Natrelle INSPIRA Breast Implants TRX-470Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628008533), received between Aug 30, 2019 and Mar 23, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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-2453-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24661129 ↗
• InjuryApr 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. PHYSICIAN LATER REPORTED "LOOKS BIGGER", "FLUID, AND "HARD." PHYSICIAN ADDITIONALLY REPORTED "RADIAL FOLDS", "A CAPSULE WITHIN A CAPSULE", "THERE WAS NO FLUID ACCUMULATION". PHYSICIAN ALSO REPORTED "DENSE FIBROSIS", DEEMED NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21902062 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED A EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED "RIGHT SIDE FLUID." THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Seroma

  MAUDE report 21345762 ↗
• InjuryOct 10, 2024Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE VIA ULTRASOUND, BEEN POORLY NOW WITH CHRONIC FATIGUE, EYE DROOPS AND BURNING SENSATION, SHAPE CHANGED FROM TIME TO TIME" AND FEAR OF CANCER. DEVICE REMAINS IMPLANTED. THE RELATES TO THE RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 20424627 ↗
• InjuryOct 10, 2024Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE VIA ULTRASOUND, LUMPS, BEEN POORLY NOW WITH CHRONIC FATIGUE, EYE DROOPS AND BURNING SENSATION, SHAPE CHANGED FROM TIME TO TIME" AND FEAR OF CANCER. DEVICE REMAINS IMPLANTED. THE RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 20422866 ↗
• InjurySep 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL LATER REPORTED "LOOKS BIGGER", "FLUID, AND "HARD."

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 17819565 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED CONCERN ABOUT TEXTURED IMPLANTS AND LEFT SIDE SEROMA FOUND DURING EXPLANT. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 14790635 ↗
• InjuryDec 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR CAPSULAR CONTRACTURE BAKER GRADE III AND WRINKLING/RIPPLING. THE RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 12964389 ↗
• InjuryAug 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND REMOVAL DUE TO TEXTURED SHELL. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8950776 ↗

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-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle 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-