Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-340Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07445161010582), received between May 7, 2025 and Apr 16, 2026 — 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.

• InjuryApr 16, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, THE PATIENT¿S LEFT BREAST IMPLANT HAS DESCENDED AND SITS SLIGHTLY LOWER THAN THE RIGHT. THE LEFT IMPLANT APPEARS LESS ROUND AND PALPABLY SOFTER COMPARED TO THE RIGHT, ALTHOUGH IT DEMONSTRATES NORMAL MOBILITY WITHIN THE POCKET. ULTRASOUND EVALUATION SHOWS NO DEFINITIVE EVIDENCE OF IMPLANT RUPTURE, SILICONE LEAKAGE, OR ANTERIOR SHELL DISRUPTION; HOWEVER, THESE FINDINGS MAY BE LIMITED BY THE POTENTIAL LOCATION OF A RUPTURE.

  Patient problems: Ptosis

  MAUDE report 24900249 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2026 DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III IN HER RIGHT BREAST ((B)(6)). HER RIGHT SIDE STARTED TO BECOME HARDER, MORE PAINFUL, AND SIT HIGHER THAN THE LEFT.

  Patient problems: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24730780 ↗
• InjuryAug 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  USA. IT WAS REPORTED THAT A PATIENT WHO HAD MOTIVA IMPLANTS IN (B)(6) 2025, WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE BAKER GRADE III IN HER RIGHT BREAST (SN (B)(6)). A REVISION SURGERY IS PLANNED. 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 22845475 ↗
• InjuryJun 24, 2025Break; Break

  USA- IT WAS REPORTED THAT A PATIENT WHO HAD A BREAST SURGERY AUGMENTATION IN (B)(6) 2025 PRESENTS PAIN IN HER RIGHT BREAST. AN ULTRASOUND WAS PERFORMED AND SHE WAS DIAGNOSED WITH A RUPTURE. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 22323354 ↗
• InjuryMay 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SOUTH KOREA. IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY IN (B)(6) 2023 CONSULTED WITH HER SURGEON EIGHT MONTHS AFTER SURGERY DUE TO LEFT BREAST FIRMNESS. SHE WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE BAKER GRADE III AND REQUIRED A REVISION SURGERY. THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Capsular Contracture

  MAUDE report 21982155 ↗