Per ninjrk of the BEA:

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.