Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07445161010803), received between Jan 15, 2025 and Jan 22, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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.

• InjuryJan 22, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE; A TOTAL CAPSULEPTOMY WAS 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: Capsular Contracture

  MAUDE report 24147565 ↗
• InjuryJan 22, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE; A TOTAL CAPSULEPTOMY WAS 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: Capsular Contracture

  MAUDE report 24147500 ↗
• InjuryMar 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA- IT WAS REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE BAKER GRADE III.

  Patient problems: Capsular Contracture

  MAUDE report 21693957 ↗
• InjuryFeb 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  UNITED STATES. IT WAS REPORTED THAT A 38 YEAR OLD PATIENT WHO HAD A MASTOPEXY WITH MOTIVA IMPLANTS PRESENTED A FRANK PURULENT FLUID COMING OUT FROM HER BREASTS. SHE WAS ADVISED TO UNDERGO IMPLANT REMOVAL SURGERY. 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: Cyanosis; Seroma

  MAUDE report 21411655 ↗
• InjuryFeb 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  UNITED STATES. IT WAS REPORTED THAT A 38 YEAR OLD PATIENT WHO HAD A MASTOPEXY WITH MOTIVA IMPLANTS PRESENTED A FRANK PURULENT FLUID COMING OUT FROM HER BREASTS. SHE WAS ADVISED TO UNDERGO IMPLANT REMOVAL SURGERY. 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: Cyanosis; Seroma

  MAUDE report 21411438 ↗
• InjuryJan 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SOUTH KOREA. A PATIENT REPORTED EXPERIENCING FIRMNESS IN HER RIGHT BREAST AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL 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 WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 21160101 ↗