Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-625Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full 625 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07445161010834), received between Oct 15, 2025 and Oct 15, 2025 — classified as 2 injuries.
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
- Insufficient Information1
- Seroma1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Break; Break
USA. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS ON (B)(6) 2025, PRESENTED A LEAKING YELLOWISH CLEAR FLUID AND A RUPTURE ON HER RIGHT BREAST. SHE UNDERWENT EXPLANTATION SURGERY. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Seroma
MAUDE report 23281189 ↗InjuryOct 15, 2025Break; Break
USA. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS ON (B)(6) 2025, PRESENTED A RUPTURE ON HER LEFT BREAST. SHE UNDERWENT EXPLANTATION SURGERY. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Insufficient Information
MAUDE report 23280660 ↗
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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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