NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MM-410185Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MM 185CC 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628003590), received between Nov 9, 2021 and Apr 26, 2024 — classified as 5 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.
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
- Device Appears to Trigger Rejection3
- Material Rupture3
- Migration2
Patient problems
- Capsular Contracture3
- Failure of Implant2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2024Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 19192569 ↗InjuryApr 25, 2024Device Appears to Trigger Rejection; Material Rupture; Migration; Device Appears to Trigger Rejection; Material Rupture; Migration
PREVIOUS MEDWATCH SUBMISSION NOTED RUPTURE. UPON FURTHER INFORMATION, ABBVIE HAS DETERMINED THAT THE EVENT OF RUPTURE DID NOT OCCUR.
Patient problems: Capsular Contracture
MAUDE report 19180707 ↗InjurySep 12, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT." HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE FOUND DURING THE EXPLANTING." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17733351 ↗InjurySep 11, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17720198 ↗InjuryNov 9, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE "TIGHT" AND REASON FOR REMOVAL DUE TO CAPSULAR CONTRACTURE, BAKER GRADE IV.
Patient problems: Capsular Contracture
MAUDE report 12782913 ↗
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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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