Natrelle INSPIRA Breast Implants TRX-445Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628008526), received between May 1, 2020 and Nov 3, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "FEELS LIKE CONCRETE, LUMP, POSSIBLE LEAKING" AND "CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18068381 ↗
• InjuryJan 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16269743 ↗
• InjuryJan 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED. (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 16254147 ↗
• InjuryAug 18, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15252501 ↗
• InjuryAug 18, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 15252452 ↗
• InjuryNov 18, 2021Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12836614 ↗
• InjuryNov 17, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 12830232 ↗
• InjuryJul 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND TEXTURED DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10260284 ↗
• InjuryJul 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10259809 ↗
• InjuryMay 5, 2020Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "BREAST LYMPHOMA." WHEN THE DEVICE WAS EXPLANTED "THERE WAS SOME FLUID WITHIN THE POCKET THAT WAS SENT TO CYTOLOGY" AND CONFIRMED "ABNORMAL CD4+/CD30+ LARGE T-CELLS IDENTIFIED, CONSISTENT WITH ANAPLASTIC LARGE CELL LYMPHOMA." WHILE THE MARKER OF CD30+ HAS BEEN REPORTED AND PATHOLOGY HAS BEEN RECEIVED, THE MARKER OF ALK- HAS NOT. AFFECTED SIDE IS LEFT. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Lymphoma; Seroma; Unspecified Infection

  MAUDE report 10026728 ↗
• InjuryMay 1, 2020Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SIGNIFICANT SWELLING OF RIGHT BREAST", "SIGNIFICANT AMOUNT OF EDEMA", AND "SWELLING IN SURROUNDING BREAST TISSUE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Lymphoma; Seroma; Unspecified Infection

  MAUDE report 10017363 ↗

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
• 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-