Natrelle INSPIRA Breast Implants TRM-330Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10888628008090), received between Aug 22, 2019 and Aug 14, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Material Rupture” (14 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Material Rupture

  Healthcare professional reported an "intracapsular rupture". This record is for the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263006 ↗
• InjuryNov 21, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". PATIENT LATER REPORTED "RUPTURE" AND "PAIN". LATER, PATIENT REPORTED "DEFORMED IMPLANT". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV" AND "OLD IMPLANT, TEXTURED, RUPTURED, DOUBLE CAPSULE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. IT IS AVAILABLE FOR RETURN.

  Patient problems: Capsular Contracture

  MAUDE report 23618568 ↗
• InjurySep 29, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "DOUBLE CAPSULE DURING EXPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23168214 ↗
• InjuryOct 20, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17976244 ↗
• InjuryJul 13, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "POSSIBLE RUPTURE", "INCREASED PAIN", AND "SWELLING." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17320324 ↗
• InjuryJan 27, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 16254542 ↗
• InjurySep 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "TEXTURED" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15450510 ↗
• InjurySep 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "TEXTURED" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15448607 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED THE FOLLOWING INFORMATION. " PATIENT HAS SUFFERED PAIN AND BURNING, LUMPS, ALCL(NOT CONFIRM BY HEALTHCARE PROFESSIONAL, AND, CD30+/ALK, PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED) PAINFUL REMOVAL PROCEDURES, SCARRING, DISFIGUREMENT,MENTAL PAIN AND SUFFERING, AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Lymphoma

  MAUDE report 13862506 ↗
• InjuryAug 5, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE NO COMPLAINT AGAINST DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 12281879 ↗
• InjuryJul 23, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 12218848 ↗
• InjuryApr 8, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT'S CONCERN WITH THE DEVICE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11636172 ↗
• InjuryApr 2, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV, AND "PATIENT'S CONCERN WITH THE DEVICE." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11606943 ↗
• InjuryFeb 26, 2021Material Rupture; Material Rupture

  PHYSICIAN REPORTED A LEFT SIDE "IMPLANT RUPTURE". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11389266 ↗
• InjuryJan 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11217505 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. ADDITIONAL RIGHT SIDE REPORT OF CAPSULAR CONTRACTURE BAKER GRADE I, DOUBLE CAPSULE, "FLUID IN THE CAPSULE" AND MALPOSITION, RIGHT SIDE IS RIDING HIGHER. THE DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 10610277 ↗
• InjuryMar 5, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9795084 ↗
• InjuryFeb 18, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9720769 ↗
• InjuryDec 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND "CAPS CONTRACT" BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9512388 ↗
• InjuryDec 13, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, RUPTURE AND PAIN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9467681 ↗
• InjuryOct 3, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE WITH BURNING SENSATIONS," "LATE SEROMA, DOUBLE CAPSULE, WAITING FOR ALCL RESULTS." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 9153038 ↗
• InjuryAug 22, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III," "SWELLING OF LYMPH ON THE RIGHT SIDE, PAIN, SICK WITH FATIGUE, & SWELLING," "RESPIRATORY INFECTION ABOUT A MONTH AGO," AND "A WEIRD SWOLLEN LUMP UNDER HER RIGHT ARM ABOUT A MONTH AGO IN "(B)(6) 2019". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8920102 ↗

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-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-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-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-