Fat grafting safety review published; no increased risk of cancer

Jan 24 2011

Published clinical experience in over 2,000 patients who received autologous fat grafts showed no evidence of increased risk of development, metastasis or recurrence of breast cancer in contrast to laboratory data.

The newly published review entitled “Oncologic Risks of Autologous Fat Grafting to the Breast” in the January issue of the American Society of Aesthetic Plastic Surgery’s Aesthetic Surgery Journal discusses the data disparity between the clinical and certain laboratory-based scientific literature regarding fat grafting procedures to the breast. This includes procedures in which the graft has been enriched with adipose-derived stem and regenerative cells (ADRCs).

The article, authored by John Fraser, Ph.D. and Marc Hedrick, M.D. of Cytori Therapeutics (NASADQ: CYTX) and Steve Cohen, MD, one of the leading plastic surgeons in the U.S., critically evaluates the theoretical concerns raised by fat grafting procedures to the breast (particularly in women who have undergone treatment for breast cancer).

Through the comprehensive review of published reports, the article explores potential issues and concludes that the apparent data discrepancy between the laboratory and the clinic are the result of the application of artificial conditions used in certain laboratory studies that do not arise in a clinical setting. This analysis is consistent with Cytori preclinical studies, demonstrating that cell-enriched fat grafting did not increase the risk of breast cancer development or metastasis, and in some situations, actually decreased cancer growth.

“Patient safety is paramount in the development of PureGraft™ and Celution® products,” said Christopher Calhoun, CEO of Cytori Therapeutics. “There is increased patient and physician demand for our technologies and this careful review supports our view that our recommended fat grafting techniques are safe in the breast. We will continue to conduct our own safety research and analyze data from sources external to Cytori, as part of the regulatory progress and the ultimate commercial adoption of our products.”

The January issue of the Aesthetic Surgery Journal is currently available online at http://aes.sagepub.com/content/current.