Projected regulations by the US Food and Drug Administration (FDA) have the potential to restrict certain uses of fat grafting, a technique used by plastic surgeons for almost 20 years in breast reconstruction surgery. A recent article reviews the utility and after-effects of this procedure.
Fat grafting is the use of fat cells to remodel certain parts of the body. In many cases, this procedure is utilized after breast reconstruction surgery typically after the removal of a cancerous growth. This removal may leave the shape or volume of the breast altered and many patients opt for reconstructive surgery.
Many plastic surgeons may argue that fat grafting has significantly improved the process of breast reconstruction by allowing for greater aesthetic outcomes for the patient and increasing their overall satisfaction with the procedure. A recently published article in JAMA Surgery reviews the utility and after effects of this procedure.
There are some concerns raised by the procedure that have not been properly evaluated by studies yet. These include the possibility of fat necrosis, which is disorganized fat cell death and can lead to many complications, and cancer cell development.
Further, since the fat cells that are being used for the breast reconstruction are harvested from different parts of the body and refashioned to mimic breast tissue the FDA classifies these cells as drug, device, or biological product. This classification carries regulations that may make the procedure more difficult to authorize for plastic surgeons.
Since this procedure is believed to be safe and effective, these researchers sought to produce a study that could prove that. The main outcome measure they chose was any improvement in patient reported outcomes (PROs) or simply data directly reported by the patient to assess the treatment’s efficacy.
This is usually collected through questionnaires. This particular study used the BREAST-Q survey which has been validated by previous studies meaning it is a reliable measure of PROs. Simply; it measures the patient’s satisfaction with the surgery on a scale of 0 to 100 with the higher values indicating greater satisfaction. Within this survey were other measures such as breast satisfaction, psychosocial well-being, physical well-being, and sexual well-being that were measured in the same manner.
The study took place over 3.5 years and enrolled over 2048 patients who had undergone initial breast reconstruction, of these about 8% then underwent the fat-grafting procedure. The results reported were very straightforward with those who underwent the fat-grafting procedure showing increased satisfaction in all scales of the BREAST-Q survey.
Although this data seems easy enough to understand there were some limitations to the study including the fact that so few of the participants elected to undergo the fat-grafting procedure. Furthermore, because of the nature of this study along with ethical concerns, it was impossible to randomize the participants which would have eliminated any unseen variables that could have affected the data.
The researchers also made sure to point out that other concerns such as fat necrosis and cancer cell stimulation are still valid, albeit not as significant as they used to be before the procedure became more commonplace. Further research will likely continue to make use of the validated BREAST-Q survey as a reliable measure of PROs to reinforce the belief that fat grafting is an effective procedure for successful breast reconstruction.
These researchers hope that these findings will bolster the ongoing assertion that fat grafting is an important tool in breast reconstruction and that this option should remain available to reconstructive surgeons and to the patients they serve.