Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-380Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 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
- 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 07445161010605), received between Oct 25, 2024 and Apr 20, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Break” (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
- Break3
- Device Appears to Trigger Rejection2
Patient problems
- Capsular Contracture2
- No Clinical Signs, Symptoms or Conditions2
- Breast Discomfort/Pain1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Device Appears to Trigger Rejection
KOREA. ALLEGEDLY, THE PATIENT WAS IMPLANTED IN (B)(6) 2023 AND SUBSEQUENTLY DEVELOPED CAPSULAR CONTRACTURE, BAKER GRADE III. DUE TO THIS CONDITION, THE IMPLANT WAS EXPLANTATED IN (B)(6) 2026. (SN: (B)(6)).
Patient problems: Capsular Contracture
MAUDE report 24932708 ↗InjuryMar 30, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE IV ON HER LEFT BREAST (B)(6). A REVISION SURGERY IS PLANNED. 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: Capsular Contracture
MAUDE report 24716797 ↗InjuryDec 22, 2025Break; Break
KOREA. ALLEGEDLY, ONE YEAR AFTER BREAST IMPLANT SURGERY, THE PATIENT VISITED THE HOSPITAL DUE TO PAIN AND VISIBLE SHAPE DEFORMATION OF THE RIGHT BREAST. ULTRASOUND AND CLINICAL EXAMINATION CONFIRMED THAT THE RIGHT BREAST IMPLANT HAD RUPTURED (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: Breast Discomfort/Pain
MAUDE report 23871186 ↗InjuryOct 9, 2025Break; Break
SOUTH KOREA. IT WAS REPORTED THAT A RUPTURE OF THE LEFT BREAST IMPLANT WAS DETECTED DURING A ROUTINE FOLLOW-UP ULTRASOUND (SN: (B)(6)). A REVISION SURGERY WAS PERFORMED. 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 23257883 ↗InjuryOct 25, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY WITH AN AXILLARY INCISION AND SUBSEQUENTLY TRAVELED TO (B)(6). FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED PAIN, AND AN ULTRASOUND MAMMOGRAM CONFIRMED AN IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 20536001 ↗
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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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