NATRELLE Silicone-Filled Breast Implants 20-450Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-450 High profile |smooth|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
Quick summary
This Allergan Natrelle is a smooth, round silicone gel breast implant. The FDA records hold 97 reports, with no deaths and 96 injuries; many describe the implant rupturing or capsular contracture, where scar tissue tightens around it, and some report other symptoms. Reports rose to 23 in the last 12 months from 10 in the prior 12 months. No recalls name this device.
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
- 107
- Deaths reported
- 0
- Injuries reported
- 106
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10888628001725), received between Aug 6, 2015 and Sep 22, 2026 — classified as 106 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (61 reports).
4 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
Most reported problems
Device problems
- Material Rupture61
- Device Appears to Trigger Rejection39
- Patient-Device Incompatibility17
- Adverse Event Without Identified Device or Use Problem5
- Migration2
- No Apparent Adverse Event2
- Device Handling Problem1
- Malposition of Device1
Patient problems
- Capsular Contracture56
- Failure of Implant38
- No Clinical Signs, Symptoms or Conditions12
- Neonatal Deformities2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Impaired Healing1
- Lymphoma1
- Seroma1
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Material Rupture
Healthcare professional reported "pain and rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854678 ↗InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831133 ↗InjurySep 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade III/IV Capsular contracture". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50797254 ↗InjurySep 16, 2026Device Appears to Trigger Rejection; Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50782506 ↗InjurySep 13, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50746947 ↗InjurySep 9, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695330 ↗InjurySep 7, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650158 ↗InjurySep 1, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541879 ↗InjuryAug 3, 2026Material Rupture
Healthcare professional reported of the left side device: "possible rupture" and "age of implant". The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111704 ↗InjuryAug 3, 2026Material Rupture
Healthcare professional reported of the left side device: "possible rupture" and "age of implant". The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111680 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "grade 3/4 cap con secondary to pain and visible asymmetry". Patient was prescribed Singulair. This record is for the left side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50021946 ↗InjuryJul 8, 2026Material Rupture
Patient reported having a child with a new Neurological diagnosis and specified ¿seizure disorder¿. This record is for the left side. Device was explanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 25753945 ↗InjuryJun 11, 2026Material Rupture; Malposition of Device
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473036 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A ¿LUMP ON THE RIGHT SIDE OF THE NIPPLE,¿ ¿SWOLLEN LYMPH NODES UNDER THE ARMPIT,¿ ¿BREAST TENDER TO THE TOUCH,¿ ¿PAIN,¿ AND "HASHIMOTO¿S" -NOT DEVICES RELATED-. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 25437938 ↗InjuryMay 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25176933 ↗InjuryApr 13, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24865679 ↗InjuryApr 11, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24847648 ↗InjuryApr 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A "CAPSULAR CONTRACTURE BAKER GRADE II-III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24818834 ↗InjuryMar 31, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "LEAK" AND "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24750344 ↗InjuryMar 30, 2026Material Rupture
Healthcare professional did not report an adverse event. Patient later reported "rupture". Healthcare professional later reported "leaking". This record is for the left side. The device was explanted.
Patient problems: Failure of Implant
MAUDE report 24716232 ↗InjuryMar 23, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION¿. THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660358 ↗InjuryMar 21, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". PATIENT LATER REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24656650 ↗InjuryFeb 26, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24457963 ↗InjuryJan 27, 2026Material Rupture; Migration
PATIENT REPORTED "RUPTURE" AND "FREE FLOWING SILICONE IN MY AXILLA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24195632 ↗InjuryJan 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE AVAILABLE FOR RETURN.
Patient problems: Failure of Implant
MAUDE report 24021568 ↗
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-2454-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
- 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
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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
- 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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