NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants ML-410285Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628003576), received between Oct 26, 2020 and Apr 1, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "RASH ON THE CHEST FOR A PROLONGED AMOUNT OF TIME". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Rash

  MAUDE report 24754242 ↗
• InjuryMar 31, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "RASH ON THE CHEST FOR A PROLONGED AMOUNT OF TIME". HEALTHCARE PROFESSIONAL LATER REPORTED "ECZEMA¿, "BRAIN FOG, VERTIGO, RASH ON BREASTS, BACK, CHEST, PAIN FROM CAPSULAR CONTRACTURE, EAR FULLNESS". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED. PATIENT WAS PRESCRIBED STEROIDS (ORAL).

  Patient problems: Capsular Contracture; Rash

  MAUDE report 24741784 ↗
• InjuryApr 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED "PLAINTIFF UNDERWENT PAINFUL REMOVAL PROCEDURES AS WELL AS TREATMENT, THERAPY, RECOVERY, AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS DUE TO FEAR OF ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL INCLUDING: MENTAL ANGUISH, INCREASED RISK OF ALCL, EVALUATION FOR ALCL, EXPLANT, RECONSTRUCTION, SEROMAS, PHYSICAL PAIN, SCARRING AND DISFIGUREMENT. PLAINTIFF EXPERIENCED BILATERAL BREAST PAIN, HARDENING OF BREASTS, ASYMMETRY, AND ATYPICAL LYMPHOID INFILTRATE AND ATYPICAL LYMPHOCYTIC HYPERPLASIA. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE AND DEPRESSION; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. PLAINTIFF HAS NOT BEEN DIAGNOSED WITH BIA-ALCL." THE EVENTS OF "SCARRING AND DISFIGUREMENT," "ASYMMETRY¿ AND "ATYPICAL LYMPHOID INFILTRATE AND ATYPICAL LYMPHOCYTIC HYPERPLASIA" ARE NOT DEVICE RELATED. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 16705142 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "INFECTION", "HARD LIKE ROCK", "EXTREMELY PAINFUL AT TIMES", IS "LARGER" AND "TOO BIG AND INTERFERES WITH ARM MOVEMENT." DEVICE REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 10734527 ↗