Motiva® SmoothSilk® Round Breast Implant RSF-375+Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07445161002112), received between Dec 30, 2024 and Apr 8, 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24818211 ↗
• InjuryNov 12, 2025Break; Break

  CHILE. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN 2021 WAS DIAGNOSED WITH A RUPTURE IN THE LEFT IMPLANT (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 23533709 ↗
• InjuryOct 17, 2025Break; Break

  CHILE. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY IN 2022, REQUIRED A REVISION SURGERY DUE TO A DEVICE RUPTURE IN HER LEFT 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: Insufficient Information

  MAUDE report 23324672 ↗
• InjurySep 11, 2025Break; Break

  GERMANY. IT WAS REPORTED THAT THE PATIENT, WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MOTIVA IMPLANTS IN 2015, PRESENTED ON (B)(6) 2025 WITH ULTRASOUND FINDINGS SUGGESTIVE OF A DEFECT OF THE RIGHT IMPLANT, WHICH WAS LATER CONFIRMED AS A RUPTURE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025, WHERE INTRAOPERATIVE FINDINGS INCLUDED LEAKAGE OF STICKY MATERIAL UPON THE FIRST INCISION, CONSISTENT WITH AN IMPLANT DEFECT. THE EXPLANTED DEVICE CORRESPONDED TO THE RIGHT BREAST IMPLANT (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 23031430 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTED DEHISCENCE, ACCOMPANIED BY PAIN AND SWELLING. LEFT SIDE

  Patient problems: Breast Discomfort/Pain; Wound Dehiscence

  MAUDE report 21036898 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTED DEHISCENCE, ACCOMPANIED BY PAIN AND SWELLING. RIGHT SIDE.

  Patient problems: Breast Discomfort/Pain; Wound Dehiscence

  MAUDE report 21036798 ↗