The clinical trial enrolled patients at 32 centers in the U.S. and three sites in Western Europe. Three years after implantation, compliance among the 451 participants in the primary augmentation cohort of the trial was 92.4%. The rate of capsular contracture, the hardening of scar tissue around the implant, was 0.5%. The rate of confirmed or suspected rupture was 0.6%. 

Establishment Labs said 6.1% of patients underwent a reoperation, in some cases to change the implant size. The authors of a paper about the study said the data suggests “the leading cause of revisional surgery has shifted from capsular contracture and rupture to more subjective indications for reoperation such as malposition and size change.” The complication rate, including reoperations, was 8.4%.