Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-475Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07445161010629), received between Jun 11, 2025 and Dec 17, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III, AND A REVISION SURGERY WAS REQUIRED. ON THE PHYSICAL EXAMINATION, IT WAS OBSERVED THAT THE LEFT BREAST WAS FIRMER THAN THE RIGHT AND A BILATERAL SYMMASTIA. THE PATIENT ALSO REPORTED RIPPLING IN HER LEFT BREAST (SNS (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; Ptosis; Wrinkling

  MAUDE report 23828957 ↗
• InjuryDec 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III, AND A REVISION SURGERY WAS REQUIRED. ON THE PHYSICAL EXAMINATION, IT WAS OBSERVED THAT THE LEFT BREAST WAS FIRMER THAN THE RIGHT AND A BILATERAL SYMMASTIA. THE PATIENT ALSO REPORTED RIPPLING IN HER LEFT BREAST (SNS (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; Ptosis; Wrinkling

  MAUDE report 23828955 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA. IT WAS REPORTED THAT A PATIENT HAD HER BREAST SURGERY AUGMENTATION ON (B)(6) 2025, AFTER THAT, SHE WAS DIAGNOSED WITH AN INFECTION IN HER LEFT BREAST AND WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE, AND THE INVESTIGATION WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 22187481 ↗