NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410410Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10888628002982), received between Aug 12, 2019 and Sep 22, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (16 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 37 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 right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50855587 ↗
• InjuryAug 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22823888 ↗
• InjuryMay 1, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED" DIAGNOSED VIA MRI AND "CONCERNS OF THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "SMALL MASS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21946392 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "LATE SEROMA, ULTRASOUND GUIDED BIOPSY, PATHOLOGY REPORTED AS BREAST IMPLANT- ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA", LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE II CONFIRMED VIA US. HISTOPATHOLOGICAL MARKERS ARE NOT REPORTED, THEREFORE, ALCL CANNOT BE CONFIRMED. THIS RECORD IS FOR A LEFT SIDE. THE DEVICE HAS BEEN REMOVED WITHOUT REPLACEMENT AND A TOTAL CAPSULECTOMY WAS PERFORMED.

  Patient problems: Lymphoma; Seroma

  MAUDE report 21759490 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "SEROMA AND TEXTURED BREAST IMPLANT RECALL". THIS RECORD IS FOR A RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 21358624 ↗
• InjuryAug 11, 2023Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 17508899 ↗
• InjuryAug 11, 2023Material Rupture; Material Rupture

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17508843 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.

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

  MAUDE report 17256278 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.

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

  MAUDE report 17255369 ↗
• InjuryMay 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16872868 ↗
• InjuryApr 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE III/IV AND EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16811562 ↗
• InjuryApr 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, III/IV. AND EXCHANGE, DUE TO CONCERNS WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16811497 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE ¿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¿, ¿SEROMAS¿, ¿PHYSICAL PAIN¿, ¿SCARRING AND DISFIGUREMENT¿, ¿BILATERAL BREAST PAIN¿, ¿BREAST PAIN¿, ¿HOT AND COLD SENSATIONS¿, ¿RASHES OR ITCHING¿, ¿STIFFNESS AND NUMBNESS IN RIGHT ARM¿, ¿ASYMMETRY¿ AND ¿SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS, PTSD, AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE, PANIC DISORDER AND DEPRESSION¿. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Deformity/ Disfigurement; Seroma

  MAUDE report 16678129 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT EXCHANGE DUE TO PATIENT CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "SWOLLEN LYMPH NODE". DEVICE WAS EXPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 15190770 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE IMPLANT EXCHANGE DUE TO PATIENT CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED ADDITIONAL REASON FOR REMOVAL AS "ENLARGED LYMPH NODE". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 15190733 ↗
• InjuryJul 20, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED/SHAPED" AGAINST RIGHT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15067012 ↗
• InjuryJun 3, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE IS "HARD", PAIN, SWELLING. HEALTHCARE PROFESSIONAL REPORTED A BILATERAL REMOVAL OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE REPORTED "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, CHRONIC GASTROINTESTINAL UPSET OR REFLUX, SIGNIFICANT WEIGHT LOSS, CAPSULAR CONTRACTURE, ITCHING, SWELLING, HARDENING OF BREASTS, SCARRING AND DISFIGUREMENT. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 11933028 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "A LEFT SIDE IMPLANT EXCHANGE FROM A TEXTURED TO A SMOOTH BREAST IMPLANT DUE TO CONCERN WITH THE PRODUCT AND FLUID FOUND AROUND THE IMPLANT" HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE FLUID AROUND THE IMPLANT AND SEROMA AND EXCHANGE." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 11372756 ↗
• InjuryNov 13, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10835987 ↗
• InjuryOct 1, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REMOVAL WAS NOTED AS "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND TEXTURED IMPLANT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10615119 ↗
• InjurySep 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REMOVAL WAS NOTED AS "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND TEXTURED IMPLANT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10609904 ↗
• InjurySep 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10529267 ↗
• InjuryAug 31, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT-SIDE "CAPSULAR CONTRACTURE, BAKER GRADE III/IV AND MISSHAPED." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10470867 ↗
• InjuryAug 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV, "MISSHAPEN AND EXCHANGE". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10448266 ↗
• InjuryJul 10, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 10260649 ↗