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

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07445161010575), received between Nov 14, 2024 and Jan 29, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  USA. ALLEGEDLY, THE PATIENT REQUIRED REMOVAL OF THE RIGHT BREAST IMPLANT AT THE END OF OCTOBER DUE TO DEVELOPMENT OF A HEMATOMA. IMPLANT REPLACEMENT IS PLANNED FOR (B)(6), 2026. THE INVESTIGATION IS IN PROGRESS.

  Patient problems: Hematoma

  MAUDE report 24215927 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III/IV IN HER RIGHT BREAST, SHE NOTED THAT HER RIGHT BREAST WAS HIGHER AND HARDNESS THAN THE LEFT ONE. SHE UNDERWENT EXPLANTATION SURGERY. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 23842878 ↗
• 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 HARDNESS, UNNATURAL MOVEMENT, AND DISSATISFACTION WITH THE SHAPE. AN ULTRASOUND WAS PERFORMED, AND THE CAPSULE WAS NOTED. 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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 23783343 ↗
• 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 23783063 ↗
• InjuryMay 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SOUTH KOREA. IT WAS REPORTED A PATIENT OPERATED IN (B)(6) 2024. VISITED THE DOCTOR IN (B)(6) 2024 AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III IN LEFT BREAST IMPLANT (SN: (B)(6). REVISION SURGERY WAS NECESSARY. 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 22084751 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA- IT WAS REPORTED THAT A PATIENT WAS EXPLANTED ON (B)(6) 2025 BECAUSE SHE PRESENTED A HARDENED RIGHT BREAST, REDNESS AND SWELLING. FREE FLUID WAS OBSERVED UPON REMOVAL OF IMPLANTED DEVICE. CULTURES AND BLOOD SAMPLES WERE SENT TO THE LAB.

  Patient problems: Unspecified Infection

  MAUDE report 22071691 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA- IT WAS REPORTED THAT A PATIENT HAD HER BREAST SURGERY AUGMENTATION ON (B)(6) 2025, ON (B)(6) 2025 THE IMPLANT WAS REMOVED BECAUSE AN EARLY SEROMA IN HER RIGHT BREAST. 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: Seroma

  MAUDE report 22070655 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USA- IT WAS REPORTED THAT A PATIENT NOTED HER LEFT BREAST WAS SWOLLEN AND THE DRAINAGE WAS PURULENT. PLANNED FOR EXPLANT WASHOUT ON (B)(6) 2025. NO PATIENTS DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENTS HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Unspecified Infection

  MAUDE report 22044692 ↗
• InjuryMar 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  US. PATIENT IMPLANTED WITH MOTIVA IMPLANTS PRESENTED LEFT IMPLANT PAIN AND HARDNESS. SHE WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III/IV AND WILL HAVE AND EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE BEING MADE AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 21654470 ↗
• InjuryFeb 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  15 MONTHS AFTER BREAST AUGMENTATION SURGERY, THE PATIENT VISITED THE HOSPITAL DUE TO HARDNESS AND SHAPE DEFORMITY OF THE RIGHT BREAST. BASED ON ULTRASOUND AND PHYSICAL EXAMINATION IT WAS DETERMINED THAT THE RIGHT BREAST HAD A CAPSULAR CONTRACTURE (GRADE III). NO PATIENTS DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENTS HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 21374763 ↗
• InjuryJan 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A PATIENT PRESENTED CAPSULAR CONTRACTURE BAKER (GRADE AND SIDE UNKNOWN). SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, 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 21102621 ↗
• InjuryJan 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A PATIENT PRESENTED CAPSULAR CONTRACTURE BAKER (GRADE AND SIDE UNKNOWN). SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, 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 21102619 ↗
• InjuryNov 14, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN, AND EXAMINATION CONFIRMED A RUPTURE ON THE LEFT SIDE. A REOPERATION WAS SUBSEQUENTLY PERFORMED TO EXCHANGE THE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 20687492 ↗
• InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SOUTH KOREA. A PATIENT REPORTED EXPERIENCING HARDENING AND PAIN IN HER LEFT BREAST. PHYSICAL EXAMINATION AN ULTRASOUND REPORT REVEALED CAPSULAR CONTRACTURE BAKER GRADE III. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. NO PATIENT DEMOGRAPHICS, 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 20683795 ↗