Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-275Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 275 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 07445161010384), received between Aug 4, 2025 and Jan 26, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 Rejection4
Patient problems
- Capsular Contracture4
- Physical Asymmetry1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT DEVELOPED A BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST. THE BREAST IS HIGHER AND TIGHTER THAN THE LEFT. 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 24178619 ↗InjuryJan 8, 2026Device Appears to Trigger Rejection
SOUTH KOREA. ALLEGEDLY, TWO MONTHS POSTOPERATIVE, THE RIGHT BREAST WAS NOTICEABLY FIRM AND HAD MIGRATED UPWARD; A BAKER GRADE III/IV CAPSULAR CONTRACTURE WAS DIAGNOSED AND A REVISION SURGERY WAS REQUIRED (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: Capsular Contracture
MAUDE report 24003864 ↗InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
KOREA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 WAS DIAGNOSED WITH A BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST AFTER COMPLAINING OF PAIN AND BREAST DEFORMITY. A REVISION SURGERY WAS PERFORMED. THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 23842479 ↗InjuryAug 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS ON (B)(6) 2025, PRESENTS FIRM BREAST AND DISPLACEMENT. SHE WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE GRADE III IN HER LEFT BREAST. SHE WILL UNDERGO EXPLANTATION SURGERY. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture; Physical Asymmetry
MAUDE report 22701520 ↗
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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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