Motiva® SmoothSilk® Round Breast Implant RSF-450+QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 450 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 07445161002945), received between Oct 20, 2025 and Apr 23, 2026 — classified as 3 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
- Break1
Patient problems
- Capsular Contracture3
- Physical Asymmetry1
- Seroma1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Break; Device Appears to Trigger Rejection
BRAZIL. ALLEGEDLY, THE PATIENT PRESENTED WITH PERSISTENT MASTALGIA AND WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE. BREAST ULTRASOUND AND MRI FINDINGS INDICATED IMPLANT ROTATION AND RUPTURE. THE AFFECTED SIDE IS UNKNOWN, AND IT IS ALSO UNCLEAR WHETHER ADDITIONAL SURGERY WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture; Physical Asymmetry
MAUDE report 24968383 ↗InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ARGENTINA. ALLEGEDLY, A PATIENT IMPLANTED IN (B)(6) 2023 WAS DIAGNOSED WITH A BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST. SHE PREVIOUSLY HAD A DRAINAGE RELATED TO AN EARLY SEROMA IN (B)(6) 2023. A REVISION SURGERY IS SCHEDULED. 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: Capsular Contracture; Seroma
MAUDE report 23761181 ↗InjuryOct 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
MÉXICO. IT WAS REPORTED THAT THE PATIENT, WHO UNDERWENT AUGMENTATION MAMMOPLASTY IN (B)(6) 2025, WAS DIAGNOSED WITH A BAKER GRADE III CAPSULAR CONTRACTURE AND INFECTION IN (B)(6) 2025 (SN: (B)(6)). 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: Capsular Contracture; Unspecified Infection
MAUDE report 23337580 ↗
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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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