NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410775Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10888628003040), received between Jun 27, 2019 and Jul 27, 2026 — classified as 58 injuries.

The most frequently reported specific device problem is “Material Rupture” (14 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015736 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "intracapsular rupture". This record is for the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015723 ↗
• InjuryJun 13, 2025Migration; Migration

  PATIENT REPRESENTATIVE REPORTED VIA LEGAL DOCUMENTATION LEFT SIDE "INCREASED RISK OF BIA-ALCL, EMOTIONAL DISTRESS INCLUDING FEAR AND ANXIETY RELATED TO CANCER, ACCUMULATION OF FOREIGN AND ADULTERATED SILICONE PARTICLES IN THEIR BODIES, INCLUDING THE RESULTING INFLAMMATION, CELLULAR DAMAGE, AND SUBCELLULAR DAMAGE, PAST AND FUTURE MEDICAL EXPENSES, LOST WAGES, PHYSICAL AND EMOTIONAL PAIN, SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISFIGUREMENT, EXPLANT SURGERY AND/OR RECONSTRUCTION SURGERY". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22206678 ↗
• InjuryApr 17, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RUPTURE ON UNKNOWN SIDE VIA MRI AND ULTRASOUND AS WELL AS EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE CONFIRMED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL CONFIRMED LEFT-SIDE RUPTURE CONFIRMED VIA MRI AND CT SCAN, NEEDLE BIOPSY OF -SILICONE GRANULOMA. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Granuloma; Swollen Lymph Nodes/Glands

  MAUDE report 21853384 ↗
• InjuryApr 15, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21842304 ↗
• InjuryFeb 7, 2024Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "MY RECONSTRUCTION SURGERY WAS COMPLETED ON (B)(6) 2016 AND I RECEIVED NOTICE THAT THESE WERE BEING RECALLED DUE TO OCCURRENCE OF BIA-ALCL ON (B)(6) 2019." HEALTHCARE PROFESSIONAL LATER REPORTED AND CONFIRMED RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18661780 ↗
• InjuryOct 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17861427 ↗
• InjuryJun 7, 2023Migration; Migration

  PATIENT REPORTED LEFT SIDE "ELEVATED LIVER ENZYMES", "JOINT PAIN", "BRAIN FOG", "HAIR LOSS", "FLUID AROUND IMPLANT", "SILICONE POISONING" AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 17083646 ↗
• InjuryMay 31, 2023Material Rupture; Migration; Material Rupture; Migration

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 17031250 ↗
• InjuryApr 12, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 16728767 ↗
• InjuryApr 7, 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" AND "ASYMMETRY,¿ AND ¿ATYPICAL LYMPHOID INFILTRATE AND ATYPICAL LYMPHOCYTIC HYPERPLASIA¿ ARE NOT DEVICE RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 16704615 ↗
• InjuryFeb 1, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE RUPTURE. AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS, DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16281314 ↗
• InjuryJan 31, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16272913 ↗
• InjuryJul 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT'S RELATIVE REPORTED A LEFT SIDE EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE REPORTED "PLAINTIFF HAS SUFFERED FROM PAIN, CAPSULAR CONTRACTURE, IMPLANT MALPOSITION, DEFORMITY, AND ASYMMETRY. PLAINTIFF DID NOT RECEIVE ANY UPDATE OR WARNING FROM ALLERGAN ANY TIME BEFORE OR AFTER SURGERIES ABOUT THE CLEARLY ESTABLISHED LINK BETWEEN ALLERGAN'S BIOCELL TEXTURED BREAST IMPLANTS AND BIA-ALCL. FOLLOWING THE WORLDWIDE RECALL AND REVELATIONS ABOUT THE DANGERS OF ALLERGAN'S PRODUCTS, THE PLAINTIFF CONSULTED WITH DOCTOR WHO RECOMMENDED REMOVAL OF BREAST IMPLANTS AND CAPSELECTOMY AS WELL AS THE REMOVAL AND REPLACEMENT OF ALL DERMACELL, TO REMOVE THE RISK OF ALCL. PLAINTIFF UNDERWENT A REMOVAL OF THE POTENTIALLY CANCER-CAUSING BREAST IMPLANTS, EXCHANGE TO SMOOTH IMPLANTS, AND TOTAL BILATERAL CAPSULECTOMIES TO RULE OUT ANAPLASTIC LARGE CELL LYMPHOMA TO IMPLANT CAPSULES. PLAINTIFF HAD TO PAY OUT OF POCKET FOR THE REMOVAL OF BREAST IMPLANTS BECAUSE ALLERGAN HAS REFUSED TO DO SO. PLAINTIFF HAS WORRIED ABOUT THE RISK THEY FACE, HAVE ALSO BEEN SUBJECT TO OUT OF POCKET EXPENSES IN RELATION TO SEEKING MEDICAL ADVICE, EVALUATING THE FLA

  Patient problems: Capsular Contracture

  MAUDE report 15131970 ↗
• InjuryJul 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT'S RELATIVE REPORTED A RIGHT SIDE EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE REPORTED "PLAINTIFF HAS SUFFERED FROM PAIN, CAPSULAR CONTRACTURE, IMPLANT MALPOSITION, DEFORMITY, AND ASYMMETRY. PLAINTIFF DID NOT RECEIVE ANY UPDATE OR WARNING FROM ALLERGAN ANY TIME BEFORE OR AFTER SURGERIES ABOUT THE CLEARLY ESTABLISHED LINK BETWEEN ALLERGAN'S BIOCELL TEXTURED BREAST IMPLANTS AND BIA-ALCL. FOLLOWING THE WORLDWIDE RECALL AND REVELATIONS ABOUT THE DANGERS OF ALLERGAN'S PRODUCTS, THE PLAINTIFF CONSULTED WITH DOCTOR WHO RECOMMENDED REMOVAL OF BREAST IMPLANTS AND CAPSELECTOMY AS WELL AS THE REMOVAL AND REPLACEMENT OF ALL DERMACELL, TO REMOVE THE RISK OF ALCL. PLAINTIFF UNDERWENT A REMOVAL OF THE POTENTIALLY CANCER-CAUSING BREAST IMPLANTS, EXCHANGE TO SMOOTH IMPLANTS, AND TOTAL BILATERAL CAPSULECTOMIES TO RULE OUT ANAPLASTIC LARGE CELL LYMPHOMA TO IMPLANT CAPSULES. PLAINTIFF HAD TO PAY OUT OF POCKET FOR THE REMOVAL OF BREAST IMPLANTS BECAUSE ALLERGAN HAS REFUSED TO DO SO. PLAINTIFF HAS WORRIED ABOUT THE RISK THEY FACE, HAVE ALSO BEEN SUBJECT TO OUT OF POCKET EXPENSES IN RELATION TO SEEKING MEDICAL ADVICE, EVALUATING THE FL

  Patient problems: Capsular Contracture

  MAUDE report 15131808 ↗
• InjuryJul 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED "PLAINTIFF HAS SUFFERED FROM PAIN, CAPSULAR CONTRACTURE, IMPLANT MALPOSITION, DEFORMITY, AND ASYMMETRY. PLAINTIFF DID NOT RECEIVE ANY UPDATE OR WARNING FROM ALLERGAN ANY TIME BEFORE OR AFTER SURGERIES ABOUT THE CLEARLY ESTABLISHED LINK BETWEEN ALLERGAN'S BIOCELL TEXTURED BREAST IMPLANTS AND BIA-ALCL. FOLLOWING THE WORLDWIDE RECALL AND REVELATIONS ABOUT THE DANGERS OF ALLERGAN'S PRODUCTS, THE PLAINTIFF CONSULTED WITH DOCTOR WHO RECOMMENDED REMOVAL OF BREAST IMPLANTS AND CAPSELECTOMY AS WELL AS THE REMOVAL AND REPLACEMENT OF ALL DERMACELL, TO REMOVE THE RISK OF ALCL. PLAINTIFF UNDERWENT A REMOVAL OF THE POTENTIALLY CANCER-CAUSING BREAST IMPLANTS, EXCHANGE TO SMOOTH IMPLANTS, AND TOTAL BILATERAL CAPSULECTOMIES TO RULE OUT ANAPLASTIC LARGE CELL LYMPHOMA TO IMPLANT CAPSULES. PLAINTIFF HAD TO PAY OUT OF POCKET FOR THE REMOVAL OF BREAST IMPLANTS BECAUSE ALLERGAN HAS REFUSED TO DO SO. PLAINTIFF HAS WORRIED ABOUT THE RISK THEY FACE, HAVE ALSO BEEN SUBJECT TO OUT OF POCKET EXPENSES IN RELATION TO SEEKING MEDICAL ADVICE, EVALUATING THE FLAWED PRODUCT IMPLANTED INTO BODY, REMOVAL OF THE CANCER-CAUSING BREAST IMPLANTS, AD SEEKING RECOMMENDATIONS FOR FUTURE CARE A

  Patient problems: Capsular Contracture

  MAUDE report 15130840 ↗
• InjuryJul 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND INCREASED RISK OF ALCL. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14946875 ↗
• InjuryJul 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND INCREASED RISK OF ALCL. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14935634 ↗
• InjuryJun 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV AND "IMPLANT VERY SUPERIOR" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 14688697 ↗
• InjuryJun 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED RIGHT SIDE ¿DISFIGUREMENT,¿ ¿INFECTION,¿ ¿CHRONIC PAIN,¿ ¿PAIN PRIOR TO EXPLANT PROCEDURE,¿ ¿SWELLING,¿ ¿HEAT SENSATION,¿ ¿ITCHING," "SEROMA,¿ ¿RASHES,¿ ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN, ¿INCREASED RISK OF ALCL, MENTAL PAIN, ANGUISH AND FEAR DUE TO RISK OF ALCL, MENTAL PAIN AND SUFFERING," AND "ANXIETY." PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "DEPRESSION," ¿DISABILITY,¿ ¿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 AND REPLACED.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands; Unspecified Infection

  MAUDE report 14621661 ↗
• InjuryJun 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED LEFT SIDE ¿DISFIGUREMENT,¿ ¿INFECTION,¿ ¿CHRONIC PAIN,¿ ¿PAIN PRIOR TO EXPLANT PROCEDURE,¿ ¿SWELLING,¿ ¿HEAT SENSATION,¿ ¿ITCHING," "SEROMA,¿ ¿RASHES,¿ ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN, ¿INCREASED RISK OF ALCL, MENTAL PAIN, ANGUISH AND FEAR DUE TO RISK OF ALCL, MENTAL PAIN AND SUFFERING," AND "ANXIETY." PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "DEPRESSION," ¿DISABILITY,¿ ¿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 AND REPLACED.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands; Unspecified Infection

  MAUDE report 14621326 ↗
• InjuryMay 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED LEFT SIDE "BREAST WOUND REQUIRING DEBRIDEMENT OF NECROTIC TISSUE," "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN,". THE FOLLOWING EVENTS ARE NDR "POST OPERATIVE HEMATOMA," AND "INCREASED RISK OF ALCL." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Necrosis

  MAUDE report 14290789 ↗
• InjuryApr 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REPORTED LEFT SIDE "CHEST PAIN AND THEY HAVE NO CLEAVAGE LINE." HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE PAIN AND FULLNESS ACROSS THE TOP OF HER CHEST CREATING A ¿UNI-BREAST APPEARANCE¿ OR ¿DUMBBELL APPEARANCE BETWEEN BREASTS. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14237978 ↗
• InjuryApr 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REPORTED RIGHT SIDE "CHEST PAIN AND THEY HAVE NO CLEAVAGE LINE." HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE PAIN AND FULLNESS ACROSS THE TOP OF HER CHEST CREATING A ¿UNI-BREAST APPEARANCE¿ OR ¿DUMBBELL APPEARANCE BETWEEN BREASTS. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14229311 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED BILATERAL "NON-STOP ITCHING" AND "DEEP PAINS AROUND THE SIDES OF THE BREAST." HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT" BREAST PAIN, JOINT PAIN, AND NIGHT SWEATS." PATIENT REPRESENTATIVE REPORTED "REMOVAL OF IMPLANTS DUE TO FEAR OF ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL: MENTAL ANGUISH AND FEAR OF ALCL, EVALUATION FOR ALCL, INCREASED RISK OF ALCL, IMPLANT REMOVAL, CAPSULECTOMY, SIGNIFICANT SCARRING, DISFIGUREMENT, TISSUE DAMAGE, PAIN, SWELLING, RASHES, ITCHING, SEROMA, ASYMMETRY, CHRONIC INFLAMMATION, DEPRESSION, ANXIETY, PANIC DISORDER, POSTTRAUMATIC STRESS, CHRONIC INSOMNIA, SIGNIFICANT WEIGHT LOSS AND GAIN, IRRITABLE BOWEL, CHRONIC HEADACHE, CHRONIC GI UPSET/REFLUX; POST-OPERATIVE COMPLICATIONS INCLUDING INFLAMMATION, FLUID ACCUMULATION, INFECTION; AGGRAVATION OF UNDERLYING CONDITIONS; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. AT THIS TIME IT IS UNCLEAR IF PLAINTIFF WAS ENROLLED IN ANY OF DEFENDANT¿S CLINICAL TRIALS OR STUDIES. PATIENT HAS NOT BEEN DIAGNOSED WITH BIA-ALCL." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 14212330 ↗