NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants LL-410135Recalls & reported problems
Allergan, Inc. · STYLE 410, LL, 135G 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 10888628003170), received between Jan 22, 2020 and Jul 31, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.
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 Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture2
- Swollen Lymph Nodes1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "ENLARGED LYMPH NODE" AND THEY "FEEL EXTREMELY THREATENED AND SCARED BY HAVING AN IMPLANT THAT HAS BEEN RECALLED." PATIENT ADDITIONALLY REPORTED "BENIGN LYMPHOMA IN ARMPIT RECENTLY DIAGNOSED BY BIOPSY;" THIS EVENT IS NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes
MAUDE report 10353432 ↗InjuryFeb 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING, REASON FOR LEFT SIDE REMOVAL AS "LEFT BREAST CAPSULAR CONTRACTURE, BAKER GRADE NOT SPECIFIED". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9739895 ↗InjuryJan 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED AND CONFIRMED BAKER GRADE III.
Patient problems: Capsular Contracture
MAUDE report 9616846 ↗
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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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