Motiva® SmoothSilk® Round Breast Implant RSD-265+QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 265 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
- 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 07445161002686), received between Nov 6, 2024 and Aug 28, 2025 — 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
Patient problems
- Seroma2
- Unspecified Infection2
- Insufficient Information1
- 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.
InjuryAug 28, 2025Break; Break
AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH IMPLANTS IN (B)(6) 2020 WAS DIAGNOSED WITH AN IMPLANT RUPTURE ON THE LEFT SIDE. NO REVISION SURGERY SCHEDULED YET. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22913102 ↗InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO BONE LOSS. PATIENT WAS PRESENT FOR A FLAP AND DEBRIDEMENT SURGERY OF IMPLANT NUMBER 7. UPON FLAPPING THE TISSUE DR. SCANLON NOTED BONE LOSS SURROUNDING THE IMPLANT AND DECIDED THE BEST COURSE OF TREATMENT WAS IMPLANT REMOVAL. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO ADDITIONAL APPOINTMENT REQUIRED: NO SYMPTOMS AS A RESULT OF THE EVENT: NOT INDICATED.
Patient problems: Seroma; Unspecified Infection
MAUDE report 20620082 ↗InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IT BECAME NECESSARY TO REOPEN THE SURGICAL SITE TO REMOVE THE IMPLANT, REVIEW THE AREA, AND ASSESS FOR ANY SUBCLINICAL INFECTION AND SEROMA. A DECISION WOULD THEN BE MADE REGARDING TEMPORARY EXPLANTATION OR THE RE-IMPLANTATION OF A NEW PROSTHESIS. RIGHT SIDE
Patient problems: Seroma; Unspecified Infection
MAUDE report 20619901 ↗
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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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