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

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07445161002099), received between Nov 14, 2024 and Nov 6, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  USA. ALLEGEDLY, A PATIENT WHO HAD AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2025 DEVELOPED A POSTOPERATIVE WOUND INFECTION, FOLLOWED BY WOUND DEHISCENCE AND IMPLANT EXPOSURE ON HER RIGHT BREAST. THE SURGEON REPORTS THAT HE PRESCRIBED ORAL ANTIBIOTICS A FEW DAYS AFTER THE SURGERY, AS THE PATIENT REPORTED THAT SHE WENT SWIMMING IN A POOL. SHE UNDERWENT A DELAYED WOUND CLOSURE 24 DAYS AFTER SURGERY, AS A SUPERFICIAL WOUND DEHISCENCE WAS FOUND. THE PATIENT RESUMED PHYSICAL ACTIVITY PREMATURELY AND ADMITTED INCONSISTENT ADHERENCE TO THE POSTOPERATIVE RESTRICTIONS. WHEN SHE WENT BACK TO EVALUATION IN (B)(6) 2025, AN IMPLANT EXPOSURE WAS VISIBLE. REVISION SURGERY IS 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: Impaired Healing; Unspecified Infection; Wound Dehiscence

  MAUDE report 23490485 ↗
• InjuryNov 6, 2025Break; Break

  SOUTH AFRICA. ALLEGEDLY, A RENT IN THE IMPLANT AT THE INFERIOR POLE WAS DETECTED DURING A MAMMOGRAM (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: Insufficient Information

  MAUDE report 23486456 ↗
• InjuryAug 29, 2025Break; Break

  SOUTH AFRICA. IT WAS REPORTED THAT A PATIENT WHO HAD MOTIVA IMPLANTS IN (B)(6) 2024, PRESENTED PAIN AND DISPLACEMENET (MALPOSITION) AND WAS DIAGNOSED WITH AN INTRACAPSULAR AND EXTRACAPSULAR 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: Breast Discomfort/Pain; Insufficient Information; Ptosis

  MAUDE report 22923864 ↗
• InjuryAug 29, 2025Break; Break

  SOUTH AFRICA. IT WAS REPORTED THAT A PATIENT WHO HAD MOTIVA IMPLANTS IN (B)(6) 2024, PRESENTED PAIN AND DISPLACEMENT (MALPOSITION) AND WAS DIAGNOSED WITH AN INTRACAPSULAR AND EXTRACAPSULAR 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: Breast Discomfort/Pain; Insufficient Information; Ptosis

  MAUDE report 22923860 ↗
• InjuryNov 14, 2024Break; Break

  THE PATIENT'S PRIMARY AUGMENTATION WAS PERFORMED IN 2016. AFTER 8 YEARS, THE PATIENT BEGAN TO FEEL PAIN AND DISCOMFORT IN THE CHEST AREA. THE MRI CONCLUSION CONFIRMED A LEFT IMPLANT RUPTURE. 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: Discomfort; Pain

  MAUDE report 20689170 ↗