Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-430QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with Qid 430 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 07445161012036), received between Jun 16, 2025 and Jun 16, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
- Device Appears to Trigger Rejection2
Patient problems
- Capsular Contracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
TAIWAN. IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION SURGERY IN (B)(6) 2022. SUBSEQUENTLY, IN (B)(6) 2024, SHE BEGAN EXPERIENCING DISCOMFORT AND PAIN. AFTER A MEDICAL EVALUATION, IN (B)(6) 2025 WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III IN BOTH BREAST IMPLANTS (SN: (B)(6)). A REVISION SURGERY IS PLANNED. 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 22212540 ↗InjuryJun 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
TAIWAN. IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION SURGERY IN (B)(6) 2022. SUBSEQUENTLY, IN (B)(6) 2024, SHE BEGAN EXPERIENCING DISCOMFORT AND PAIN. AFTER A MEDICAL EVALUATION, IN (B)(6) 2025 WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III IN BOTH BREAST IMPLANTS (SN: (B)(6)). A REVISION SURGERY IS PLANNED. 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 22212534 ↗
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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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