NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410615Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10888628003026), received between May 24, 2019 and Sep 23, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Material Rupture” (19 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 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870594 ↗
• InjuryAug 31, 2026Material Rupture

  The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525642 ↗
• InjuryDec 1, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23688521 ↗
• InjuryMay 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED VIA REGULATORY AGENCY "PAINS" AND THAT THE RIGHT SIDE IMPLANT WAS INTACT, CONFIRMED VIA MRI. PATIENT LATER REPORTED "CAPSULAR CONTRACTURE". HEALTHCARE PROFESSIONAL LATER REPORTED " CAPSULAR CONTRACTURE BAKER GRADE III IMPLANT EXCHANGE ". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22085305 ↗
• InjuryMay 2, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 21950077 ↗
• InjuryFeb 21, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED VIA REGULATORY AGENCY "INTRACAPSULAR RUPTURE CONFIRMED VIA MRI, AFTER FEELING PAINS, ONE SIDE ENLARGED AND TENDER". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 21431011 ↗
• InjuryJan 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED " CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE II/III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18553398 ↗
• InjuryNov 17, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 18165212 ↗
• InjuryJul 10, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE TEXTURED TO SMOOTH EXCHANGE AND LATER RUPTURE FOUND DURING EXPLANT. THE DEVICE HAS BEEN REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17292858 ↗
• InjuryApr 4, 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 SWELLING, SEROMA, ASYMMETRY, SHOOTING BREAST PAIN, SCRATCHING AND PULLING SENSATION IN CHEST, DIMINISHED AND/OR LIMITED ABILITY TO COMPLETE HOUSEHOLD DUTIES AND/OR AMBULATE, MASS UNDER ARM OR BREAST, LYMPHEDEMA, CHRONIC INSOMNIA, SIGNIFICANT WEIGHT GAIN, CHRONIC GASTROINTESTINAL UPSET OR REFLUX, AND CONSTIPATION. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE, PANIC DISORDER, PTSD, AND DEPRESSION; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. PLAINTIFF HAS NOT BEEN DIAGNOSED WITH BIA-ALCL." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 16676412 ↗
• InjuryApr 4, 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 SWELLING, SEROMA, ASYMMETRY, SHOOTING BREAST PAIN, SCRATCHING AND PULLING SENSATION IN CHEST, DIMINISHED AND/OR LIMITED ABILITY TO COMPLETE HOUSEHOLD DUTIES AND/OR AMBULATE, MASS UNDER ARM OR BREAST, LYMPHEDEMA, CHRONIC INSOMNIA, SIGNIFICANT WEIGHT GAIN, CHRONIC GASTROINTESTINAL UPSET OR REFLUX, AND CONSTIPATION. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE, PANIC DISORDER, PTSD, AND DEPRESSION; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. PLAINTIFF HAS NOT BEEN DIAGNOSED WITH BIA-ALCL." THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma; Swelling/ Edema

  MAUDE report 16676164 ↗
• InjuryFeb 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND AN EXCHANGE FROM TEXTURED TO SMOOTH. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16373571 ↗
• InjuryJan 6, 2023Gel Leak; Gel Leak

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING A RIGHT SIDE "BILATERAL REMOVAL WAS NOTED AS ¿TEXTURED CONCERN.¿ HEALTHCARE PROFESSIONAL LATER RIGHT BREAST IMPLANT GEL BLEED NOTED ON BREAST MRI. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 16118137 ↗
• InjuryOct 24, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV WITH "PAIN", "FOLD REPORTED WITH ULTRASOUND ON (B)(6) 2022" AND "FIRMNESS." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15663117 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED FOR LEFT SIDE, THE PATIENT SUFFERED AN "ACCUMULATION OF FLUID¿, ¿DRAINAGE OF FLUID¿, ¿DELAYED SEROMA¿, ¿GRANULOMATOUS CHANGES¿, ¿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, INCREASED RISK OF ALCL¿, ¿ANXIETY¿, AND ¿IMAGING AND PATHOLOGICAL EVALUATION TO RULE OUT BIA-ALCL¿, ¿CHRONIC INFLAMMATION¿, ¿SWELLING¿, ¿PAIN¿, ¿REDNESS¿, "ERYTHEMA", ¿TIGHTNESS¿, ¿DEPRESSION¿. IN ADDITION, THE FOLLOWING NON-DEVICE RELATED EVENTS WERE ALSO REPORTED AS FOLLOWS: ¿SIGNIFICANT SCARRING AND DISFIGUREMENT¿, ¿OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING¿ AND ¿SUFFERED LOSS OF WAGES AND WAGE-EARNER CAPACITY¿. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Granuloma; Seroma

  MAUDE report 14759800 ↗
• InjuryJun 17, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED RIGHT SIDE "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, INCREASED RISK OF ALCL¿, ¿ANXIETY¿, AND ¿IMAGING AND PATHOLOGICAL EVALUATION TO RULE OUT BIA-ALCL", "CHRONIC INFLAMMATION"," SWELLING, "PAIN", "REDNESS"," ¿ACCUMULATION OF FLUID¿, ¿DRAINAGE OF FLUID¿, AND ¿DELAYED SEROMA¿, "ERYTHEMA", "TIGHTNESS"," GRANULOMATOUS CHANGES", "DEPRESSION", "SIGNIFICANT SCARRING AND DISFIGUREMENT¿, ¿OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING¿ AND ¿SUFFERED LOSS OF WAGES AND WAGE-EARNER CAPACITY¿. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Granuloma; Seroma

  MAUDE report 14738754 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "LATE SEROMA OBSERVED DURING SURGERY." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 13715812 ↗
• InjuryMar 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE "LATE SEROMA". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 13636876 ↗
• InjuryFeb 24, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 13592374 ↗
• InjuryFeb 22, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 13579413 ↗
• InjuryNov 18, 2021Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12836251 ↗
• InjuryNov 7, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12759962 ↗
• InjuryMar 25, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11569187 ↗
• InjuryFeb 1, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND "CAP CONTRACTURE," BAKER GRADE UNKNOWN. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11263042 ↗
• InjuryNov 26, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 10909373 ↗