NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410560Recalls & reported problems
Allergan, Inc. · STYLE, 410, FX, 560 G BIOCELL |textured|contour|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Natrelle 410 textured silicone gel-filled breast implant from Allergan appears in 47 adverse event reports, which describe the implant rupturing, hardening of the surrounding tissue (capsular contracture), and fluid collecting around the implant. Reports include 46 injuries and 1 death. One open recall, started in July 2019, follows FDA information about a higher rate of anaplastic large cell lymphoma in patients with textured breast implants.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 1
- Injuries reported
- 48
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10888628003019), received between May 24, 2019 and Sep 15, 2026 — classified as 1 death, 48 injuries.
The most frequently reported specific device problem is “Material Rupture” (24 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Material Rupture24
- Patient-Device Incompatibility12
- Adverse Event Without Identified Device or Use Problem8
- Device Appears to Trigger Rejection5
- Insufficient Device Problem Information1
- Malposition of Device1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant22
- Capsular Contracture17
- Seroma6
- Unspecified Infection3
- No Clinical Signs, Symptoms or Conditions2
- Anxiety1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Appears to Trigger Rejection
Healthcare professional reported "implant exchange with no complaint against the device". Later healthcare professional reported "capsular contracture Baker grade unknown". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50769007 ↗InjuryAug 7, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "rupture". This record is for the right side. The device remains implanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50181241 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "fluid around implant". This record is for the right side. Device was explanted and replaced.
Patient problems: Seroma
MAUDE report 25020864 ↗InjuryJan 29, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". LATER THE HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24209344 ↗InjuryNov 18, 2025Malposition of Device; Malposition of Device
THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23590051 ↗InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. LATER HEALTHCARE PROFESSIONAL REPORTED REMOVING APPROXIMATELY 10CC OF FLUID FROM BREAST DIAGNOSED VIA MRI, ULTRASOUND, CYTOLOGY. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Seroma
MAUDE report 23164148 ↗InjurySep 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANT BECAME FIRM, PREVIOUS FLUID ACCUMULATION AROUND IMPLANT" AND "REMOVING APPROXIMATELY 10CC OF FLUID FROM BREAST" DIAGNOSED VIA MRI, ULTRASOUND, CYTOLOGY. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Seroma
MAUDE report 23124971 ↗InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22907040 ↗InjuryAug 13, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "TEXTURED BIOCELL IMPLANTS, BILATER BAKER 1"CONFIRMED BY ULTRASOUND. LATER HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22793443 ↗InjuryJul 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURED BIOCELL IMPLANT, INTRACAPSULAR RUPTURE LEFT BREAST, AND CAPSULAR CONTRACTURE BAKER GRADE I" CONFIRMED BY ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 22474132 ↗InjuryJun 30, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "BIOCELL TEXTURED IMPLANTS" AND "CAPSULAR CONTRACTURE BAKER GRADE I". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22364507 ↗InjuryJun 30, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "BIOCELL TEXTURED IMPLANTS" AND "CAPSULAR CONTRACTURE BAKER GRADE I". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22353091 ↗InjuryJun 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TEXTURED IMPLANT" AND "RUPTURE". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22172347 ↗InjuryMar 5, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE OF LEFT IMPLANT. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21530217 ↗InjuryNov 7, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE VIA MRI, MAMMOGRAM, AND ULTRASOUND, LEAK, AND EXCHANGE OF TEXTURED IMPLANTS DUE TO PATIENTS CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND NOT REPLACED.
Patient problems: Failure of Implant
MAUDE report 18089069 ↗InjuryNov 7, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE RUPTURE. CONFIRMED BY MRI, MAMMOGRAM AND ULTRASOUND. LEAK AND EXCHANGE OF TEXTURED IMPLANTS, DUE TO PATIENTS CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18089016 ↗DeathAug 9, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
PREVIOUS MEDWATCH SUBMISSION NOTED DEATH. UPON FURTHER INFORMATION, ALLERGAN MEDICAL SAFETY TEAM HAS DETERMINED THAT THE EVENT OF DEATH IS NOT DEVICE RELATED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17494930 ↗InjuryJun 27, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERN OF THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17209464 ↗InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED AGAINST LEFT DEVICE "TEXTURED" AND THEN LATER "MILD PERICAPSULAR FLUID". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Seroma
MAUDE report 16342378 ↗InjuryOct 31, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, LEFT-SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. LATER, PATIENT'S HUSBAND REPORTED ON BEHALF OF THE PATIENT, LEFT-SIDE RUPTURE IDENTIFIED UPON EXPLANT SURGERY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICES.
Patient problems: Failure of Implant
MAUDE report 15700085 ↗InjuryOct 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15522583 ↗InjuryAug 23, 2022Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15276171 ↗InjuryAug 10, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿IMPLANT RECALL¿ AND ¿DISTORTION OF RECONSTRUCTED BREAST.¿ HEALTHCARE PROFESSIONAL LATER REPORTED A "RIGHT SIDE RUPTURE" AND "CAPSULAR CONTRACTURE, BAKER GRADE, III." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15205028 ↗InjuryDec 20, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE MALPOSITION AND IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. ADDITIONALLY, LEFT SIDE OBSERVATION MADE DURING SURGERY "HOLE, NON SPECIFIC". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13043659 ↗InjuryApr 23, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "ANY CREASES ASSOCIATED WITH HOLE."
Patient problems: Failure of Implant
MAUDE report 11717413 ↗
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page