Motiva® SmoothSilk® Round Breast Implant RSF-425+QRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07445161002938), received between Dec 2, 2024 and May 5, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Break

  COLOMBIA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2023, HAD AND ULTRASOUND AND MRI THAT REVEALS SILICONOMAS AND DEVICE RUPTURE ON HER LEFT BREAST. REVISION SURGERY WAS PERFORMED. THE INVESTIGATION IS IN PROCESS.

  Patient problems: Granuloma; Swollen Lymph Nodes/Glands

  MAUDE report 25087648 ↗
• InjuryMar 18, 2026Device Appears to Trigger Rejection

  COLOMBIA. ALLEGEDLY, THE PATIENT WAS IMPLANTED IN (B)(6) 2023 AND LATER DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24628327 ↗
• InjuryMar 18, 2026Device Appears to Trigger Rejection

  COLOMBIA. ALLEGEDLY, THE PATIENT WAS IMPLANTED IN OCTOBER 2023 AND LATER DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24627660 ↗
• InjuryMar 9, 2026Device Appears to Trigger Rejection

  ARGENTINA. ALLEGEDLY, THE PATIENT WAS IMPLANTED IN (B)(6) 2025 AND PRESENTED WITH A BAKER GRADE IV CAPSULAR CONTRACTURE, ACCOMPANIED BY PAIN IN BOTH BREASTS. (SN: (B)(6)). REVISION SURGERY 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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24553432 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MÉXICO. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY PRESENTED WITH BREAST IMPLANT EXPOSURE FOLLOWING SPONTANEOUS SEROMA DRAINAGE CONFIRMED BY ULTRASOUND FIVE WEEKS POST-OP (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: Impaired Healing; Seroma

  MAUDE report 23559671 ↗
• InjuryOct 15, 2025Break; Break

  (B)(6). IT WAS REPORTED THAT A PATIENT WHO LIVES IN (B)(6) HAD AN AUGMENTATION MAMMOPLASTY IN (B)(6) ON (B)(6) 2025. SHE NOTICED A CHANGE IN THE SHAPE AND PAIN IN HER LEFT BREAST. AFTER EXAMINATION AND AN ULTRASOUND, SHE WAS DIAGNOSED WITH AN IMPLANT RUPTURE IN HER LEFT 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: Breast Discomfort/Pain; Insufficient Information

  MAUDE report 23280875 ↗
• InjuryJun 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DOMINICAN REPUBLIC. IT WAS REPORTED A PATIENT WHO UNDERWENT SURGERY IN (B)(6) 2023. VISITED THE DOCTOR IN (B)(6) 2024 AND WAS DIAGNOSED WITH BOTH BREASTS ARE DEFORMED, THE LEFT ONE WITH CONTRACTURE, AND THEY ARE NOT SYMMETRICAL WITH EACH OTHER. (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: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22137501 ↗
• InjuryJan 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A PATIENT PREVIOUSLY OPERATED ON BY ANOTHER SURGEON SOUGHT CONSULTATION DUE TO PAIN IN THE RIGHT BREAST. UPON PHYSICAL EXAMINATION, THE PATIENT EXHIBITED TENDERNESS ON PALPATION, INCREASED FIRMNESS COMPARED TO THE LEFT BREAST, AND GREATER PROJECTION IN THE AFFECTED AREA. A DIAGNOSIS OF GRADE III CAPSULAR CONTRACTURE WAS MADE FOR THE RIGHT BREAST.

  Patient problems: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 21079912 ↗
• InjuryDec 2, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  PATIENT SHOWED UP TO CONSULTATION WITH EXPOSURE OF THE IMPLANT THROUGH THE INFRAMAMMARY WOUND. A 1 CM RUPTURE WAS VISUALIZED IN THE INFERIOR POLE OF THE IMPLANT. SHE REPORTED TWO DAYS WITH EXPOSURE AND WAS SCHEDULED FOR EXPLANTATION SURGERY AND IMPLANT EXCHANGE. 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: Impaired Healing

  MAUDE report 20824846 ↗