Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-375QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 375 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 07445161012371), received between Jan 3, 2025 and Oct 15, 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
- Patient-Device Incompatibility2
Patient problems
- Bacterial Infection2
- Capsular Contracture2
- Post Operative Wound Infection2
- Seroma2
- Wound Dehiscence2
- Breast Discomfort/Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ARGENTINA. IT WAS REPORTED THAT THE PATIENT PRESENTED INCREASED PERICAPSULAR PAIN IN THE RIGHT BREAST, CONSISTENT WITH CAPSULAR CONTRACTURE BAKER GRADE III (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; Capsular Contracture
MAUDE report 23301914 ↗InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
MEXICO. IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT DEVELOPED BILATERAL WOUND DEHISCENCE WITH IMPLANT EXPOSURE AND LIQUID DISCHARGE FOLLOWING AUGMENTATION AND MASTOPEXY ON (B)(6) 2025. CONSERVATIVE MANAGEMENT FAILED, AND BOTH IMPLANTS WERE EXPLANTED ON POSTOPERATIVE DAY 21. CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT EVOLVED FAVORABLY AFTER EXPLANTATION AND ANTIBIOTIC TREATMENT.
Patient problems: Bacterial Infection; Post Operative Wound Infection; Seroma; Wound Dehiscence
MAUDE report 22994772 ↗InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
MEXICO. IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT DEVELOPED BILATERAL WOUND DEHISCENCE WITH IMPLANT EXPOSURE AND LIQUID DISCHARGE FOLLOWING AUGMENTATION AND MASTOPEXY ON (B)(6) 2025. CONSERVATIVE MANAGEMENT FAILED, AND BOTH IMPLANTS WERE EXPLANTED ON POSTOPERATIVE DAY 21. CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT EVOLVED FAVORABLY AFTER EXPLANTATION AND ANTIBIOTIC TREATMENT.
Patient problems: Bacterial Infection; Post Operative Wound Infection; Seroma; Wound Dehiscence
MAUDE report 22994771 ↗InjuryJan 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
A PATIENT REPORTED EXPERIENCING CAPSULAR CONTRACTURE BAKER GRADE III ON HER LEFT BREAST. SHE WAS ADVISED TO UNDERWENT EXPLANTATION SURGERY. 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 21072186 ↗
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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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