Natrelle INSPIRA Breast Implants TRX-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888628008601), received between Sep 3, 2019 and May 30, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Rupture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE RUPTURE AND TEXTURED TO SMOOTH IMPLANT EXCHANGE." DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17020294 ↗
• InjuryApr 5, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 14018190 ↗
• InjuryJan 15, 2021Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND REPORTED "RIGHT SIDE IS INFLAMED, PAINFUL, AND FLUID BUILD UP AND CAPSULAR CONTRACTURE ALL ON ONE SIDE,¿ THE BAKER GRADE IS UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant; Seroma

  MAUDE report 11178631 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "LATE STAGE INFECTION." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9465574 ↗
• InjurySep 26, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9122715 ↗
• InjurySep 20, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9101166 ↗
• InjurySep 3, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "ANY CREASES".

  Patient problems: Capsular Contracture

  MAUDE report 8958411 ↗

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-