Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-265QRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07445161012142), received between Dec 6, 2024 and Dec 10, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Break; Patient-Device Incompatibility; Break; Patient-Device Incompatibility

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED BILATERAL EXTRACAPSULAR IMPLANT RUPTURE WITH SUBSEQUENT FORMATION OF SILICONOMAS AND LYMPHADENOPATHY. NO PATIENT DEMOGRAPHICS, SUCH AS 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: Granuloma; Rupture; Swollen Lymph Nodes/Glands

  MAUDE report 20891648 ↗
• InjuryDec 10, 2024Break; Patient-Device Incompatibility; Break; Patient-Device Incompatibility

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED BILATERAL EXTRACAPSULAR IMPLANT RUPTURE WITH SUBSEQUENT FORMATION OF SILICONOMAS AND LYMPHADENOPATHY. NO PATIENT DEMOGRAPHICS, SUCH AS 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: Granuloma; Rupture; Swollen Lymph Nodes/Glands

  MAUDE report 20891623 ↗
• InjuryDec 6, 2024Break; Break

  BRAZIL. A PATIENT REPORTED EXPERIENCING A RUPTURE IN HER LEFT BREAST IMPLANT ACCORDING TO MRI SCAN. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. NO PATIENT DEMOGRAPHICS, SUCH AS 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: Insufficient Information

  MAUDE report 20871605 ↗