Motiva® SmoothSilk® Round Breast Implant RSF-400+Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07445161002129), received between Dec 11, 2024 and May 5, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III ON HER LEFT BREAST, AN EXPLANTATION SURGERY HAS BEEN SCHEDULED. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 25083424 ↗
• InjuryMar 23, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION WITH MOTIVA IMPLANTS, PRESENTED BILATERAL GRADE III CAPSULAR CONTRACTURE, CHARACTERIZED BY SIGNIFICANT FIRMNESS AND VISIBLE BREAST DISTORTION. REVISION SURGERY WAS REQUIRED. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24669948 ↗
• InjuryMar 23, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION WITH MOTIVA IMPLANTS, PRESENTED BILATERAL GRADE III CAPSULAR CONTRACTURE, CHARACTERIZED BY SIGNIFICANT FIRMNESS AND VISIBLE BREAST DISTORTION. REVISION SURGERY WAS REQUIRED. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24669945 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST (SN (B)(6)). A REVISION SURGERY WAS PERFORMED. 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 24211083 ↗
• InjuryJan 26, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST. SHE PRESENTED WITH PAIN CAUSED BY THE CAPSULE; REVISION SURGERY IS REQUIRED (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; Capsular Contracture

  MAUDE report 24178898 ↗
• InjurySep 17, 2025Break; Break

  SOUTH AFRICA. IT WAS REPORTED THAT A PATIENT WHO HAD HER MOTIVA IMPLANTS ON (B)(6) 2022, WAS DIAGNOSED WITH A RIGHT BREAST IMPLANT RUPTURE. AN EXPLANT SURGERY WAS REQUIRED. THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 23078402 ↗
• InjuryFeb 25, 2025Break; Positioning Problem; Break; Positioning Problem

  LEBANON. IT WAS REPORTED THAT A PATIENT IMPLANTED WITH MOTIVA IMPLANTS COMPLAINED OF A BURNING SENSATION AND BOTTOMING OUT AND WAS DIAGNOSED WITH A DEVICE RUPTURE AFTER IMPLANTATION. SHE 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: Burning Sensation; Insufficient Information; Physical Asymmetry

  MAUDE report 21462579 ↗
• InjuryFeb 25, 2025Break; Positioning Problem; Break; Positioning Problem

  LEBANON. IT WAS REPORTED THAT A PATIENT IMPLANTED WITH MOTIVA IMPLANTS COMPLAINED OF A BURNING SENSATION AND BOTTOMING OUT AND WAS DIAGNOSED WITH A DEVICE RUPTURE AFTER IMPLANTATION. SHE 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: Burning Sensation; Insufficient Information; Physical Asymmetry

  MAUDE report 21462445 ↗
• MalfunctionDec 11, 2024Break; Break

  THIS PATIENT WAS IMPLANTED THREE YEARS AGO. DURING AN IMPLANT EXCHANGE (MASTOPEXY) SURGERY PERFORMED, BOTH IMPLANTS WERE FOUND RUPTURED. 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: Insufficient Information

  MAUDE report 20903942 ↗
• MalfunctionDec 11, 2024Break; Break

  THIS PATIENT WAS IMPLANTED THREE YEARS AGO. DURING AN IMPLANT EXCHANGE (MASTOPEXY) SURGERY PERFORMED, BOTH IMPLANTS WERE FOUND RUPTURED. 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: Insufficient Information

  MAUDE report 20903623 ↗