Natrelle Inspira Cohesive Breast Implants TCM-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888628030923), received between Dec 12, 2019 and Jul 5, 2022 — classified as 2 injuries.

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

• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "BACTERIAL INFECTION". HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REMOVAL/REPLACEMENT OF TEXTURED FOR SMOOTH IMPLANTS. PATIENT REPRESENTATIVE ADDITIONALLY REPORTED SIGNIFICANTLY INCREASED RISK OF DEVELOPING CANCER, EMOTIONAL DISTRESS INCLUDING FEAR AND ANXIETY OF DEVELOPING CANCER, ACCUMULATION OF FOREIGN AND ADULTERATED SILICONE PARTICLES IN THEIR BODIES, INCLUDING THE RESULTING INFLAMMATION, CELLULAR DAMAGE, AND SUBCELLULAR DAMAGE, PHYSICAL PAIN AND SUFFERING. THE EVENTS OF "ADULTERATED SILICONE PARTICLES IN THEIR BODIES, CELLULAR DAMAGE, AND SUBCELLULAR DAMAGE" HAVE BEEN DEEMED NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 14918987 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A RIGHT SIDE "RANDOM WEIRD THINGS" AND " SWOLLEN GLANDS IN HER NECK AND ARMPIT". DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes

  MAUDE report 9463501 ↗

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-