OK. This is as much research as I have time for right now.
Drs Hodges and Humphreys are indeed well qualified surgeons. They are not quacks.
They've been developing this implant for "many years."
They have been performing this surgery for about 10 years, beginning in South Africa. It is still not clear how many total patients have had this surgery.
They are now in the Caymen Islands to "offer this surgery at affordable rates" to Americans with money.
This discounted price is so they can build up clinical data.
They have not yet even developed or filed a clinical study in the US to apply for FDA approval. No wonder I couldn't find an application or any clinical trials.
I checked a few medical journals without success in finding professional articles authored by them to bolster up their claims. But I didn't spend much time on that.
Now I can understand why when you have a spiffy new "medical breakthrough" the FDA process is incredibly onerous. I can understand the frustration of patients wanting the new technology when it doesn't yet have FDA approval.
But FDA approval has a purpose. This surgery's success and the longevity of the implants are not guaranteed at all. There is an aspect of "you get what you pay for." Or, in John Shrader's case, you get what someone else has paid for.
So, as @squiddysquid says, Johnny is a guinea pig. And if something goes wrong with his implants he may decide these doctors are possessed by Satan.
Also the lack of professional articles troubles me, but I did not do a long search at all. This does not count as a "professional" article. It is a puff piece by Dr Humphreys justifying why they are performing this surgery without FDA approval. On their glossy site.
And I do have serious ethical concerns about this overseas "collection of data" at cheap rates. Mileage may vary on that.