Natrelle INSPIRA Breast Implants TRX-495Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628008540), received between Jun 5, 2019 and Jul 28, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Device Appears to Trigger Rejection

  Patient reported "pain in the breasts that spread to the arm". Patient's representative later reported "Breast nodules" and "Capsular contracture¿ Baker grade unknown, "pain radiating to the arm", "swelling" "emotional distress", "anxiety and anguish" and "Edema". This record is for the left side. Patient also reported "not being able to sleep" which is not device related. Healthcare professional later reported "Solid nodule" which is not device related. Patient's representative later reported "Cystic cluster" and "simple breast cysts" which are not device related. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50056249 ↗
• InjuryJul 28, 2026Device Appears to Trigger Rejection

  Patient reported "pain in the breasts that spread to the arm". Patient's representative later reported "Breast nodules" and "Capsular contracture¿ Baker grade unknown, "pain radiating to the arm", "swelling" "emotional distress", "anxiety and anguish" and "Edema". This record is for the right side. Patient also reported "not being able to sleep" which is not device related. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50056089 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SLIMY FILM ACROSS THE AREA", "CALCIFICATIONS IN BOTH BREASTS", AND "CONCERN REGARDING IMPLANT RECALL". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Fluid Discharge

  MAUDE report 16613611 ↗
• InjuryMar 10, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED A LEFT SIDE "DEFORMITY ON THE LATERAL PORTION OF BREAST," "FILMY DRAINAGE" AND "SLIMY FILM ACROSS THE IMPLANT," "A 5MM NODULAR DENSITY," "CALCIFICATIONS IN BOTH BREASTS," "LEFT LATERAL BREAST PAIN," "PERIIMPLANT FLUID," "INTRACAPSULAR RUPTURE," "BURNING IRRITATION LEFT-SIDED BREAST," AND "CONCERN REGARDING IMPLANT RECALL." HEALTHCARE PROFESSIONAL ALSO REPORTED "TINY CYST IN LEFT BREAST," WHICH IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Fluid Discharge; Seroma

  MAUDE report 16526627 ↗
• InjuryNov 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED TO REPORT LEFT SIDE BEGAN DISINTEGRATING. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE NO RUPTURE AND "EXPLANT DUE TO TEXTURED IMPLANTS¿, AND ¿LEFT SIDE HAD A MURKY TYPE OF FLUID AND INFECTION AROUND THE IMPLANT¿. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 15741199 ↗
• InjuryNov 6, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. LATER HEALTHCARE PROFESSIONAL CONFIRMED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15741177 ↗
• InjuryNov 10, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE DUE TO CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "FISSURE AND FISTULA OF NIPPLE" AND "LEFT BREAST LUMP FOR WEEKS." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Fistula

  MAUDE report 10820296 ↗
• InjuryDec 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9454911 ↗
• InjuryDec 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9445487 ↗
• InjuryAug 27, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED A RIGHT SIDE RUPTURE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8936592 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROVIDER REPORTED LEFT SIDE "LATE SEROMA OF UNDETERMINED VOLUME". DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 8808027 ↗
• InjuryJun 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, THE IMPLANT "IS HIGH" AND IS "DISTORTED." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8675466 ↗
• InjuryJun 5, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, AND IMPLANT IS "HIGH," AND "DISTORTED." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8670851 ↗

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-