Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-425QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 425 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 07445161012395), received between Dec 2, 2024 and Jul 18, 2025 — classified as 4 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Capsular Contracture2
- Impaired Healing1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2025Break; Break
AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AUGMENTATION SURGERY IN (B)(6) 2021 WAS DIAGNOSED WITH A RUPTURE IN THE RIGHT IMPLANT (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: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22544000 ↗InjuryJan 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SENSATION OF HARDNESS AND AN UNNATURAL APPEARANCE IN HER BREAST. UPON CLINICAL EVALUATION, A DIAGNOSIS OF CAPSULAR CONTRACTURE, BAKER GRADE III, WAS CONFIRMED. LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 21172813 ↗InjuryJan 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SENSATION OF HARDNESS AND AN UNNATURAL APPEARANCE IN HER BREAST. UPON CLINICAL EVALUATION, A DIAGNOSIS OF CAPSULAR CONTRACTURE, BAKER GRADE III, WAS CONFIRMED. RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 21172755 ↗InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AN EXTRUSION OF THE PROSTHESIS. 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: Impaired Healing
MAUDE report 20820333 ↗
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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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