Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-245Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07445161010537), received between Dec 30, 2024 and May 5, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Break

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A PRESERVE SURGERY AUGMENTATION ON (B)(6) 2026, PRESENTS TO CONSULTATION WITH PAIN (SWELLING), BRUISING IN THE LEFT MEDIAL BREAST AND A PALPABLE LUMP, SHE HAD AN ULTRASOUND THAT REVEALS SIGNS OF RUPTURE LEFT MEDIAL BREAST IMPLANT. THE INVESTIGATION IS IN PROGRESS.

  Patient problems: Hematoma; Nodule; Swelling/ Edema

  MAUDE report 25088204 ↗
• InjuryFeb 17, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION IN (B)(6) 2025 DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III IN HER RIGHT BREAST. SHE COMPLAINED ABOUT HER BREASTS FEELING UNCOMFORTABLE AND DIFFERENT (SN (B)(6)). A REVISION SURGERY IS BEING PLANNED. 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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24365829 ↗
• InjuryMay 21, 2025Break; Break

  SOUTH KOREA. IT WAS REPORTED THAT A PATIENT WHO WAS OPERATED IN (B)(6) 2020, VISITED THE DOCTOR IN (B)(6) 2024, AND WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT. REVISION SURGERY WAS NECESSARY. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 22062873 ↗
• MalfunctionMay 15, 2025Break; Break

  KOREA. IT WAS REPORTED A PATIENT OPERATED IN (B)(6) 2020. VISITED A DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT. 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: Insufficient Information

  MAUDE report 22030983 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA- IT WAS REPORTED THAT A SURGEON DIDN'T LISTEN TO SIZE THAT PATIENT WANTED AND THIS SIZE CAUSING PHYSICAL PAIN. THE EXPLANT SURGERY WAS PERFORMED ON (B)(6) 2025. 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: Breast Discomfort/Pain

  MAUDE report 22006081 ↗
• MalfunctionMar 19, 2025Break; Break

  THE IMPLANT WAS REMOVED BECAUSE A RUPTURE. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643572 ↗
• InjuryDec 30, 2024Break; Break

  SOUTH KOREA. PHYSICAL EXAMINATION AND ULTRASOUND SURVEILLANCE REVEALED A RIGHT BREAST IMPLANT RUPTURE IN A PATIENT IMPLANTED WITH MOTIVA IMPLANTS. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. 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 WERE MADE, AND THE INVESTIGATION WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 21044506 ↗