Motiva® SmoothSilk® Round Breast Implant RSD-340+QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 340 cc · Class 3 · Implant
All models of Motiva SmoothSilk Round Breast Implant (53)
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 07445161002723), received between Jan 17, 2025 and Feb 25, 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.
InjuryFeb 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ARGENTINA. ON (B)(6) 2025, IT WAS REPORTED THAT THE RIGHT IMPLANT WAS IDENTIFIED WITH CAPSULAR CONTRACTURE CLASSIFIED AS BAKER GRADE III.
Patient problems: Capsular Contracture
MAUDE report 21459399 ↗InjuryJan 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT A PATIENT, THREE MONTHS POST BREAST IMPLANT REPLACEMENT SURGERY PERFORMED FOR AESTHETIC PURPOSES, PRESENTED WITH COMPLAINTS OF RESTRICTION OF THE LEFT IMPLANT. UPON PHYSICAL EXAMINATION, CAPSULAR CONTRACTURE WAS IDENTIFIED AND CLASSIFIED AS BAKER GRADE III.
Patient problems: Capsular Contracture
MAUDE report 21180223 ↗
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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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