NATRELLE Silicone-Filled Breast Implants 15-234Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-234 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 Natrelle Style 15-234 silicone gel-filled breast implant is a smooth, round implant made by Allergan. Most of the 34 reports describe implants that ruptured, with gel leaking out, along with the surrounding scar tissue tightening around the implant so the breast becomes hard, firm and painful. All 34 reports involve injuries, and no deaths are reported. There are no recalls naming 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628001428), received between Jun 6, 2019 and Sep 25, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Material Rupture” (21 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 Rupture21
- Device Appears to Trigger Rejection13
- Patient-Device Incompatibility8
Patient problems
- Capsular Contracture21
- Failure of Implant12
- No Clinical Signs, Symptoms or Conditions7
- Swollen Lymph Nodes/Glands2
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50898708 ↗InjurySep 17, 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 50801607 ↗InjurySep 8, 2026Material Rupture
Healthcare professional reported "replacement due to rupture". Later healthcare professional reported "implant rupture was confirmed during surgery" and "multiple neoplasms of the breast". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677194 ↗InjurySep 8, 2026Material Rupture
Healthcare professional reported "replacement due to rupture". Later healthcare professional reported "implant rupture was confirmed during surgery" and "multiple neoplasms of the breast". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673220 ↗InjurySep 8, 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 50671688 ↗InjurySep 1, 2026Material Rupture
Healthcare professional reported "rupture". Later, healthcare professional reported "deformity", "lumpiness and bumpiness over the area", and "silicone bleed coming through the capsule". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544272 ↗InjuryAug 23, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "intracapsular rupture". This record is for the left side. Patient is being treated with Doxycycline, Singulair and Vitamine E. Device remains implanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50395269 ↗InjuryJul 28, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "rupture", "Capsular Contracture Baker Grade IV" and "malposition". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50059704 ↗InjuryApr 23, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974220 ↗InjuryFeb 5, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE I AND POSSIBLE RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24265231 ↗InjuryDec 18, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER, HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23838068 ↗InjuryDec 2, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23695250 ↗InjuryNov 29, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURES". THIS RECORD IS FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23675947 ↗InjuryNov 28, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED AND IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23673986 ↗InjuryNov 21, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23617991 ↗InjuryOct 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "NON-DEVICE RELATED ASYMMETRY". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "NO RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WAS DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 23357308 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAP CON " AND "BAKER GRADE: 4 ". THIS RECORD IS FOR THE LEFT-SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF IT WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23294321 ↗InjurySep 30, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "IMPLANT RUPTURE" CONFIRMED VIA MRI. DEVICE REMAINS IMPLANTED. DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23187123 ↗InjurySep 2, 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.
Patient problems: Capsular Contracture
MAUDE report 22933108 ↗InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22906028 ↗InjuryMay 5, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RIGHT SIDE RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21964258 ↗InjuryApr 18, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19139468 ↗InjuryFeb 2, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED HOLE, NON-SPECIFIC. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16288047 ↗InjuryJan 17, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE PER CT SCAN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16186658 ↗InjuryNov 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL CALLED TO REPORT A CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, ON AN UNKNOWN SIDE AND EXCHANGE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15804873 ↗
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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