Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-425Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07445161010797), received between Nov 14, 2024 and Mar 10, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryMar 10, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2024, PRESENTS WITH HARDNESS, BOTTOMING OUT, AND DEVELOPED A BAKER GRADE IV CAPSULAR CONTRACTURE ON HER RIGHT BREAST. REVISION SURGERY IS SCHEDULED ((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; Ptosis

  MAUDE report 24560294 ↗
• InjuryDec 11, 2025Break; Break

  KOREA. ALLEGEDLY, A PATIENT PRESENTED AN INTRACAPSULAR RUPTURE IN HER RIGHT BREAST. SHE VISITED THE CLINIC COMPLAINING ABOUT BREAST FIRMNESS. ULTRASOUND AND PHYSICAL EXAM WERE PERFORMED, AND A RIGHT BREAST RUPTURE WAS DIAGNOSED. 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

  MAUDE report 23782610 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  KOREA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2022 REQUIRED A REVISION SURGERY DUE TO A BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT 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 23762353 ↗
• InjuryJul 23, 2025Break; Break

  USA. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS IN (B)(6) 2025 PRESENTED FOR AN IMPLANT EXCHANGE. DURING THE IMPLANT EXCHANGE PROCEDURE, THE SURGEON NOTED THAT THE LEFT IMPLANT WAS RUPTURED. AT THIS POINT, THE MAIN REASON FOR THE EXCHANGE PROCEDURE IS UNKNOWN. 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 22577310 ↗
• 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. A REVISION SURGERY WAS REQUIRED. THIS INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 21920633 ↗
• InjuryNov 14, 2024Break; Break

  A PATIENT REPORTED EXPERIENCING BREAST FIRMNESS DISCOMFORT ON HER LEFT BREAST. PHYSICAL EXAMINATION AND ULTRASOUND SURVEILLANCE REVEALED A RUPTURE. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. 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: Insufficient Information

  MAUDE report 20684359 ↗