FEDERAL | ASPS and PSF Physician Leaders Testify Before the FDA on Fat Grafting
Beginning in December 2014, the Food and Drug Administration (FDA) released a series of draft guidance documents that would dramatically change the regulation of human cells, tissues, and cellular or tissue-based products (HCT/Ps) derived from adipose tissue. After reviewing these documents, ASPS found that they contain biological inaccuracies and erroneous depictions of some common procedures. These documents are particularly concerning for members who use adipose tissue for fat grafting procedures, and, as a result, ASPS opposed them through a series of comment letters submitted in December and February of 2015 and September 2016.
In its 2015 comments and subsequent outreach, ASPS strongly encouraged the FDA to engage in ongoing dialogue with groups impacted by the guidance. In response to this request – widely made among other stakeholders in the regenerative medicine space – the FDA held a hearing on the issue on September 12-13. Six ASPS and PSF physician leaders, including J. Peter Rubin, MD; Paul S. Cederna, MD; Scot B. Glasberg, MD; Adam Katz, MD; Ricardo Rodriguez, MD; and Thomas Davenport, MD testified along with stakeholders in industry, organized medicine and patient advocates. During the hearing, ASPS and PSF physician leaders spoke specifically to the clinical aspects of fat grafting, noting that autologous fat grafting has been commonly used in plastic surgery for aesthetic/cosmetic and reconstructive purposes for decades.
ASPS focused its testimony on the important role of fat grafting in breast reconstruction, a role that was explicitly called into question by the FDA when it deemed the use of adipose in the breast as a non-homologous use because it does not restore the breast's ability to lactate. ASPS noted that lactation is not the sole function of the breast, which serves as a secondary sex organ in adulthood, and requested that the FDA revise its position and deem fat grafting to the breast homologous use. This argument rests on our specialty's understanding that the basic function of adipose tissue includes providing structural support to assist with contours within the human body. Because autologous adipose tissue is used to supplement, repair, and replace the breast tissue during breast augmentation or reconstruction, such a use is homologous to the structural function of fat.
Following ASPS's presentation, the PSF underscored its arguments by highlighting key studies showing that fat grafting does not increase the risk of cancer and that demonstrate the safety and efficacy of fat grafting to the breast. The PSF also testified to important safety initiatives it is spearheading – the CRAFT study focused on cancer recurrence among patients undergoing fat transfer to the breast and the GRAFT registry of autologous fat transfer procedures – as a quality improvement initiative to monitor adverse events and ensure quality of care.
ASPS and PSF physician leaders testifying at the hearing were pleased with the majority of stakeholder input and reported that the FDA was receptive to their feedback. ASPS and the PSF will continue to keep its members abreast of updates on this issue, expected sometime in 2017.