NATRELLE Silicone-Filled Breast Implants 15-421Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-421 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 implant. Most of the 126 reports describe implants rupturing, and many describe capsular contracture, where scar tissue tightens around the implant. The reports include no deaths and 126 injuries. Reports rose to 43 in the last 12 months from 20 in the previous 12. 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
- 133
- Deaths reported
- 0
- Injuries reported
- 133
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 10888628001497), received between May 30, 2019 and Sep 28, 2026 — classified as 133 injuries.
The most frequently reported specific device problem is “Material Rupture” (93 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 Rupture93
- Device Appears to Trigger Rejection36
- Patient-Device Incompatibility14
- No Apparent Adverse Event3
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Gel Leak1
- Malposition of Device1
Patient problems
- Failure of Implant64
- Capsular Contracture50
- No Clinical Signs, Symptoms or Conditions21
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Breast Discomfort/Pain1
- Necrosis1
- Scar Tissue1
- Seroma1
Recent adverse event reports
The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Healthcare professional reported ¿found to be ruptured¿. This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912367 ↗InjurySep 25, 2026Gel Leak; Material Invagination
Healthcare professional reported "implant folded". Later healthcare professional reported "palpable lump breast", "folding of the breast implant may correspond with palpable abnormality", "slight silicone bleeding but no disruption of the implant shell grossly". This record is for the left side. Device has been explanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50894692 ↗InjurySep 18, 2026Material Rupture
Patient reported "rupture". Healthcare professional later reported "rupture and exchange". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818329 ↗InjurySep 16, 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 50786301 ↗InjurySep 16, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786103 ↗InjurySep 14, 2026Material Rupture
Healthcare professional reported a "rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761375 ↗InjurySep 14, 2026Material Rupture; No Apparent Adverse Event
Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755909 ↗InjurySep 8, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680181 ↗InjurySep 1, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541880 ↗InjuryAug 28, 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 50508597 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
Patient reported "pain, scar tissue". This record is for the right side. Device was explanted.
Patient problems: Breast Discomfort/Pain; Scar Tissue
MAUDE report 50502781 ↗InjuryAug 23, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50396057 ↗InjuryAug 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 50379127 ↗InjuryAug 18, 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 50303549 ↗InjuryJul 31, 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 50096720 ↗InjuryJul 21, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported ¿Rupture¿ and ¿Capsular Contracture Baker grade III¿. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25894109 ↗InjuryJul 20, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "PAIN, RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25873226 ↗InjuryJul 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN", LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813550 ↗InjuryJun 23, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE DISCOVERED DURING SURGERY". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25602505 ↗InjuryJun 9, 2026Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443654 ↗InjuryJun 2, 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 25363280 ↗InjuryApr 23, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "SWOLLEN LYMPH NODES, AND EXCHANGE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands
MAUDE report 24966812 ↗InjuryApr 22, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL REPORTED LATER VIA RETURNED GOOD AUTHORIZATION (RGA) "IMPLANT RUPTURED". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24960608 ↗InjuryApr 9, 2026Material Rupture
PATIENT REPORTED "I'VE HAD PROBLEMS" AND "COMPLETELY COLLAPSED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835693 ↗InjuryApr 6, 2026Material Rupture
PHYSICIAN REPORTED TREATMENT FOR LEFT SIDE DEVICE DUE TO "MODERATE IMPLANT PALPABILITY/VISIBILITY". LATER PATIENT REPORTED "RUPTURE", "ITCHING", "HOT TO TOUCH", "PAIN" AND SOME PARTS FEEL HARD TO THE TOUCH". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24793572 ↗
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-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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- 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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