NATRELLE Silicone-Filled Breast Implants 120-300Recalls & reported problems
Allergan, Inc. · NATRELLE Style 120-300 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 textured silicone gel-filled breast implants. The 37 reports mostly describe implants rupturing or leaking, and scar tissue tightening around them (capsular contracture), often severe enough that the implant had to be removed; two reports mention lymphoma and one mentions fatigue. There are 36 injuries and no deaths. One recall, started in July 2019 and still open, 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
- 39
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628002531), received between Dec 10, 2014 and Sep 30, 2026 — classified as 38 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (19 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
- Device Appears to Trigger Rejection19
- Material Rupture19
- No Apparent Adverse Event3
- Patient-Device Incompatibility3
- Adverse Event Without Identified Device or Use Problem1
- Gel Leak1
- Out-Of-Box Failure1
Patient problems
- Capsular Contracture22
- Failure of Implant13
- No Clinical Signs, Symptoms or Conditions4
- Lymphoma2
- Fatigue1
- Fever1
- Granuloma1
- Inflammation1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Rupture
Healthcare professional reported "Rupture" against the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946601 ↗InjuryJul 27, 2026Material Rupture
Healthcare professional reported "device rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50012113 ↗InjuryMay 29, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "PAIN", "CAPSULAR CONTRACTURE BAKER GRADE II/III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25337794 ↗InjuryMar 18, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24630720 ↗InjuryJan 22, 2026Material Rupture
(B)(6) REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF THE EXPLANTED DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 24156543 ↗InjuryJan 21, 2026Device Appears to Trigger Rejection
PATIENT, THROUGH OTHER COMPANY REPRESENTATIVE, REPORTED "PAIN" AND "TEXTURED IMPLANT". HEALTHCARE PROFESSIONAL LATER REPORTED "RECALLED". LATER HEALTHCARE PROFESSIONAL REPORTED "GRADE 3", CAPSULAR CONTRACTURE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24129942 ↗InjuryJan 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24010758 ↗InjuryJan 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24010337 ↗InjuryJan 6, 2026Device Appears to Trigger Rejection
InjuryNov 19, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23597648 ↗InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA." PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Lymphoma
MAUDE report 22952517 ↗InjuryJul 31, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED" AND "GRADE 3 CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22681792 ↗InjuryJul 29, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE, NON-SPECIFIC." PATIENT UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22645261 ↗InjuryJun 4, 2025Gel Leak; Device Appears to Trigger Rejection; Gel Leak; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "RUPTURE, REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERN OF THE PRODUCT AND CAPSULAR CONTRACTURE BAKER GRADE III". HEALTHCARE PROFESSIONAL LATER REPORTED LOOSE GEL WITHIN THE BREAST CAPSULAR BUT NO OBVIOUS IMPLANT RUPTURE". DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICE.
Patient problems: Capsular Contracture
MAUDE report 22144273 ↗InjuryJun 4, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED RIGHT SIDE "RUPTURE AND REPLACEMENT FROM TEXTURED TO SMOOTH". HEALTHCARE PROFESSIONAL LATER REPORTED EXCHANGE FROM TEXTURED TO SMOOTH, LUMP AND PAIN TOWARD THE ARMPIT, FIRM AND PROTUBERANT, AND DOES NOT LIKE THE APPEARANCE, AND INTERCASPULAR GEL, GRADE IV CAPSULAR CONTRACTURE WITH PAIN. " HEALTHCARE PROFESSIONAL LATER REPORTED "NO OBVIOUS IMPLANT RUPTURE". DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICE.
Patient problems: Capsular Contracture
MAUDE report 22144269 ↗InjuryMay 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. TREATMENT: DEVICE REMOVAL, COMPLETE CAPSULECTOMY.
Patient problems: Capsular Contracture
MAUDE report 21990689 ↗InjuryMay 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.
Patient problems: Capsular Contracture
MAUDE report 21981452 ↗InjuryMay 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE PLAN ON HAVING THE DEVICE REMOVED AND WANTED TO KNOW IF WE WOULD HELP WITH REGARDS TO THE DOCTOR'S FEE. HEALTHCARE PROVIDER REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21960177 ↗InjuryMay 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE PLAN ON HAVING THE DEVICE REMOVED AND WANTED TO KNOW IF WE WOULD HELP WITH REGARDS TO THE DOCTOR'S FEE. HEALTHCARE PROFESSIONAL LATER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED AND NOT REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21942261 ↗InjuryDec 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryDec 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJan 24, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED PATIENT WITH LEFT SIDE TEXTURED IMPLANT. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE 'SILICONE LEAK.' THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18570793 ↗InjuryOct 6, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
IT HAS BEEN DETERMINED, THAT THE EVENT ASSOCIATED WITH THIS COMPLAINT DID NOT OCCUR. THIS RECORD IS NO LONGER REPORTABLE TO FDA. AND WILL BE UN-REPORTED
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17886619 ↗InjuryAug 21, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17592599 ↗InjuryJul 12, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT "GRANULOMA FORMATIONS" AND "CYSTIC NODULE" (NON DEVICE RELATED). THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; Granuloma
MAUDE report 17312744 ↗
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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