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Natrelle INSPIRA Breast Implants TRM-195Recalls & reported problems

Allergan, Inc. · NATRELLE INSPIRA Sty TRM-195 Low Plus profile BIOCELL |textured|round|silicone · Class 3 · Implant

All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Breast Implants (197)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888628008021), received between Aug 16, 2019 and Feb 8, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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

Device problems

  • Device Appears to Trigger Rejection1
  • Patient-Device Incompatibility1

Patient problems

  • Capsular Contracture2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    HEALTHCARE PROFESSIONAL REPORTED "GRADE 3 BREAST CAPSULES" AND "TEXTURED BREAST IMPLANTS" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Capsular Contracture

    MAUDE report 13479955 ↗
  • InjuryAug 16, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

    Patient problems: Capsular Contracture

    MAUDE report 8903548 ↗

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-

Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices

All Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page