NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410495Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10888628003002), received between May 16, 2019 and Sep 30, 2026 — classified as 62 injuries.

The most frequently reported specific device problem is “Material Rupture” (22 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 62 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "possible rupture", "fluid" and "possible ALCL". Histopathological markers CD30+ and ALK- have not been received, hence the report of ALCL has not been confirmed. Healthcare professional later confirmed "rupture; peri prosthetic fluid collection" and reported "capsular contracture" Baker grade unknown. This record is for the right side. Device remains implanted.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Capsular Contracture; Seroma

  MAUDE report 50947852 ↗
• InjuryAug 6, 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 50159600 ↗
• InjuryJul 14, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade unknown". Later healthcare professional reported "acquired breast deformity", "developed asymmetry and deformity", "the breast has become smaller", 'also there are calcific changes seen on the anterior ans posterior surface of the implant". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25813928 ↗
• InjurySep 30, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II", "BIOCELL REPLACEMENT" AND "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23180848 ↗
• InjuryJul 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RECALL AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22680353 ↗
• InjuryJun 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE"RUPTURE" CONFIRMED VIA MAMMOGRAM AND ULTRASOUND. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22330179 ↗
• InjuryJun 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE" CONFIRMED VIA MAMMOGRAM AND ULTRASOUND. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22330173 ↗
• InjuryJun 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". LATER "CAPSULAR CONTRACTURE GRADE 3". THIS REPORT IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22173136 ↗
• InjuryJun 9, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "THREE TUMORS FOUND ON A MAMMOGRAM" AND "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN". LATER HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED RUPTURE" AND "CAPSULAR CONTRACTURE BAKER GRADE IV". LATER HEALTHCARE PROFESSIONAL REPORTED "LESS CALCIFICATION". THIS IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22172696 ↗
• InjuryJun 4, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "RUPTURE", "LEAKING SILICONE", AND "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN" VIA MAMMOGRAM. LATER, HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED RUPTURE" AND "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22146552 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "FLUID WAS EXTRACTED AND SENT FOR TESTING" AND "REMOVAL FROM TEXTURE TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD RELATES TO THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 22019343 ↗
• InjuryNov 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Failure of Implant

  MAUDE report 18199703 ↗
• InjuryOct 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. AND EXCHANGE FROM TEXTURED TO SMOOTH, DUE TO CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17981050 ↗
• InjurySep 6, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE", "HOLE, NON-SPECIFIC" OBSERVED DURING EXPLANT SURGERY. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17691228 ↗
• InjuryMar 28, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA SUS VOLUNTARY EVENT REPORT "SUSPECTED RUPTURE" AND "DEVICE MALFUNCTION-THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO."

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 16632369 ↗
• InjuryMar 28, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INCREASING HYPERMETABOLIC ACTIVITY OF A FEW RIGHT INTERNAL MAMMARY NODULES". HEALTHCARE PROFESSIONAL REPORTED VIA SUS VOLUNTARY EVENT REPORT "SUSPECTED RUPTURE" AND "DEVICE MALFUNCTION-THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 16632362 ↗
• InjuryMar 3, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16481997 ↗
• InjuryJan 18, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ''ROTATION IN POCKET.'' HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE II, AND RUPTURED IMPLANT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16195317 ↗
• InjuryJan 17, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  COMPANY REPRESENTATIVE REPORTED A CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 16188738 ↗
• InjuryJan 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "BREAST AND UNDER LEFT ARM AREA WAS ENLARGED AND HARDENED", "PAIN", CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, "CONCERNS OF THE PRODUCT" AND "TESTED POSITIVE FOR LYMPHOMA." PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Lymphoma

  MAUDE report 16105644 ↗
• InjuryAug 18, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTION", BAKER GRADE III. ADDITIONALLY, MRI SHOWED RUPTURED IMPLANT. AFFECTED SIDE IS RIGHT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15254322 ↗
• InjuryJul 25, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 15096139 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED THAT THE PATIENT "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, CHRONIC SWELLING AND INFLAMMATION, PHYSICAL PAIN, KELOIDS AND HYPERTROPHIC SCARRING, LYMPHEDEMA, AND ASYMMETRY OF AREOLAS AND DISFIGUREMENT. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND PTSD, ANXIETY AND DEPRESSION, AS WELL AS LOSS OF QUALITY OF LIFE; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. PATIENT HAS NOT BEEN DIAGNOSED WITH ALCL". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma; Swelling/ Edema

  MAUDE report 15079359 ↗
• InjuryMay 26, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14518268 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED THAT THE PATIENT "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, CHRONIC SWELLING AND INFLAMMATION, PHYSICAL PAIN, KELOIDS AND HYPERTROPHIC SCARRING, LYMPHEDEMA, AND ASYMMETRY OF AREOLAS AND DISFIGUREMENT. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND PTSD, ANXIETY AND DEPRESSION, AS WELL AS LOSS OF QUALITY OF LIFE; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. PATIENT HAS NOT BEEN DIAGNOSED WITH ALCL". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED,

  Patient problems: Seroma; Swelling/ Edema

  MAUDE report 14270538 ↗