look at my concerns about the "Y-Strap":