Establishment Labs reports 3-year Motiva IDE study data; capsular contracture rate 0.5%

ESTABLISHMENT LABS HOLDINGS INC.

3-year follow-up on 451 primary augmentation patients; compliance 92.4%.
Kaplan-Meier risk rates: capsular contracture 0.5%, rupture 0.6%, breast pain 0.7%, infection 0.9%.
Any reoperation 6.1%, any complication 8.4% at 3 years.
Data submitted to FDA as part of final PMA module; device not yet approved in US.
Results consistent from year 2 to year 3 with no increase in capsular contracture or rupture.

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