Natrelle INSPIRA Breast Implants TRM-295Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10888628008076), received between May 30, 2019 and Sep 7, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Material Rupture” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions; Seroma

  MAUDE report 50652171 ↗
• InjuryJun 5, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THROUGH DISTRIBUTOR ¿DURING SURGERY RUPTURE OF THE IMPLANT WAS FOUND¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408393 ↗
• InjuryJun 3, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THROUGH DISTRIBUTOR ¿RUPTURE OF THE BREAST IMPLANT WAS FOUND¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382195 ↗
• InjuryAug 11, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICES HAVE BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22779048 ↗
• InjuryJul 17, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "MRI FINDINGS INDICATE THAT THE IMPLANT HAS RUPTURED". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22530817 ↗
• InjuryJul 19, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE VIA MRI AND EXCHANGE DUE TO CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17352836 ↗
• InjuryJun 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17094206 ↗
• InjuryMar 14, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, "A RIGHT RUPTURE". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16542107 ↗
• InjuryJul 13, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "PAIN AND CAPSULAR CONTRACTURE BAKER GRADE IV AND A SUSPECTED RUPTURE" AGAINST LEFT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15007652 ↗
• InjuryJul 13, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "PAIN AND CAPSULAR CONTRACTURE BAKER GRADE IV AND A SUSPECTED RUPTURE" AGAINST RIGHT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15006258 ↗
• InjuryJul 7, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 14947768 ↗
• InjuryJul 5, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "CONCERNS WITH THE PRODUCT" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14921718 ↗
• InjuryDec 7, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED PATIENT'S CONCERN WITH THE PRODUCT AND RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12954991 ↗
• InjuryAug 16, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDED RUPTURE AND "TEXTURED ALLERGAN IMPLANTS". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12328852 ↗
• InjuryApr 8, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED " NOTED THAT THE LEFT IMPLANT WAS RUPTURED [DURING EXPLANT SURGERY]." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11637806 ↗
• InjuryApr 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED FOR RIGHT SIDE "WATERFALL DEFORMITY" AND THE CAPSULAR CONTRACTURE BAKER GRADE AMENDED FROM IV TO III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11634809 ↗
• InjuryOct 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED "BILATERAL EXCHANGE OF TEXTURED BREAST IMPLANTS." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 10655226 ↗
• InjuryJun 13, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10151377 ↗
• InjuryJun 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED EXCHANGE OF TEXTURED BREAST IMPLANTS. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 10148797 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SWELLING OF THE RIGHT SIDE OF THE ARMPIT LYMPH NODE DURING THEIR MENSTRUAL CYCLE. DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes

  MAUDE report 9889114 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE SWELLING, HARDENING, PAIN AND EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 9830113 ↗
• InjuryJan 6, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT AND RUPTURE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9553235 ↗
• InjuryMay 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND DOUBLE CAPSULE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8654201 ↗

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-