Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-320QRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07445161012173), received between Oct 31, 2024 and Apr 21, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Device Appears to Trigger Rejection

  TAIWAN. ALLEGEDLY, THE PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION SURGERY ON (B)(6), 2021. FOLLOWING THE INITIAL PROCEDURE, SHE WAS CLINICALLY DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III AFFECTING THE LEFT BREAST. A REVISION SURGICAL PROCEDURE HAS BEEN RECOMMENDED; HOWEVER, THE DATE OF THE REVISION SURGERY REMAINS PENDING CONFIRMATION (SN: (B)(6)). NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER.

  Patient problems: Capsular Contracture

  MAUDE report 24942541 ↗
• InjuryMar 16, 2026Device Appears to Trigger Rejection

  THAILAND. ALLEGEDLY, CAPSULAR CONTRACTURE BAKER GRADE III WAS IDENTIFIED ON THE LEFT SIDE, AND NO EXPLANT SURGERY HAS BEEN 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 24613718 ↗
• InjuryFeb 26, 2026Break

  AUSTRALIA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2022 WAS DIAGNOSED WITH AN IMPLANT RUPTURE IN HER LEFT 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: Insufficient Information

  MAUDE report 24462041 ↗
• InjuryJul 1, 2025Break; Break

  SINGAPORE. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS IN (B)(6) 2023 HAD AN MRI AND WAS DIAGNOSED WITH A RIGHT BREAST IMPLANT RUPTURE (SN (B)(6). THE REMOVAL SURGERY WAS PERFORMED IN (B)(6) 2025. 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 22373452 ↗
• InjuryJun 24, 2025Break; Break

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO HAD AUGMENTATION SURGERY IN (B)(6) 2019 WAS DIAGNOSED WITH AN IMPLANT RUPTURE IN HER RIGHT BREAST (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: Insufficient Information

  MAUDE report 22320510 ↗
• InjuryMay 14, 2025Break; Break

  AUSTRALIA. IT WAS REPORTED THAT A PATIENT WHO HAD AUGMENTATION SURGERY IN (B)(6) 2019 WAS DIAGNOSED IN (B)(6) 2025 WITH A DEVICE RUPTURE AFTER AN MRI SCAN. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023298 ↗
• InjuryMay 6, 2025Break; Break

  TAIWAN. IT WAS REPORTED THAT A PATIENT WAS OPERATED IN (B)(6) 2023. SHE HAD A REVISION SURGERY IN (B)(6) 2025 BECAUSE OF A MALPOSITION OF THE LEFT IMPLANT; DURING THE SURGERY, IT WAS NOTICED THAT THE IMPLANT WAS RUPTURED (SN: (B)(6)).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21968611 ↗
• InjuryFeb 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  I SWITCHED A PATIENT FROM ALLERGAN (DEFECT) TO MOTIVA ON OCTOBER 24 AND AFTER A RELATIVELY SHORT TIME, SHE DEVELOPED PRONOUNCED CAPSULAR FIBROSIS ON ONE SIDE. I WILL OPERATE THE PATIENT AGAIN IN MARCH. IT'S ERGONOMIX.

  Patient problems: Capsular Contracture

  MAUDE report 21298494 ↗
• InjuryJan 28, 2025Break; Break

  MEXICO. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED LEFT-SIDED RUPTURE ACCORDING TO MRI EXAMINATION. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY, BUT IS IS UNKNOWN IS SHE WAS EXPLANTED YET. NO PATIENT DEMOGRAPHICS, SUCH AS 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: Insufficient Information

  MAUDE report 21252325 ↗
• InjuryOct 31, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE OF THE LEFT-SIDE IMPLANT

  Patient problems: Insufficient Information

  MAUDE report 20577155 ↗