NATRELLE Silicone-Filled Breast Implants 15-457Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-457 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 is a silicone gel-filled breast implant. Its 105 reports, all injury reports, often describe the implant rupturing, hardening of the scar tissue around it, and some describe what appears to be an immune reaction to the implant. There were no deaths, and no recalls name this device. Reports rose to 41 in the last 12 months from 14 in the previous 12 months.
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
- 117
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10888628001503), received between May 23, 2019 and Sep 28, 2026 — classified as 117 injuries.
The most frequently reported specific device problem is “Material Rupture” (78 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 Rupture78
- Device Appears to Trigger Rejection38
- Patient-Device Incompatibility10
- Adverse Event Without Identified Device or Use Problem4
- Malposition of Device1
- Migration1
Patient problems
- Capsular Contracture48
- Failure of Implant43
- No Clinical Signs, Symptoms or Conditions21
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Facial Paralysis1
- Hematoma1
- Pain1
- Pallor1
Recent adverse event reports
The 25 most recent of 117 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 50925942 ↗InjurySep 28, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50923984 ↗InjurySep 25, 2026Device Appears to Trigger Rejection; Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50903219 ↗InjurySep 25, 2026Material Rupture
Healthcare professional did not report a complaint against the device. Later healthcare professional reported "was ruptured". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896456 ↗InjurySep 24, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892073 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported possible previous Capsular Contracture Baker grade Unknown. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50885329 ↗InjurySep 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 50885311 ↗InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812811 ↗InjurySep 16, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796645 ↗InjurySep 14, 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 50759934 ↗InjurySep 13, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50746930 ↗InjurySep 11, 2026Device Appears to Trigger Rejection
Patient reported "soreness", "pain", "tenderness" and "burning sensation". Patient reported being diagnosed with Lupus and Rheumatoid Arthritis which are not device related. Patient was prescribed with injections every three months and Etoricoxib as needed. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50728699 ↗InjurySep 10, 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 50715915 ↗InjurySep 8, 2026Material Rupture
Healthcare professional reported ¿rupture¿. This record if for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672369 ↗InjuryAug 31, 2026Material Rupture
Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533010 ↗InjuryAug 24, 2026Material Rupture
Patient reported "Implant exchange with no complaint against the device.". Healthcare professional then reported "Rupture". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421778 ↗InjuryAug 20, 2026Material Rupture
Patient reported "Leaking" and "Crinkling". Healthcare professional then reported "Rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356629 ↗InjuryAug 11, 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 50210558 ↗InjuryAug 7, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Capsular contracture" Baker Grade III and "Rupture". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50173279 ↗InjuryAug 7, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Capsular contracture" Baker Grade III and "Rupture". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50173151 ↗InjuryAug 6, 2026Material Rupture
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 50167281 ↗InjuryAug 6, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade III. This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50167278 ↗InjuryJul 30, 2026Material Rupture
Healthcare professional later reported "Rupture", "Protrusion" and "Folding". Healthcare professional later reported "Rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093566 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Capsular Contracture Baker Grade III-IV", "Suspected/Actual Rupture/Deflation" and "Change shape/size/style, Ptosis" via the National Breast Implant Registry (NBIR). This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50015600 ↗InjuryJul 17, 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 25857545 ↗
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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