Natrelle Inspira SoftTouch Breast Implants TSM-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628033962), received between Mar 13, 2020 and Jul 1, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, "RUPTURED RIGHT PROSTHESIS. CONFIRMED BY MAGNETIC RESONANCE IMAGING". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19651992 ↗
• InjuryAug 7, 2020Material Rupture; Migration; Material Rupture; Migration

  PATIENT REPRESENTATIVE REPORTED "VISIBILITY OF THE SHELL," "INSOMNIATING AND RADIATING BREAST PAIN IN THE UPPER LIMBS", AND A "CRACK IN THE LEFT SIDE DEVICE WITH SILICONE GEL TAMPERING" (DIAGNOSED BY ULTRASOUND/MAMMOGRAPHY). DEVICE HAS BEEN EXPLANTED. "EVIDENCE OF SILICONE BLADE" SEEN AFTER CAPSULECTOMY. PATIENT EXPERIENCED "PRURITUS AND SKIN LESIONS ON THE LEFT UPPER LIMB SUGGESTING A SILICONE GEL ALLERGY." PATIENT RECEIVED "LOCAL TREATMENT." ALSO REPORTED "PAINFUL AFTER-EFFECTS RELATED TO THE PRESENCE OF SILICONE AND BREAST NECROSIS, UNATTRACTIVE RESULTS, AND INCONVENIENCE/FEELS DISCOMFORT IN EVERYDAY TASKS."

  Patient problems: Necrosis

  MAUDE report 10382459 ↗
• InjuryAug 7, 2020Migration; Migration

  PATIENT REPRESENTATIVE REPORTED "VISIBILITY OF THE SHELL", "INSOMNIATING AND RADIATING BREAST PAIN IN THE UPPER LIMBS", "INFLAMMATION OF THE BREAST DIAGNOSED ON IMAGERY SCAN", "SILICONE GEL TAMPERING AND SILICONE BLADE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED. PATIENT PRESENTS IMPORTANT PAINFUL AFTER-EFFECTS, IS INCONVENIENT/FEELS DISCOMFORT IN EVERYDAY TASKS. .

  Patient problems: Failure of Implant

  MAUDE report 10379456 ↗
• InjuryMar 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9836097 ↗
• InjuryMar 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9828801 ↗

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-