Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-550Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full 550 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07445161010827), received between Nov 14, 2024 and Feb 20, 2026 — classified as 4 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
- Break1
Patient problems
- Capsular Contracture3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY REVISION DUE TO A CAPSULAR CONTRACTURE DEVELOPED A NEW BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE (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 24402358 ↗InjuryFeb 20, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY REVISION DUE TO A CAPSULAR CONTRACTURE DEVELOPED A NEW BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE (24101829-05/ 25020260-17). 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 24402351 ↗InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA. IT WAS REPORTED THAT A PATIENT WHO HAD MOTIVA IMPLANTS IN (B)(6) 2025, WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE BAKER GRADE III/IV. THE REVISION SURGERY IS NOT SCHEDULED YET. 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 22868609 ↗InjuryNov 14, 2024Break; Break
IT WAS REPORTED THAT AN ULTRASOUND EXAMINATION OF THE PATIENT'S RIGHT BREAST IMPLANT REVEALED AN INTRACAPSULAR RUPTURE, PRIMARILY LOCATED IN THE CENTRAL LOWER PORTION OF THE IMPLANT. THERE WAS NO EVIDENCE OF AXILLARY SILICONE LYMPHADENOPATHY. THE IMPLANT FILLER REMAINED WITHIN NORMAL RANGE AND WAS NOT THICKENED.
Patient problems: Insufficient Information
MAUDE report 20684675 ↗
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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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