Motiva® SmoothSilk® Round Breast Implant RSD-300+QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 300 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07445161002709), received between Jan 3, 2025 and Mar 30, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
Patient problems
- Capsular Contracture2
- Inflammation1
- Nodule1
- Seroma1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Break
CHILE. ALLEGEDLY, A PATIENT IS EXPERIENCING A LEFT-BREAST NODULE CONSIDERED PROBABLY BENIGN, REQUIRING FOLLOW-UP IN SIX MONTHS WITH TARGETED ULTRASOUND. ADDITIONALLY, THERE IS A MILD LOSS OF CONFIGURATION AND ECHOGENICITY OF THE LEFT BREAST IMPLANT SUGGESTING A RUPTURE. THE PATIENT HASN'T UNDERGONE ANY ADDITIONAL SURGERY. THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Nodule
MAUDE report 24735025 ↗InjuryDec 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
MEXICO. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 HAD A BILATERAL EARLY SEROMA THAT REQUIRED DRAINING. THE PAIN PERSISTED DUE TO A CAPSULAR CONTRACTURE. THE PATIENT WAS GIVEN TREATMENT AND THERAPY WITHOUT IMPROVEMENT. A REVISION SURGERY WAS PERFORMED. THE INVESTIGATION IS IN PROGRESS.
Patient problems: Capsular Contracture
MAUDE report 23783486 ↗InjuryDec 11, 2025Break; Break
MEXICO. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 HAD A BILATERAL EARLY SEROMA THAT REQUIRED DRAINING. THE PAIN PERSISTED DUE TO A CAPSULAR CONTRACTURE. THE PATIENT WAS GIVEN TREATMENT AND THERAPY WITHOUT IMPROVEMENT. AFTER AN MRI, A RUPTURE IN THE RIGHT IMPLANT WAS DIAGNOSED. A REVISION SURGERY WAS PERFORMED. THE INVESTIGATION IS IN PROGRESS.
Patient problems: Capsular Contracture; Seroma
MAUDE report 23783293 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE RIGHT IMPLANT EXHIBITED EXCESSIVE SWELLING, WITH AN ULTRASOUND CONFIRMING THE PRESENCE OF FLUID. THE CONDITION BECAME EVIDENT AS THE PATIENT'S BREAST DEMONSTRATED SIGNIFICANT SWELLING, FOLLOWED BY THE SUDDEN DRAINAGE OF FLUID.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 21069315 ↗
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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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