Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-285Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07445161010551), received between Apr 25, 2025 and Apr 27, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8 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.

• InjuryApr 27, 2026Device Appears to Trigger Rejection

  KOREA. ALLEGEDLY, THE PATIENT UNDERWENT BREAST AUGMENTATION SURGERY IN (B)(6) 2025 USING A TRANSAXILLARY DUAL-PLANE APPROACH AND WAS SUBSEQUENTLY DIAGNOSED SIX MONTHS LATER WITH BAKER GRADE IV CAPSULAR CONTRACTURE BAKER GRADE IV, PRESENTING WITH SEVERE UPPER POLE FULLNESS AND RIGIDITY. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 25008710 ↗
• 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 24167729 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2024 WAS DIAGNOSED WITH A BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AFTER COMPLAINING OF FIRMNESS, IMMOBILE IMPLANTS, PAIN, AND DISCOMFORT. 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 23762624 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2024 WAS DIAGNOSED WITH A BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AFTER COMPLAINING OF FIRMNESS, IMMOBILE IMPLANTS, PAIN, AND DISCOMFORT. 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 23762622 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA. IT WAS REPORTED A PATIENT OPERATED IN (B)(6) 2025. VISITED THE DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE IN RIGHT BREAST IMPLANT (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 22100522 ↗
• InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA- IT WAS REPORTED THAT A PATIENT COMPLAINED ABOUT HER BREAST FIRMNESS, CAPSULAR CONTRACTURE GRADE III WAS OBSERVED ON HER BOTH BREASTS. LEFT SIDE (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 21922990 ↗
• InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA- IT WAS REPORTED THAT A PATIENT COMPLAINED ABOUT HER BREAST FIRMNESS, CAPSULAR CONTRACTURE GRADE III WAS OBSERVED ON HER BOTH BREASTS. RIGHT SIDE (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 21922932 ↗
• InjuryApr 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA. IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY IN (B)(6) 2023, WAS DIAGNOSED WITH A BAKER III/IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST BN. A REVISION SURGERY WAS REQUIRED. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 21913540 ↗