NATRELLE Silicone-Filled Breast Implants 120-440Recalls & reported problems

Allergan, Inc. · NATRELLE Style 120-440 High profile BIOCELL |textured|round|silicone · Class 3 · Implant

All models of Natrelle Breast Implants (1167) · NATRELLE Silicone-Filled Breast Implants (128)

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.

Quick summary

This is a Natrelle silicone-filled breast implant with a textured surface. The 47 adverse event reports mostly describe implants that rupture or break, and scar tissue that tightens around the implant, making the breast feel hard, painful and misshapen; some implants were removed or swapped for smooth ones. All47 reports involve injuries, with no deaths. One open recall, started in July 2019, concerns a rare type of blood cancer (BIA-ALCL) seen with textured breast implants.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 50
Deaths reported: 0
Injuries reported: 50
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10888628002562), received between Dec 12, 2018 and Sep 30, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Material Rupture” (29 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.

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-2454-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Material Rupture29
Device Appears to Trigger Rejection12
Patient-Device Incompatibility6
Adverse Event Without Identified Device or Use Problem5
Fluid/Blood Leak1
Migration1
Migration or Expulsion of Device1

Patient problems

Failure of Implant22
Capsular Contracture18
Seroma4
No Clinical Signs, Symptoms or Conditions3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Breast Discomfort/Pain2
Anaplastic Large Cell Lymphoma1
Breast Mass1

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Material Rupture
Healthcare professional reported ¿asymmetry¿, ¿deflation¿, ¿rupture¿, ¿bottomed out¿, ¿too large¿ and ¿ptosis¿, which is not device related. This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949016 ↗
InjurySep 21, 2026Material Rupture
Patient reported "Rupture", "Hardening", "Swelling large fluid collection" and "I have every symptom of what's described for BIA-AICL". Then healthcare professional reported "Rupture" and "Removal and exchange from texture to smooth". This record is for the left side. Device remains implanted.
Patient problems: Swelling/ Edema
MAUDE report 50839603 ↗
InjurySep 18, 2026Material Rupture
Healthcare professional reported "Rupture" and "moderate pain". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819588 ↗
InjurySep 18, 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 50819466 ↗
InjurySep 14, 2026Device Appears to Trigger Rejection
Patient reported "exchange of implant with no complaint against the device". Later, patient reported "Capsular Contracture Baker grade III/IV" and "exchange from textured to smooth breast implants due to concern with the product". Patient later reported "hardness", "removal and exchange from texture to smooth" and "pain". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50762588 ↗
InjuryJun 1, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25355536 ↗
InjuryApr 13, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "CALCIFIED, INFLAMMATION, ARTHRITIS, SKIN ISSUES AND BEING SUICIDAL, EXPERIENCING WEIGHT GAIN AND PSORIATIC ARTHRITIS AND EXCHANGE FROM TEXTURED TO SMOOTH". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24860639 ↗
InjuryFeb 18, 2026Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24378744 ↗
InjuryFeb 10, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24308293 ↗
InjuryFeb 10, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24305502 ↗
InjuryDec 11, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". HEALTHCARE PROFESSIONAL REPORTED "RUPTURED AND FEAR ALCL". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23782804 ↗
InjuryDec 4, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT". HEALTHCARE PROFESSIONAL REPORTED "RUPTURED AND FEAR ALCL". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23719892 ↗
InjuryOct 30, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE", "PAIN", "HARDNESS, TENDERNESS", "EXCHANGE FROM TEXTURED TO SMOOTH", "LIQUID IN BREAST" AND "FOGGY MEMORY" CONFIRMED VIA ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED. THE DEVICE WILL BE RETURNED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain
MAUDE report 23431037 ↗
InjuryOct 28, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE", "PAIN", "HARDNESS, TENDERNESS", "EXCHANGE FROM TEXTURED TO SMOOTH" AND "FOGGY MEMORY" - NOT RELATED TO THE DEVICE CONFIRMED VIA ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain
MAUDE report 23403873 ↗
InjuryApr 24, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV AND RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21904858 ↗
InjuryJul 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III" AND "TEXTURED DEVICE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19692890 ↗
InjuryFeb 27, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TEXTURED IMPLANTS". DEVICE HAS BEEN EXPLANTED. HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE RUPTURE SEEN UPON EXPLANT.
Patient problems: Failure of Implant
MAUDE report 18793169 ↗
InjuryFeb 26, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURED IMPLANTS". DEVICE HAS BEEN EXPLANTED. HEALTHCARE PROFESSIONAL LATER REPORTED "LEFT SIDE DEVICE FOUND RUPTURED DURING EXPLANT" AND "CAPSULAR CONTRACTURE BAKER GRADE III".
Patient problems: Capsular Contracture
MAUDE report 18785188 ↗
InjuryJun 7, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE TEXTURED EXCHANGE DUE TO PRODUCT CONCERN AND RUPTURE DISCOVERED ON EXPLANT. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17083364 ↗
InjuryJan 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16081349 ↗
InjuryDec 27, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 16057446 ↗
InjuryDec 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED A CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15941970 ↗
InjurySep 26, 2022Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE" AND "TEXTURED" AGAINST RIGHT DEVICE. HEALTH CARE PROFESSIONAL LATER CALLED AND CONFIRMED THE RIGHT SIDE RUPTURE AND EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15485640 ↗
InjurySep 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER CALLED AND REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III" AND "TEXTURED" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15485463 ↗
InjuryJul 31, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT AND A RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15136877 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

Z-0700-2020 · Nov 6, 2019 · Terminated
Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
Z-0701-2020 · Nov 6, 2019 · Terminated
Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
Z-2453-2019 · Jul 24, 2019 · Open, Classified
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR

Device details

UDI-DI	`10888628002562`
Brand	NATRELLE Silicone-Filled Breast Implants
Model	120-440
Company	Allergan, Inc.
Product code	FTR · Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Class	Class 3
FDA submission	P020056
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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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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