Fat is awesome. I see it moved to new sites (face, breast, buttock), where it lives. Not only does it give volume, it can make the skin look pretty and dewy again. BUT it is unpredictable. We don’t know how exactly best to harvest it, concentrate it (centrifuge or filter), inject it. There seems to be variability from person to person as well.
New developments:
1. FDA is in on this now.
The FDA draft wants to make a distinction between the use of fat grafting for homologous use (ie when you are putting fat into the subcutaneous space where fat already is- so a liposuction defect, the face where the fat has naturally atrophied, or the back of the hands, where the fat naturally atrophied.
- Surgeons would have to be registered as a tissue bank and be regulated by the FDA
VERSUS non-homologous uses, where you treat bone or joint disease, or if you are injecting fat into the breast.
- FDA would require these products be regulated as a drug, device, or biologic. You would need to file an application for premarket FDA approval of the product and get a license to distribute biologic drugs.
- This would involve investigation of the personnel, processes, facilities, equipment, and record keeping.
- This would cause a great deal of financial and compliance burdens
It tries to make a distinction between adipose tissue if you intend to use the extracellular matrix or the cells. So if you use it for non structure uses, it would be regulated as a drug.
ISSUE?
This is problematic, because it is trying to cubbyhole the fat into one function. Fat has been shown to cause pain reduction, improvement of scarring, endocrine organ function, immunity, and regenerative organ function. The FDA classifications are not correct: using fat transfer for breast reconstruction is listed by them as “non homologous” but in many women most of the breast is made up of fat.
SO, our society is strongly urging the FDA to reconsider. The points as outlined by our society:
- Expand the categories of adipose tissue from exclusively structural to structural and nonstructural, depending on its intended use.
- Revise its position that decellularizing the adipose diminishes its ability to perform structural function
- Revise position fat grafting for breast cancer reconstruction is non-homologous
- Revise position stromal vascular fraction involves more than minimal manipulation (all we do is centrifuge and separate)
2. New alliance: ASPS and IPRES
We plastic surgeons get how exciting fat grafting is, but we also get we need to study it more and understand it better. To this end, the ASPS is making and alliance with the International Society of Plastic Regenerative Surgery. Why? IT is to create a forum and group of colleagues among whom they will share knowledge and interests in fat surgery. This will include surgeons, scientists, and others. It will help look at things like stem cells, preadipoctye cells, and other related terms which are influencing our outcomes. They will look at current techniques and try to advance the field.