Motiva® SmoothSilk® Round Breast Implant RSD-245+Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi 245 cc · Class 3 · Implant
All models of Motiva SmoothSilk Round Breast Implant (53)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07445161001870), received between Jun 30, 2025 and Jun 30, 2025 — classified as 2 injuries.
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
Patient problems
- Impaired Healing2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6). IT WAS REPORTED THAT EIGHT WEEKS AFTER BREAST AUGMENTATION SURGERY, THE PATIENT SUFFERED FROM EXPOSURE OF THE IMPLANTS THROUGH THE SKIN. LEFT SIDE (SN:(B)(6).
Patient problems: Impaired Healing
MAUDE report 22367036 ↗InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UK. IT WAS REPORTED THAT EIGHT WEEKS AFTER BREAST AUGMENTATION SURGERY, THE PATIENT SUFFERED FROM EXPOSURE OF THE IMPLANTS THROUGH THE SKIN. RIGHT SIDE(SN: (B)(6).
Patient problems: Impaired Healing
MAUDE report 22366904 ↗
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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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