NATRELLE Silicone-Filled Breast Implants 20-425Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-425 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 silicone breast implant is used in breast augmentation or reconstruction. Most of the 82 reports describe the implant rupturing, and some describe capsular contracture, where scar tissue hardens around the implant. The reports include 82 injuries and no deaths, and reports rose from 10 in the previous 12 months to 27 in the last 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
- 90
- Deaths reported
- 0
- Injuries reported
- 90
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10888628001718), received between Aug 10, 2015 and Sep 29, 2026 — classified as 90 injuries.
The most frequently reported specific device problem is “Material Rupture” (51 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 Rupture51
- Device Appears to Trigger Rejection26
- Patient-Device Incompatibility16
- No Apparent Adverse Event9
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Device Handling Problem1
- Malposition of Device1
Patient problems
- Capsular Contracture42
- Failure of Implant25
- No Clinical Signs, Symptoms or Conditions20
- Teratogenic Effects3
- Breast Mass2
- Neonatal Deformities2
- Deformity/ Disfigurement1
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927184 ↗InjurySep 16, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796746 ↗InjurySep 15, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777941 ↗InjurySep 9, 2026Material Rupture; No Apparent Adverse Event
Healthcare professional reported Rupture. This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696344 ↗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 50695189 ↗InjuryAug 19, 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 50331447 ↗InjuryAug 19, 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 50331406 ↗InjuryAug 17, 2026Device 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 50278030 ↗InjuryAug 4, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade III". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50126825 ↗InjuryJul 30, 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 50087082 ↗InjuryJul 30, 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 50085304 ↗InjuryJul 27, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038845 ↗InjuryJul 27, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026304 ↗InjuryJul 20, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874644 ↗InjuryJul 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, Baker grade unknown". Later healthcare professional reported "Capsular contracture Baker grade IV" and "severely encapsulated". This record is for the right side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 25858486 ↗InjuryJul 7, 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 25729810 ↗InjuryJul 6, 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 25727991 ↗InjuryJun 15, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULE/ RUPTURE¿. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25500079 ↗InjuryJun 11, 2026Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25472120 ↗InjuryJun 10, 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 25458137 ↗InjuryMay 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25175248 ↗InjuryApr 22, 2026Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957678 ↗InjuryApr 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A "CAPSULAR CONTRACTURE BAKER GRADE II-III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24818838 ↗InjuryApr 3, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "PAIN". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24775645 ↗InjuryMar 23, 2026Material Rupture
PATIENT REPORTED "TENDER AND SORE". LATER HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24663377 ↗
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
- 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-
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- 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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