Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07445161010568), received between Apr 23, 2025 and Apr 28, 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.

• InjuryApr 28, 2026Device Appears to Trigger Rejection

  KOREA. ALLEGEDLY, THE PATIENT UNDERWENT BREAST AUGMENTATION SURGERY IN JUNE 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 25022001 ↗
• InjuryMar 30, 2026Improper or Incorrect Procedure or Method; Device Handling Problem

  UNITED STATES. IT WAS REPORTED THAT A PATIENT EXPERIENCED CAPSULAR CONTRACTURE AND QUALIFIED FOR COVERAGE. AN INCORRECT IMPLANT WAS REPORTEDLY PROVIDED TO THE PRACTICE FOR THE REPLACEMENT PROCEDURE. THE DISCREPANCY IN IMPLANT SIZE WAS NOT IDENTIFIED PRIOR TO IMPLANTATION, AND AN IMPLANT OF UNINTENDED SIZE WAS IMPLANTED. AS A RESULT, THE PATIENT REPORTEDLY UNDERWENT A REOPERATION TWO DAYS LATER. THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 24736016 ↗
• InjuryFeb 13, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2025 COMPLAINED ABOUT PAIN AND TIGHTNESS IN HER LEFT BREAST. A CAPSULAR CONTRACTURE BAKER GRADE III WAS DIAGNOSED IN HER LEFT BREAST (B)(6). A REVISION SURGERY IS SCHEDULED. 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 24338216 ↗
• InjuryJan 19, 2026Device Appears to Trigger Rejection

  US. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 WAS DIAGNOSED WITH A BAKER III CAPSULAR CONTRACTURE IN HER LEFT BREAST. A REVISION SURGERY IS SCHEDULED. 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 24109126 ↗
• InjuryDec 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SOUTH KOREA. ALLEGEDLY, A PATIENT DEVELOPED A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE; SHE COMPLAINED ABOUT BREAST FIRMNESS. A REVISION SURGERY WAS REQUIRED. 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 23783061 ↗
• InjuryDec 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT PRESENTS A CAPSULAR CONTRACTURE BAKER GRADE III IN HER LEFT BREAST. SHE HASN'T UNDERGONE EXPLANTATION YET. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 23782956 ↗
• InjuryOct 30, 2025Break; Break

  ARGENTINA. IT WAS REPORTED THAT, DURING A REVISION SURGERY FOR LEFT-BREAST SKIN NECROSIS, THE IMPLANT WAS FOUND RUPTURED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Necrosis

  MAUDE report 23425874 ↗
• InjuryOct 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE IV IN HER RIGHT BREAST. A REVISION SURGERY WAS REQUIRED. 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 23379646 ↗
• InjurySep 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. IT WAS REPORTED THAT A PATIENT WHO HAD MOTIVA IMPLANTS IN (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III IN HER RIGHT BREAST. A REMOVAL SURGERY WAS REQUIRED. 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 22980461 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA- IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION SURGERY ON (B)(6) 2025. FOLLOWING THE PROCEDURE, SHE WAS DIAGNOSED WITH AN INFECTION IN HER LEFT BREAST. AN EXPLANT SURGERY WAS PERFORMED ON (B)(6) 2025, AND THE PATIENT WAS SUBSEQUENTLY REIMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21894642 ↗
• InjuryApr 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA - IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY IN (B)(6) 2024, VISITED HER DOCTOR THREE YEARS AFTER COMPLAINING OF BREAST FIRMNESS. A CAPSULAR CONTRACTURE BAKER GRADE III WAS DIAGNOSED. A REVISION SURGERY WAS REQUIRED.

  Patient problems: Capsular Contracture

  MAUDE report 21892761 ↗
• InjuryApr 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA - IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY IN (B)(6) 2024, VISITED HER DOCTOR THREE YEARS AFTER COMPLAINING OF BREAST FIRMNESS. A CAPSULAR CONTRACTURE BAKER GRADE III WAS DIAGNOSED. A REVISION SURGERY WAS REQUIRED.

  Patient problems: Capsular Contracture

  MAUDE report 21892458 ↗