Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-295QRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07445161012333), received between May 14, 2025 and Feb 3, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Break

  BRAZIL. ALLEGEDLY, THE PATIENT UNDERWENT A RECONSTRUCTION PROCEDURE POST-CANCER USING BREAST IMPLANTS FIVE YEARS AGO. SHE NOW REPORTS HAVING A RUPTURED IMPLANT (SN: (B)(6)). IT IS UNKNOWN WHETHER THIS EVENT IS AFFECTING ONE BREAST OR BOTH, AND THE SERIAL NUMBER INVOLVED. 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 24248076 ↗
• InjuryOct 30, 2025Break; Break

  BRAZIL. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON 2020, PRESENTS PAIN IN HER LEFT BREAST, AFTER AN ECHOGRAPHY, A RUPTURE WAS OBSERVED IN HER LEFT BREAST. EFFORTS TO OBTAIN ADDITIONAL INFORMATION ARE ONGOING.

  Patient problems: Implant Pain

  MAUDE report 23427530 ↗
• InjuryOct 24, 2025Break; Device Appears to Trigger Rejection; Break; Device Appears to Trigger Rejection

  SAUDI ARABIA. ALLEGEDLY, BOTH IMPLANTS WERE REMOVED DUE TO PAIN ON THE LEFT SIDE; THE LEFT IMPLANT HAD A SMALL CUT, AND THE RIGHT IMPLANT WAS TOTALLY RUPTURED. (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: Breast Discomfort/Pain; Insufficient Information

  MAUDE report 23380833 ↗
• InjuryOct 24, 2025Break; Device Appears to Trigger Rejection; Break; Device Appears to Trigger Rejection

  SAUDI ARABIA. ALLEGEDLY, BOTH IMPLANTS WERE REMOVED DUE TO PAIN ON THE LEFT SIDE; THE LEFT IMPLANT HAD A SMALL CUT, AND THE RIGHT IMPLANT WAS TOTALLY RUPTURED. (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: Breast Discomfort/Pain

  MAUDE report 23380832 ↗
• InjurySep 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  BRAZIL. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS, WAS DIAGNOSED WITH ROTATION, CAPSULAR CONTRACTURE BAKER GRADE III AND DEFORMATION ON BOTH BREASTS EXPLANT SURGERY WAS REQUIRED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23022411 ↗
• InjurySep 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  BRAZIL. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS, WAS DIAGNOSED WITH ROTATION, CAPSULAR CONTRACTURE BAKER GRADE III AND DEFORMATION ON BOTH BREASTS EXPLANT SURGERY WAS REQUIRED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 23022410 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  GERMANY. IT WAS REPORTED THAT A PATIENT PRESENTED FOR CONSULTATION IN (B)(6) 2025, REQUESTING AN IMPLANT REPLACEMENT. IN 2020, SHE UNDERWENT AESTHETIC BREAST AUGMENTATION WITH MOTIVA IMPLANTS. SUBSEQUENTLY, SHE EXPERIENCED BILATERAL BOTTOMING OUT, REQUIRING REOPERATION WITHOUT IMPLANT REPLACEMENT (SN (B)(6).

  Patient problems: Ptosis

  MAUDE report 22890094 ↗
• InjuryAug 19, 2025Break; Break

  GERMANY. IT WAS REPORTED THAT A PATIENT PRESENTED FOR CONSULTATION IN (B)(6) 2025, REQUESTING AN IMPLANT REPLACEMENT. IN 2020, SHE UNDERWENT AESTHETIC BREAST AUGMENTATION WITH MOTIVA IMPLANTS. SUBSEQUENTLY, SHE EXPERIENCED BILATERAL BOTTOMING OUT, REQUIRING REOPERATION WITHOUT IMPLANT REPLACEMENT. DURING A ROUTINE CHECKUP, A RUPTURE OF THE RIGHT IMPLANT WAS DISCOVERED (SN (B)(6)).

  Patient problems: Insufficient Information; Ptosis

  MAUDE report 22845821 ↗
• InjuryJul 10, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  MEXICO. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS ON (B)(6) 2022, DEVELOP CAPSULAR CONTRACTURE BAKER GRADE III/IV, INFECTION AND EXTRUSION. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. O PATIENT DEMOGRAPHICS, 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 BEING MADE, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture; Impaired Healing; Unspecified Infection

  MAUDE report 22475254 ↗
• InjuryJul 10, 2025Break; Break

  MEXICO. IT WAS REPORTED THAT PATIENT THAT HAD HER MOTIVA IMPLANTS ON (B)(6) 2024. PATIENT IS SCHEDULED FOR EXCHANGE UNDER AND AT THE MOMENT OF THE SURGERY, THE IMPLANTS WERE FOUND RUPTURED. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 22465756 ↗
• InjuryJul 10, 2025Break; Break

  MEXICO. IT WAS REPORTED THAT PATIENT THAT HAD HER MOTIVA IMPLANTS ON (B)(6) 2024. PATIENT IS SCHEDULED FOR EXCHANGE UNDER AND AT THE MOMENT OF THE SURGERY, THE IMPLANTS WERE FOUND RUPTURED. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 22465753 ↗
• MalfunctionMay 26, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  COLOMBIA. IT WAS REPORTED A PATIENT OPERATED IN (B)(6) 2022. VISITED THE DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH RUPTURE AND BOTTOMING OUT IN LEFT BREAST IMPLANT. 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: Ptosis

  MAUDE report 22084743 ↗
• InjuryMay 14, 2025Break; Break

  TAIWAN. IT WAS REPORTED A PATIENT OPERATED IN (B)(6) 2020; IN (B)(6) 2021 SHE PRESENTED WITH DISCOMFORT AND INCREASED TENDERNESS IN THE LEFT BREAST, AND AN MRI REVEALED THAT THE IMPLANT WAS ROTATED AND DEFORMED. IN (B)(6) 2025 THE DISCOMFORT INCREASED, AND AN ULTRASOUND CONFIRMED RUPTURE OF THE LEFT IMPLANT (SN: (B)(6)). REVISION SURGERY WAS NECESSARY.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22021082 ↗