Motiva® SmoothSilk® Round Breast Implant RSF-315+Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07445161002082), received between Nov 11, 2024 and Feb 26, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Break

  SOUTH AFRICA. ALLEGEDLY, THE PATIENT REPORTED RIGHT-BREAST PAIN. THERE WAS NO HISTORY OF TRAUMA. ULTRASOUND EXAMINATION CONFIRMED AN INTRACAPSULAR IMPLANT LEAK 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

  MAUDE report 24462297 ↗
• InjuryFeb 9, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A BILATERAL BAKER GRADE III/IV CAPSULAR CONTRACTURE (SNS: (B)(6)/ (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: Capsular Contracture

  MAUDE report 24292376 ↗
• InjuryJan 23, 2026Device Appears to Trigger Rejection

  USA (NO NATIVE). ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) DEVELOPED A BAKER GRADE IV CAPSULAR CONTRACTURE IN THE RIGHT BREAST AND A BAKER GRADE III IN THE LEFT SIDE. A REVISION SURGERY WAS PERFORMED. THE IDENTIFICATION DETAILS OF THE SECOND DEVICE HAVE NOT BEEN PROVIDED. 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 24167440 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAUDI ARABIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT SURGERY. POSTOPERATIVELY, BLEEDING OCCURRED FROM THE DRAINAGE HOLES, AND AFTER TUBE REMOVAL, INTERNAL BLEEDING PERSISTED, REQUIRING A SECOND SURGERY 10 DAYS LATER TO IDENTIFY THE CAUSE AND STOP THE BLEEDING. THE DOCTOR CHOSE NOT TO REMOVE THE IMPLANTS TO ALLOW THE BODY TIME TO ADAPT (SN INVOLVED AND SIDE AFFECTED WERE NOT SPECIFIED). 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; Hemorrhage/Blood Loss/Bleeding; Infiltration into Tissue; Physical Asymmetry; Wrinkling

  MAUDE report 22829958 ↗
• InjuryJun 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA- IT WAS REPORTED THAT A PATIENT HAD HER BREAST SURGERY AUGMENTATION ON (B)(6) 2025 AND WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE IN HER RIGHT BREAST (GRADE UNKNOWN). THE EXPLANT SURGERY WAS PERFORMED ON (B)(6) 2025. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE AND THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 22128411 ↗
• InjuryMar 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA- PATIENT WITH MOTIVA IMPLANTS PRESENTED AN UNILATERAL RIGHT SIDE SEROMA AS A RESULT OF SOME TRAUMA WHICH LIKELY CAUSED CAPSULAR CONTRACTURE BAKER GRADE III. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY AND REPLACEMENT OF THE 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: Capsular Contracture; Seroma

  MAUDE report 21646549 ↗
• InjuryNov 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT DR. (B)(6) EVALUATED A PATIENT WITH CAPSULAR CONTRACTURE WHO HAD PREVIOUSLY RECEIVED MOTIVA IMPLANTS IN TURKEY. THE PATIENT EXPRESSED INTEREST IN AN IMPLANT EXCHANGE AND REIMPLANTATION OF MOTIVA IMPLANTS. RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20658344 ↗
• InjuryNov 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT DR. (B)(6) EVALUATED A PATIENT WITH CAPSULAR CONTRACTURE WHO HAD PREVIOUSLY RECEIVED MOTIVA IMPLANTS IN TURKEY. THE PATIENT EXPRESSED INTEREST IN AN IMPLANT EXCHANGE AND REIMPLANTATION OF MOTIVA IMPLANTS. LEFT SIDE

  Patient problems: Capsular Contracture

  MAUDE report 20658239 ↗