NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410420Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MF 420CC 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.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628003484), received between May 29, 2019 and Sep 11, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Material Rupture” (9 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 Rupture9
- Adverse Event Without Identified Device or Use Problem6
- Patient-Device Incompatibility5
- Device Appears to Trigger Rejection2
- Failure to Osseointegrate2
Patient problems
- Failure of Implant9
- Capsular Contracture7
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)2
- No Clinical Signs, Symptoms or Conditions2
- Seroma2
- Unspecified Infection2
- Granuloma1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)
MAUDE report 50740271 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)
MAUDE report 50740227 ↗InjuryJun 15, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH A REGULATORY AGENCY "RUPTURED IMPLANT". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25499190 ↗InjuryMay 12, 2026Material Rupture
HEALTHCARE PROFESSIONAL THROUGH SALES REPRESENTATIVE REPORTED "RUPTURED/CRACKED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154722 ↗InjuryAug 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22787752 ↗InjuryMay 19, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AGAINST A TEXTURED IMPLANT. HEALTHCARE PROFESSIONAL LATER REPORTED "DOUBLE CAPSULE." DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22043042 ↗InjuryFeb 19, 2025Material Rupture; Material Rupture
PATIENT REPORTED NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED RUPTURE AND CONCERN WITH THE PRODUCT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21411674 ↗InjuryFeb 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT'S CONCERNS WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21401569 ↗InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21241201 ↗InjuryDec 4, 2024Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE "APPEARS TO BE SMALLER, AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANT DUE TO THEIR CONCERN WITH THE PRODUCT." PATIENT ALSO REPORTED "REOCCURRENCE OF BREAST CANCER" WHICH IS NOT DEVICE RELATED. PATIENT LATER REPORTED LEFT SIDE RUPTURE DISCOVERED VIA MRI, LEFT SIDE SMALLER, LEFT SIDE HANGING LOWER AND NOT ROUND. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 20843108 ↗InjuryFeb 10, 2023Material Rupture; Material Rupture
PATIENT REPORTED HAVING "A LUMP OR THICKENING IN OR NEAR THE BREAST OR IN THE UNDERARM AREA." SIDE UNSPECIFIED, THIS RECORD IS FOR THE LEFT SIDE. NO TREATMENT OR SURGICAL REOPERATION HAS OCCURRED. LATER HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16357307 ↗InjuryJan 19, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE CONCERN WITH THE PRODUCT, BREAST PAIN, INFLAMMATION, AND RUPTURE. HEALTHCARE PROFESSIONAL CONFIRMED RUPTURE. PATIENT ADDITIONALLY REPORTED "DEPRESSION", "VERY TIRED", "HAD WEIGHT GAIN", "THYROID NOT FUNCTIONING", "COULD HARDLY WALK", "JOINT PAIN", "SEVERE KIDNEY INFECTION", AND "POSITIVE FOR LUPUS"; THESE EVENTS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16210021 ↗InjuryOct 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED AGAINST LEFT SIDE "RECALL FOR TEXTURED" AND LATER CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "FOREIGN BODY GIANT CELL REACTION". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Granuloma
MAUDE report 15672613 ↗InjuryOct 15, 2020Material Rupture; Material Rupture
PATIENT REPORTED THEY WERE "CONCERNED ABOUT THE RECALL.", "SOME ITCHING AROUND MY AREOLA" AND "SOME PAIN WHEN [THEY] MOVE A CERTAIN WAY" ON THE LEFT SIDE. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10684186 ↗InjuryAug 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10439882 ↗InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REMOVAL DUE TO ¿IMPLANT RECALL" AND "EFFUSION.¿ DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 9623019 ↗InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REMOVAL DUE TO ¿IMPLANT RECALL/EFFUSION.¿ DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 9612217 ↗InjuryDec 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE NOT SPECIFIED. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9465553 ↗InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTED LEFT BREAST." PATIENT WAS TREATED WITH ANTIBIOTICS. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9182074 ↗InjuryOct 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9157452 ↗InjuryOct 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9156608 ↗InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED IMPLANT EXCHANGE" DUE TO AN INFECTION". THE PATIENT ADDITIONALLY REPORTED "BREAST CANCER" WHICH IS NOT DEVICE RELATED. THE DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Unspecified Infection
MAUDE report 9117807 ↗InjuryAug 14, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8894927 ↗InjuryMay 29, 2019Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8650124 ↗
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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.
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