Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07445161010780), received between Jan 2, 2025 and Mar 9, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY IN (B)(6) 2026 COMPLAINED ABOUT PAIN AND SKIN SAGGING, THE DOCTORS DIAGNOSED HER WITH A CAPSULAR CONTRACTURE BAKER GRADE IV ON HER RIGHT BREAST (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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24553635 ↗
• InjuryJan 22, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT COMPLAINED ABOUT A CHANGE IN FIRMNESS IN BOTH BREASTS, MAINLY ON THE LEFT SIDE, WITH PAIN AND SWELLING. A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE WAS DIAGNOSED ((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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24148054 ↗
• InjuryJan 22, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT COMPLAINED ABOUT A CHANGE IN FIRMNESS IN BOTH BREASTS, MAINLY ON THE LEFT SIDE, WITH PAIN AND SWELLING. A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE WAS DIAGNOSED (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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24148045 ↗
• InjuryDec 18, 2025Break; Break

  KOREA. ALLEGEDLY, TWO YEARS AND SIX MONTHS POSTOPERATIVELY, THE PATIENT VISITED THE CLINIC COMPLAINING OF DISCOMFORT. AN INTRACAPSULAR RUPTURE OF THE RIGHT BREAST IMPLANT WAS DIAGNOSED FOLLOWING PHYSICAL EXAMINATION AND ULTRASONOGRAPHIC EVALUATION. THE INVESTIGATION IS IN PROGRESS.

  Patient problems: Discomfort

  MAUDE report 23845951 ↗
• InjuryMay 22, 2025Break; Break

  KOREA. IT WAS REPORTED A PATIENT OPERATED IN (B)(6) 2023. VISITED THE DOCTOR IN (B)(6)2025 AND WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT (SN: (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 22071045 ↗
• InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA. IT WAS REPORTED THAT A PATIENT WHO HAD A SECONDARY AUGMENTATION IN (B)(6) 2023 FELT HER BREASTS HARD TWO MONTHS AFTER SURGERY. SIX MONTHS AFTER SURGERY WAS DIAGNOSED WITH A BILATERAL BAKER III CAPSULAR CONTRACTURE (SNS: (B)(6)). A REVISION SURGERY WAS REQUIRED. THIS INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 21920629 ↗
• InjuryJan 2, 2025Break; Patient-Device Incompatibility; Break; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED UNILATERAL RIGHT IMPLANT RUPTURE WITH SUBSEQUENT FORMATION OF SILICONOMAS. 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 ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Granuloma

  MAUDE report 21061105 ↗