Midpoint data from a 10-year clinical study show low rates of reoperation, rupture, and capsular contracture in primary augmentation patients.
Establishment Labs Holdings Inc, a medical technology company specializing in breast aesthetics and reconstruction solutions, noted a presentation of an update on the Motiva US IDE Study regarding five-year patient follow-up data for primary augmentation subjects.
The medical director of the study, Caroline Glicksman, MD, who is also an investigator in the study, will present the results at The Aesthetic MEET 2025, the annual meeting of The Aesthetic Society, in Austin, Texas.
Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the five-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at four years was 88.5%. The five-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows:
| Primary Augmentation | 5-year (N=451), 95% CI |
| Capsular contracture (Baker Grade III/IV) | 0.5% |
| Rupture, suspected or confirmed; MRI cohort1 | 0.6% |
| Breast pain | 1.2% |
| Infection | 0.9% |
| Implant removal, with or without replacement | 3.1% |
| Any reoperation2 | 8.8% |
| Any complication3 | 12.0% |
“At the mid-point of the 10-year core study, Motiva implants continue to show low rates of complication,” says Glicksman in a release. “The consistency in these clinical results is particularly notable, as we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture since we began reporting at two years. Overall, patient follow-up remains very high, and the rates of complication remain very low.”
Establishment Labs received approval from the US Food and Drug Administration for the use of Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants in primary and revision breast augmentation on Sept 26, 2024.
“Our momentum in the US continues to exceed expectations,” says Peter Caldini, Establishment Labs’ interim CEO, in a release. “This is driven by differentiated clinical data, along with the complete lack of innovation in this market for years. Our core thesis is proving true: better technology can improve patient outcomes, take market share, and expand the market. We now have over 800 accounts on board with more than 550 placing orders.”
1 MRI cohort N=176
2 Any surgery on the breast or chest area, device or non-device related, including size change
3 Any device or non-device related event, including reoperation
File photo / Motiva implant
