NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410580Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MF 580CC 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 Allergan Natrelle 410 breast implant is a silicone-filled breast prosthesis. Its 24 reports mostly describe scar tissue tightening around the implant, rupture or failure, and fluid buildup; there were 24 injuries and no deaths. It has 1 open recall, begun in July 2019, concerning updated safety information about a higher incidence of BIA-ALCL with textured breast implants; 1 report was filed in the past year versus 0 in the previous year.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10888628003514), received between Jun 13, 2019 and Sep 24, 2026 — classified as 26 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility9
- Material Rupture7
- Adverse Event Without Identified Device or Use Problem5
- Device Appears to Trigger Rejection5
- Gel Leak1
Patient problems
- Capsular Contracture14
- Failure of Implant6
- Seroma4
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported ¿Capsular Contracture Baker grade unknown¿ and ¿exchange from texture to smooth¿. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50880212 ↗InjurySep 5, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50625289 ↗InjuryApr 23, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "VISIBLE RIPPLING & RECALL¿. LATER HEALTHCARE PROFESSIONAL REPORTED "PT HAS CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24965728 ↗InjuryJun 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14844714 ↗InjuryApr 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE-3. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14116587 ↗InjuryJul 30, 2021Material Rupture; Material Rupture
PATIENT'S SPOUSE REPORTED RIGHT SIDE "BREAKING DOWN AND HAS LUMP AND ALSO A POSSIBLE BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12252791 ↗InjuryApr 14, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11667887 ↗InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A LEFT SIDE "FLUID BUILD UP." PATIENT REPRESENTATIVE REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ THIS EVENT IS NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 11664433 ↗InjuryApr 13, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11657807 ↗InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A RIGHT SIDE "FLUID BUILD UP." PATIENT REPRESENTATIVE REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ THIS EVENT IS NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Seroma
MAUDE report 11618934 ↗InjuryFeb 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO CONCERN WITH THE PRODUCT" AND "CAPSULAR CONTRACTURE," BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11267073 ↗InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED THEY "BEEN HAVING BREAST PAINS", "FLUID AROUND BREASTS AND UNDER [THEIR] ARMS". PATIENT ADDITIONALLY REPORTED [THEIR] BREATHING HAS BEEN FUNNY", HAD A BLOOD CLOT IN [THEIR] NECK, AND [THE PATIENT] HAS BEEN FIGHTING TWO TYPES OF CANCER¿, "NECK WAS REAL, REAL SWOLLEN AND COULDN'T DO MUCH"; THESE EVENTS ARE UNRELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Seroma
MAUDE report 10643502 ↗InjurySep 15, 2020Gel Leak; Material Rupture; Gel Leak; Material Rupture
PATIENT REPORTED RIGHT SIDE "RUPTURE, PAIN SENSATION, HARDENING AND ENLARGEMENT". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10534172 ↗InjuryAug 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PAINFUL CONTRACTURE,¿ BAKER GRADE NOT SPECIFIED. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10463653 ↗InjuryAug 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PAINFUL CONTRACTURE,¿ BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10454637 ↗InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE SEROMA. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 10379987 ↗InjuryJul 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10289251 ↗InjuryMar 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED LEFT SIDE "ACCUMULATION OF BLOOD (HEMATOMA) BEHIND THE BREAST" AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9884306 ↗InjuryMar 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryMar 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PAINFUL CAPSULAR CONTRACTURE¿, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9829393 ↗InjuryMar 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PAINFUL CAPSULAR CONTRACTURE,¿ BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9818313 ↗InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "INFECTION". DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9580302 ↗InjuryDec 18, 2019Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE" AND "EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9491997 ↗InjuryDec 10, 2019Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9444187 ↗InjuryOct 16, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
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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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