Motiva® SmoothSilk® Round Breast Implant RSF-550+Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07445161002167), received between Jul 10, 2025 and Sep 22, 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.

• InjurySep 22, 2026Device Appears to Trigger Rejection

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Immune System Problem

  MAUDE report 50862351 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION IN (B)(6) 2025, REQUIRED AN EARLY SEROMA EVACUATION ON HER LEFT BREAST (B)(6) 2025) AND WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE BAKER GRADE III IN HER RIGHT BREAST. A REVISION SURGERY WAS PERFORMED.

  Patient problems: Seroma

  MAUDE report 24366010 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, THE PATIENT DEVELOPED A BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST (SN (B)(6)). A REVISION SURGERY IS PLANNED. 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 24210802 ↗
• InjuryNov 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 WAS DIAGNOSED WITH A BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST. 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 23660660 ↗
• InjuryNov 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN AUGUST 2025 HAS A BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE. SHE HAS BEEN ON MONTELUKAST AND HAD WEEKLY ULTRASOUND THERAPY; SHE ALSO REPORTS INTERMITTENT BREAST PAIN. 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: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 23522537 ↗
• InjuryAug 29, 2025Break; Device Appears to Trigger Rejection; Break; Device Appears to Trigger Rejection

  SOUTH AFRICA. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PERI-PROSTHETIC FLUID AND MINIMAL FIBROUS DEBRIS BENEATH THE RIGHT PROSTHESIS. PROGRESSIVE INFLAMMATION AND SEROMA DEVELOPMENT LED TO BREAKDOWN OF THE INFRAMAMMARY IMPLANT INSERTION SITE, RESULTING IN IMPLANT EXTRUSION. THE PATIENT ALSO STARTED TO DEVELOP TIGHTNESS AND PAIN IN THE SAME BREAST, CLINICALLY CLASSIFIED AS BAKER GRADE III CAPSULAR CONTRACTURE WITH PALPABLE FIRMNESS AND TENDERNESS OF THE CAPSULE (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; Impaired Healing; Seroma; Wound Dehiscence

  MAUDE report 22924226 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BRAZIL. IT WAS REPORTED THAT A PATIENT WHO HAD HER FIRST BREAST RECONSTRUCTION IN (B)(6) 2023 WAS DIAGNOSED WITH A MALPOSITION THAT REQUIRED A REVISION SURGERY, WHICH WAS PERFORMED IN (B)(6) 2024. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Breast Discomfort/Pain; Physical Asymmetry; Ptosis; Seroma

  MAUDE report 22473749 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BRAZIL. IT WAS REPORTED THAT A PATIENT WHO HAD HER FIRST BREAST RECONSTRUCTION IN (B)(6) 2023 WAS DIAGNOSED WITH A MALPOSITION THAT REQUIRED A REVISION SURGERY, WHICH WAS PERFORMED IN (B)(6) 2024. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Breast Discomfort/Pain; Physical Asymmetry; Ptosis; Seroma

  MAUDE report 22473744 ↗