Motiva® SmoothSilk® Round Breast Implant RSF-295+Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 295 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
- 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 07445161002075), received between Mar 20, 2025 and Mar 24, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Device Appears to Trigger Rejection1
Patient problems
- Breast Discomfort/Pain1
- Burning Sensation1
- Capsular Contracture1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III ON HER LEFT BREAST. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 24682379 ↗InjuryMar 20, 2025Break; Break
(B)(6). IT WAS REPORTED THAT, A PATIENT WHO WAS IMPLANTED IN (B)(6) 2023, PRESENTED A HIGH LEVEL OF PAIN AND BURNING SENSATION DUE TO A DEVICE RUPTURE ON THE LEFT SIDE IMPLANT. BOTH IMPLANTS WERE REPLACED.
Patient problems: Breast Discomfort/Pain; Burning Sensation; Insufficient Information
MAUDE report 21657341 ↗
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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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