Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-360QRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07445161012197), received between Nov 8, 2024 and May 11, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Device Appears to Trigger Rejection

  TAIWAN. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2023 REQUIRED A REVISION SURGERY DUE TO A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. 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 25139224 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  TAIWAN. ALLEGEDLY, A PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION SURGERY IN (B)(6) 2023. THE PATIENT PRESENTED TO THE HOSPITAL IN (B)(6) 2026 AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE GRADE III/IV FOLLOWING BILATERAL BREAST AUGMENTATION WITH IMPLANTS. REVISION SURGERY WAS PERFORMED IN (B)(6) 2026. (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 24716750 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  THAILAND. ALLEGEDLY, THE PATIENT REPORTED BREAST PAIN ASSOCIATED WITH CAPSULAR CONTRACTURE GRADE III AFFECTING BOTH SIDES. (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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24715908 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  TAIWAN. ALLEGEDLY, A PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION SURGERY IN (B)(6) 2023. THE PATIENT PRESENTED TO THE HOSPITAL IN (B)(6) 2026 AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE GRADE III/IV FOLLOWING BILATERAL BREAST AUGMENTATION WITH IMPLANTS. REVISION SURGERY WAS PERFORMED IN (B)(6) 2026. (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 24715872 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  THAILAND. ALLEGEDLY, THE PATIENT REPORTED BREAST PAIN ASSOCIATED WITH CAPSULAR CONTRACTURE GRADE III AFFECTING BOTH SIDES. (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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24715420 ↗
• InjuryOct 27, 2025Break; Break

  SINGAPORE. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2021 PRESENTED DISCOMFORT AND FIRMNESS OVER THE LEFT LATERAL BREAST. AN MRI WAS PERFORMED AND REVEALED AN INTRACAPSULAR RUPTURE IN HER LEFT BREAST. A REVISION SURGERY IS 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

  MAUDE report 23395895 ↗
• InjuryOct 15, 2025Break; Break

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2024, WAS DIAGNOSED WITH AN IMPLANT RUPTURE IN THE RIGHT BREAST AFTER AN MRI. 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: Insufficient Information

  MAUDE report 23292206 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ARGENTINA. IT WAS REPORTED THAT A PATIENT WHO HAD AUGMENTATION SURGERY IN (B)(6) 2025 WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE (BAKER GRADE III/IV) IN BOTH BREAST IMPLANTS. (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 22153943 ↗
• InjuryMar 21, 2025Break; Break

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT IMPLANTED IN (B)(6) 2021, WAS DIAGNOSED WITH A LEFT SIDE IMPLANT RUPTURE THROUGH US AND MRI EXAMINATIONS.

  Patient problems: Insufficient Information

  MAUDE report 21667676 ↗
• InjuryFeb 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  I SWITCHED A PATIENT FROM ALLERGAN (DEFECT) TO MOTIVA ON (B)(6) AND AFTER A RELATIVELY SHORT TIME, SHE DEVELOPED PRONOUNCED CAPSULAR FIBROSIS ON ONE SIDE. I WILL OPERATE THE PATIENT AGAIN IN (B)(6). IT'S ERGONOMIX.

  Patient problems: Capsular Contracture

  MAUDE report 21298482 ↗
• InjuryJan 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SOUTH KOREA. A PATIENT REPORTED EXPERIENCING HARDNESS IN HER LEFT BREAST AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III AFTER EXAMINATION. IS IT UNKNOWN WHETHER THE PATIENT UNDERGONE BREAST IMPLANT REMOVAL SURGERY. NO PATIENT DEMOGRAPHICS, 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: Capsular Contracture

  MAUDE report 21191255 ↗
• InjuryNov 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION SURGERY ON (B)(6) 2022, USING MOTIVA IMPLANTS. FOLLOWING REPORTS OF DISCOMFORT, FURTHER EXAMINATION REVEALED THE DEVELOPMENT OF THIRD-DEGREE CAPSULAR CONTRACTURE (BAKER GRADE III) IN THE LEFT BREAST.

  Patient problems: Capsular Contracture

  MAUDE report 20645331 ↗