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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07445161012388), received between Nov 7, 2024 and May 21, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THAILAND. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AUGMENTATION SURGERY IN (B)(6) 2025 WAS DIAGNOSED WITH A BAKER III/IV CAPSULAR CONTRACTURE IN HER LEFT BREAST (SN (B)(6) DUE TO AN ABNORMAL HARNESS AND AN UPPER POSITION. A REVISION SURGERY IS PLANNED. 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 22064368 ↗
• InjuryFeb 19, 2025Increased Sensitivity; Increased Sensitivity

  IN (B)(6), PATIENT HAD A BREAST AUGMENTATION USING MOTIVA IMPLANTS. STARTED GETTING DISCOMFORT IN THE LEFT BREAST, FEELING TIGHT, FOREIGN, AND FIRMER THAN THE RIGHT. THE RIGHT ONE FELT NATURAL AND COMFORTABLE. AFTER CAREFUL CONSIDERATION AND HEALTH PROBLEMS, PATIENT DECIDED TO GET THEM OUT. WHEN THEY WERE GETTING TAKEN OUT, THE LEFT ONE WAS STILL INTACT HOWEVER, IT WAS THE ONE THAT WAS CAUSING DISCOMFORT IN THE FIRST PLACE. 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: Discomfort

  MAUDE report 21412283 ↗
• InjuryFeb 19, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2017, PATIENT HAD A BREAST AUGMENTATION USING MOTIVA IMPLANTS. STARTED GETTING DISCOMFORT IN THE LEFT BREAST, FEELING TIGHT, FOREIGN, AND FIRMER THAN THE RIGHT. THE RIGHT ONE FELT NATURAL AND COMFORTABLE. AFTER CAREFUL CONSIDERATION AND HEALTH PROBLEMS, PATIENT DECIDED TO GET THEM OUT. WHEN THEY WERE GETTING TAKEN OUT, THE RIGHT ONE WAS RUPTURED, AND THE LEFT ONE WAS STILL INTACT HOWEVER, IT WAS THE ONE THAT WAS CAUSING DISCOMFORT IN THE FIRST PLACE. 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: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 21411205 ↗
• InjuryNov 7, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT REQUESTED EXPLANTATION OF THE LEFT IMPLANT DUE TO A RUPTURE.

  Patient problems: Insufficient Information

  MAUDE report 20632453 ↗