Establishment Labs Notes Presentation of 4-Year Results from Motiva U.S. IDE Study at The Aesthetic Meeting 2024
Since we released the two-year data, we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture, including in the MRI cohort.
- Since we released the two-year data, we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture, including in the MRI cohort.
- Relative to historic benchmarks, patient follow-up remains very high and the rates of complication remain very low.
- Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States.
- This interim report describes preliminary data available to date and does not necessarily reflect final clinical results nor demonstrate the investigational device’s safety and effectiveness for the United States trial.