First off, there is no regulation discussing “compassionate use”. What
there actually is falls under Title 21, Code of Federal Regulations
Part 812-Investigational Device Exemptions and relates to the allowance
of unapproved devices to be implanted when the benefit to the patient
outweighs the risk AND specific types of data are gathered about the
test and supplied to the FDA as part of their evaluation protocols. It
has been termed “compassionate use” because that’s how it has been used
but that term strays from what the actual regulation states. It allows
exemptions if there would otherwise be significant physical or
psychological damage that the implant might alleviate, so long as prior
approval is obtained, forms signed in triplicate, etc. This act
basically means that anyone implanting such a device is in actuality
now conducting a research study for the FDA and becomes a study
director, which is a legal position within the research framework (for
example, the SD is the one who goes to jail if there is a violation of
federal law in the conduct of the study).

This is where the return policy comes in. The manufacturer supplying
the implant is part of the study and MUST evaluate and report on any
implant defects in the event of a complication. The thing to keep in
mind is that this is no longer cosmetic surgery, it is an FDA regulated
research study.

What is happening behind the scenes is that the FDA has been sailing
without a rudder for decades now. Understaffed, underfunded, and with
poor leadership this is the stuff that has been sliding big time. The
breast implant exemption is supposed to be used only for
accident/deformity reconstruction and replacing old implants with
identical ones. That’s it. Anything else is a breach of CFR 21. Now, if
you are in the right part of the country you may be submitting your
requests to an inspector who either doesn’t care or can be bought (to
be blunt). However, the FDA is cracking down on these exemptions all
across the board right now as they are starting to try and get their
house in order.

All of this means that it is going to be much harder to get silicone
breast implants put in anymore, especially ones large enough that they
are significantly larger than the woman’s normal breast size and thus
not reconstruction.