Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-315QRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07445161012340), received between Oct 22, 2024 and Aug 4, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Device Appears to Trigger Rejection

  Brazil. It was alleged that approximately three months after surgery, the patient developed a deformity of the left breast in the upper outer quadrant. It was further alleged that asymmetry of the inframammary fold was observed, prompting a bilateral breast MRI. Left breast implant was found to be ruptured. The investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130857 ↗
• InjuryMay 25, 2026Device Appears to Trigger Rejection

  MEXICO. ALLEGEDLY, A PHYSICAL EXAMINATION OF BOTH BREASTS WAS PERFORMED, REVEALING INCREASED PROJECTION AND FIRMNESS IN THE RIGHT BREAST, CAPSULAR CONTRACTURE BAKER GRADE III WAS CONFIRMED. SHE UNDERWENT AN EXPLANTATION SURGERY. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 25272681 ↗
• InjuryMar 4, 2026Device Appears to Trigger Rejection

  THAILAND. ALLEGEDLY, THE PATIENT IS EXPERIENCING A CAPSULAR CONTRACTURE BAKER GRADE III (SN: (B)(6)). A REVISION SURGERY IS RECOMMENDED. 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 24512434 ↗
• InjurySep 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ARGENTINA. IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION IN (B)(6) 2024. AT THE 9-MONTH FOLLOW-UP VISIT ((B)(6) 2025), CLINICAL EVALUATION SHOWED HARDENING OF BOTH IMPLANTS, CONSISTENT WITH CAPSULAR CONTRACTURE. THE CONDITION WAS TREATED WITH CORTICOSTEROIDS FOR 15 DAYS AND MONTELUKAST FOR 8 WEEKS, WITHOUT IMPROVEMENT. THE PATIENT WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III/IV. 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 23067040 ↗
• InjuryOct 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THREE MONTHS POST PRIMARY AUGMENTATION, THE PATIENT DEVELOPED A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. 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 WITH CAPSULE.

  Patient problems: Capsular Contracture

  MAUDE report 20511224 ↗
• InjuryOct 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THREE MONTHS POST PRIMARY AUGMENTATION, THE PATIENT DEVELOPED A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. 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: Capsular Contracture

  MAUDE report 20510400 ↗