Motiva® SmoothSilk® Round Breast Implant RSD-285+Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi 285 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 07445161001894), received between Dec 3, 2024 and Feb 18, 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
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY A PATIENT DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III ON HER RIGHT SIDE. IT IS UNKNOWN IF THE PATIENT UNDERWENT ANY ADDITIONAL SURGERY. THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 24380959 ↗InjuryJan 23, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT DEVELOPED A BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS SN (B)(6). A REVISION SURGERY IS SCHEDULED. 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 24169959 ↗InjuryDec 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE BAKER GRADE III. THE SPECIFIC PATIENT DEMOGRAPHICS SUCH AS AGE, WEIGH, ETHNICUTY, ETC HAS NOT BEEN PROVIDED BY THE REPORTER. FURTHER INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Contracture
MAUDE report 20832193 ↗
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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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