Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-355Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07445161010766), received between Nov 12, 2024 and Mar 2, 2026 — classified as 8 injuries.

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

• InjuryMar 2, 2026Device Appears to Trigger Rejection

  SOUTH KOREA. ALLEGEDLY, THE PATIENT WAS IMPLANTED IN (B)(6) 2022 AND DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III IN THE LEFT BREAST. DUE TO THE PROGRESSION OF THE CONDITION, THE IMPLANT WAS EXPLANTED IN (B)(6) 2025. (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: Capsular Contracture

  MAUDE report 24489888 ↗
• InjuryDec 18, 2025Break; Break

  KOREA. ALLEGEDLY, THREE MONTHS POSTOPERATIVELY, THE PATIENT VISITED THE CLINIC COMPLAINING OF DISCOMFORT. AN INTRACAPSULAR RUPTURE OF THE LEFT BREAST IMPLANT WAS DIAGNOSED FOLLOWING PHYSICAL EXAMINATION AND ULTRASONOGRAPHIC EVALUATION. THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Discomfort

  MAUDE report 23845740 ↗
• InjuryNov 20, 2025Break; Break

  GERMANY. ALLEGEDLY A PATIENT PRESENTS A DEVICE RUPTURE IN HER RIGHT BREAST, A REPLACEMENT SURGERY WAS REQUIRED AND A NEW MOTIVA IMPLANT WAS PUT INSTEAD THE DAMAGED DEVICE. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS,

  Patient problems: Insufficient Information

  MAUDE report 23605483 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KOREA - IT WAS REPORTED THAT A PATIENT OPERATED ON IN (B)(6) 2019, PRESENTED TO THE DOCTOR IN (B)(6) 2024 WITH BOTTOMING OUT. 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: Ptosis

  MAUDE report 21903984 ↗
• InjuryApr 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  KOREA - IT WAS REPORTED THAT A PATIENT OPERATED ON IN (B)(6) 2019, PRESENTED TO THE DOCTOR IN (B)(6) 2024 WITH BOTTOMING OUT. DURING THE REVISION SURGERY HER RIGHT IMPLANT WAS FOUND RUPTURED. 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: Ptosis

  MAUDE report 21901671 ↗
• InjuryNov 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT PROGRESS ULTRASOUND REVEALED A RUPTURE IN THE LEFT IMPLANT. THE FINDINGS INDICATED THAT THE LEFT IMPLANT WAS COMPLETELY RUPTURED, WITH THE EXCEPTION OF THE LOWER MEDIAL PORTION. THIS WAS IDENTIFIED AS AN INTRACAPSULAR RUPTURE.

  Patient problems: Insufficient Information

  MAUDE report 20724504 ↗
• InjuryNov 14, 2024Break; Break

  IT WAS REPORTED THAT, TWO YEARS AND ONE MONTH POST-OPERATIVELY, THE PATIENT EXPERIENCED DISCOMFORT AND FIRMNESS IN THE LEFT BREAST. A PHYSICAL EXAMINATION LED TO THE DIAGNOSIS OF CAPSULAR RUPTURE, FOLLOWED BY ULTRASOUND (US) SURVEILLANCE.

  Patient problems: Insufficient Information

  MAUDE report 20691070 ↗
• InjuryNov 12, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION WITH MOTIVA IMPLANTS. DURING A FOLLOW-UP VISIT, THE PATIENT WAS DIAGNOSED WITH AN INTRACAPSULAR RUPTURE OF THE LEFT IMPLANT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SUBTOTAL CAPSULECTOMY AND IMPLANT EXCHANGE FOR THE LEFT BREAST.

  Patient problems: Insufficient Information

  MAUDE report 20664989 ↗