NATRELLE Silicone-Filled Breast Implants 15-371Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-371 Moderate plus 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 breast implant has 203 adverse event reports, with 203 injuries and no deaths. Most describe the implant rupturing, and many describe capsular contracture, meaning hardening of the scar tissue around it. Reports rose to 70 in the last 12 months from 41 the year 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
- 191
- Deaths reported
- 0
- Injuries reported
- 191
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 10888628001473), received between Mar 28, 2018 and Sep 28, 2026 — classified as 191 injuries.
The most frequently reported specific device problem is “Material Rupture” (125 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 Rupture125
- Device Appears to Trigger Rejection54
- Patient-Device Incompatibility20
- Adverse Event Without Identified Device or Use Problem4
- No Apparent Adverse Event2
- Device Handling Problem1
- Gel Leak1
Patient problems
- Failure of Implant95
- Capsular Contracture74
- No Clinical Signs, Symptoms or Conditions20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Breast Discomfort/Pain2
- Nipple Sensation Changes2
- Discharge1
- Pain1
Recent adverse event reports
The 25 most recent of 191 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 50923334 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923299 ↗InjurySep 25, 2026Material Rupture
Healthcare professional reported "Rupture and exchange". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898880 ↗InjurySep 22, 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 50855818 ↗InjurySep 22, 2026Device Appears to Trigger Rejection; Material Rupture
Patient reported "capsular contracture Baker grade Unknown", "doctor thinks there's a rupture" and "feels different". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50849782 ↗InjurySep 21, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839091 ↗InjurySep 21, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838542 ↗InjurySep 18, 2026Material Rupture
Healthcare Professional reported "rupture". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816219 ↗InjurySep 15, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781565 ↗InjurySep 14, 2026Material Rupture
Patient reported "potential rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757186 ↗InjurySep 3, 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 50586620 ↗InjuryAug 27, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the left side. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482977 ↗InjuryAug 13, 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 50232757 ↗InjuryAug 4, 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 50134816 ↗InjuryJul 30, 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 50091301 ↗InjuryJul 16, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25849339 ↗InjuryJun 15, 2026Material Rupture
PATIENT REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512961 ↗InjuryJun 8, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DISCOVERED AT EXPLANT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25429045 ↗InjuryMay 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162512 ↗InjuryMay 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25104798 ↗InjuryMay 4, 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 25073348 ↗InjuryApr 21, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24944265 ↗InjuryApr 21, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24941693 ↗InjuryMar 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24592010 ↗InjuryMar 12, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24585416 ↗
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
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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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