Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-355QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 355 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07445161012364), received between Sep 8, 2025 and Feb 11, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Device Appears to Trigger Rejection1
Patient problems
- Breast Discomfort/Pain2
- Physical Asymmetry2
- Ptosis2
- Capsular Contracture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
TITLE: ASYMMETRY, LATERALIZATIONN, ROTATION AND PAIN. DESCRIPTION: FRANCE. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025. REPORTED BEING BOTHERED BY ASYMMETRY, WITH HER RIGHT BREAST SAGGING LATERALLY. SHE COMPLAINED PAIN. ON (B)(6) 2026; THE IMPLANT WAS COMPLETELY ROTATED. A SURGERY WAS REQUIRED TO REPOSITIONED THE IMPLANT AS IT WAS INTACT ON. ((B)(6)).
Patient problems: Breast Discomfort/Pain; Physical Asymmetry; Ptosis
MAUDE report 24314302 ↗InjuryNov 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
MÉXICO. ALLEGEDLY, THE PATIENT REPORTED PALPABLE CHANGES IN THE AREA OF THE BREAST IMPLANTS. DURING THE CONSULTATION IN (B)(6) 2025, SIGNS OF CAPSULAR CONTRACTURE ON THE LEFT SIDE WERE IDENTIFIED. AT THE MOST RECENT VISIT, THE PATIENT PRESENTED WITH LEFT BREAST CAPSULAR CONTRACTURE CHARACTERIZED BY FIRM CONSISTENCY AND DISTORTION OF BREAST SHAPE (BAKER GRADE III) (SN: (B)(6)). A REVISION SURGERY WAS REQUIRED. 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 23673920 ↗InjurySep 8, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
SINGAPORE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO LEFT IMPLANT MALPOSITION. DURING THE PROCEDURE, IMPLANT RUPTURE WAS DISCOVERED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions; Physical Asymmetry; Ptosis
MAUDE report 22999125 ↗
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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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