NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MX-410290Recalls & reported problems
Allergan, Inc. · STYLE 410, MX, 290G 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
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628003712), received between Dec 17, 2019 and Mar 28, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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
- Adverse Event Without Identified Device or Use Problem2
- Device Appears to Trigger Rejection2
- Material Rupture2
- Patient-Device Incompatibility2
- Migration1
Patient problems
- Capsular Contracture4
- Failure of Implant2
- Seroma2
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2025Material Rupture; Migration; Material Rupture; Migration
HEALTHCARE PROFESSIONAL REPORTED RUPTURE TO UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; Swollen Lymph Nodes/Glands
MAUDE report 21717205 ↗InjuryMar 5, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED REASON FOR RIGHT SIDE REMOVAL AS CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11423246 ↗InjuryFeb 11, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED REASON FOR LEFT SIDE REMOVAL AS CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11314626 ↗InjuryJun 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND PATIENT CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10165984 ↗InjuryJun 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10164994 ↗InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "SCAR TISSUE AND FLUID" AND HEALTHCARE PROFESSIONAL REPORTED REMOVAL DUE TO PATIENT CONCERN WITH THE PRODUCT. THE FOLLOWING REPORTED EVENTS HAVE BEEN DEEMED NOT RELATED TO THE DEVICE: "JOINT PAIN, AUTOIMMUNE ISSUES, YEAST INFECTION, ECZEMA, SWOLLEN FINGERS, EGG ALLERGY." DEVICE HAS BEEN EXPLANTED. THIS RECORD REPRESENTS THE SIDE RIGHT.
Patient problems: Seroma
MAUDE report 9628929 ↗InjuryDec 26, 2019Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "IS SMALLER AND MORE FIRM" AND THEY ARE "CONCERNED THAT IT SHRANK BECAUSE IT IS LEAKING". PATIENT ADDITIONALLY REPORTED BREAST CANCER PRIOR TO IMPLANTATION; THIS EVENT IS NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 9520008 ↗InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "SCAR TISSUE AND FLUID." ADDITIONALLY HEALTHCARE PROFESSIONAL REPORTED "PATIENT'S CONCERN WITH PRODUCT." PATIENT ALSO REPORTED "JOINT PAIN, AUTOIMMUNE ISSUES, YEAST INFECTION, ECZEMA, SWOLLEN FINGERS, EGG ALLERGY"; THESE ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Seroma
MAUDE report 9481448 ↗
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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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