Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-550QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 550 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 07445161012425), received between Jan 4, 2025 and Mar 3, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Appears to Trigger Rejection1
Patient problems
- Capsular Contracture1
- 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.
InjuryMar 3, 2025Break; Break
AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED RIGHT-SIDED INTRACAPSULAR RUPTURE ACCORDING TO ULTRASOUND EXAMINATION. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, SUCH AS 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: Insufficient Information
MAUDE report 21505906 ↗InjuryJan 4, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUDDEN AND SIGNIFICANT INCREASE IN THE SIZE OF THE RIGHT BREAST AND IMAGING STUDIES, REVEALED BILATERAL PERIPROSTHETIC FLUID, PREDOMINANTLY IN THE UPPER INNER QUADRANT OF THE RIGHT BREAST. CLINICAL EXAMINATION NOTED ENLARGEMENT AND FIRMNESS OF THE RIGHT BREAST. BY (B)(6) 2024, THE PATIENT UNDERWENT AN EXPLANTATION PROCEDURE THAT INCLUDED ANALYSIS OF THE PERIPROSTHETIC FLUID AND TUMOR-LIKE LESION, A TOTAL CAPSULECTOMY, AND REPLACEMENT OF THE IMPLANTS WITH MOTIVA ERGONOMIX.
Patient problems: Capsular Contracture; Seroma
MAUDE report 21075335 ↗
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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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