Motiva® SmoothSilk® Round Breast Implant RSF-255+QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 255 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07445161002853), received between Oct 18, 2024 and Apr 16, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Device Slipped2
- Device Appears to Trigger Rejection1
Patient problems
- Insufficient Information5
- Capsular Contracture1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Break
BRAZIL. ALLEGEDLY, A PATIENT IS EXPERIENCING A SITUATION IN WHICH PREOPERATIVE EXAMINATIONS WERE PERFORMED IN PREPARATION FOR BREAST IMPLANT REPLACEMENT; HOWEVER, THE IMPLANT RUPTURE WAS NOT IDENTIFIED DURING THOSE EXAMS AND WAS DISCOVERED ONLY DURING THE SURGICAL PROCEDURE. THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Insufficient Information
MAUDE report 24900499 ↗InjuryMar 18, 2026Break; Device Slipped
BRAZIL. ALLEGEDLY, A PATIENT IS EXPERIENCING A BILATERAL IMPLANT ROTATION AND RUPTURE. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24630664 ↗InjuryMar 18, 2026Break; Device Slipped
BRAZIL. ALLEGEDLY, A PATIENT IS EXPERIENCING A BILATERAL IMPLANT ROTATION AND RUPTURE. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24630560 ↗InjuryMar 19, 2025Break; Break
BRAZIL- IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED DEVICE RUPTURE ACCORDING TO RMN AND PHYSICAL EXAMINATION. THE SIDE (LEFT/RIGHT) WAS NOT SPECIFIED. SHE WILL HAVE AN EXPLANTATION SURGERY. 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
MAUDE report 21648876 ↗InjuryMar 19, 2025Break; Break
BRAZIL- IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED DEVICE RUPTURE ACCORDING TO RMN AND PHYSICAL EXAMINATION. THE SIDE (LEFT/RIGHT) WAS NOT SPECIFIED. SHE WILL HAVE AN EXPLANTATION SURGERY. 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
MAUDE report 21648587 ↗InjuryOct 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT BREAST PAIN, ACCOMPANIED BY CONTRACTURE AND DEFORMITY.
Patient problems: Capsular Contracture
MAUDE report 20482951 ↗
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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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