Motiva® SmoothSilk® Round Breast Implant RSF-425+Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07445161002136), received between Jun 24, 2025 and Apr 20, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION IN (B)(6) 2025, DEVELOPED A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24933346 ↗
• InjuryApr 20, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025, DEVELOPED A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24933344 ↗
• InjuryDec 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 COMPLAINED ABOUT FIRMNESS, TIGHTNESS, DISCOMFORT AND PAIN. SHE WAS DIAGNOSED WITH A BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST. 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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 23822406 ↗
• InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ARGENTINA. IT WAS REPORTED THAT THE PATIENT DEVELOPED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. (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 23102870 ↗
• InjuryJul 30, 2025Break; Break

  THAILAND. IT WAS REPORTED THAT THE PATIENT FELT A LUMP IN HER RIGHT BREAST, SHE TOOK AN EXAM AND AFTER THAT, SHE WAS FOUND TO HAVE A SILICONE LEAKAGE IN BOTH BREASTS. THE EXPLANT SURGERY DATE IS NOT SCHEDULED YET. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nodule

  MAUDE report 22666605 ↗
• InjuryJul 30, 2025Break; Break

  THAILAND. IT WAS REPORTED THAT THE PATIENT FELT A LUMP IN HER RIGHT BREAST, SHE TOOK AN EXAM AND AFTER THAT, SHE WAS FOUND TO HAVE A SILICONE LEAKAGE IN BOTH BREASTS. THE EXPLANT SURGERY DATE IS NOT SCHEDULED YET. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nodule

  MAUDE report 22666604 ↗
• InjuryJun 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  USA. IT WAS REPORTED THAT A PATIENT THAT HAD HER BREAST SURGERY AUGMENTATION ON FEBRUARY, PRESENTED A WOUND WITH AN EXPOSED IMPLANT AND WAS DIAGNOSED WITH AN INFECTION. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY IN MAY. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 22323292 ↗