Motiva® SmoothSilk® Round Breast Implant RSD-475+Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi 475 cc · Class 3 · Implant
All models of Motiva SmoothSilk Round Breast Implant (53)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07445161001962), received between Nov 19, 2025 and May 4, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 Rejection3
Patient problems
- Capsular Contracture3
- Physical Asymmetry1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2026Device Appears to Trigger Rejection
USA: ALLEGEDLY A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025, DEVELOPED A RIGHT BREAST CAPSULAR CONTRACTURE BAKER GRADE III. THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 25070333 ↗InjuryFeb 4, 2026Device Appears to Trigger Rejection
NEW EVIDENCE HAS BEEN RECEIVED, RESULTING IN UPDATED INVESTIGATION RESULTS.
Patient problems: Capsular Contracture
MAUDE report 24261933 ↗InjuryNov 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 PRESENTS A BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST. A REVISION SURGERY IS REQUIRED. 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; Physical Asymmetry
MAUDE report 23598629 ↗
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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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