Motiva® SmoothSilk® Round Breast Implant RSF-275+QRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07445161002860), received between Nov 18, 2024 and Mar 30, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Device Appears to Trigger Rejection

  MÉXICO. ALLEGEDLY, CAPSULAR CONTRACTURE BAKER GRADE III WAS IDENTIFIED IN THE LEFT SIDE. THE EXPLANT SURGERY HAS ALREADY BEEN PERFORMED (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

  MAUDE report 24715557 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BRAZIL. ALLEGEDLY, THE PATIENT, WHO HAD PREVIOUSLY UNDERGONE SUBMUSCULAR IMPLANT PLACEMENT EXPERIENCED AN INTRAMAMMARY ABSCESS THAT PROGRESSED TO IMPLANT EXTRUSION, REQUIRING SURGICAL INTERVENTION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR IMPLANT REMOVAL, POCKET IRRIGATION, AND DRAINAGE OF THE MAMMARY SPACE. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Impaired Healing

  MAUDE report 23804422 ↗
• InjuryNov 13, 2025Break; Break

  BRAZIL. LEGAL CASE. ALLEGEDLY, A PATIENT HAD A MAMMOGRAPHY AND ULTRASOUND THAT INDICATED A SUSPECTED INTRACAPSULAR RUPTURE OF HER LEFT BREAST IMPLANT, THE SUSPICION WAS CONFIRMED BY AN MRI PERFORMED ON (B)(6) 2025. A REPLACEMENT SURGERY WAS REQUIRED; NEW IMPLANTS FROM ANOTHER BRAND WERE PLACED. 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 23544173 ↗
• InjuryNov 6, 2025Break; Break

  COSTA RICA. ALLEGEDLY, THE PATIENT, WHO UNDERWENT BREAST AUGMENTATION IN (B)(6) 2020, REFERRED PAIN AND A MASS IN HER LEFT BREAST. DURING AN ULTRASOUND, A NODE WITH A SNOWSTORM EFFECT WAS FOUND IN THE LEFT BREAST, AND ANOTHER ONE WITH THE SAME EFFECT WAS FOUND IN THE AXILLA. A BIOPSY WAS PERFORMED IN BOTH LESIONS, AND SILICONE LYMPHADENITIS WAS DIAGNOSED. THIS RAISED SUSPICIONS OF A POSSIBLE RUPTURE, SO AN MRI WAS PERFORMED, WHICH SUGGESTED AN INTRACAPSULAR RUPTURE. A REVISION SURGERY WAS PERFORMED, AND THE RUPTURE WAS CONFIRMED (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: Breast Discomfort/Pain; Nodule; Swollen Lymph Nodes/Glands

  MAUDE report 23487208 ↗
• InjuryAug 19, 2025Break; Break

  MEXICO. IT WAS REPORTED THAT A PATIENT WHO HAD MOTIVA IMPLANTS IN (B)(6) 2022, PRESENTED A DEVICE RUPTURE. AT THIS POINT, THE SIDE AFFECTED, SN INVOLVED AND THE EXPLANT SURGERY DATE ARE UNKNOWN. 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 22845657 ↗
• InjuryMar 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DATA SYMPTOMS OF CAPSULAR CONTRACTURE OF THE LEFT BREAST ON (B)(6) 2025 AND AN ULTRASOUND WAS PERFORMED REPORTING CAPSULAR CONTRACTURE BACKER GRADE III/IV.

  Patient problems: Capsular Contracture

  MAUDE report 21692714 ↗
• InjuryMar 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AUSTRALIA- A PATIENT IMPLANTED WITH MOTIVA IMPLANTS WAS DIAGNOSED WITH CAPSULAR CONTRACTURE AND LATERALIZATION ON BOTH BREASTS AND SHE WAS ADVISED TO UNDERGO IMPLANT EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, 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 REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture; Physical Asymmetry

  MAUDE report 21600853 ↗
• InjuryMar 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AUSTRALIA- A PATIENT IMPLANTED WITH MOTIVA IMPLANTS WAS DIAGNOSED WITH CAPSULAR CONTRACTURE AND LATERALIZATION ON BOTH BREASTS AND SHE WAS ADVISED TO UNDERGO IMPLANT EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, 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 REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture; Physical Asymmetry

  MAUDE report 21600587 ↗
• InjuryMar 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT REPORTS A CAPSULAR CONTRACTURE BACKER GRADE III, 3 MONTHS AFTER SURGERY. SURGERY PERFORMED IN COLOMBIA. NO PATIENTS DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENTS HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 21565700 ↗
• InjuryMar 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT REPORTS A CAPSULAR CONTRACTURE BACKER GRADE III, 3 MONTHS AFTER SURGERY. SURGERY PERFORMED IN COLOMBIA. NO PATIENTS DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENTS HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Capsular Contracture

  MAUDE report 21564254 ↗
• InjuryJan 14, 2025Break; Device Appears to Trigger Rejection; Break; Device Appears to Trigger Rejection

  BRAZIL. PATIENT IMPLANTED WITH MOTIVA IMPLANTS PRESENTED LATE SEROMA, EVOLVED CAPSULAR CONTRACTURE AND RUPTURE SIGNS ON RIGHT BREAST ACCORDING TO RMN. IS IT UNKNOWN IF THE PATIENT HAS BEEN EXPLANTED. 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 WERE MADE, AND THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 21149643 ↗
• InjuryJan 14, 2025Break; Device Appears to Trigger Rejection; Break; Device Appears to Trigger Rejection

  BRAZIL. PATIENT IMPLANTED WITH MOTIVA IMPLANTS PRESENTED LATE SEROMA, EVOLVED CAPSULAR CONTRACTURE AND RUPTURE SIGNS ON RIGHT BREAST ACCORDING TO RMN. IS IT UNKNOWN IF THE PATIENT HAS BEEN EXPLANTED. 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 WERE MADE, AND THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 21149635 ↗
• InjuryDec 30, 2024Break; Break

  (B)(6). IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED LEFT IMPLANT RUPTURE. THE PATIENT UNDERWENT 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 WERE MADE AND THE INVESTIGATION REMAINS WAS COMPLETED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036425 ↗
• InjuryDec 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED A CAPSULAR CONTRACTURE BAKER GRADE III. 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 20855873 ↗
• InjuryNov 27, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEVICE RUPTURE ON THE RIGHT SIDE FOLLOWING IMPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 20798630 ↗
• InjuryNov 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  MEXICO. A PATIENT REPORTED EXPERIENCING DEFORMITY AND PAIN IN HER RIGHT BREAST. PHYSICAL EXAMINATION AN ULTRASOUND REPORT REVEALED CAPSULAR CONTRACTURE. NON-STEROID ANTI-INFLAMMATORY, MUSCLE RELAXANT, AND ANTIBIOTIC WERE PRESCRIBE. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. NO PATIENT DEMOGRAPHICS, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE, AND THE INVESTIGATION REMAINS WAS COMPLETE.

  Patient problems: Capsular Contracture

  MAUDE report 20715048 ↗