Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-375Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07445161010773), received between Nov 14, 2024 and Dec 22, 2025 — classified as 11 injuries.

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

• InjuryDec 22, 2025Break; Break

  SOUTH KOREA. ALLEGEDLY, A PATIENT COMPLAINED OF BREAST DISCOMFORT, THE EXAMINATION SHOWED A SUSPECTED RUPTURE OF THE LEFT BREAST IMPLANT, UPON PHYSICAL AND ULTRASONOGRAPHIC EXAMINATION, A RUPTURE OF LEFT BREAST IMPLANT WAS CONFIRMED. THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Discomfort

  MAUDE report 23871073 ↗
• 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 23783320 ↗
• InjuryDec 11, 2025Break; Break

  KOREA. ALLEGEDLY, 3 YEARS AND 1 MONTH AFTER AUGMENTATION, THE PATIENT PRESENTED TO THE CLINIC COMPLAINING OF FIRMNESS IN BOTH BREASTS. FOLLOWING PHYSICAL EXAMINATION AND ULTRASONOGRAPHIC ASSESSMENT, A RUPTURE OF THE RIGHT BREAST IMPLANT WAS IDENTIFIED. (SN: (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

  MAUDE report 23782487 ↗
• InjuryDec 11, 2025Break; Break

  SOUTH KOREA. ALLEGEDLY, A PATIENT WAS DIAGNOSED WITH A DEVICE RUPTURE OF HER LEFT BREAST. 22 MONTHS POST OP, THE PATIENT VISITED THE CLINIC DUE TO SHAPE DEFORMATION, BASED ON ULTRASOUND AND EXAMINATION, IT WAS DETERMINED THAT THE LEFT IMPLANT HAD RUPTURED. 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 23782410 ↗
• InjuryDec 9, 2025Break; Break

  ARGENTINA. ALLEGEDLY, DURING A SURGICAL PROCEDURE PERFORMED TO REVISE THE SCAR, THE SURGEON DISCOVERED THAT THE BREAST IMPLANT APPEARED TORN/RUPTURED. HE STATED THAT NO SHARP INSTRUMENTS HAD CONTACT WITH THE IMPLANT AND THAT NO REPLACEMENT IMPLANT HAD BEEN PLANNED, AS THE PROCEDURE WAS INTENDED ONLY TO ADDRESS THE SCAR (SN: (B)(6)). A REVISION SURGERY IS SCHEDULED. 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 23762180 ↗
• InjuryNov 26, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  AUSTRALIA. ALLEGEDLY, A PATIENT WHO RECEIVED MOTIVA IMPLANTS IN (B)(6) 2025 DEVELOPED AN INFECTION ON THE RIGHT SIDE WHILE SHE WAS STILL IN THE HOSPITAL. IN (B)(6), IT WAS DECIDED TO TAKE THE PATIENT BACK TO THE THEATRE TO DO A WASHOUT, AND DURING THE PROCEDURE, THE IMPLANT WAS FOUND TO BE RUPTURED AS AN INCIDENTAL FINDING. 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 23660784 ↗
• InjuryJan 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT VISITED THE CLINIC WITH COMPLAINTS OF FIRMNESS IN THE RIGHT BREAST. SUBSEQUENT ULTRASOUND EXAMINATION CONFIRMED THE PRESENCE OF CAPSULAR CONTRACTURE. THE PATIENT LATER UNDERWENT REVISION SURGERY TO ADDRESS THE CONDITION.

  Patient problems: Capsular Contracture

  MAUDE report 21056833 ↗
• InjuryNov 15, 2024Break; Break

  POSTOPERATIVE TWO YEARS AND FOUR MONTHS. PATIENT VISITED THE CLINIC COMPLAINING ABOUT DISCOMFORT FITNESS ON HER BILATERAL BREASTS. RUPTURE WAS DIAGNOSED ON HER BREASTS AFTER PHYSICAL EXAMINATION AND ULTRASONOGRAPHICAL SURVEILLANCE. 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 20694771 ↗
• InjuryNov 15, 2024Break; Break

  POSTOPERATIVE TWO YEARS AND FOUR MONTHS. PATIENT VISITED THE CLINIC COMPLAINING ABOUT DISCOMFORT FITNESS ON HER BILATERAL BREASTS. RUPTURE WAS DIAGNOSED ON HER BREASTS AFTER PHYSICAL EXAMINATION AND ULTRASONOGRAPHICAL SURVEILLANCE. 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 20694592 ↗
• InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HARDNESS AND PAIN IN BOTH BREASTS. AN ULTRASOUND EXAMINATION CONFIRMED A DIAGNOSIS OF GRADE 3 CAPSULAR CONTRACTURE, LEADING TO THE DECISION TO PROCEED WITH REOPERATION. LEFT SIDE

  Patient problems: Capsular Contracture

  MAUDE report 20691310 ↗
• InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HARDNESS AND PAIN IN BOTH BREASTS. AN ULTRASOUND EXAMINATION CONFIRMED A DIAGNOSIS OF GRADE 3 CAPSULAR CONTRACTURE, LEADING TO THE DECISION TO PROCEED WITH REOPERATION. RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20691249 ↗