Motiva® SmoothSilk® Round Breast Implant RSF-500+Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07445161002150), received between Aug 29, 2025 and Mar 17, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (7 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.

• InjuryMar 17, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT IS EXPERIENCING BILATERAL BREAST PAIN AND A BI-RADS 4 SUSPICIOUS BREAST MASS ADJACENT TO THE LEFT BREAST IMPLANT. THE PATIENT ALSO REPORTS SYSTEMIC SYMPTOMS INCLUDING FATIGUE, JOINT PAIN, LYMPHADENOPATHY, NIGHT SWEATS, BRAIN FOG, RASH, RAYNAUD¿S-TYPE VASCULAR DISCOLORATION, UNINTENTIONAL AND EXTREME WEIGHT LOSS, ANEMIA, AND POSITIVE ANA TESTING. ALSO, SHE PRESENTS INFECTION AND INFLAMMATORY REACTION DUE TO OTHER INTERNAL PROSTHETIC DEVICES, IMPLANTS AND GRAFTS, INITIAL ENCOUNTER, PROGRESSIVE INFERIOR POLE DISCOLORATION, CONTOUR CHANGE, AND ASYMMETRY TEMPORALLY ASSOCIATED WITH REPORTED ADVERSE DEVICE FINDINGS. THE PATIENT INDICATES ONGOING MEDICAL EVALUATION AND REPORTS IMPLANT REMOVAL WITH FULL CAPSULECTOMY HAS BEEN RECOMMENDED.

  Patient problems: Nodule; Physical Asymmetry; Skin Inflammation/ Irritation; Swollen Lymph Nodes/Glands; Unspecified Immune System Problem; Unspecified Infection

  MAUDE report 24618166 ↗
• InjuryMar 16, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT IS EXPERIENCING BILATERAL BREAST PAIN AND A BI-RADS 4 SUSPICIOUS BREAST MASS ADJACENT TO THE LEFT BREAST IMPLANT. THE PATIENT ALSO REPORTS SYSTEMIC SYMPTOMS INCLUDING FATIGUE, JOINT PAIN, LYMPHADENOPATHY, NIGHT SWEATS, BRAIN FOG, RASH, RAYNAUD¿S-TYPE VASCULAR DISCOLORATION, UNINTENTIONAL AND EXTREME WEIGHT LOSS, ANEMIA, AND POSITIVE ANA TESTING. ALSO, SHE PRESENTS INFECTION AND INFLAMMATORY REACTION DUE TO OTHER INTERNAL PROSTHETIC DEVICES, IMPLANTS AND GRAFTS, INITIAL ENCOUNTER, PROGRESSIVE INFERIOR POLE DISCOLORATION, CONTOUR CHANGE, AND ASYMMETRY TEMPORALLY ASSOCIATED WITH REPORTED ADVERSE DEVICE FINDINGS. THE PATIENT INDICATES ONGOING MEDICAL EVALUATION AND REPORTS IMPLANT REMOVAL WITH FULL CAPSULECTOMY HAS BEEN RECOMMENDED.

  Patient problems: Nodule; Physical Asymmetry; Skin Inflammation/ Irritation; Swollen Lymph Nodes/Glands; Unspecified Immune System Problem; Unspecified Infection

  MAUDE report 24613536 ↗
• InjuryMar 11, 2026Device Slipped

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025 PRESENTS HER LEFT BREAST IMPLANT FLIPPED. A REVISION SURGERY WAS REQUIRED TO PERFORM A BREAST CAPSULORRHAPHY WITH IMPLANT REPOSITIONING. THE INVESTIGATION IS IN PROCESS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24571909 ↗
• InjuryMar 5, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025, PRESENTS HER IMPLANTS SITTING HIGH AND FIRM TO TOUCH, A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III WAS DIAGNOSED. SHE UNDERWENT AN REPLACEMENT SURGERY. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24525105 ↗
• InjuryMar 5, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) PRESENTS HER IMPLANTS SITTING HIGH AND FIRM TO TOUCH, A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III WAS DIAGNOSED. SHE UNDERWENT AN REPLACEMENT SURGERY. THE INVESTIGATION WAS COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 24525104 ↗
• InjuryMar 2, 2026Break

  COLOMBIA. ALLEGEDLY, IMPLANT RUPTURE WAS IDENTIFIED DURING A ROUTINE REVISION (SN: (B)(6)). IT IS UNKNOWN IF THE EVENT AFFECTED ONE BREAST OR BOTH. 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 24490122 ↗
• InjuryMar 2, 2026Break

  COLOMBIA. ALLEGEDLY, IMPLANT RUPTURE WAS IDENTIFIED DURING A ROUTINE REVISION (SN: (B)(6)). IT IS UNKNOWN IF THE EVENT AFFECTED ONE BREAST OR BOTH. 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 24490112 ↗
• InjuryFeb 13, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2025 COMPLAINED ABOUT PAIN AND HARDENING. A CAPSULAR CONTRACTURE BAKER GRADE IV WAS DIAGNOSED IN HER LEFT BREAST ((B)(6)). 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 24338422 ↗
• InjuryFeb 3, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III IN HER RIGHT 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 24251665 ↗
• InjuryNov 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 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 23522541 ↗
• InjuryAug 29, 2025Break; Break

  SOUTH AFRICA. IT WAS REPORTED THAT A PATIENT WHO HAD BREAST AUGMENTATION SURGERY IN (B)(6) 2024 WAS DIAGNOSED WITH A RIGHT IMPLANT RUPTURE THROUGH A CT SCAN (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: Failure of Implant; Insufficient Information

  MAUDE report 22923951 ↗