Natrelle INSPIRA Breast Implants TRF-560Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628008373), received between Jul 23, 2019 and Apr 25, 2023 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16808282 ↗
• InjuryJul 18, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE" AND "CONCERNS WITH THE PRODUCT." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15042394 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "FLUID," PAIN AND IMPLANT EXCHANGE DUE TO CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 11777720 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SWELLING" AND PATIENT'S CONCERN WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "SEROMA". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 11402687 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE SWELLING AND "PATIENT'S CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED SEROMA AND "TWO LAYER CAPSULE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 11397735 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENT'S CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED SEROMA. DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.

  Patient problems: Seroma

  MAUDE report 10917822 ↗
• InjuryNov 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT'S CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV AND SEROMA. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 10913462 ↗
• InjuryAug 13, 2020Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "PAINFUL, LOSING VOLUME, AND HAS LUMPS/BUMPS." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10403597 ↗
• InjuryApr 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED VIA REGULATORY AGENCY, "SWOLLEN LYMPH NODES, HEADACHES, SWOLLEN JOINTS, STIFF JOINTS, PAIN IN ARM, PAIN IN BREAST, BURNING FEEL IN BREAST, LIGHT SENSITIVITY, ARM WEAKNESS, ANXIETY, SKIN PROBLEMS, PIGMENT CHANGE, DEPRESSION, EXTREME SEVERE FATIGUE, AND SEVERE MEMORY LOSS." DEVICE STATUS IS UNKNOWN. THIS IS THE LEFT SIDE RECORD.

  Patient problems: Swollen Lymph Nodes

  MAUDE report 9927023 ↗
• InjuryFeb 5, 2020Material Rupture; Material Rupture

  DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9670501 ↗
• InjuryOct 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9158600 ↗
• InjuryJul 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8819163 ↗
• InjuryJul 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8816928 ↗

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-