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

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07445161012166), received between Jan 9, 2025 and May 19, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Device Appears to Trigger Rejection

  LOCATION: (B)(6). ALLEGEDLY, A PATIENT REQUIRED A REVISION SURGERY DUE TO A BAKER GRADE III/IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 25219455 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  MÉXICO. ALLEGEDLY, A PATIENT IMPLANTED IN (B)(6) 2026 PRESENTED AN INFECTION ON THE LEFT SIDE, AND THE IMPLANT WAS SUBSEQUENTLY REMOVED. THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Unspecified Infection

  MAUDE report 24651123 ↗
• InjuryMar 18, 2026Break

  BELARUS. ALLEGEDLY, THE PATIENT UNDERWENT THE INITIAL BREAST IMPLANT SURGERY IN (B)(6) 2020. IN (B)(6) 2026, AN ULTRASOUND EXAMINATION DETECTED A RUPTURE OF THE LEFT IMPLANT, AND DURING SURGERY, THE RUPTURE OF BOTH IMPLANTS WAS CONFIRMED. IN (B)(6) 2026, BOTH IMPLANTS WERE REPLACED WITH MOTIVA IMPLANTS (SN: (B)(6)).

  Patient problems: Insufficient Information

  MAUDE report 24630070 ↗
• InjuryMar 18, 2026Break

  (B)(6). ALLEGEDLY, THE PATIENT UNDERWENT THE INITIAL BREAST IMPLANT SURGERY IN (B)(6) 2020. IN (B)(6) 2026, AN ULTRASOUND EXAMINATION DETECTED A RUPTURE OF THE LEFT IMPLANT, AND DURING SURGERY, THE RUPTURE OF BOTH IMPLANTS WAS CONFIRMED. IN (B)(6) 2026, BOTH IMPLANTS WERE REPLACED WITH MOTIVA IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 24627499 ↗
• InjuryFeb 9, 2026Device Appears to Trigger Rejection

  AUSTRALIA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN JULY 2025 REQUIRED A REVISION SURGERY DUE TO A BAKER GRADE III CAPSULAR CONTRACTURE AND IMPLANT DISPLACEMENT 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: Capsular Contracture

  MAUDE report 24292728 ↗
• InjuryDec 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  TAIWAN. ALLEGEDLY, THE PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION SURGERY IN (B)(6) 2024. POSTOPERATIVELY, SHE NOTICED AN ELEVATION DIFFERENCE BETWEEN THE BREASTS. DESPITE PERFORMING REGULAR MASSAGE AS INSTRUCTED, THE PATIENT WAS DIAGNOSED WITH BAKER¿S GRADE IV CAPSULAR CONTRACTURE (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 23914444 ↗
• InjuryDec 9, 2025Break; Break

  AUSTRALIA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION IN (B)(6) 2025 WAS DIAGNOSED WITH A DEVICE RUPTURE IN THE RIGHT BREAST AFTER EXPERIENCING REDNESS AND PAIN. AN ULTRASOUND CONFIRMED THE RUPTURE, AND A PATHOLOGY STUDY REVEALED AN INFECTION. 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: Insufficient Information; Unspecified Infection

  MAUDE report 23761964 ↗
• InjuryJul 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  CHINA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AUGMENTATION SURGERY IN (B)(6) 2024 DEVELOPED PAIN AND PROGRESSIVE HARDENING IN BOTH BREASTS. AFTER BEING DIAGNOSED WITH A BAKER GRADE III CAPSULAR CONTRACTURE HAD A REMOVAL SURGERY 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: Capsular Contracture

  MAUDE report 22385421 ↗
• InjuryJun 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  TAIWAN. IT WAS REPORTED A PATIENT WHO UNDERWENT SURGERY IN (B)(6) 2024. VISITED THE DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS (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 22179545 ↗
• InjuryJun 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  TAIWAN. IT WAS REPORTED A PATIENT WHO UNDERWENT SURGERY IN (B)(6) 2024. VISITED THE DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS (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 22179536 ↗
• InjuryJan 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A UNILATERAL REVISION SURGERY WAS PERFORMED DUE TO A CAPSULAR CONTRACTURE BAKER GRADE III. THE EXACT OCCURRENCE DATE WAS NOT PROVIDED. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Contracture

  MAUDE report 21118714 ↗