Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-295Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full 295 cc · Class 3 · Implant
All models of Motiva SmoothSilk Round Ergonomix Breast Implant (69)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07445161010735), received between Apr 22, 2025 and Dec 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection2
Patient problems
- Capsular Contracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
NEW ZEALAND. ALLEGEDLY, A PATIENT WHO UNDERWENT A REVISION AUGMENTATION IN SEPTEMBER 2025 WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture
MAUDE report 23871614 ↗InjuryApr 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
KOREA. IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY IN (B)(6) 2024 VISITED THE CLINIC DUE TO A SHAPE CHANGE IN HER RIGHT BREAST. AFTER AN ULTRASOUND AND PHYSICAL EXAMINATION, SHE WAS DIAGNOSED WITH A BAKER III CAPSULAR CONTRACTURE. A REVISION SURGERY WAS NECESSARY.
Patient problems: Capsular Contracture
MAUDE report 21886321 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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