Natrelle Inspira SoftTouch Breast Implants TSM-485Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888628033986), received between Jun 12, 2019 and Sep 21, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2023Device Appears to Trigger Rejection; Device Handling Problem; Device Appears to Trigger Rejection; Device Handling Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED A CAPSULAR CONTRACTURE BAKER GRADE IV, AND "WHEN REMOVING CAPSULE ON THE TABLE, IMPLANT WAS CUT." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "CAPSULE AND CONSISTS OF WHITE PLASTIC MATERIAL GROSSLY RESEMBLING A BREAST CAPSULE" AND "BENIGN LYMPHOHISTIOCYTIC INFLAMMATION." THE EVENT OF "WHEN REMOVING CAPSULE ON THE TABLE, IMPLANT WAS CUT" IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17795775 ↗
• InjuryOct 19, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15633106 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH PROFESSIONAL REPORTED RIGHT SIDE DOUBLE CAPSULE AND "FREE FLOATING WITH APPROXIMATELY 5-10 ML OF SEROUS FLUID." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 9506915 ↗
• InjuryDec 18, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED "HARDNESS AND PAIN". HEALTH PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 9490078 ↗
• InjurySep 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED. AFFECTED SIDE LEFT.

  Patient problems: Capsular Contracture

  MAUDE report 9101400 ↗
• InjuryJun 12, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND "WORD SLURRING". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8692424 ↗
• InjuryJun 12, 2019Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE AND "WORD SLURRING". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8692369 ↗

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-