Natrelle INSPIRA Breast Implants TRM-255Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10888628008052), received between Aug 30, 2019 and Jul 28, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Device Appears to Trigger Rejection

  Patient reported "capsular contracture Baker grade unknown". This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50059982 ↗
• InjuryJul 7, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND MISSHAPE" AND "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22412357 ↗
• InjuryApr 9, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21810653 ↗
• InjuryApr 9, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21810446 ↗
• InjuryJun 17, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19554864 ↗
• InjuryJan 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE II/III DIAGNOSED BY ULTRASOUND.

  Patient problems: Capsular Contracture

  MAUDE report 18589040 ↗
• InjurySep 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE PAIN, HARD AS A ROCK, AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17754646 ↗
• InjurySep 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17750472 ↗
• InjuryMar 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 16591729 ↗
• InjuryDec 7, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKE GRADE III AND RUPTURE DURING SURGERY. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15933199 ↗
• InjuryNov 30, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "HARDENING" AND RUPTURE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15886179 ↗
• InjuryMar 31, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 13968991 ↗
• InjuryJul 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURED IMPLANTS (RECALLED)" WITH A CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12166797 ↗
• InjuryJul 13, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12160471 ↗
• InjuryDec 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTH PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND EXCHANGE DUE TO CONCERN WITH PRODUCT. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10944280 ↗
• InjuryOct 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10689941 ↗
• InjurySep 23, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND "TEXTURED CLAIM". DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 9104639 ↗
• InjurySep 19, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  ADDITIONALLY REPORTED, WAS THAT THE DEVICE "APPEARED TO BE RUPTURED". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 9085870 ↗
• InjuryAug 30, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  DEVICE EXPLANTED. LAB ANALYSIS PENDING.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 8951452 ↗

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-