Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-310QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with Qid 310 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 07445161012005), received between Oct 21, 2024 and Jul 30, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 Rejection4
Patient problems
- Capsular Contracture4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO HAD BREAST AUGMENTATION WITH IMPLANTS IN (B)(6) 2024 WAS DIAGNOSED WITH A BAKER III CAPSULAR CONTRACTURE IN HER RIGHT BREAST (SN (B)(6)). 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 22667212 ↗InjuryDec 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
A PATIENT PRESENTED CAPSULAR CONTRACTURE BAKER GRADE IV IN BOTH BREASTS. NO PATIENT DEMOGRAPHICS, 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: Capsular Contracture
MAUDE report 20836385 ↗InjuryOct 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CAPSULAR CONTRACTURE CLASSIFIED AS BAKER GRADE III. RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 20550278 ↗InjuryOct 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL MASTECTOMY AND PRIMARY REVISION SURGERY. ONE YEAR LATER, UPON EXAMINATION, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE. LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 20499787 ↗
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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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