NATRELLE Silicone-Filled Breast Implants 15-304Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-304 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 silicone implant is a silicone gel-filled breast implant. Of its 164 adverse event reports, 163 are injuries and 1 is a death. Many describe the implant shell rupturing, and reports also mention hardening of scar tissue around the implant (capsular contracture), and some describe the device appearing to trigger the body's rejection response. Reports rose from 25 in the prior 12 months to 53 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
- 183
- Deaths reported
- 1
- Injuries reported
- 182
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 10888628001459), received between Jun 3, 2014 and Sep 30, 2026 — classified as 1 death, 182 injuries.
The most frequently reported specific device problem is “Material Rupture” (110 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 Rupture110
- Device Appears to Trigger Rejection62
- Patient-Device Incompatibility25
- Adverse Event Without Identified Device or Use Problem7
- No Apparent Adverse Event3
- Malposition of Device2
- Material Discolored1
- Migration1
Patient problems
- Capsular Contracture86
- Failure of Implant71
- No Clinical Signs, Symptoms or Conditions24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Breast Discomfort/Pain2
- Breast Feeding Problem2
- Granuloma2
- Breast Mass1
Recent adverse event reports
The 25 most recent of 183 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 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 50947212 ↗InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940906 ↗InjurySep 29, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935324 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920110 ↗InjurySep 25, 2026Material Rupture
Patient reported "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 50895599 ↗InjurySep 24, 2026Material Rupture
Healthcare professional reported "Rupture" against the left side. Tylenol/Ibuprofen was prescribed. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884365 ↗InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812839 ↗InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812838 ↗InjurySep 17, 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 50804675 ↗InjurySep 14, 2026Material Rupture
Healthcare professional reported through Sales representative "rupture", "possible implant illness", "Myasthenia Gravis" and "multiple rheumatologic disorders". This record is for the left side. Device status is unknown.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50756659 ↗InjurySep 14, 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 50754154 ↗InjurySep 14, 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 50753232 ↗InjurySep 12, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746290 ↗InjurySep 11, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50744549 ↗InjurySep 11, 2026Material Rupture
Healthcare professional reported through Sales representative "rupture", "possible implant illness, Myasthenia Gravis" and "multiple rheumatologic disorders" which are not device related. This record is for the right side. Device status is unknown.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50734054 ↗InjurySep 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade IV". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50716731 ↗InjurySep 7, 2026Material Rupture
Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652875 ↗InjurySep 1, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported ¿rupture¿. Later healthcare professional reported "Capsular contracture Baker grade unknown". Healthcare professional reported "Capsular contracture Baker grade III". This record is for the left side. Capsulotomy was performed. The device was explanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50543514 ↗InjuryAug 20, 2026Device Appears to Trigger Rejection
Healthcare professional reported through the National Breast Implant Registry (NBIR) ¿Capsular Contracture Baker Grade II¿. Capsulectomy/Capsulotomy was performed. This record is for the right side. Device was explanted
Patient problems: Capsular Contracture
MAUDE report 50355612 ↗InjuryAug 19, 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 50331643 ↗InjuryAug 19, 2026Material Rupture
Healthcare professional reported "subcapsular implant rupture" and "loculated fluid accumulating". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331386 ↗InjuryAug 12, 2026Material Rupture
Healthcare professional reported "intracapsular rupture". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50219592 ↗InjuryAug 11, 2026Device Appears to Trigger Rejection
Healthcare professional reported no complaint against the device. Healthcare professional later reported "Unsatisfied breast size, breast asymmetry, breast ptosis, capsular contracture Baker Grade unknown". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50209194 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "exchange with no complaint against the device". Later healthcare professional reported "capsular contracture grade unknown". This record is for the right side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50001543 ↗InjuryJul 16, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE IV, "HARD" AND "DISPLACED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25846571 ↗
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
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page