Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-380QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 380 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 07445161012203), received between Dec 12, 2024 and Jun 16, 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 Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2025Break; Break
(B)(6). IT WAS REPORTED THAT A PATIENT WHO HAD AUGMENTATION SURGERY ON (B)(6) 2022 WAS DIAGNOSED WITH AN INTRACAPSULAR RUPTURE IN HER LEFT BREAST AFTER AN ULTRASOUND AND MRI. 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 22212894 ↗InjuryDec 12, 2024Break; Break
IT WAS REPORTED THAT THE RIGHT BREAST PROSTHESIS DEMONSTRATED AN INTRACAPSULAR RUPTURE, WITH NO EVIDENCE OF EXTRACAPSULAR RUPTURE.
Patient problems: Insufficient Information
MAUDE report 20919447 ↗
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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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