Motiva® SmoothSilk® Round Breast Implant RSF-335+QRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07445161002891), received between Nov 8, 2024 and Jul 28, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Break

  Brazil. Allegedly, a patient who underwent a breast augmentation surgery, had an ultrasound that reveals signs of extrcapsular rupture on her left implan and a small amount of silicone present in the breast tissue and in the axilary lymph nodes. THere is no information on wheter th patient underwent an explantation surgery. The investigation is ongoing.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 50055809 ↗
• InjuryFeb 16, 2026Break

  COLOMBIA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025 REQUIRED A REVISION SURGERY DUE TO A DEVICE RUPTURE IN BOTH BREASTS. 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: Insufficient Information

  MAUDE report 24346112 ↗
• InjuryFeb 3, 2026Device Appears to Trigger Rejection

  COLOMBIA. ALLEGEDLY, THE PATIENT PRESENTED WITH OCCASIONAL PAIN IN THE RIGHT BREAST AND REPORTED FEELING THE BREAST HARDER THAN USUAL; THE CLINICAL EVALUATION SHOWED A BAKER GRADE III CAPSULAR CONTRACTURE (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; Capsular Contracture

  MAUDE report 24251810 ↗
• InjuryOct 30, 2025Break; Break

  BRAZIL. ALLEGEDLY, DURING ROUTINE RADIOLOGICAL EXAMINATIONS (ULTRASOUND/MRI), A RUPTURE OF THE RIGHT BREAST IMPLANT WAS IDENTIFIED IN A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY ON (B)(6) 2022 (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: Insufficient Information

  MAUDE report 23426332 ↗
• InjuryOct 29, 2025Break; Break

  BRAZIL. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2022 HAD AN MIR THAT INDICATED AN INTRACAPSULAR SILICONE LEAK IN THE RIGHT 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: Insufficient Information

  MAUDE report 23414801 ↗
• InjuryJun 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ARGENTINA. IT WAS REPORTED THAT A PATIENT WHO HAD A BREAST AUGMENTATION SURGERY IN (B)(6) 2024 DEVELOPED A CAPSULAR CONTRACTURE, BAKER GRADE III/IV IN BOTH HER BREASTS. THE REVISION SURGERY WILL BE PERFORMED IN (B)(6) 2025. 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; Physical Asymmetry

  MAUDE report 22212785 ↗
• InjuryJun 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  (B)(6). IT WAS REPORTED THAT A PATIENT WHO HAD A BREAST AUGMENTATION SURGERY ON (B)(6) 2024 DEVELOPED A CAPSULAR CONTRACTURE, BAKER GRADE III/IV IN BOTH HER BREASTS. THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2025. 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; Physical Asymmetry

  MAUDE report 22212781 ↗
• InjuryDec 4, 2024Break; Fracture; Device Appears to Trigger Rejection; Break; Fracture; Device Appears to Trigger Rejection

  MEXICO. PATIENT MANIFESTED RUPTURE, INFLAMMATION, PAIN, CAPSULAR CONTRACTURE BAKER GRADE III AND EXPOSURE OF THE IMPLANT THAT REQUIRED RE-ADMISSION TO SURGERY FOR EXPLANTATION.

  Patient problems: Capsular Contracture; Impaired Healing; Insufficient Information

  MAUDE report 20845084 ↗
• InjuryNov 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A PATIENT REPORTED EXPERIENCING PAIN IN BOTH BREASTS. MRI SCAN REVEALED SIGNS OF CAPSULAR CONTRACTURE. 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

  MAUDE report 20667994 ↗
• InjuryNov 8, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED RUPTURE, LEADING TO AN ASYMMETRY ON THE LEFT SIDE THAT PROGRESSIVELY WORSENED. ADDITIONALLY, THE PATIENT EXPERIENCED LOCALIZED PAIN IN THE AFFECTED AREA.

  Patient problems: Implant Pain

  MAUDE report 20643512 ↗
• InjuryNov 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PERIAREOLAR LIFT IN (B)(6) 2022 PRESENTED WITH BILATERAL PAIN, MORE PRONOUNCED ON THE LEFT SIDE, WHICH PROGRESSIVELY INTENSIFIED. INDURATION WAS NOTED UPON PALPATION, AND AN MRI CONFIRMED THE PRESENCE OF CAPSULAR CONTRACTURE. IMAGING FINDINGS INDICATED CONTRACTURE CHANGES PREDOMINANTLY IN THE LEFT CAPSULE, WHILE THE RIGHT BREAST EXHIBITED NORMAL SKIN THICKNESS WITHOUT EVIDENCE OF FOCAL OR DIFFUSE THICKENING.

  Patient problems: Capsular Contracture

  MAUDE report 20642145 ↗