NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FM-410440Recalls & reported problems

Allergan, Inc. · NATRELLE 410 STYLE FM 440CC 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: 10
Deaths reported: 0
Injuries reported: 10
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888628002876), received between Sep 13, 2019 and Sep 8, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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

Last 36 months. The most recent month may be incomplete.

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 Rejection6
Material Rupture3
Adverse Event Without Identified Device or Use Problem1
Patient-Device Incompatibility1

Patient problems

Capsular Contracture7
Failure of Implant1
No Clinical Signs, Symptoms or Conditions1
Seroma1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

InjurySep 8, 2026Material Rupture
Patient reported "Rupture" against the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50659310 ↗
InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22868498 ↗
InjuryAug 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22854366 ↗
InjuryAug 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22687966 ↗
InjuryApr 3, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE EXCHANGE DUE TO "TEXTURED SILICONE IMPLANT", "RUPTURE", AND "CAPSULAR CONTRACTURE". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19034932 ↗
InjuryFeb 1, 2024Material Rupture; Material Rupture
SALES REPRESENTATIVE REPORTED "PLEASE SHIP AN EXPLANT BOX". THIS RECORD REPRESENTS THE RIGHT SIDE. SALES REP LATER REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18625265 ↗
InjuryJan 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER ALSO REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16274056 ↗
InjuryJan 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER ALSO REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16273900 ↗
InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED REMOVAL DUE TO "TEXTURED IMPLANT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 9446568 ↗
InjurySep 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "ASYMMETRY" AND "CONTRACTURE," BAKER GRADE UNKNOWN. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9033522 ↗

Device details

UDI-DI	`10888628002876`
Brand	NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
Model	FM-410440
Company	Allergan, Inc.
Product code	FTR · Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Class	Class 3
FDA submission	P040046
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	Not in Commercial Distribution
Record updated	Oct 12, 2021

Device type (GMDN): Silicone gel-filled breast implant, textured-surface

An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is textured. The implant may vary in shape, profile, volume and shell thickness.

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All Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices →

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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