Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-285QRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07445161012159), received between Dec 5, 2024 and Feb 20, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (4 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.

• InjuryFeb 20, 2026Device Appears to Trigger Rejection

  THAILAND. ALLEGEDLY, HARDNESS AND TENDERNESS IN THE BREASTS, AS WELL AS A HIGH IMPLANT POSITION, WERE OBSERVED DUE TO CAPSULAR CONTRACTURE GRADE III IN THE RIGHT BREAST (SN: (B)(6). A REVISION SURGERY WAS REQUIRED. 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 24404587 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEXICO. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2025, REFERRED PAIN AND PHYSICAL CHANGES IN SKIN TEXTURE IN (B)(6) 2025. A BREAST ULTRASOUND WAS REQUESTED, AND REVEALED A SEROMA ON BOTH BREASTS, PREDOMINATING ON THE RIGHT. ANALGESIC AND ANTIBIOTIC TREATMENT WAS PRESCRIBED, AND 14 DAYS LATER, A NEW ULTRASOUND SHOWED NO CHANGES. THE PATIENT REPORTED PAIN UPON MOVEMENT AND ANATOMICAL CHANGES. AN EXPLORATORY SURGERY WAS PERFORMED, AND A RUPTURE WAS FOUND IN HER RIGHT BREAST (SNS: (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; Seroma

  MAUDE report 23426825 ↗
• InjuryOct 30, 2025Break; Break

  MEXICO. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2025, REFERRED PAIN AND PHYSICAL CHANGES IN SKIN TEXTURE IN (B)(6) 2025. A BREAST ULTRASOUND WAS REQUESTED, AND REVEALED A SEROMA ON BOTH BREASTS, PREDOMINATING ON THE RIGHT. ANALGESIC AND ANTIBIOTIC TREATMENT WAS PRESCRIBED, AND 14 DAYS LATER, A NEW ULTRASOUND SHOWED NO CHANGES. THE PATIENT REPORTED PAIN UPON MOVEMENT AND ANATOMICAL CHANGES. AN EXPLORATORY SURGERY WAS PERFORMED, AND A RUPTURE WAS FOUND IN HER RIGHT BREAST SN'S (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; Seroma

  MAUDE report 23426824 ↗
• InjuryMay 6, 2025Break; Break

  UNITED ARAB EMIRATES. IT WAS REPORTED THAT A PATIENT, APPROXIMATELY 3 MONTHS POST SURGERY NOTED AN ALTERATION ON SHAPE AND SIZE ON HER RIGHT BREAST. SHE WAS DIAGNOSED WITH A RUPTURE AND WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, SUCH AS 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 21972112 ↗
• InjuryMay 6, 2025Break; Break

  UKRAINE. IT WAS REPORTED THAT A PATIENT OPERATED ON IN 2019 REQUIRED A REVISION SURGERY IN 2025 AS SHE WAS DIAGNOSED WITH A RUPTURE OF THE LEFT IMPLANT DURING A ROUTINE HEALTH CHECK-UP. NO PATIENT DEMOGRAPHICS, SUCH AS 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 21971598 ↗
• InjuryDec 5, 2024Break; Device Appears to Trigger Rejection; Break; Device Appears to Trigger Rejection

  THE RUPTURE WAS DISCOVERED DURING THE EXPLANTATION SURGERY, AND THE EXPLANTATION WAS CAUSED BY A CAPSULAR CONTRACTURE. 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: Capsular Contracture

  MAUDE report 20855827 ↗