NATRELLE Silicone-Filled Breast Implants 20-500Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-500 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 a gel-filled implant. Its 96 reports mostly describe the implant shell rupturing, and many describe capsular contracture, where scar tissue tightens around the implant, while a few report infection or removal of the implant. The reports include 95 injuries and no deaths. Reports rose to 33 in the last 12 months from 11 in the 12 months before. 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
- 104
- Deaths reported
- 0
- Injuries reported
- 103
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10888628001749), received between Jun 14, 2019 and Sep 30, 2026 — classified as 103 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 Rejection35
- Patient-Device Incompatibility10
- Adverse Event Without Identified Device or Use Problem4
- Malposition of Device4
- No Apparent Adverse Event2
- Break1
- Migration1
Patient problems
- Capsular Contracture45
- Failure of Implant41
- No Clinical Signs, Symptoms or Conditions18
- Breast Mass2
- Unspecified Infection2
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pallor1
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
InjurySep 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 50947856 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926144 ↗InjurySep 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847394 ↗InjurySep 18, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker grade IV. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50820948 ↗InjurySep 15, 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 50776255 ↗InjurySep 15, 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 50773951 ↗InjurySep 11, 2026Material Rupture
Healthcare professional reported "rupture". The inner silicone gel came into contact with the patient. This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733737 ↗InjurySep 9, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701479 ↗InjurySep 8, 2026Material Rupture
Healthcare professional reported "rupture." This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671242 ↗InjuryAug 17, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "Capsular Contracture Baker grade III". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50273677 ↗InjuryAug 13, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported via sales representative "Capsular Contracture Baker grade IV", "Pain", "Fever" and "Post pectoral silicone intracapsular rupture". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture; Unspecified Infection
MAUDE report 50241254 ↗InjuryAug 11, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported via company representative the event Capsular Contracture Baker grade III and "Post pectoral silicone intracapsular rupture". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture; Unspecified Infection
MAUDE report 50216335 ↗InjuryAug 7, 2026Material Rupture
Patient reported "rupture". This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50178019 ↗InjuryAug 6, 2026Device Appears to Trigger Rejection; Material Rupture
Patient reported "rupture" & "sagging". This record is for the right side. Device remains implanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 50165421 ↗InjuryJul 29, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072195 ↗InjuryJul 20, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. LATER HEALTHCARE PROFESSIONAL REPORTED "HIGH DENSITY SURFACE IRREGULARITY ALONG POSTERIOR SUPERIOR ASPECT" AND "MAY REFLECT CHRONIC EXTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25872987 ↗InjuryJul 10, 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 25782223 ↗InjuryJun 30, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25668081 ↗InjuryJun 23, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25594934 ↗InjuryJun 11, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25471304 ↗InjuryJun 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465561 ↗InjuryJun 4, 2026Device Appears to Trigger Rejection
PATIENT REPORTED HAVING "SOME CONTRACTION AND SCARRING" THAT "WAS CAUSING PAIN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25388269 ↗InjuryMay 21, 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 25241812 ↗InjuryMay 13, 2026Material Rupture
PATIENT REPORTED "RUPTURE", "PAIN FOR SEVERAL YEARS", AND "PLEURISY DIAGNOSED IN 2018". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161710 ↗InjuryApr 6, 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 24795767 ↗
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-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-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-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-
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- 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
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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
- 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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