NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FM-410270Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE FM 270CC 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 10888628002838), received between Mar 25, 2021 and Sep 21, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 Rejection4
- Material Rupture3
- Malposition of Device2
- Migration1
Patient problems
- Capsular Contracture4
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported a "capsular contracture Baker grade III". Later contacted back reporting "textured implants used". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50836328 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported a "capsular contracture Baker grade III". Later contacted back reporting "textured implants used". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50836256 ↗InjurySep 15, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775981 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection; Malposition of Device
Patient reported ¿flipped and upside down¿. Later, healthcare professional reported "Capsule". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50115333 ↗InjuryJul 27, 2026Migration
Healthcare professional reported "Implant bottoming out". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015681 ↗InjuryJul 10, 2026Device Appears to Trigger Rejection; Malposition of Device
PATIENT REPORTED ¿FLIPPED AND UPSIDE DOWN¿. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25787648 ↗InjuryMay 27, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22089321 ↗InjuryMar 25, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11568613 ↗
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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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