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

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07445161002914), received between Mar 19, 2025 and Sep 28, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Break

  Patient problems: Implant Pain

  MAUDE report 50925319 ↗
• InjuryMay 14, 2026Break

  COLOMBIA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY HAD AN MRI SCAN THAT SHOWED SIGNS OF SEROMA AND RUPTURE ON THE RIGHT SIDE. DURING THE REVISION SURGERY, THOSE FINDINGS WERE CONFIRMED. THE INVESTIGATION IS ONGOING.

  Patient problems: Seroma

  MAUDE report 25178537 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  ARGENTINA. ALLEGEDLY, IMAGING SHOWED BILATERAL RETROPECTORAL IMPLANTS, WITH THE RIGHT SIDE PRESENTING CAPSULAR CONTRACTURE BAKER GRADE III. FIRMNESS AND PAIN WERE NOTICED. A REVISION SURGERY IS SCHEDULED.

  Patient problems: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24720911 ↗
• InjuryMar 2, 2026Device Appears to Trigger Rejection

  MÉXICO. ALLEGEDLY, PAIN AND INFLAMMATION WERE PRESENT. AN ULTRASOUND WAS PERFORMED, REVEALING A BAKER GRADE III CAPSULAR CONTRACTURE, FOR WHICH AN IMPLANT REPLACEMENT IS REQUIRED. (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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24489476 ↗
• InjuryMar 2, 2026Device Appears to Trigger Rejection

  MÉXICO. ALLEGEDLY, UPON PALPATION, PAIN AND INFLAMMATION WERE PRESENT. AN ULTRASOUND REVEALED A GRADE III CAPSULAR CONTRACTURE, FOR WHICH IMPLANT REPLACEMENT IS REQUIRED (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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24488358 ↗
• InjuryDec 16, 2025Break; Break

  COLOMBIA. ALLEGEDLY, FIVE YEARS AFTER UNDERGOING SUBMUSCULAR BREAST AUGMENTATION, IMAGING STUDIES REVEALED A RUPTURE OF 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 23821991 ↗
• InjuryDec 11, 2025Break; Break

  AUSTRALIA. ALLEGEDLY, A PATIENT WHO HAD AN AUGMENTATION SURGERY IN (B)(6) 2023 REQUIRED A REVISION SURGERY DUE TO A RUPTURE IN HER LEFT BREAST IMPLANT. 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 23782737 ↗
• InjuryNov 12, 2025Break; Break

  COLOMBIA. ALLEGEDLY, DURING A REVISION PROCEDURE, THE IMPLANT WAS REMOVED AND FOUND TO BE RUPTURED (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 23533702 ↗
• InjuryAug 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  (B)(6). IT WAS REPORTED THAT THE PATIENT WAS EVALUATED IN THE OPERATING ROOM DUE TO PERSISTENT PAIN MORE THAN ONE YEAR AFTER THE PROCEDURE, AND THE IMPLANT WAS OBSERVED TO BE OUT OF ITS PROPER POSITION (SN NUMBER INVOLVED AND SIDE NOT SPECIFIED). A CAPSULAR CONTRACTURE BAKER GRADE III WAS ALSO FOUND. 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; Physical Asymmetry; Ptosis

  MAUDE report 22829648 ↗
• InjuryMay 27, 2025Break; Break

  MEXICO. IT WAS PATIENT OPERATED IN (B)(6) 2023. VISITED THE DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH RUPTURE IN LEFT SIDE (SN: (B)(6). A REVISION SURGERY WAS REQUIRED.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22088925 ↗
• InjuryMay 27, 2025Break; Break

  IN MEXICO. IT WAS PATIENT OPERATED IN (B)(6) 2023. VISITED THE DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH RUPTURE IN RIGHT SIDE (SN: (B)(6). A REVISION SURGERY WAS REQUIRED.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22088700 ↗
• MalfunctionMay 5, 2025Break; Break

  (B)(6). IT WAS REPORTED THAT A PATIENT WHO HAD A BREAST AUGMENTATION ON (B)(6) 2021 WAS DIAGNOSED WITH A DEVICE RUPTURE IN HER RIGHT BREAST. 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: Insufficient Information; Rupture

  MAUDE report 21964373 ↗
• InjuryMar 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ARGENTINA- IT WAS REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE BAKER GRADE III/IV.

  Patient problems: Capsular Contracture

  MAUDE report 21648285 ↗