NATRELLE Silicone-Filled Breast Implants 120-400Recalls & reported problems
Allergan, Inc. · NATRELLE Style 120-400 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
These are Allergan NATRELLE Style 120-400 BIOCELL textured silicone gel-filled breast implants. The 54 reports mostly describe implants that rupture or leak, and scar tissue tightening around the implant (capsular contracture) that can make the breast hard, painful or distorted; some patients also mention swelling, infection or immune-system symptoms. All 54 reports describe injuries, with no deaths reported. One recall, started in July 2019 and still open, follows 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
- 58
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10888628002555), received between Jun 7, 2019 and Sep 28, 2026 — classified as 58 injuries.
The most frequently reported specific device problem is “Material Rupture” (28 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 Rupture28
- Device Appears to Trigger Rejection19
- Patient-Device Incompatibility10
- Adverse Event Without Identified Device or Use Problem3
- Device Handling Problem1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture29
- Failure of Implant20
- No Clinical Signs, Symptoms or Conditions7
- Unspecified Infection4
- Seroma3
- Swollen Lymph Nodes/Glands2
- Granuloma1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924085 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923246 ↗InjurySep 21, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem
Healthcare professional later reported "pain, swelling, lymphadenopathy and textured device".
Patient problems: No Clinical Signs, Symptoms or Conditions; Swollen Lymph Nodes/Glands
MAUDE report 50848827 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50847590 ↗InjurySep 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846989 ↗InjurySep 7, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656445 ↗InjuryJul 14, 2026Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED "NIPPLE IS ITCHY". PATIENT REPORTED "RUPTURE, "SUSPICIOUS" LYMPH NODES UNDER ARMPIT, SILICONE "FULL OF SILICONE"". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Granuloma
MAUDE report 25821198 ↗InjuryJun 11, 2026Device Appears to Trigger Rejection
Device has been explanted and replaced.
Patient problems: Capsular Contracture
MAUDE report 25473879 ↗InjuryJun 3, 2026Material Rupture
PATIENT REPORTED "INNER CAPSULATING LEAKING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25377944 ↗InjuryFeb 17, 2026Material Rupture; No Apparent Adverse Event
IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2026-03095, IS A DUPLICATE OF MRN 9617229-2025-22147. PLEASE SEE MRN 9617229-2025-22147 FOR REPORTABLE EVENTS.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 24363795 ↗InjuryJan 28, 2026Material Rupture
PATIENT REPORTED "I JUST READ ABOUT THE TEXTURED SILICONE BEING RECALLED", "LARGER BREAST", "BURNING" ,"PAIN" AND "CHRONIC FATIGUE, MUSCLE ACHES, BRAIN FOG, AUTOIMMUNE DISEASE" NOT DEVICE RELATED. LATER PATIENT REPORTED "POSSIBLE RUPTURE" AND "EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT". LATER, HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE SILICONE RUPTURE" AND "IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". LATER, PATIENT CONFIRMED "RUPTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "DOUBLE CAPSULE", "FREE SILICONE" AND "THE SILICONE THAT WAS SPILLED WAS NOTED TO BE WHITISH IN COLOR AND PERHAPS A MIX OF SILICONE AND SEROMA". LATER, HEALTHCARE PROFESSIONAL REPORTED "HOLE-NON SPECIFIC". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24200028 ↗InjuryJan 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". LATER HEALTHCARE PROFESSIONAL REPORTED "FEAR ALCL" AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24004338 ↗InjuryJan 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". LATER HEALTHCARE PROFESSIONAL REPORTED "FEAR ALCL" AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24003661 ↗InjuryOct 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "SIZE EXCHANGE". LATER, HEALTHCARE PROFESSIONAL REPORTED "DOUBLE CAPSULE (CAPSULAR CONTRACTURE BAKER GRADE III/IV), IMPLANT DISTORTION AND CALCIFICATION." THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23378797 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
PATIENT REPORTED A RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT", AND "LUMP ". LATHER HEALTHCARE REPORT A RIGHT SIDE "RUPTURE" AND A BILATERAL "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH" VIA MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23293775 ↗InjuryJun 20, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22297322 ↗InjuryDec 4, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "IMPLANTS ARE RECALLED", "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR A LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 20845400 ↗InjuryAug 6, 2024Material Rupture; Device Handling Problem; Material Rupture; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED POSSIBLE LEFT IMPLANT RUPTURE. DEVICE EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 19918615 ↗InjuryFeb 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANT DUE TO CONCERN WITH THE PRODUCT. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18789290 ↗InjuryFeb 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANT DUE TO CONCERN WITH THE PRODUCT. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18789216 ↗InjuryOct 23, 2023Material Rupture; Material Rupture
InjuryAug 29, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17644781 ↗InjuryJul 5, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17262623 ↗InjuryJan 31, 2023Material Rupture; Material Rupture
PATIENT REPORTED POSSIBLE RIGHT SIDE RUPTURE AND IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT'S CONCERN WITH THE DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16274496 ↗InjuryOct 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15525692 ↗
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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