Will the Bra Cupʼs Contents Remain 60 Percent Full, 40 Percent Empty, or Develop Microcalcifications? The Need for Long-Term Independent Studies of Brava and Fat Grafting (2011)

Sir:FigureI read the recent article by Del Vecchio and Bucky and invited commentaries by Rubin and Adams.1 Adams noted that “The claims of breast enlargement with the Brava system in the early 2000s were never realized by those not associated with the product.” Was this a truly independent study? This article had no trial registration listed. I could not imagine that the Journal would have violated its own policies on trial registration, and I thought that perhaps through some clerical error the clinical trial number was omitted. I discovered clinical trial NCT00466765, supported by Brava, (http://clinicaltrials.gov/ct2/show/NCT00466765), which stated that as of September 9, 2007, Del Vecchio had become a subinvestigator and continued as such until April 6, 2011. Thus, he was a subinvestigator for the entire study period of this publication. This article's first sentence said: “Recent evidence from a variety of independent investigators [emphasis added] suggests fat grafting to the breast is a procedure that can yield natural, long term results.” To support this, the authors cited unverifiable references to presentations by Baker and Khouri at 2006 and 2008 American Society for Aesthetic Plastic Surgery meetings, respectively. Contradicting any notion of independence is the fact that Baker and Khouri co-wrote two articles on Brava in the Journal.2,3 Further contradicting any notion of independence are the facts that in 2007 Khouri became both the principal investigator of clinical trial NCT00466765 and the applicant for a U.S. patent for this technique.4 Both commentators noted that a 6-month follow-up was inadequate. The authors claim that by subjecting their data to a paired open-ended t test there was a statistically significant difference in volume increase with a value of p = 0.0000003. I subjected their data for volume loss to the two-tailed paired t test with matched groups and found a statistically significant difference with p = 0.0000000021. In other words, at 6-month follow-up, it was highly likely that a breast subjected to their method would have lost 40.35 percent of the volume injected. Does the volume loss continue at the same rate every 6 months, increase, decrease, or eventually cease? For example, if there were a uniform 40.35 percent loss of residual graft volume every 6 months, then by 24 months, only 54 cc of fat would remain for the average volume injected. As Rubin noted, we do not know when volume stabilizes. Unfortunately, trial NCT00466765 will never answer this question, as its objective follow-up period is just 6 months. Its “current primary outcome measures” is “digital photographic interpretation by board-certified plastic surgeon or radiologist” at “6 months” with “patient satisfaction with the cosmetic or reconstructive result” at “12 months” being the sole secondary outcome measured.5 Wang et al. reported microcalcifications developing after fat grafting no earlier than 18 months and as late as 72 months after fat grafting.6 I believe that, in the interest of patient safety, further registered clinical trials should be conducted by plastic surgeons who are independent of Brava and with longer follow-up. These trials should include either magnetic resonance imaging or three-dimensional photography to provide objective volumetric analysis and mammography to detect microcalcifications. M. Felix Freshwater, M.D., 9100 South Dadeland Boulevard, Suite 502, Miami, Fla. 33156-7815