Motiva® SmoothSilk® Round Breast Implant RSF-295+QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 295 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 07445161002877), received between Nov 12, 2024 and Aug 11, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Break” (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
- Break3
- Device Appears to Trigger Rejection2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information3
- Capsular Contracture2
- Breast Discomfort/Pain1
- Physical Asymmetry1
- Ptosis1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Physical Asymmetry; Ptosis
MAUDE report 50213851 ↗InjuryNov 24, 2025Break; Break
BRAZIL. ALLEGEDLY, A RUPTURE IN THE RIGHT BREAST IMPLANT WAS NOTICED DURING A REOPERATION PROCEDURE. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Insufficient Information
MAUDE report 23633105 ↗InjuryOct 27, 2025Break; Break
COLOMBIA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION ON (B)(6) 2024 HAD AN ULTRASOUND THAT REVEALED A DEVICE RUPTURE IN HER RIGHT BREAST. 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; Insufficient Information
MAUDE report 23396922 ↗InjuryAug 21, 2025Break; Break
MEXICO. IT WAS REPORTED THAT THE IMPLANTS WERE EXPLANTED AFTER 6 MONTHS. UPON REMOVAL, THE RIGHT IMPLANT WAS FOUND TO BE COMPLETELY RUPTURED (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: Insufficient Information
MAUDE report 22868523 ↗InjuryMar 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
MEXICO. IT WAS REPORTED THAT, A PATIENT THAT WAS IMPLANTED IN (B)(6) 2024, STARTED TO HAVE SYMPTOMS OF CAPSULAR CONTRACTURE IN HER RIGHT BREAST A MONTH AFTER THE SURGERY. 45 DAYS AFTER SURGERY, PATIENT HAD PAIN, INDURATION, AND EVIDENT SIGNS OF CAPSULAR CONTRACTURE; AT THIS POINT, THE SYMPTOMS WERE PRESENT IN THE LEFT BREAST AS WELL. AN MRI, ULTRASOUND AND CT CONFIRMED THE DIAGNOSIS. THE PATIENT HAD REVISION SURGERY ONLY FOR THE RIGHT-SIDE BREAST AS THE PAIN IN THE LEFT BREAST CEASED.
Patient problems: Capsular Contracture
MAUDE report 21552793 ↗InjuryNov 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
A PATIENT REPORTED EXPERIENCING PAIN IN BOTH BREASTS. MRI SCAN REVEALED SIGNS OF CAPSULAR CONTRACTURE. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture
MAUDE report 20669301 ↗
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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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