NATRELLE Silicone-Filled Breast Implants 110-240Recalls & reported problems
Allergan, Inc. · NATRELLE Style 110-240 Moderate 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 Natrelle BIOCELL textured silicone-gel breast implant from Allergan is reported in 28 adverse event reports, all involving injuries and no deaths. Most describe implant rupture and the surrounding scar tissue tightening (capsular contracture), sometimes with pain or deformity and exchange to a smooth implant; a few mention swelling or lumps. One open recall, started July 2019, followed FDA notice of a higher rate of anaplastic large cell lymphoma in patients 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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10888628002203), received between May 29, 2019 and Feb 19, 2026 — classified as 26 injuries.
The most frequently reported specific device problem is “Material Rupture” (15 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
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 Rupture15
- Device Appears to Trigger Rejection6
- Patient-Device Incompatibility4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant13
- Capsular Contracture10
- Granuloma2
- Inflammation1
- Seroma1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "PAINFUL, BREAST DEFORMITY, HIGH GRADE CAPSULES, CAPSULAR CONTRACTURE BAKER GRADE III, AND AN EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24389403 ↗InjuryFeb 19, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "PAINFUL, BREAST DEFORMITY, HIGH GRADE CAPSULES, CAPSULAR CONTRACTURE BAKER GRADE III, AND AN EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24389095 ↗InjuryDec 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23760689 ↗InjuryJun 23, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE VIA ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22309682 ↗InjuryOct 31, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE TEXTURED MAMMARY IMPLANT. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT IMPLANT WAS COMPLETELY RUPTURED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18038743 ↗InjurySep 21, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17790207 ↗InjurySep 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryAug 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE ¿CAPSULAR CONTRACTURE(GRADE IS UNKNOWN)¿. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17440609 ↗InjuryJul 17, 2023Material Rupture; Material Rupture
PHYSICIAN REPORTED, RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17336010 ↗InjuryJun 14, 2023Material Rupture; Material Rupture
InjuryJan 18, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "INTRACAPSULAR AND EXTRACAPSULAR IMPLANT RUPTURE", "A BREAST TUMOR" DIAGNOSED THROUGH ULTRASOUND. THE EVENT OF "A BREAST TUMOR" IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16199936 ↗InjuryJul 18, 2022Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE AND TEXTURED IMPLANT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; Seroma
MAUDE report 15047575 ↗InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT'S GUARDIAN INITIALLY REPORTED NO COMPLAINT AGAINST RIGHT SIDE DEVICE. THE EVENT OF "INJECTION GRANULOMAS" WAS REPORTED VIA MRI REPORT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Granuloma
MAUDE report 14960060 ↗InjuryJun 22, 2022Material Rupture; Material Rupture
PATIENT'S GUARDIAN REPORTED "RUPTURE" AGAINST LEFT SIDE DEVICE. THE EVENT OF "INJECTION GRANULOMAS" WAS REPORTED VIA MRI REPORT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Granuloma
MAUDE report 14776140 ↗InjuryMay 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14431077 ↗InjuryApr 21, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE OF RECALLED IMPLANTS." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14177481 ↗InjuryFeb 15, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT, RUPTURE AND ANY CREASES ASSOCIATED WITH HOLE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13535850 ↗InjuryJun 30, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE RUPTURE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12092371 ↗InjuryDec 11, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE FOR LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10990928 ↗InjurySep 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE" BAKER GRADE III. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10556977 ↗InjuryFeb 12, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9703356 ↗InjuryJan 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9597659 ↗InjuryJan 9, 2020Material Rupture; Material Rupture
PATIENT REPORTS RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9571797 ↗InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFLAMMATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Inflammation
MAUDE report 8959943 ↗InjuryAug 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROVIDER REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8858340 ↗
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-0701-2020 · Nov 6, 2019 · TerminatedNatrelle 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-0700-2020 · Nov 6, 2019 · TerminatedNatrelle 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-2453-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle 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
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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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