NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410525Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888628003507), received between Jun 24, 2019 and Jun 5, 2026 — classified as 1 death, 28 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "RUPTURES AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT". THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409403 ↗
• InjuryJun 5, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "RUPTURES AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT". THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409343 ↗
• InjuryJan 31, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN AND RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16273428 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED, ""THE 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 BREAST PAIN, HARDENING OF BREASTS, BREAST SWELLING, ASYMMETRY, HEAT SENSATIONS, RASHES OR ITCHING, POOR CIRCULATION IN RIGHT LEG, PHYSICAL WEAKNESS AND LIMITED MOBILITY, AND AGGRAVATION OF LYMPHEDEMA. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS, PANIC DISORDER, AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE, DEPRESSION, AND PTSD; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING." PATIENT DOES NOT HAVE AND WAS NOT DIAGNOSED WITH ALCL. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma; Swelling/ Edema

  MAUDE report 14855635 ↗
• InjuryJun 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED "PLAINTIFF ALLEGES THAT ONE OR MORE BIOCELL DEVICES CAUSED PERSONAL INJURIES AND DAMAGES INCLUDING BUT NOT LIMITED TO THE FOLLOWING: RECONSTRUCTION, HOSPITALIZATION, ADDITIONAL CARE, INFECTION, DENIED DISABILITY, CHRONIC PAIN, OTHER SYMPTOMS TO PAIN, RASHES, ITCHING, SWELLING, ASYMMETRY OF BREASTS, CAPSULAR CONTRACTURE, COLD SENSATION, INCREASED RISK OF ALCL, ANGUISH AND FEAR DUE TO RISK OF ALCL, AND OTHER PAST AND FUTURE ECONOMIC AND NONECONOMIC DAMAGES SUCH AS MEDICAL CARE COSTS, LOST WAGES, AND LOST WAGE EARNING CAPACITY. DUE TO THE MEDICAL TREATMENT AND HOSPITALIZATIONS RELATED TO THE BREAST IMPLANTS, PLAINTIFF IS UNABLE TO PROVIDE CARE FOR HANDICAPPED FAMILY MEMBER. IN ADDITION, PLAINTIFF IS UNABLE TO WORK DUE TO THE HOSPITALIZATIONS, AS THE HOSPITALIZATIONS PREVENT THEM AND KEPT FROM PERFORMING JOB DUTIES." THE REPORTED EVENTS OF MENTAL PAIN AND SUFFERING, SCARRING, DISFIGUREMENT, BLOOD DISORDER, AND IRON DEFICIENCY HAVE BEN DEEMED NOT RELATED TO THE DEVICE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 14601313 ↗
• InjuryNov 11, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL VIA DEVICE TRACKING REPORTED "CAPSULAR CONTRACTURE GRADE UNKNOWN/FEAR OF ALCL" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12800388 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT¿S REPRESENTATIVE REPORTED FOR LEFT SIDE, THE PATIENT SUFFERED "INFECTION", "CHRONIC PAIN", "RASHES", "ITCHING", "SWELLING", "HEAT SENSATION", AND "PAIN PRIOR TO EXPLANT PROCEDURE¿. PATIENT REPRESENTATIVE ADDITIONALLY REPORTED NON-DEVICE RELATED EVENTS OF "ANXIETY (GENERALIZED)", "CHRONIC INSOMNIA", "SIGNIFICANT WEIGHT LOSS", "CHRONIC GASTROINTESTINAL REFLUX", "CHRONIC HEADACHES", AND "DEPRESSION". THE DEVICE HAS BEEN REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 12549987 ↗
• InjuryJul 9, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12145674 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED PATIENT ¿HAD SEROMAS REQUIRING ASPIRATION AND EXPERIENCED SYSTEMATIC ILLNESSES RESULTING IN BILATERAL CAPSULOTOMIES,¿ ¿DEBILITATING PHYSICAL PAIN,¿ ¿SUFFERED, AND WILL SUFFER, PAINFUL REMOVAL PROCEDURES AS WELL AS ANY TREATMENT, THERAPY, RECOVERY, AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS, THE POTENTIAL FOR THE DEVELOPMENT OF BIA-ALCL, AND ANY CONDITION OR SYMPTOMS ASSOCIATED WITH BIA-ALCL OR THE PREVENTION OF THAT ISSUE,¿ ¿MENTAL SUFFERING, WAS/WILL BE REQUIRED TO UNDERGO ADDITIONAL SURGERIES AND OTHER PROCEDURES. SUFFERED EMOTIONAL DISTRESS, ANXIETY, AND LOSS OF QUALITY OF LIFE,¿ ¿ENDURE EMOTIONAL DISTRESS INCLUDING SUFFERING, ANGUISH, FRIGHT, HORROR, NERVOUSNESS, GRIEF, ANXIETY, WORRY, SHOCK, HUMILIATION, AND SHAME DUE TO THE RISK OF BIA-ALCL.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ DEPRESSION,¿ ¿DISFIGUREMENT¿ AND ¿DISABILITY;¿ THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED AND REPLACED. THIS RECORD IS FOR THE LEFT SIDE. A CAPSULECTOMY WAS PERFORMED DURING BOTH THE IMPLANTING AND EXPLANTING PROCEDURES.

  Patient problems: Seroma

  MAUDE report 11574592 ↗
• DeathJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED PATIENT'S DISCOMFORT. PATIENT DEVELOPED A COUGH AND SAW PULMONOLOGIST AND CARDIOLOGIST WITH NO DIAGNOSIS GIVEN. SYMPTOMS GREW TO SORES ALL OVER BODY AND NOT SLEEPING AS WELL AS THE PERSISTENT COUGH AND WAS TAKEN TO THE HOSPITAL IN WHICH PATIENT STAYED FOR 17 DAYS AND SENT HOME WITH DIAGNOSIS OF LYMPHOMA CD30 POSITIVE. THE PATIENT HAS PASSED AWAY. THE MARKER OF ALK(-) HAS NOT BEEN REPORTED OR CONFIRMED. AFFECTED SIDE IS LEFT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Lymphoma

  MAUDE report 11135762 ↗
• InjuryDec 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPRESENTATIVE REPORTED PATIENT EXPERIENCED ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE NOT SPECIFIED, ¿SCABBING AND DELAYED HEALING,¿ ¿INCREASED RISK OF BIA-ALCL,¿ ¿ANGUISH AND ANXIETY,¿ ¿BILATERAL TIGHTNESS¿ AND ¿MENTAL PAIN.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT EXPERIENCED ¿SUFFERING,¿ ¿DISFIGUREMENT¿ AND ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES;¿ THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture; Impaired Healing

  MAUDE report 10992446 ↗
• InjuryDec 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPRESENTATIVE REPORTED PATIENT EXPERIENCED ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE NOT SPECIFIED, ¿BILATERAL TIGHTNESS,¿ ¿MENTAL PAIN,¿ ¿INCREASED RISK OF BIA-ALCL¿ AND ¿ANGUISH AND ANXIETY.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ ¿SUFFERING¿ AND ¿DISFIGUREMENT;¿ THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 10983573 ↗
• InjuryDec 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10951902 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "GREW TO SIZE OF SPAGHETTI SQUASH" AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. HEALTHCARE PROVIDER REPORTED "ASPIRATED SEROMA FLUID AND THE RESULTS WERE CD30 PRECURSOR TO LYMPHOMA/BIA-ALCL. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Lymphoma; Seroma

  MAUDE report 10951701 ↗
• InjuryDec 5, 2020Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10950274 ↗
• InjuryOct 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT EXCHANGE DUE TO VOLUNTARY RECALL, "BREAST DEFORMITY, BREAST CAPSULE CONTRACTURE RIGHT", BAKER GRADE UNSPECIFIED. HEALTHCARE PROFESSIONAL ALSO REPORTED "RIGHT BREAST CARCINOMA", UNRELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10683556 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE ¿PAIN", "SPASMS", "SOMETHING THAT FELT LIKE A POCKET OF FLUID", AND "TENDER". PATIENT ALSO REPORTED "SPOT ON THEIR BACK THAT LOOKED LIKE SKIN CANCER", "SUDDEN FEELING OF INCREASED SALIVATION IN THEIR MOUTH", AND "WILL VOMIT¿; THESE ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 10640968 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE ¿PAIN", "SPASMS", "SOMETHING THAT FELT LIKE A POCKET OF FLUID", AND "TENDER". PATIENT ALSO REPORTED "SPOT ON THEIR BACK THAT LOOKED LIKE SKIN CANCER", "SUDDEN FEELING OF INCREASED SALIVATION IN THEIR MOUTH", AND "WILL VOMIT¿; THESE ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 10640960 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "IMPLANT HAS BEEN FILLING UP WITH FLUID." DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 10432037 ↗
• InjuryJun 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CONCERN WITH THE PRODUCT." ADDITIONALLY HEALTHCARE PROVIDER REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND DOUBLE CAPSULE. DEVICE HAS BEEN EXPLANTED. PHOTOS OF THE DEVICE HAVE BEEN RECEIVED AND REVIEWED.

  Patient problems: Capsular Contracture

  MAUDE report 10165450 ↗
• InjuryJun 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CONCERN WITH THE PRODUCT." ADDITIONALLY HEALTHCARE PROVIDER REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "DOUBLE CAPSULE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10125257 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED IMPLANTS "GOT INFECTED." DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 9949153 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "SWELLING AND HOT" AND CONCERNS WITH TEXTURED IMPLANT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Inflammation; Irritation

  MAUDE report 9897749 ↗
• InjuryMar 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED AN UNKNOWN SIDE INFECTION OF BREAST. THIS RECORD WILL BE FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9896271 ↗
• InjuryMar 11, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, DISCOMFORT, UPPER POLE THICKENING AND AN EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9819463 ↗