Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-205Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 205 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07445161010339), received between Apr 22, 2025 and Mar 18, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- Breast Discomfort/Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2026Break
SOUTH KOREA. ALLEGEDLY, THE PATIENT WAS IMPLANTED IN (B)(6) 2019 AND AN ULTRASOUND LATER CONFIRMED A RUPTURE OF THE LEFT IMPLANT. A REVISION SURGERY WAS PERFORMED. THE INVESTIGATION IS IN PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24628439 ↗MalfunctionApr 22, 2025Break; Break
KOREA - IT WAS REPORTED THAT THE PATIENT VISITED THE CLINIC DUE BREAST PAIN, THE EXAMINATION REVEALED A DEFECT IN THE ANTERIOR SHELL OF THE LEFT IMPLANT INDICATING RUPTURE. IT WAS DISCOVERED DURING ROUTINE CHECK UP USING THE ULTRASOUND. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Breast Discomfort/Pain
MAUDE report 21885607 ↗
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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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