Motiva® SmoothSilk® Round Breast Implant RSF-550+QRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07445161002969), received between Oct 21, 2024 and Jul 1, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 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

  MEXICO. IT WAS REPORTED A PATIENT OPERATED IN (B)(6) 2025. VISITED THE DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III, INFECTION, SEROMA IN LEFT BREAST IMPLANT (B)(6).

  Patient problems: Capsular Contracture; Seroma; Unspecified Infection

  MAUDE report 22370872 ↗
• InjuryJun 19, 2025Break; Break

  COLOMBIA. IT WAS REPORTED THAT DURING A REVISION SURGICAL PROCEDURE SCHEDULED FOR SCAR CORRECTION AND BREAST POCKET ADJUSTMENT, AN EXTRACAPSULAR RUPTURE OF THE RIGHT IMPLANT WAS IDENTIFIED INTRAOPERATIVELY (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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292968 ↗
• InjuryMar 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT WHO WAS IMPLANTED IN (B)(6) 2022 WAS SUFFERING FROM EXTREME JOINT PAIN, WEIGHT LOSS, BRAIN FOG, AND ANXIETY. 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: Connective Tissue Disease

  MAUDE report 21644698 ↗
• InjuryMar 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT WHO WAS IMPLANTED ON (B)(6) 2022 WAS SUFFERING FROM EXTREME JOINT PAIN, WEIGHT LOSS, BRAIN FOG, AND ANXIETY. 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: Connective Tissue Disease

  MAUDE report 21644597 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NINE MONTHS AFTER THE INITIAL SURGERY ON (B)(6) 2023, THE PATIENT EXPERIENCED A LATERALIZATION OF THE IMPLANT, SO REVISION SURGERY WAS PERFORMED TO CORRECT IT. AT THE TIME OF REIMPLANTING THE SAME DEVICE THE PATCH RUPTURED. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20708962 ↗
• InjuryNov 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A GRADE III CAPSULAR CONTRACTURE IN THE RIGHT BREAST.

  Patient problems: Capsular Contracture

  MAUDE report 20667250 ↗
• InjuryOct 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REOPERATION DUE TO FLUID LEAKAGE FROM A FISTULA, WITH A SUSPECTED IMPLANT RUPTURE BASED ON ULTRASOUND FINDINGS. DURING THE PROCEDURE, IT WAS CONFIRMED THAT NO RUPTURE WAS PRESENT IN THE IMPLANTS. A CAPSULECTOMY OF UNSPECIFIED DEGREE WAS PERFORMED, AND TWO NODULES FOUND WITHIN THE CAPSULE WERE EXCISED AND SENT FOR BIOPSY. THE BIOPSY RESULTS ARE CURRENTLY PENDING. RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20501640 ↗
• InjuryOct 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REOPERATION DUE TO FLUID LEAKAGE FROM A FISTULA, WITH A SUSPECTED IMPLANT RUPTURE BASED ON ULTRASOUND FINDINGS. DURING THE PROCEDURE, IT WAS CONFIRMED THAT NO RUPTURE WAS PRESENT IN THE IMPLANTS. A CAPSULECTOMY OF UNSPECIFIED DEGREE WAS PERFORMED, AND TWO NODULES FOUND WITHIN THE CAPSULE WERE EXCISED AND SENT FOR BIOPSY. THE BIOPSY RESULTS ARE CURRENTLY PENDING. LEFT SIDE

  Patient problems: Capsular Contracture

  MAUDE report 20500952 ↗