Natrelle INSPIRA Breast Implants TRX-615Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888628008595), received between Sep 2, 2019 and Jul 29, 2022 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "RIGHT-SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". HEALTHCARE ADDITIONALLY REPORTED UPON REMOVAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15131695 ↗
• InjuryJun 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV" AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14760181 ↗
• InjuryMay 11, 2022Material Rupture; Material Rupture

  PATIENT REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14365810 ↗
• InjuryMay 10, 2022Material Rupture; Material Rupture

  PATIENT REPRESENTATIVE REPORTED PATIENT ¿HAS WORRIED ABOUT THE RISKS¿ ¿MENTAL STRESS, ANXIETY, WORRY, HUMILIATION, FEAR, CONCERN DUE TO THE CONTINUOUS FEAR OF BIA-ALCL," "DEBILITATING PAIN AND MENTAL SUFFERING," "EMOTIONAL DISTRESS, ANXIETY, DEPRESSION." PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "DISABILITY"; THIS EVENT IS NOT RELATED TO THE DEVICE. PATIENT ADDITIONALLY REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 14347572 ↗
• InjuryMar 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13939628 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 11462350 ↗
• InjuryMar 10, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV, AND "5CC¿S OF FLUID.¿ DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 11454260 ↗
• InjuryFeb 12, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11320803 ↗
• InjuryJun 17, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10165027 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Pain

  MAUDE report 9498137 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED LEFT SIDE PAIN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Pain

  MAUDE report 9208387 ↗
• InjurySep 2, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8953947 ↗

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-