NATRELLE Silicone-Filled Breast Implants 15-286Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-286 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 Natrelle silicone-filled breast implant is used in breast reconstruction or augmentation. The 64 reports mostly describe implants that rupture or leak, and scar tissue that tightens around the implant making the breast hard, painful and misshapen. Sixty-three reports involve injuries and no deaths are mentioned. Report numbers have grown sharply, from 8 in the prior12 months to 26 in the most recent 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
- 71
- Deaths reported
- 0
- Injuries reported
- 70
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10888628001442), received between Jul 8, 2019 and Sep 22, 2026 — classified as 70 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (44 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 Rupture44
- Device Appears to Trigger Rejection21
- Patient-Device Incompatibility5
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Gel Leak1
- Malposition of Device1
Patient problems
- Failure of Implant28
- Capsular Contracture26
- No Clinical Signs, Symptoms or Conditions15
- Inflammation2
- Purulent Discharge2
- Tissue Irritation2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Material Rupture
Healthcare professional reported a "Rupture/Deflation". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860045 ↗InjurySep 22, 2026Material Rupture
Healthcare professional reported a "Rupture/Deflation". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860001 ↗InjurySep 22, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849390 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported "no complaint against the device". Later healthcare professional reported "Capsular contracture Baker grade unknown". Later healthcare professional reported "Capsular contracture Baker grade III". This record is for the right side. Device has been explanted and replaced.
Patient problems: Capsular Contracture
MAUDE report 50836441 ↗InjurySep 19, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50831678 ↗InjurySep 19, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50831663 ↗InjurySep 10, 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 50717507 ↗InjurySep 8, 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 50671498 ↗InjurySep 7, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656684 ↗InjuryAug 24, 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 50411812 ↗InjuryJul 31, 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 50100445 ↗InjuryJul 30, 2026Material Rupture
Healthcare professional reported a rupture. This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090694 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Rupture". This record is for the right side. The device remains implanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50015334 ↗InjuryJul 16, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER SALES REPRESENTATIVE REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "DESIRE FOR LARGER IMPLANTS", "RUPTURED", "SILLICONE GRANULOMAS" AND "HOLE, NON-SPECIFIC". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Granuloma
MAUDE report 25850201 ↗InjuryJul 8, 2026Material Rupture
Healthcare professional reported "Ruptured Implant". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25756271 ↗InjuryJul 1, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680869 ↗InjuryJun 3, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385617 ↗InjuryJun 3, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382218 ↗InjuryMay 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25157760 ↗InjuryApr 22, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24960801 ↗InjuryApr 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "GEL DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24839810 ↗InjuryMar 17, 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 24620812 ↗InjuryFeb 12, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". CAPSULE WAS RESECTED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24322720 ↗InjuryFeb 5, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE I AND POSSIBLE RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24265243 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "LOW GRADE FEVER", "RIPPLING, INDENTATION", "YELLOWISH GREEN PUSS" AND "REDNESS, SWOLLEN AND FUSSY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Inflammation; Purulent Discharge; Tissue Irritation; Unspecified Infection
MAUDE report 24258099 ↗
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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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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