NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FL-410320Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628002784), received between Nov 6, 2019 and Jul 20, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 24, 2019Class IOpen, Classified

   The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

   Z-2452-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17368288 ↗
• InjuryJul 20, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE "PAIN, RUPTURE (CONFIRMED WITH MRI), CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17360111 ↗
• InjuryApr 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14164267 ↗
• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE PAIN". DEVICE WAS EXPLANTED.

  Patient problems: Pain

  MAUDE report 10017615 ↗
• InjuryJan 12, 2020Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE AND DEVICE "UPSIDE DOWN," "THEY TURNED AROUND." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9579575 ↗
• InjuryJan 10, 2020Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE AND DEVICE "UPSIDE DOWN (TURNED AROUND)." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9575054 ↗
• InjuryDec 27, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9523102 ↗
• InjuryDec 6, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "ANY CREASES."

  Patient problems: Failure of Implant

  MAUDE report 9427968 ↗
• InjuryNov 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9284775 ↗