Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-275QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 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 07445161012326), received between Nov 22, 2024 and Dec 8, 2025 — classified as 4 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture3
- Impaired Healing1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Rupture1
- 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 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
FRANCE. 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.
Patient problems: Capsular Contracture
MAUDE report 23738899 ↗InjuryJul 10, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
MEXICO. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS ON (B)(6) 2022, DEVELOP CAPSULAR CONTRACTURE BAKER GRADE III/IV, INFECTION AND EXTRUSION. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. O PATIENT DEMOGRAPHICS, AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE BEING MADE, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture; Impaired Healing; Unspecified Infection
MAUDE report 22475272 ↗InjuryDec 2, 2024Break; Break
MEXICO. IT WAS REPORTED A FEMALE PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH A MOTIVA IMPLANT EXPERIENCED LEFT-SIDED RUPTURE ACCORDING TO MRI SURVEILLANCE. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, 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; Rupture
MAUDE report 20825407 ↗InjuryNov 22, 2024Break; Device Appears to Trigger Rejection; Break; Device Appears to Trigger Rejection
A REPLACEMENT SURGERY WAS PERFORMED ON THE RIGHT BREAST DUE TO CAPSULAR CONTRACTURE CAUSING DEFORMITY. DURING THE EXPLANTATION, A RUPTURE WAS DISCOVERED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 20759327 ↗
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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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