NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants LF-410595Recalls & reported problems
Allergan, Inc. · STYLE 410, LF, 595G 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628003163), received between Feb 18, 2021 and May 5, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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
- 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
- Device Appears to Trigger Rejection3
- Biofilm coating in Device1
Patient problems
- Capsular Contracture3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING LEFT SIDE "BIA-ALCL FEAR", "PAIN", "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14292765 ↗InjuryMar 5, 2021Biofilm coating in Device; Device Appears to Trigger Rejection; Biofilm coating in Device; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED PATIENT'S CONCERN WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. HEALTH PROFESSIONAL ALSO NOTED "THE SURFACE OF THE IMPLANT WAS FOUND TO HAVE A BIOFILM WHICH LED TO A SLIMY FEEL." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11422158 ↗InjuryFeb 18, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
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- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
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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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