NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MX-410520Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10888628003767), received between Dec 17, 2019 and Jul 27, 2026 — classified as 30 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker Grade IV" via National Breast Implant Record. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50031698 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker Grade IV" via National Breast Implant Record. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50031696 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED OF THE LEFT SIDE DEVICE: "RIPPLES IN THE SKIN". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24483626 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED OF THE RIGHT SIDE DEVICE: "RIPPLES IN THE SKIN". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24413026 ↗
• InjuryDec 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT'S REPRESENTATIVE REPORTED "ONE OR MORE BIOCELL DEVICES CAUSED PERSONAL INJURIES AND DAMAGES INCLUDING BUT NOT LIMITED TO THE FOLLOWING: PLAINTIFF WAS IMPLANTED WITH BIOCELL TEXTURED BREAST IMPLANTS AND HAS SUFFERED, OR WILL SUFFER, BIA-ALCL, PAINFUL REMOVAL PROCEDURES, SCARRING, DISFIGUREMENT, DIAGNOSTICS AND EXPLANT, RECONSTRUCTION, HOSPITALIZATION, ADDITIONAL CARE, CAPSULAR CONTRACTURE, AS WELL AS OTHER TREATMENT, THERAPY, RECOVERY AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS, ALONG WITH INCREASED RISK OF ALCL, FEAR DUE TO RISK OF ALCL, AND ANY CONDITION OR SYMPTOMS ASSOCIATED WITH ALCL OR THE PREVENTION OF THAT ISSUE, AND OTHER PAST AND FUTURE ECONOMIC AND NON-ECONOMIC DAMAGES SUCH AS MEDICAL CARE COSTS, LOST WAGES, LOST WAGE EARNING CAPACITY AND MENTAL PAIN AND SUFFERING, AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING", "DESIRE TO HAVE HER IMPLANTS REMOVED DUE TO THE INCREASED RISK OF BIA-ALCL". THE BAKER GRADE OF THE CAPSULAR CONTRACTURE IS UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. PATIENT WAS HOSPITALIZED.

  Patient problems: Capsular Contracture

  MAUDE report 23871981 ↗
• InjuryDec 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT'S REPRESENTATIVE REPORTED "ONE OR MORE BIOCELL DEVICES CAUSED PERSONAL INJURIES AND DAMAGES INCLUDING BUT NOT LIMITED TO THE FOLLOWING: PLAINTIFF WAS IMPLANTED WITH BIOCELL TEXTURED BREAST IMPLANTS AND HAS SUFFERED, OR WILL SUFFER, BIA-ALCL, PAINFUL REMOVAL PROCEDURES, SCARRING, DISFIGUREMENT, DIAGNOSTICS AND EXPLANT, RECONSTRUCTION, HOSPITALIZATION, ADDITIONAL CARE, CAPSULAR CONTRACTURE, AS WELL AS OTHER TREATMENT, THERAPY, RECOVERY AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS, ALONG WITH INCREASED RISK OF ALCL, FEAR DUE TO RISK OF ALCL, AND ANY CONDITION OR SYMPTOMS ASSOCIATED WITH ALCL OR THE PREVENTION OF THAT ISSUE, AND OTHER PAST AND FUTURE ECONOMIC AND NON-ECONOMIC DAMAGES SUCH AS MEDICAL CARE COSTS, LOST WAGES, LOST WAGE EARNING CAPACITY AND MENTAL PAIN AND SUFFERING, AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING", "DESIRE TO HAVE HER IMPLANTS REMOVED DUE TO THE INCREASED RISK OF BIA-ALCL" AND "BEEN DIAGNOSED WITH BIA-ALCL". THE BAKER GRADE OF THE CAPSULAR CONTRACTURE IS UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. PATIENT WAS HOSPIT

  Patient problems: Capsular Contracture; Lymphoma

  MAUDE report 23856951 ↗
• InjuryJul 17, 2025Malposition of Device; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED " EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT AND IMPLANT KEEPS FLIPPING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22531794 ↗
• InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  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 IMPLANT 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, ASYMMETRY, BREAST PAIN, HEAT SENSATIONS, RASHES OR ITCHING, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN , AND MASS UNDER THE ARM OR BREAST. ALSO REPORTED SWOLLEN LYMPH NODES. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS, PANIC DISORDER, AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE, PTSD, AND DEPRESSION; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. PLAINTIFF HAS NOT BEEN DIAGNOSED WITH BIA-ALCL." ALSO REPORTED CHRONIC INSOMNIA. SIGNIFICANT WEIGHT LOSS OR GAIN, ULCER, IRRITABLE BOWEL/CROHN'S DISEASE, CHRONIC HEADACHE, FATIGUE AND WEAKNESS , CONNECTIVE TISSUE DISEASE, JOINT AND MUSCLE PAIN, NERVE DAMAGE (ALL EVENTS ARE NOT RELATED TO THE DEVICE.) THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEE

  Patient problems: Capsular Contracture; Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 16731971 ↗
• InjuryFeb 15, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 16382296 ↗
• InjuryOct 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE "CAPSULAR CONTRACTURE" BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15532388 ↗
• InjuryJul 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15041651 ↗
• InjuryApr 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14106702 ↗
• InjuryMar 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13778626 ↗
• InjuryJan 11, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN WITH THE PRODUCT" AS WELL AS SEROMA, RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "EVACUATION HEMATOMA." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 13231055 ↗
• InjurySep 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III/IV." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12513078 ↗
• InjurySep 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III/IV." THE DEVICE HAS BEEN REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 12507082 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED LEFT SIDE ¿CHRONIC PAIN,¿ ¿ITCHING,¿ ¿SWELLING,¿ ¿HEAT SENSATION,¿ ¿ANXIETY¿ ¿EXPLANT SURGERY DUE TO FEAR OF DEVELOPING ALCL, TO REDUCE THE RISK OF ALCL¿ ¿MENTAL ANGUISH AND FEAR OF DEVELOPING ALCL,¿ ¿PATIENT HAS BEEN DIAGNOSED WITH BIA-ALCL.¿ PATIENT REPRESENTATIVE ADDITIONALLY REPORTED ¿CHRONIC INSOMNIA, SIGNIFICANT WEIGHT GAIN,¿ ¿CHRONIC GASTROINTESTINAL REFLUX¿ ¿DISFIGUREMENT,¿ AND ¿CHRONIC HEADACHES¿ NOT RELATED TO THE DEVICE. PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Lymphoma

  MAUDE report 12475114 ↗
• InjuryMar 17, 2021Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "CONCERN WITH THE TEXTURED IMPLANTS." PATIENT ADDITIONALLY REPORTED RIGHT SIDE RUPTURE AND INFECTION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 11504898 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE INFECTION AND AN EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO HER CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 11171544 ↗
• InjuryDec 30, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV.

  Patient problems: Capsular Contracture

  MAUDE report 11098709 ↗
• InjuryNov 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10854193 ↗
• InjuryOct 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT¿S CONCERN WITH THE PRODUCT". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10697699 ↗
• InjuryOct 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENT¿S CONCERN WITH THE PRODUCT". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10697661 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT'S CONCERN WITH THE DEVICE". ADDITIONALLY, PATIENT REPORTED RIGHT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 10661129 ↗
• InjuryAug 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10460759 ↗