Motiva® SmoothSilk® Round Breast Implant RSD-425+Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07445161001955), received between Mar 20, 2025 and Nov 10, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED HARDENING OF THE BREAST 2 WEEKS POST OP. TAKEN TO THE OR, A SMALL AMOUNT OF FLUID (BLOOD) AND A FIRM CAPSULE (BAKER III/IV) WERE FOUND. CAPSULECTOMY AND IMPLANT EXCHANGE WERE 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: Capsular Contracture; Hematoma

  MAUDE report 23513224 ↗
• InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION IN (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III IN HER LEFT BREAST ((B)(6)) AND BAKER GRADE IV ON HER RIGHT BREAST ((B)(6)). DEVICES WERE REPLACED. 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 23280458 ↗
• InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION IN (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III IN HER LEFT BREAST (B)(6) AND BAKER GRADE IV ON HER RIGHT BREAST (B)(6). DEVICES WERE REPLACED. 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 23280421 ↗
• InjuryAug 28, 2025Break; Break

  SOUTH AFRICA. IT WAS REPORTED THAT A PATIENT WHO HAD AUGMENTATION SURGERY WITH MOTIVA IMPLANTS REQUIRED A REVISION SURGERY IN (B)(6) 2025 DUE TO A RIGHT BREAST IMPLANT RUPTURE. 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 22913558 ↗
• InjuryMar 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA- BAKER GRADE 3 CONTRACTURE NOTED ON RIGHT SIDE DURING IN PERSON EXAM, ONLY THE RIGHT BREAST HAD THE CAPSULAR CONTRACTURE (B)(6) BUT BOTH IMPLANTS WERE REMOVED.

  Patient problems: Capsular Contracture

  MAUDE report 21659416 ↗