NATRELLE Silicone-Filled Breast Implants 15-533Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-533 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 is a NATRELLE Style 15-533 silicone gel-filled breast implant made by Allergan. The 53 adverse event reports mostly describe implants rupturing or breaking, along with scarring that tightens around the implant (capsular contracture) and the body appearing to reject the implant; many of these implants were removed. There are no deaths and 53 injuries, and no recalls name this device. Reports rose sharply in the past 12 months, from 7 to 24.
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
- 58
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10888628001527), received between May 29, 2019 and Sep 28, 2026 — classified as 58 injuries.
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 Rejection15
- Patient-Device Incompatibility3
- Device Handling Problem2
- Fluid/Blood Leak1
- Malposition of Device1
- Migration1
Patient problems
- Failure of Implant28
- Capsular Contracture18
- No Clinical Signs, Symptoms or Conditions14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Fluid/Blood Leak
Healthcare professional reported "Rupture". This record if for the left side. the device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912297 ↗InjurySep 23, 2026Material Rupture
Patient reported "fluid, breast pain and denser" and "become sick and went to urgent care on (b)(6) 2026 were prescribed antibiotics". Later, patient reported "Rupture". This record is for the right side. The device remains implanted. Patient received antibiotics as treatment.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874127 ↗InjurySep 18, 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 50818851 ↗InjurySep 14, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764195 ↗InjurySep 12, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746277 ↗InjurySep 10, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "pain", "firmness", "intracapsular rupture", "area rupture of intracapsular linearity in the upper outer quadrant", "focal pain in the lateral aspect" and capsular contracture Baker Grade III. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50722442 ↗InjurySep 9, 2026Device Appears to Trigger Rejection
Healthcare professional reported through National Breast Implant Registry "Capsular Contracture Baker Grade III, Device Migration/Implant Malposition". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50696350 ↗InjuryAug 13, 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 50237753 ↗InjuryAug 7, 2026Material Rupture
Healthcare professional reported "exchange with no complaint against device". Later healthcare professional reported "intracapsular rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169514 ↗InjuryAug 5, 2026Material Rupture
Healthcare professional reported "rupture and felt weird". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144374 ↗InjuryJul 14, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANT FOUND RUPTURED DURING SURGERY". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814552 ↗InjuryJul 8, 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 25753018 ↗InjuryJul 7, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported on operative report "rupture". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25734349 ↗InjuryJun 30, 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 25665224 ↗InjuryJun 4, 2026Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25395180 ↗InjuryApr 22, 2026Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24951631 ↗InjuryApr 8, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24820788 ↗InjuryMar 17, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH SALES REPRESENTATIVE "RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24623949 ↗InjuryMar 11, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24568718 ↗InjuryFeb 24, 2026Material Rupture
HEALTHCARE PROFESSIONAL DID NOT REPORTED A COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED "GEL BLEED". . LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24426721 ↗InjuryFeb 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24276478 ↗InjuryFeb 2, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24239745 ↗InjuryJan 30, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "FLIPPED OVER". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24223259 ↗InjuryJan 21, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXPERIENCED A FALL WHILE JOGGING AND THERE IS A CONCERN FOR IMPLANT RUPTURE". LATER HEALTCARE PROFESSIONAL REPORTED "MULTIPLE TEARS ON SHELL SURFACE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24128148 ↗InjuryJan 15, 2026Material Rupture
PATIENT REPORTED "RUPTURE" LATER CONFIRMED BY HEALTHCARE PROFESSIONAL. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 24080467 ↗
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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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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