Natrelle INSPIRA Breast Implants TRX-545Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628008564), received between Dec 30, 2019 and Feb 4, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 24, 2019Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE FROM TEXTURED IMPLANTS DUE TO CONCERN WITH THE PRODUCT AND "INTRACAPSULAR RUPTURE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11278005 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT¿S CONCERN WITH THE PRODUCT" AND SEROMA FLUID. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 10482127 ↗
• InjuryAug 31, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND SEROMA FLUID. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 10470964 ↗
• InjuryDec 30, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿RUPTURE AND PATIENT¿S CONCERN WITH THE PRODUCT." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9531577 ↗

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 · 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-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 108
• 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, 110-210,