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

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07445161010544), received between Nov 14, 2024 and Sep 11, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Device Appears to Trigger Rejection

  USA. It was alleged that a patient who underwent breast revision surgery in (b)(6) 2025 developed Baker Grade III capsular contracture, implant flipping, bottoming out, and rippling of the left breast. Revision surgery was performed, during which a gel fracture was observed. The investigation is ongoing.

  Patient problems: Capsular Contracture

  MAUDE report 50726422 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT COMPLAINED ABOUT FIRMNESS AND CHANGES IN THE SHAPE OF HER BREASTS. SHE WAS DIAGNOSED WITH A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. A REVISION SURGERY WAS PERFORMED. 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 24210705 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT COMPLAINED ABOUT FIRMNESS AND CHANGES IN THE SHAPE OF HER BREASTS. SHE WAS DIAGNOSED WITH A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. A REVISION SURGERY WAS PERFORMED. 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 24210704 ↗
• InjuryJan 23, 2026Device Appears to Trigger Rejection

  KOREA. ALLEGEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HARDNESS IN BOTH BREASTS, UNNATURAL MOVEMENT, AND DISSATISFACTION WITH THEIR SHAPE. AN ULTRASOUND EXAMINATION WAS PERFORMED, AND A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE WAS DIAGNOSED (SN: (B)(6). A REVISION SURGERY WAS PERFORMED. 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 24167714 ↗
• InjuryJan 22, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A PAINFUL BAKER GRADE IV CAPSULAR CONTRACTURE ON HER RIGHT BREAST. 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 24147619 ↗
• InjuryJan 8, 2026Device Appears to Trigger Rejection

  SOUTH KOREA. ALLEGEDLY, THE PATIENT REPORTED BREAST FIRMNESS AND OBSERVED BREAST ASYMMETRY IN BOTH BREASTS. A BILATERAL BAKER GRADE III/IV WAS DIAGNOSED, AND A REVISION SURGERY WAS PERFORMED (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 24004775 ↗
• InjuryJan 8, 2026Device Appears to Trigger Rejection

  SOUTH KOREA. ALLEGEDLY, THE PATIENT REPORTED BREAST FIRMNESS AND OBSERVED BREAST ASYMMETRY IN BOTH BREASTS. A BILATERAL BAKER GRADE III/IV WAS DIAGNOSED, AND A REVISION SURGERY WAS PERFORMED (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 24004774 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA. ALLEGEDLY, IMPLANTS PLACED TOO CLOSE TOGETHER AND TOO LOW IN THE AUGMENTATION MAMMOPLASTY PERFORMED IN (B)(6) 2025, SHE WAS DIAGNOSED WITH MILD SYMMASTIA. A REVISION SURGERY WAS PERFORMED. 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: Discomfort; Ptosis

  MAUDE report 23829100 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA. ALLEGEDLY, IMPLANTS PLACED TOO CLOSE TOGETHER AND TOO LOW IN THE AUGMENTATION MAMMOPLASTY PERFORMED IN (B)(6) 2025, SHE WAS DIAGNOSED WITH MILD SYMMASTIA. A REVISION SURGERY WAS PERFORMED. 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: Discomfort; Ptosis

  MAUDE report 23829097 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 COMPLAINED ABOUT FIRMNESS AND PAIN IN HER LEFT BREAST AND WAS DIAGNOSED WITH A BAKER GRADE III CAPSULAR CONTRACTURE. A REVISION SURGERY WAS PERFORMED. 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 23762809 ↗
• 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 22005706 ↗
• InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT SURGERY AT ANOTHER HOSPITAL IN (B)(6) 2021. ONE YEAR LATER, IN (B)(6) 2022, A REVISION SURGERY WAS PERFORMED AT THE SAME HOSPITAL TO FILL THE SPACE BETWEEN THE PATIENT'S TISSUE AND THE IMPLANT PLACED DURING THE PRIMARY SURGERY. HOWEVER, DUE TO RECURRENT BREAST DEFORMATION AND HARDNESS, FURTHER EXAMINATION CONFIRMED A RECURRENCE OF CAPSULAR CONTRACTURE. CONSEQUENTLY, THE PATIENT UNDERWENT AN ADDITIONAL REVISION SURGERY AT OUR HOSPITAL IN (B)(6) 2024, PERFORMED VIA AN INFRAMAMMARY INCISION. LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20689236 ↗
• InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT SURGERY AT ANOTHER HOSPITAL ON (B)(6) 2021. ONE YEAR LATER, ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED AT THE SAME HOSPITAL TO FILL THE SPACE BETWEEN THE PATIENT'S TISSUE AND THE IMPLANT PLACED DURING THE PRIMARY SURGERY. HOWEVER, DUE TO RECURRENT BREAST DEFORMATION AND HARDNESS, FURTHER EXAMINATION CONFIRMED A RECURRENCE OF CAPSULAR CONTRACTURE. CONSEQUENTLY, THE PATIENT UNDERWENT AN ADDITIONAL REVISION SURGERY AT OUR HOSPITAL ON (B)(6) 2024, PERFORMED VIA AN INFRAMAMMARY INCISION. RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20689046 ↗