Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07445161010810), received between Jun 4, 2025 and Sep 16, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50796558 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA. ALLEGEDLY, A PATIENT HAD MOTIVA IMPLANTS IN (B)(6) 2025, AND HER IMPLANTS HAVE MIGRATED MEDIALLY, CREATING A PARTIAL SYMMASTIA. 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: Ptosis

  MAUDE report 23581807 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA. ALLEGEDLY, A PATIENT HAD MOTIVA IMPLANTS IN (B)(6) 2025, AND HER IMPLANTS HAVE MIGRATED MEDIALLY, CREATING A PARTIAL SYMMASTIA. 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: Ptosis

  MAUDE report 23581802 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA- IT WAS REPORTED THAT A PATIENT WHO HAD A BREAST SURGERY AUGMENTATION ON (B)(6) 2025 WAS DIAGNOSED WITH AN INFECTION, AND THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2025. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Unspecified Infection

  MAUDE report 22145579 ↗