NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410450Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10888628002999), received between Jul 10, 2019 and Sep 22, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Material Rupture” (20 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Device Appears to Trigger Rejection

  Healthcare professional reported via National Breast Implant Registry (NBIR) ¿Capsular Contracture Baker Grade III¿, ¿Change shape/size/style¿ and ¿Ptosis" which is not device related. Capsulectomy/Capsulotomy was performed. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50854921 ↗
• InjurySep 10, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "grade 3 capsules with firmness of the breast but notsignificant distortion" and "there are some deep folds and it is possible there could be a fracture or localized rupture, there is no fluid around the implant". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50714211 ↗
• InjuryAug 6, 2026Material Rupture

  Patient reported "Retropectoral silicone implant with questioned key hole signs/possible intracapsular rupture". Later healthcare professional reported "questionable rupture" and "ptosis" determined as Not Device Related. This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165664 ↗
• InjurySep 18, 2025Material Rupture; Migration; Material Rupture; Migration

  PATIENT REPORTED "INTRACAPSULAR RUPTURE, SILICONE MIGRATION AS WELL AS EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". LATER PATIENT REPORTED "REACTIVE LYMPH NODES" AND "SILICONE IN TWO ARMPIT LYMPH NODES AND ENLARGED LYMPH NODES IN BREAST AREA". LATER HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE AND IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23085332 ↗
• InjurySep 11, 2025Material Rupture; Migration; Material Rupture; Migration

  PATIENT REPORTED "INTRA AND EXTRACAPSULAR RUPTURE, SILICONE MIGRATION AS WELL AS EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". LATER PATIENT REPORTED "REACTIVE LYMPH NODES" AND "SILICONE IN TWO ARMPIT LYMPH NODES AND ENLARGED LYMPH NODES IN BREAST AREA". LATER HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR (AND EXTRACAPSULAR) RUPTURE AND IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant; Swollen Lymph Nodes/Glands

  MAUDE report 23023952 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE PAIN, "FIRMNESS," "INCREASE IN SIZE," AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED "BREAST FLUID." DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Seroma

  MAUDE report 18394893 ↗
• InjuryOct 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL CALLED, TO REPORT A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17970635 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED, EXCHANGE FROM TEXTURED TO SMOOTH, DUE TO CONCERN WITH THE PRODUCT. AS WELL AS, FLUID IN UNKNOWN SIDE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Seroma

  MAUDE report 17720151 ↗
• InjurySep 8, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CONCERN WITH THE PRODUCT. AS WELL AS FLUID IN RIGHT SIDE. ALSO, IT WAS REPORTED, VIA RGA THAT A HOLE WAS IDENTIFIED, DURING SURGERY. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Seroma

  MAUDE report 17715526 ↗
• InjuryJun 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER UNKNOWN AND ASYMMETRY". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR, CONTRACTURE, BAKER GRADE IV AND CONCERNS WITH ALCL. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17109669 ↗
• InjuryApr 26, 2023Material Rupture; Material Rupture

  THIS RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16820368 ↗
• InjuryApr 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16702696 ↗
• InjuryMar 1, 2023Material Rupture; Material Rupture

  PATIENT REPORTED NO COMPLAINT AGAINST THE RIGHT SIDE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "PALPABLE RIGHT BREAST MASS," "PALE POLARIZABLE MATERIAL, SUGGESTIVE OF SILICONE," "BREAST TENDERNESS," "DISCOMFORT IN BREASTS," "LUMPS," "SWELLINGS," "HIVES." HEALTHCARE PROFESSIONAL ALSO REPORTED "BRAIN FOG," AND "UNEXPLAINED ILLNESSES" WHICH ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16465088 ↗
• InjuryJan 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, SEROMA, AND "VOLUNTARY RECALL". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 16185585 ↗
• InjuryJan 9, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 16126846 ↗
• InjuryJan 9, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 16126071 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿FLUID COLLECTION¿ AND ¿EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN". THE DEVICE HAS BEEN REPLACED.

  Patient problems: Seroma

  MAUDE report 15764989 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿FLUID COLLECTION¿ AND ¿EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN.¿ THE DEVICE HAS BEEN REPLACED.

  Patient problems: Seroma

  MAUDE report 15764894 ↗
• InjuryMay 4, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. PATIENT REPRESENTATIVE REPORTED "SCARRING AND DISFIGUREMENT, RECONSTRUCTION, CHRONIC PAIN, SEROMA, ITCHING, SWELLING, ASYMMETRY OF BREASTS, CAPSULAR CONTRACTURE, ANXIETY, PAIN PRIOR TO EXPLANT PROCEDURE, EVALUATION FOR ALCL, REMOVAL OF IMPLANTS DUE TO FEAR OF ALCL, TO DECREASE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL, INCREASED RISK OF ALCL, AND OTHER INJURIES." THIS RECORD WILL BE FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14280639 ↗
• InjuryJan 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN. DEVICE EXPLANTED. LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 13362079 ↗
• InjuryJan 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "BILATERAL REMOVAL WAS NOTED AS ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN AGAINST THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13359067 ↗
• InjuryNov 6, 2021Material Rupture; Material Rupture

  THIS REPRESENTS THE RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 12755773 ↗
• InjurySep 1, 2021Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12410763 ↗
• InjuryJul 13, 2021Material Rupture; Material Rupture

  PATIENT REPORTED "HAVING EXPERIENCED AUTOIMMUNE ISSUES SUCH AS SKIN REACTIONS, ILLNESSES AND INFECTIONS". PATIENT REPORTED ADDITIONAL EVENTS OF ¿MULTIPLE HEALTH PROBLEMS LEADING TO HIGHER AND HIGHER THYROID MEDS, CURRENTLY TAKING THE MAX AMOUNT OF HORMONES FOR THAT (CONSIDERING I STILL HAVE MY THYROID). I AM ON A DOSE THAT REPLACES ONE ALL TOGETHER AND BLOOD TESTS HAVE BEEN STUMPING MY DOCTOR.¿, ¿DEBILITATING MIGRAINES¿, ¿SINUS INFECTIONS¿, ¿YEAST IN GUT AND THROAT¿, ¿ANXIETY ATTACKS, SKIN RASHES AND BLISTERS¿, ¿REALLY BAD GASTROINTESTINAL PROBLEMS CAUSING IRREGULAR WEIGHT GAIN AND URINARY PROBLEMS WITH URGENCY AND FREQUENCY¿, AND ¿INSOMNIA¿. THE AFOREMENTIONED EVENTS ARE NOT RELATED TO THE DEVICE. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12156981 ↗
• InjuryApr 15, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED A RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 11672080 ↗