Natrelle INSPIRA Breast Implants TRM-375Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10888628008120), received between Jul 16, 2019 and Aug 28, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Material Rupture” (22 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Material Rupture

  Healthcare professional reported "implant rupture, with the inner capsule floating freely in the silicone, separation between inner and outer capsule, Cysts and ductectasias". This record is for the right side. The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497466 ↗
• InjuryAug 28, 2026Material Rupture

  Healthcare professional reported "implant rupture, with the inner capsule floating freely in the silicone, separation between inner and outer capsule, small silicone island measuring 1 x 0.8 cm outside the prosthesis, Cysts and ductectasias ". This record is for the left side. The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497249 ↗
• InjuryApr 14, 2026Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT." HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE", LATER HEALTHCARE PROFESSIONAL REPORTED " PATIENT DID NOT HAVE A LEFT SIDE RUPTURE". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877025 ↗
• InjuryJun 12, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22194727 ↗
• InjuryMay 22, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA ANSM "INTRACAPSULAR RUPTURE AND STAGE 1 SHELL ". THIS REPORT IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22075358 ↗
• InjuryApr 9, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. PATIENT CALLED TO REPORT A LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDEDEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21806798 ↗
• InjuryDec 26, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  DEVICE HAS BEEN EXPLANTED. PATIENT REPORTED RUPTURE.

  Patient problems: Capsular Contracture

  MAUDE report 18395602 ↗
• InjurySep 1, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17673190 ↗
• InjuryAug 18, 2023Material Rupture; Material Rupture

  PATIENT ADDITIONALLY REPORTED LEFT SIDE RUPTURE.

  Patient problems: Failure of Implant

  MAUDE report 17577490 ↗
• InjuryAug 17, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 17562544 ↗
• InjuryApr 24, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE RUPTURE PER MRI. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16794664 ↗
• InjuryApr 24, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE RUPTURE PER MRI. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16794643 ↗
• InjuryMar 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16606161 ↗
• InjuryFeb 20, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE PER MAMMOGRAM AND EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. ADDITIONALLY, PATIENT REPORTED SHARP PAIN FROM SHOULDER THROUGH LEFT BREAST. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16403569 ↗
• InjuryNov 29, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 15883243 ↗
• InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTS BILATERAL IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO HARDENING AND DISCOMFORT AND BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15629878 ↗
• InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTS BILATERAL IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO HARDENING AND DISCOMFORT AND BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN . DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15629877 ↗
• InjuryOct 5, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEVICE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15544742 ↗
• InjuryAug 29, 2022Gel Leak; Gel Leak

  PATIENT REPRESENTATIVE REPORTED LEFT SIDE CONCERN WITH PRODUCT. HEALTHCARE PROFESSIONAL REPORTED MRI INDICATES LEFT SIDE "POSSIBLE GEL BLEED." DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15317252 ↗
• InjuryJul 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE REPORTED BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE , BAKER GRADE II/III AND SEROMA. THIS IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Lymphoma; Seroma

  MAUDE report 14962549 ↗
• InjuryJun 13, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14675882 ↗
• InjuryJun 13, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14675778 ↗
• InjurySep 21, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12510310 ↗
• InjuryMar 25, 2021Material Rupture; Material Rupture

  PATIENT REPORTED ¿JOINTS ACHE ALL OVER THE BODY, SPECIFICALLY BACK AND FEET; THIS EVENT IS NOT DEVICE RELATED. PATIENT LATER REPORTED RIGHT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL CONFIRMED RUPTURE AND "CONCERNS ABOUT IMPLANTED RELATED ILLNESS". HEALTHCARE PROFESSIONAL ALSO REPORTED "SIGNS OF SYSTEMIC INFLAMMATION"; THIS EVENT IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11572676 ↗
• InjuryDec 12, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10994801 ↗

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-