Natrelle INSPIRA Breast Implants TRF-415Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10888628008335), received between Jun 6, 2019 and Sep 15, 2026 — classified as 53 injuries.

The most frequently reported specific device problem is “Material Rupture” (21 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker Grade III and "exchange from textured to smooth implant". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50779375 ↗
• InjuryFeb 25, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "DEVICES ARE COMPLETELY DESTROYED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24444885 ↗
• InjuryDec 12, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. RETURN STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 23794727 ↗
• InjurySep 8, 2025Material Rupture; Material Rupture

  PATIENT REPORTED ¿RIGHT SIDE RUPTURE¿ DIAGNOSED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22993326 ↗
• InjuryJul 8, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22440038 ↗
• InjuryMay 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERN OF THE PRODUCT, PAIN, ITCHY, HARDNESS, CAPSULE, SCAR TISSUE, TUMOR ON LEFT ARM, DISCOMFORT AND A FLUID" OR POSSIBLE SEROMA"". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 4". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 21957616 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE PAIN AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. PATIENT ADDITIONALLY REPORTED "I HAVE DEVELOPED 2 LUMPS UNDER MY RIGHT ARMPIT" AND "INFLAMED LYMPH NODES". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 19326326 ↗
• InjuryMar 29, 2023Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16638437 ↗
• InjuryMar 28, 2023Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16632707 ↗
• InjuryFeb 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT" AND "GRADE IV CAPSULAR CONTRACTURE" CONFIRMED VIA MRI. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16315186 ↗
• InjuryNov 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT¿. HEALTHCARE PROFESSIONAL REPORTED "PATIENT WITH A LEFT BREAST IMPLANT RUPTURE" AND THEN REPORTED NO RUPTURE BUT CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15887638 ↗
• InjuryNov 29, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND A IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15882576 ↗
• InjuryNov 29, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND A IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15882387 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A LEFT SIDE FLUID BUILDUP AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 15736681 ↗
• InjurySep 15, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE DUE TO THE PATIENT CONCERN WITH THE PRODUCT AND LATER REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15427053 ↗
• InjuryAug 19, 2022Material Rupture; Material Rupture

  PATIENT REPORTED "EXPERIENCING PAIN." HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND TEXTURED TO SMOOTH EXCHANGE DUE TO PATIENT CONCERN. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15259693 ↗
• InjuryAug 2, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE REMOVAL DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15153117 ↗
• InjuryAug 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND ANXIETY AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15147643 ↗
• InjuryJul 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV, PAIN, HARDNESS AND LEFT SIDE 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 15126381 ↗
• InjuryMay 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14500002 ↗
• InjuryMay 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14468583 ↗
• InjuryMay 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14435711 ↗
• InjuryMar 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13654733 ↗
• InjuryMar 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13654461 ↗
• InjuryFeb 11, 2022Material Rupture; Material Rupture

  DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13516902 ↗

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-