Natrelle INSPIRA Breast Implants TRF-605Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10888628008380), received between Jun 13, 2019 and Nov 4, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICE DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANT EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE BAKER GRADE IV", CONFIRM VIA EXAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23470897 ↗
• InjuryAug 8, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM ¿TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT, AND RUPTURE." HEALTHCARE PROFESSIONAL ALSO REPORTED "BRAIN CANCER¿. THIS EVENT IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15182441 ↗
• InjuryAug 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, AND A CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15146486 ↗
• InjuryAug 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE PAIN. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "LUMP" UNDER THE ARMPIT. PATIENT REPORTED "THYROID CANCER"; THIS EVENT IS NOT RELATED TO THE DEVICE. PATIENT REPRESENTATIVE REPORTED PATIENT EXPERIENCED "BREAST PAIN, GRADE III CAPSULAR CONTRACTURE AND INCREASED RISK OF ALCL." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15138685 ↗
• InjuryMay 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, AND A CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14378793 ↗
• InjuryApr 12, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿TEXTURE" AND RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14090422 ↗
• InjuryApr 11, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿TEXTURE" AND RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14079387 ↗
• InjuryJul 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 12137424 ↗
• InjuryAug 19, 2020Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE AND "CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10424364 ↗
• InjuryMar 27, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "HARDENING". IN ADDITION PATIENT REPORTED "HAD A FLUID COLLECTION ON THE LEFT BREAST." DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 9889589 ↗
• InjuryFeb 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9706030 ↗
• InjuryJan 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE "SORENESS," "MISSHAPEN," AND "BIGGER THAN THE RIGHT SIDE." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE IV, "LEFT BREAST LARGER THAN RIGHT DUE TO POSSIBLE FLUID COLLECTION", AND "PATIENT'S CONCERN WITH PRODUCT/PROCEDURE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 9622305 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, FEVER, MILD REDNESS TO THE LOWER BORDER OF BREAST, DOUBLE CAPSULE," AND "SEROMA." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 9597617 ↗
• InjuryDec 19, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED "RIGHT SIDE IS SORE ". HEALTHCARE PROFESSIONAL LATER CONFIRMED THE EVENTS OF " SEVERE CAPSULAR CONTRACTURE" BAKERS GRADE IV AND RUPTURE. HEALTHCARE PROFESSIONAL ALSO REPORTED "PATIENT'S CONCERN WITH THE PRODUCT" AND "SEROMA FORMATION". DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 9494736 ↗
• InjuryDec 9, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE "SORENESS ON BOTH BREASTS, CONCERN ABOUT ALCL," AND "BIGGER THAN THE RIGHT SIDE." HEALTHCARE PROVIDER REPORTED "CAPSULAR CONTRACTURE." BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9438990 ↗
• InjuryNov 1, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED "THE LEFT SIDE HAS A LUMP THAT IS SO BIG IT IS CAUSING ISSUES ON THE SURFACE OF HER SKIN". HEALTHCARE PROFESSIONAL LATER CONFIRMED THE EVENTS OF "SEVERE CAPSULAR CONTRACTURE" BAKERS GRADE IV, "SEROMA FORMATION," AND RUPTURE. HEALTHCARE PROFESSIONAL ALSO REPORTED "PATIENT'S CONCERN WITH THE PRODUCT". DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 9268481 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE "DOUBLE BUBBLE".

  Patient problems: Seroma

  MAUDE report 8949684 ↗
• InjuryAug 26, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE "KNOTS UNDER LEFT ARMPIT," AND PAIN. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8932872 ↗
• InjuryJun 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8695685 ↗

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-