Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-245QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 245 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07445161012135), received between Dec 27, 2024 and Mar 18, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 Rejection3
- Break2
Patient problems
- Capsular Contracture3
- Breast Discomfort/Pain2
- Chills1
- Hematoma1
- Impaired Healing1
- Insufficient Information1
- Seroma1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2025Break; Break
BELARUS. A PATIENT UNDERWENT AN INITIAL SURGERY WITH MOTIVA IMPLANTS AND SHOWED AN INCREASE IN VOLUME IN THE LEFT UPPER POLE THAT SUGGESTED A HEMATOMA. A SECOND SURGERY WAS PERFORMED TO DRAIN THE HEMATOMA AND DUE TO WOUND DEHISCENCE AND SERIOUS DISCHARGE, A THIRD OPERATION WAS NECESSARY AS THE IMPLANT BECAME EXPOSED. A RUPTURE WAS DETECTED WHEN THE IMPLANT WAS REINSERTED. 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: Chills; Hematoma; Impaired Healing; Seroma
MAUDE report 21635752 ↗InjuryMar 6, 2025Break; Break
AUSTRALIA- PATIENT IMPLANTED WITH MOTIVA IMPLANTS REPORTED LEFT INTRACAPSULAR RUPTURE ACCORDING TO ULTRASOUND REPORT. 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 21543137 ↗InjuryJan 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
CAPSULAR CONTRACTURE BAKER GRADE III. LEFT SIDE.
Patient problems: Breast Discomfort/Pain; Capsular Contracture
MAUDE report 21219459 ↗InjuryJan 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
CAPSULAR CONTRACTURE BAKER GRADE III. RIGHT SIDE.
Patient problems: Breast Discomfort/Pain; Capsular Contracture
MAUDE report 21219187 ↗InjuryDec 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
A PATIENT REPORTED EXPERIENCING CAPSULAR CONTRACTURE BAKER GRADE III ON HER RIGHT BREAST. NO PATIENT DEMOGRAPHICS, 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: Capsular Contracture
MAUDE report 21029266 ↗
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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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