Natrelle INSPIRA Breast Implants TRX-375Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888628008496), received between Sep 6, 2019 and Sep 29, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "texture implants" and "Baker grade 4". This record is for the right side. Device remains implanted. Capsulectomy treatment was performed.

  Patient problems: Capsular Contracture

  MAUDE report 50932301 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PATIENT WITH COMPLAINT OF PAIN AND HARDENED BREAST, WITH CHANGE IN SHAPE." AND " CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25376540 ↗
• InjuryJul 16, 2024Material Rupture; Material Rupture

  PATIENT REPORTED UNKNOWN SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19750770 ↗
• InjurySep 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED AGAINST LEFT SIDE "PAIN" AND "CHRONIC HIVES, HEART PALPITATIONS, AND THINNING HAIR" (NON DEVICE RELATED). HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15513744 ↗
• InjuryFeb 16, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Migration; Material Rupture; Adverse Event Without Identified Device or Use Problem; Migration

  PHYSICIAN REPORTED A LEFT SIDE RUPTURE, GRANULOMA, SILICONE MIGRATION AND LYMPHADENOPATHY. DEVICE HAS BEEN EXPLANTED. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Granuloma; Swollen Lymph Nodes/Glands

  MAUDE report 13543923 ↗
• InjuryFeb 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND IMPLANT EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9670535 ↗
• InjurySep 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8972708 ↗

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-