Natrelle INSPIRA Breast Implants TRF-295Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10888628008274), received between Jun 7, 2019 and Feb 4, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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.

• InjuryFeb 4, 2026Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24259438 ↗
• InjuryJul 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". HEALTHCARE PROFESSIONAL LATER REPORTED "EXPLANT INTACT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22665623 ↗
• InjuryJul 28, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III." HEALTHCARE PROFESSIONAL LATER REPORTED "LEFT IMPLANT RUPTURED." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22637095 ↗
• InjuryApr 7, 2024No Apparent Adverse Event; Migration; No Apparent Adverse Event; Migration

  BASED ON ADDITIONAL INFORMATION RECEIVED, FROM THE PHYSICIAN. THERE IS NO COMPLAINT REPORTED FOR THE LEFT SIDE. HENCE, UNREPORTING THE PREVIOUSLY REPORTED EVENT OF LYMPHADENOPATHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Swollen Lymph Nodes/Glands

  MAUDE report 19057153 ↗
• InjuryFeb 24, 2023Material Rupture; Material Rupture

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16435258 ↗
• InjuryMar 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 13760403 ↗
• InjuryMar 9, 2021Material Rupture; Material Rupture

  PATIENT REPORTED RUPTURE, UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11445127 ↗
• InjuryFeb 1, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE DUE TO PATIENT¿S CONCERN WITH TEXTURED PRODUCT. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11263336 ↗
• InjuryOct 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE "SWELLING," "PAIN ALL OF THE TIME," AND "INFLAMED FOR SEVERAL MONTHS." HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND PRODUCT "ANXIETY." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10713063 ↗
• InjuryMar 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE OF TEXTURED BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9802114 ↗
• InjuryJan 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9597718 ↗
• InjuryJan 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE "III/IV." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9581804 ↗
• InjuryJan 6, 2020Material Rupture; Patient-Device Incompatibility; Migration; Material Rupture; Patient-Device Incompatibility; Migration

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9554378 ↗
• InjuryJan 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROVIDER REPORTED REASON FOR LEFT SIDE REMOVAL AS CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9540995 ↗
• InjuryDec 23, 2019Material Rupture; Patient-Device Incompatibility; Migration; Material Rupture; Patient-Device Incompatibility; Migration

  PATIENT REPORTED THEY ¿HAVE ALL OF THE SYMPTOMS OF BIA-ALCL¿, ¿RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE IV¿ AND ¿3D MAMMOGRAM AND ULTRASOUND OF LYMPH NODES IN ARMPITS; FOUND A NUMBER OF CYSTS IN BREAST AND A LOT OF SILICONE FLOATING AROUND¿. THE DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 9512358 ↗
• InjuryDec 18, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED UNKNOWN SIDE "CAPSULAR CONTRACTURE," BAKER GRADE IV. PATIENT ADDITIONALLY REPORTED "FATIGUE, ANXIETY, RINGING IN EARS, VISION DECLINE, DECREASE IN LIBIDO, MEMORY, SLEEP DISTURBANCES, VERTIGO, MOOD CHANGES, TEMPERATURE INTOLERANCES;" THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9491793 ↗
• InjuryDec 5, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9416002 ↗
• InjuryAug 15, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿LEFT SIDE -TENDERNESS, SWELLING, PAIN ON BREAST.¿ AND A RUPTURED DEVICE DIAGNOSED BY MRI. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8897742 ↗
• InjuryJun 7, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8680153 ↗

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-