Motiva® SmoothSilk® Round Breast Implant RSF-400+QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 400 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
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07445161002921), received between Oct 28, 2024 and Sep 22, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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 Rejection13
- Break3
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture13
- Breast Discomfort/Pain3
- Insufficient Information3
- Seroma2
- Deformity/ Disfigurement1
- Ptosis1
- Swollen Lymph Nodes/Glands1
- Wound Dehiscence1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands
MAUDE report 50860980 ↗InjuryFeb 3, 2026Device Appears to Trigger Rejection
ARGENTINA. ALLEGEDLY, A PATIENT PRESENTED WITH A BILATERAL BAKER GRADE III/IV CAPSULAR CONTRACTURE, FOLLOWING BREAST AUGMENTATION SURGERY PERFORMED IN (B)(6) 2025 (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
MAUDE report 24251996 ↗InjuryFeb 3, 2026Device Appears to Trigger Rejection
ARGENTINA. ALLEGEDLY, A PATIENT PRESENTED WITH A BILATERAL BAKER GRADE III/IV CAPSULAR CONTRACTURE, FOLLOWING BREAST AUGMENTATION SURGERY PERFORMED 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
MAUDE report 24251982 ↗InjuryDec 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
BRAZIL. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 PRESENTED WITH A BAKER GRADE III CAPSULAR CONTRACTURE ON THE RIGHT SIDE. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture
MAUDE report 23905749 ↗InjuryNov 10, 2025Break; Break
AUSTRALIA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2024, WAS UNDERGOING A REVISION SURGERY DUE TO SYNMASTIA AND THE LEFT IMPLANT WAS FOUND RUPTURED. 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: Deformity/ Disfigurement; Ptosis
MAUDE report 23511610 ↗InjuryJul 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
BRAZIL. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR CONSULTATION WITH BILATERAL GRADE IV CAPSULAR CONTRACTURE, CHARACTERIZED BY SIGNIFICANT HARDENING, PAIN ON PALPATION, AND BOTH AESTHETIC AND FUNCTIONAL IMPAIRMENT OF THE BREASTS (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
MAUDE report 22632555 ↗InjuryJul 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
BRAZIL. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR CONSULTATION WITH BILATERAL GRADE IV CAPSULAR CONTRACTURE, CHARACTERIZED BY SIGNIFICANT HARDENING, PAIN ON PALPATION, AND BOTH AESTHETIC AND FUNCTIONAL IMPAIRMENT OF THE BREASTS. (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
MAUDE report 22632540 ↗InjuryJul 2, 2025Break; Break
UK. A PATIENT REPORTED THAT SHE HAD MOTIVA IMPLANTS REMOVED AFTER 6 YEARS. WHEN THE IMPLANTS WERE REMOVED, ONE WAS RUPTURE.
Patient problems: Insufficient Information
MAUDE report 22390835 ↗InjuryMay 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AUGMENTATION IN (B)(6) 2024, WAS DIAGNOSED WITH A BAKER GRADE IV CAPSULAR CONTRACTURE DUE TO INTENSE PAIN AND DEFORMITY. A REVISION SURGERY WAS PERFORMED. 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; Capsular Contracture
MAUDE report 22029689 ↗InjuryMar 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
CHILE. PATIENT PRESENTED PAIN AND HARDNESS ON HER RIGHT BREAST AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III ACCORDING TO RMN FINDINGS. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE, AND THE INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 21566878 ↗InjuryFeb 5, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION ON (B)(6) 2024 WITH PERIPROSTHETIC SEROMA 7 WEEKS AFTER SURGERY, SUBSEQUENT LEAKAGE OF FLUID FROM THE SURGICAL WOUND, WHICH GRADUALLY SUBSIDES. SUBSEQUENTLY, SHE DEVELOPED PAINFUL CAPSULAR CONTRACTURE GRADE III-IV, REASON FOR WHICH THE CAPSULE AND IMPLANT WERE REMOVED AT 12 WEEKS ((B)(6) 2024; 8 MONTHS AFTER THE REMOVAL OF THE IMPLANT IT WAS DECIDED TO PLACE THE IMPLANT AGAIN. NO PATIENTS DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENTS HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture; Seroma
MAUDE report 21315508 ↗InjuryDec 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV, ACCOMPANIED BY PERSISTENT DAILY PAIN. RIGHT SIDE
Patient problems: Breast Discomfort/Pain; Capsular Contracture
MAUDE report 20921437 ↗InjuryDec 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV, ACCOMPANIED BY PERSISTENT DAILY PAIN. LEFT SIDE.
Patient problems: Breast Discomfort/Pain; Capsular Contracture
MAUDE report 20921147 ↗InjuryNov 14, 2024Fracture; Device Appears to Trigger Rejection; Fracture; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE CLASSIFIED AS BAKER GRADE III. LEFT SIDE.
Patient problems: Capsular Contracture; Insufficient Information
MAUDE report 20688325 ↗InjuryNov 8, 2024Fracture; Device Appears to Trigger Rejection; Fracture; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE CLASSIFIED AS BAKER GRADE III. RIGHT SIDE
Patient problems: Capsular Contracture; Insufficient Information
MAUDE report 20646326 ↗InjuryOct 28, 2024Break; Break
IT WAS REPORTED THAT, ON (B)(6), A DECISION WAS MADE TO PROCEED WITH SURGERY DUE TO THE PRESENCE OF ABUNDANT FLUID OBSERVED IN AN ULTRASOUND CONDUCTED SHORTLY BEFOREHAND, ALONG WITH DEHISCENCE OF THE SURGICAL WOUND. DURING THIS SECOND PROCEDURE, SEROHEMATIC FLUID WAS NOTED, AND UPON REMOVAL, THE IMPLANT WAS FOUND TO BE RUPTURED IN ITS UPPER SECTION. AN EXPLANTATION WAS PERFORMED, AND THE SURGICAL WOUND WAS CLOSED WITH ANTIBIOTIC TREATMENT.
Patient problems: Seroma; Wound Dehiscence
MAUDE report 20549226 ↗
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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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