Natrelle Inspira SoftTouch Breast Implants TSX-340Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628034310), received between Jan 20, 2021 and Sep 5, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 16, 2026.

Recalls naming this device

1. Jul 24, 2019Open, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50625533 ↗
• InjuryJun 25, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "PERSISTENT PAIN", "BREAST SWELLING", "PHYSICAL DISCOMFORT" AND "ANXIETY ATTACKS" AGAINST THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Anxiety; Capsular Contracture; Pain; Swelling/ Edema

  MAUDE report 25620173 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTS "PATIENT'S LEFT BREAST SWELLED, IT WAS 3 TIMES LARGER THAN IT WAS". PATIENT "DRAINED THE FLUID AND TOOK ANTI INFLAMMATORY." THIRD PARTY LAWYER LATER REPORTED "THE PATIENT WAS SURPRISED BY THE NEWS OF A WORLDWIDE RECALL OF ALLERGAN BREAST IMPLANTS DUE TO THE HIGH RISK OF DEVELOPING A RARE TYPE OF CANCER - ANAPLASTIC LYMPHOMA, DIRECTLY ASSOCIATED WITH THE TEXTURED SURFACE OF THE IMPLANTS" "THE SITUATION CAUSED IMMENSE ANGUISH, FEAR AND EMOTIONAL INSTABILITY FOR THE PATIENT, WHO WAS FORCED TO SEEK IMMEDIATE PHYSICIAN ASSISTANCE." ¿IT EVOLVED WITH BAKER IV CAPSULAR CONTRACTURE AND DISTORTION OF THE SHAPE OF THE BREASTS¿. "THE PATIENT DEVELOPED BAKER IV CAPSULAR CONTRACTURE AND DISTORTION OF THE SHAPE OF HER BREASTS." THIS IS FOR THE LEFT SIDE DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 22444124 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED "THE PATIENT WAS SURPRISED BY THE NEWS OF A WORLDWIDE RECALL OF ALLERGAN BREAST IMPLANTS DUE TO THE HIGH RISK OF DEVELOPING A RARE TYPE OF CANCER - ANAPLASTIC LYMPHOMA, DIRECTLY ASSOCIATED WITH THE TEXTURED SURFACE OF THE IMPLANTS", "THE SITUATION CAUSED IMMENSE ANGUISH, FEAR AND EMOTIONAL INSTABILITY FOR THE PATIENT, WHO WAS FORCED TO SEEK IMMEDIATE PHYSICIAN ASSISTANCE", ¿IT EVOLVED WITH BAKER IV CAPSULAR CONTRACTURE AND DISTORTION OF THE SHAPE OF THE BREASTS¿. AFFECTED SIDE IS RIGHT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22437406 ↗
• InjuryJun 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN" AND "CAPSULAR CONTRACTURE BAKER GRADE III". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22144590 ↗
• InjuryJun 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED " EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN." AND " BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22144296 ↗
• InjuryJan 21, 2021Material Rupture; Material Rupture

  PATIENT ADDITIONALLY REPORTED RIPPLED IMPLANT, BURNING/ITCHING FEELING, LOST OF FEELING/COMPLETELY NUMB, VERY SENSITIVE, AND SHARP SHOOTING PAIN.

  Patient problems: Failure of Implant

  MAUDE report 11206719 ↗
• InjuryJan 20, 2021Material Rupture; Material Rupture

  PATIENT ADDITIONALLY REPORTED RIPPLED IMPLANT, BURNING/ITCHING FEELING, LOSS OF FEELING/COMPLETELY NUMB, VERY SENSITIVE, AND SHARP SHOOTING PAIN.

  Patient problems: Failure of Implant

  MAUDE report 11205620 ↗

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 108
• 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, 110-210,