NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants LF-410390Recalls & reported problems
Allergan, Inc. · STYLE 410, LF, 390G 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 10888628003125), received between Aug 27, 2021 and Aug 22, 2023 — 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
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.
InjuryAug 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PLAINTIFF REPORTED LEFT SIDE ONE OR MORE BIOCELL® DEVICES CAUSED PERSONAL INJURIES AND DAMAGES INCLUDING BUT NOT LIMITED TO THE FOLLOWING: REMOVAL OF IMPLANTS DUE TO FEAR ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL INCLUDING: MENTAL ANGUISH AND FEAR OF ALCL, INCREASED RISK OF ALCL, CELLULAR CHANGES AND DAMAGE OF BREAST TISSUE, INFLAMMATION, EVALUATION FOR ALCL, PATHOLOGICAL TESTING OF SURGICAL SPECIMENS, EXPLANT, CAPSULECTOMY, CONTRACTURE, DISCOMFORT, TIGHTNESS, ASYMMETRY, RECONSTRUCTION AND RE-IMPLANTATION, PAIN, ITCHING, SCARRING; AGGRAVATION OF UNDERLYING CONDITIONS; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. PLAINTIFF HAS NOT BEEN DIAGNOSED WITH BIA-ALCL. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17599692 ↗InjuryAug 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryAug 27, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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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