Motiva® SmoothSilk® Round Breast Implant RSF-355+Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07445161002105), received between Jan 17, 2025 and Apr 30, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Break

  ARGENTINA. ALLEGEDLY, IN MARCH, A PATIENT UNDERWENT IMPLANTATION SURGERY. A FEW DAYS AFTER THE PROCEDURE, ONE OF THE IMPLANTS BECAME EXPOSED. DUE TO THIS COMPLICATION, THE TREATING PHYSICIAN DECIDED TO REINTERVENE SURGICALLY TO EVALUATE THE SITUATION. DURING THE SURGICAL PROCEDURE, BOTH IMPLANTS WERE REMOVED FOR ASSESSMENT. UPON INSPECTION, IT WAS CONFIRMED THAT THE IMPLANT IN THE RIGHT BREAST WAS RUPTURED, WITH SERIAL NUMBER 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: Wound Dehiscence

  MAUDE report 25046489 ↗
• InjuryFeb 3, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, THE PATIENT DEVELOPED BILATERAL CAPSULAR CONTRACTURE. THE BAKER GRADE IS CURRENTLY UNKNOWN. REVISION SURGERY WAS REQUIRED. THE INVESTIGATION IS STILL IN PROCESS.

  Patient problems: Capsular Contracture

  MAUDE report 24247543 ↗
• InjuryFeb 3, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, THE PATIENT DEVELOPED BILATERAL CAPSULAR CONTRACTURE. THE BAKER GRADE IS CURRENTLY UNKNOWN. REVISION SURGERY WAS REQUIRED. THE INVESTIGATION IS STILL IN PROCESS.

  Patient problems: Capsular Contracture

  MAUDE report 24247275 ↗
• InjuryOct 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  VENEZUELA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2024 WAS DIAGNOSED WITH A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE AND IMPLANT ROTATION IN THE 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: Capsular Contracture

  MAUDE report 23380494 ↗
• InjuryOct 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  VENEZUELA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2024 WAS DIAGNOSED WITH A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE AND IMPLANT ROTATION IN THE 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: Capsular Contracture

  MAUDE report 23380487 ↗
• InjuryOct 20, 2025Break; Break

  BRAZIL. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2021, PRESENTED PAIN IN HER RIGHT BREAST. AN MRI WAS PERFORMED, AND AN INTRACAPSULAR DEVICE RUPTURE IN HER RIGHT BREAST WAS FOUND. 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 23341600 ↗
• InjuryMar 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  CHILE- PATIENT PRESENTED PAIN AND ASYMMETRY ON HER RIGHT BREAST AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III ACCORDING TO ULTRASOUND FINDINGS. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. NO 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 WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 21567116 ↗
• InjuryJan 17, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BOTTOMING OUT AND DEVICE DEFORMATION ON THE RIGHT SIDE. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Contracture; Wrinkling

  MAUDE report 21180775 ↗