NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FM-410310Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10888628002845), received between Jul 16, 2019 and Sep 23, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Material Rupture” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "Micro-ruptures" and "Capsular contracture Baker grade III". This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50870307 ↗
• InjurySep 23, 2026Material Rupture

  Healthcare professional reported "Rupture". This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870252 ↗
• InjuryAug 6, 2026Material Rupture

  Healthcare professional reported "rupture" and "exchange from textured to smooth implants due to the patient's concern with the product". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159056 ↗
• InjuryMar 30, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH". LATER THE HEALTHCARE PROFESSIONAL REPORTED "HOLE NON-SPECIFIC". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729988 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RECALL/CAPSULE CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23757294 ↗
• InjuryNov 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RECALL/CAPSULE CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23667655 ↗
• InjuryNov 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT IS TEXTURED A TYPE THAT HAS BEEN ASSOCIATED WITH SPECIFIC RISKS AND HAVE BEEN RECALLED", "SOME CYSTS NOTED", "CAPSULAR CONTRACTURE BAKER GRADE II", "INCLUDING SEVERE FOOD SENSITIVITIES", "SIGNIFICANT FATIGUE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23568386 ↗
• InjuryNov 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT IS TEXTURED A TYPE THAT HAS BEEN ASSOCIATED WITH SPECIFIC RISKS AND HAVE BEEN RECALLED", "SOME CYSTS NOTED", "CAPSULAR CONTRACTURE BAKER GRADE II", "INCLUDING SEVERE FOOD SENSITIVITIES", "SIGNIFICANT FATIGUE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Cyst(s); Fatigue

  MAUDE report 23501022 ↗
• InjuryJan 24, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 18576743 ↗
• InjuryJan 24, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 18576690 ↗
• InjuryOct 31, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18043687 ↗
• InjuryJul 19, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT, CAPSULAR CONTRACTURE, BAKER GRADE IV, AND A POSSIBLE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15053040 ↗
• InjuryAug 19, 2021Migration; Migration

  PATIENT REPORTED A RIGHT SIDE "RIPPLING" AND "RUBBER LOOKING." PATIENT REPRESENTATIVE REPORTED "DISFIGUREMENT", "ALONG WITH INCREASED RISK OF ALCL, FEAR DUE TO RISK OF ALCL, AND ANY CONDITION OR SYMPTOMS ASSOCIATED WITH ALCL" AND "MENTAL PAIN AND SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING", "BECAUSE OF THE ACCUMULATION OF FOREIGN AND ADULTERATED SILICONE PARTICLES IN BREAST TISSUE, LYMPH NODES, AND THROUGHOUT HER BODY", "RESULTING IN INFLAMMATION, CELLULAR, AND SUBCELLULAR DAMAGE", "PAIN", AND "ITCHING." PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "PAINFUL REMOVAL PROCEDURES", "SCARRING", "DIAGNOSTICS AND EXPLANT, RECONSTRUCTION, HOSPITALIZATION, ADDITIONAL CARE, AS WELL AS OTHER TREATMENT, THERAPY, RECOVERY, AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS, THE MONITORING FOR OR PREVENTION OF THE DISEASE", "AND OTHER PAST AND FUTURE ECONOMIC AND NON-ECONOMIC DAMAGES SUCH AS MEDICAL CARE COSTS, LOST WAGES, LOST WAGE EARNING CAPACITY"; THESE EVENTS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346291 ↗
• InjuryApr 14, 2021Device Appears to Trigger Rejection; Device Dislodged or Dislocated; Device Appears to Trigger Rejection; Device Dislodged or Dislocated

  PATIENT REPORTED "THEY ALWAYS HURT, I HAVE SHARP PAINS UNDER MY RIGHT BREAST AND IT FEELS HOT. I HAVE SHARP PAINS UNDER MY ARMPITS." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "UNSATISFACTORY, SYMMASTIA WORSE ON LEFT THAN RIGHT AND GROSS DISTORTION OF THE INFRAMAMMARY FOLD ON RIGHT SIDE AND CHANGE TO SMOOTH IMPLANTS." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 11663824 ↗
• InjurySep 1, 2020Material Rupture; Patient-Device Incompatibility; Migration; Material Rupture; Patient-Device Incompatibility; Migration

  PATIENT REPORTED LEFT CAPSULAR CONTRACTURE AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE CONCERNS WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 10477234 ↗
• InjuryAug 14, 2020Device 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

  ADDITIONALLY THE PATIENT REPORTED HAVING SOME RADIATION WHICH IS CAUSING CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 10410544 ↗
• InjuryAug 10, 2020Device 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

  ADDITIONALLY THE PATIENT REPORTED HAVING SOME RADIATION WHICH IS CAUSING CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 10384797 ↗
• InjuryJul 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10289950 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "PAIN AND INFLAMMATION." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Inflammation

  MAUDE report 9985711 ↗
• InjuryDec 20, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND REMOVAL DUE TO "PATIENT'S CONCERN OF THE PRODUCT." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9505178 ↗
• InjuryNov 1, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9266936 ↗
• InjuryJul 16, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8795586 ↗