Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-310Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 310 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07445161010407), received between Nov 14, 2024 and Dec 18, 2025 — classified as 4 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Capsular Contracture2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA. ALLEGEDLY, THE A DEVELOPED A RIGHT BREAST CAPSULAR CONTRACTURE BAKER GRADE III. THE PATIENT REPORTED BREAST FIRMNESS AND SUPERIOR¿LATERAL DISPLACEMENT OF THE IMPLANT TOWARD THE AXILLARY REGION, DESPITE ATTEMPTS TO MANAGE THE CONDITION WITH BAND USAGE. THE PATIENT HAS AN REPLACEMENT SURGERY SCHEDULED FOR NEXT YEAR. THE INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 23842853 ↗InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT DEVELOP A CAPSULAR CONTRACTURE BAKER GRADE IV IN HER RIGHT BREAST. A REVISION SURGERY IS SCHEDULED. 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 23771744 ↗InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
USA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION IN (B)(6) 2025, REQUIRED A BREAST WASHOUT, REMOVAL, AND REPLACEMENT OF THE RIGHT SIDE IMPLANT BECAUSE OF AN INFECTION. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 22159611 ↗InjuryNov 14, 2024Break; Break
IT WAS REPORTED THAT A RUPTURE OCCURRED ONE YEAR AND EIGHT MONTHS POST-IMPLANTATION. A DIAGNOSIS OF CAPSULE RUPTURE WAS CONFIRMED FOLLOWING A PHYSICAL EXAMINATION AND ULTRASOUND SURVEILLANCE OF THE PATIENT'S BREAST.
Patient problems: Insufficient Information
MAUDE report 20683848 ↗
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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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