NATRELLE Silicone-Filled Breast Implants 15-265Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-265 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
These are Natrelle Style 15-265 Moderate plus profile silicone gel-filled breast implants made by Allergan. Most of the 55 reports describe implants that ruptured or began leaking, along with hardening and tightening of the surrounding scar tissue that shrank or deformed the breast, and in some cases the implant shifting out of position. All 55 reports involve injuries, and no deaths are described. Reports were more frequent in the past 12 months (17) than the12 months before (10). No recalls name this implant.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10888628001435), received between Jun 18, 2019 and Sep 28, 2026 — classified as 59 injuries.
The most frequently reported specific device problem is “Material Rupture” (30 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 Rupture30
- Device Appears to Trigger Rejection20
- Patient-Device Incompatibility9
- Migration2
- Gel Leak1
Patient problems
- Capsular Contracture29
- Failure of Implant24
- No Clinical Signs, Symptoms or Conditions6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Granuloma1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Healthcare professional reported "Rupture" and "hardening" against the left side record. The device was explanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50919333 ↗InjurySep 28, 2026Material Rupture
Healthcare professional reported "Rupture" against the left side record. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918855 ↗InjurySep 28, 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 50917549 ↗InjurySep 28, 2026Device Appears to Trigger Rejection
Patient reported "exchange with no complaint against device". Later healthcare professional reported "capsular contracture" Baker grade III. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50915478 ↗InjurySep 25, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade lll". This record is for left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50897983 ↗InjurySep 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740612 ↗InjurySep 11, 2026Material Rupture
Patient reported "ruptures, pain, swelling and looks lumpy". Later, patient reported "intracapsular rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734944 ↗InjurySep 9, 2026Material Rupture
Patient reported "leaking" and "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681413 ↗InjuryJun 16, 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 25524264 ↗InjuryMar 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24559977 ↗InjuryMar 9, 2026Material Rupture
PATIENT REPORTED "LEAKING DISCOVERED DURING EXPLANT SURGERY", "HURT", "MAKING ME SICK FOR SEVERAL YEARS", "CONTACT RASH AND SYMPTOMATIC RASH, ALL OVER THE BODY", "STOMACH AND DIGESTIVE ISSUES", "EXHAUSTED AND NOT SLEEPING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED. PATIENT WAS PRESCRIBED CREAM FOR RASH.
Patient problems: Failure of Implant
MAUDE report 24546569 ↗InjuryMar 9, 2026Material Rupture
PATIENT REPORTED "LEAKING DISCOVERED DURING EXPLANT SURGERY", "MAKING ME SICK FOR SEVERAL YEARS", "CONTACT RASH AND SYMPTOMATIC RASH, ALL OVER THE BODY", "STOMACH AND DIGESTIVE ISSUES", "EXHAUSTED AND NOT SLEEPING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED. PATIENT WAS PRESCRIBED CREAM FOR RASH.
Patient problems: Failure of Implant
MAUDE report 24546384 ↗InjuryJan 27, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24189256 ↗InjuryJan 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24019258 ↗InjuryJan 7, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23996021 ↗InjuryJan 5, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND IT IS UNKNOWN IF IT WAS REPLACED; IT WAS DISCARDED.
Patient problems: Failure of Implant
MAUDE report 23962190 ↗InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23773611 ↗InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23773178 ↗InjuryDec 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE III". THE DEVICE WAS EXPLANTED AND REPLACED, AND WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23752845 ↗InjuryDec 3, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE III" AND "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC". THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23705568 ↗InjuryNov 3, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE WILL BE RETURN.
Patient problems: Failure of Implant
MAUDE report 23450256 ↗InjuryOct 30, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "NON-DEVICE RELATED ASYMMETRY". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WAS DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 23427001 ↗InjuryOct 20, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED WITH ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23337223 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED.
Patient problems: Failure of Implant
MAUDE report 23303473 ↗InjurySep 2, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22937515 ↗
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-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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