[Cyborg] DIY implanter (meredith scheff)

[Robert Picone]

On Sun, Jan 2, 2011 at 5:49 PM, Paul Gentemann <beriukay at gmail.com> wrote:

> I am now highly curious as to why Cosmetic Surgeons aren't interested in
> this field.  There's obviously interest, because I never even thought of the
> idea until reading Wired's article.  There's obviously things surgeons can
> do that tattoo parlors can't.  And there's no obvious reason why slipping
> silicone into a boob is somehow acceptable while slipping magnets into a
> fingertip is weird.  Plus there's all kinds of research opportunities, and a
> chance for me to respect them.
>

So I just spend some time browsing the surprisingly helpful FDA site.
 Basically, it seems that it's technically illegal to actually market these
at all in the US without FDA approval, it's less illegal to preform the
procedure without that approval, but seems liable to cost a doctor his
medical license outside of an established clinical trial.

To get FDA approval you would involve:
1.  Getting all manufacturing facilities demonstrably sterile, and paying a
FDA registration fee as such.
2.  Applying as a medical device, which requires comparing it to an existing
medical device, and claiming that the two are equivalent in terms of
intended use and safety.  There of course won't be one, so the implants
would become a class III device.

The FDA will now be more aware of its regulatory power over this stuff, and
it basically seems like it'd be much more illegal to market.

3.  You would then probably apply for de novo process classification,
sending them any claims you can gather that the implants don't cause
unreasonable risk of illness or injury, and thus don't deserve a Class III
classification...  Most likely, it will stay class III device, but there is
a small chance the FDA will believe you, and your life gets a lot simpler by
dropping to class II, in which case, you're good to go
4.  If however, the device remains in class III, you need premarket
approval, I haven't delved quite deep enough into the arcane process here,
but basically you need a significant body of scientific evidence, meeting
certain guidelines, proving that the product in question is safe.  Clinical
trials, etc  The companies selling those little silicone bubbles, various
face injections, etc. spent quite large sums of money on this part.  You
meet with a review board to present stuff, etc.
5.  As an alternative to the above step, you could conceivably apply for it
to be reclassified whenever possible, and wait.


So, it seems remotely possible to get them made available, if you're really
confident that you can prove them to be safe, but otherwise there probably
isn't the market to justify the amount of investment.  You also probably
want as little attention as possible until you're sure there's a large
market.
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