Establishment Labs Holdings Inc. global medical technology company focused on women’s health and wellness, has provided an update on the Motiva US IDE Study, which includes three-year patient follow-up data for primary breast augmentation subjects. Caroline Glicksman, MD, the study’s medical director, presented the results this week at the Aesthetic Surgery Education and Research Foundation Premier Global Hot Topics session during The Aesthetic Meeting 2023 in Miami.
Glicksman presented data for the 451 primary augmentation patients enrolled in the study through the three-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at three years was 92.4%. The three-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 | 3-year (N=451), 95% CI |
| Capsular contracture (Baker Grade III/IV) | 0.5% |
| Rupture, suspected or confirmed; MRI cohort1 | 0.6% |
| Breast pain | 0.7% |
| Infection | 0.9% |
| Implant removal, with or without replacement | 1.6% |
| Any reoperation2 | 6.1% |
| Any complication3 | 8.4% |
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
“The Motiva US IDE study is still in follow-up, but the consistency in clinical outcomes from year two to year three are notable, with no increase in capsular contracture or the number of patients with suspected or confirmed rupture, including in the MRI cohort. The preliminary results and the continued high rates of patient follow-up remain encouraging,” says Glicksman.
“These results are the latest evidence of the performance of Motiva implants, adding to data collected over 12 years and from over 3 million implants placed in markets globally,” Glicksman adds. “The clinical results presented today have been submitted to the FDA as part of the final module of the PMA, and we look forward to this new standard in breast implants being made available to women in the United States.”
