NATRELLE Silicone-Filled Breast Implants 115-354Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10888628002395), received between Jun 19, 2019 and Sep 22, 2026 — classified as 96 injuries.

The most frequently reported specific device problem is “Material Rupture” (75 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Jul 24, 2019Class IOpen, Classified

   The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

   Z-2454-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abscess

  MAUDE report 50860429 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50812346 ↗
• InjurySep 11, 2026Material Rupture

  Patient reported "rupture", "hip and joint pain" (considered not device related), and "exchange from textured to smooth breast implants due to the patient¿s concern of the device". Later, healthcare professional reported "rupture" and "removal from textured to smooth due to the concerns of the product". Healthcare professional then reported "intracapsular appearance concerning for possible rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732744 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675411 ↗
• InjurySep 8, 2026Material Rupture

  Patient reported "rupture", "hip and joint pain" (considered not device related), and "exchange from textured to smooth breast implants due to the patient¿s concern of the device". Later, healthcare professional reported "rupture" and "removal from textured to smooth due to the concerns of the product". This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672965 ↗
• InjurySep 4, 2026Device Appears to Trigger Rejection; Migration

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 50621047 ↗
• InjuryAug 6, 2026Material Rupture

  Patient reported "rupture". This record is for left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50167851 ↗
• InjuryAug 6, 2026Material Rupture

  Patient reported "rupture". This record is for right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50167850 ↗
• InjuryAug 6, 2026Material Rupture

  Healthcare professional reported "Textured to smooth". Later Healthcare professional reported "Rupture" against the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159102 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED, ¿MAMMOGRAM AND US EVERY 6 MONTHS FOR SMALL LUMP IN LEFT BREAST." NO TREATMENT OR SURGICAL REOPERATION HAS OCCURRED. DEVICE WAS EXPLANTED.

  Patient problems: Nodule

  MAUDE report 25874638 ↗
• InjuryMar 3, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "PAIN" AND "DISTORTION OF BREASTS". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24498504 ↗
• InjuryFeb 26, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "PAIN" AND "DISTORTION OF BREASTS". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24458717 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "SMALL AMOUNT OF FLUID". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 24436639 ↗
• InjuryFeb 24, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "SMALL AMOUNT OF FLUID" AND "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 24431392 ↗
• InjuryFeb 18, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE, NON-HOMOGENEOUS FLUID LAYER SURROUNDING THE IMPLANT, EDEMA". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24377906 ↗
• InjuryFeb 10, 2026Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "IMPLANT SHOWED ONLY MILD STRETCHING, WITH NO CRACKS OR RUPTURE IDENTIFIED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. THIS RECORD IS BEING UN-REPORTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308296 ↗
• InjuryFeb 2, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED POSSIBLE RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24240203 ↗
• InjuryJan 8, 2026Material Rupture

  PATIENT REPORTED "RUPTURE AND IT HAS ALWAYS LOOKED WEIRD". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 24007544 ↗
• InjuryDec 29, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "PAIN", "FEELS DIFFERENT", "RUPTURE" AND "LINGUINE FOLDS". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF IT WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23905060 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PATIENT'S CONCERN WITH THE PRODUCT" AND "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23842905 ↗
• InjuryDec 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PATIENT'S CONCERN WITH THE PRODUCT" AND "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23833809 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR BREAST IMPLANT RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23780793 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV" AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23761015 ↗
• InjuryDec 4, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED SILICONE AND TEXTURED IMPLANTS". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23720717 ↗
• InjuryOct 30, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND REMOVAL OF TEXTURED BREAST IMPLANT DUE TO CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23429322 ↗

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 · Terminated
  Natrelle 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 · Terminated
  Natrelle 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, Classified
  Natrelle 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