Natrelle Inspira SoftTouch Breast Implants TSF-415Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628034167), received between Mar 21, 2018 and Aug 18, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Rupture” (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 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Material Rupture

  Healthcare professional reported ¿Rupture¿. This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50302721 ↗
• InjuryJul 27, 2026Material Rupture

  Patient reported "no complaint against the device". Patient later reported "implant remains intact with small number of radial folds, small cysts". Healthcare professional later reported "ruptured, foreign body giant cell reaction, chronic inflammation, synovial metaplasia and nerve bundle proliferation". This record is for the left side. The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038082 ↗
• InjuryJun 5, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULE RUPTURE", "FREE FLUID BETWEEN INTERNAL QUADRANTS" AND "RUPTURE OF CAPSULE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408784 ↗
• InjuryAug 26, 2024Material Rupture; Material Rupture

  PATIENT REPORTED "SHE IS SCARED TO DEATH AND WANTS THEM OUT. SHE HAS ALREADY HAD NON-HODGKIN'S LYMPHOMA - NOT RELATED TO THE DEVICE AND SWELLING IN THE RIGHT BREAST". PATIENT LATER REPORTED "RUPTURE VIA MRI AND MAMMOGRAM, PAIN, DRASTICALLY DEFORMED, AND ONE SIDE HEADED UP TO THE SHOULDER AND OTHER HANGING DOWN WAIST". HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20065384 ↗
• InjuryMar 10, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, A "RIGHT SIDE RUPTURE". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16527135 ↗
• InjuryMar 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16526670 ↗
• InjuryJun 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, "FLUID ON THE IMPLANT," AND CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 11992148 ↗
• InjuryMar 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTED EVENTS OF RIGHT SIDE ¿FLUID ACCUMULATION,¿ AND ¿SUBACUTE HEMATOMA¿ FOR A PATIENT IMPLANTED WITH A ¿ROUND SILICONE¿ ALLERGAN TSF DEVICE WERE NOTED IN ¿SUBACUTE ARTERIAL BLEEDING AFTER SIMULTANEOUS MASTOPEXY AND BREAST AUGMENTATION WITH IMPLANTS: CASE REPORT." DURING REVISION SURGERY, ¿A BLOOD CLOT OF 650 ML WAS REMOVED,¿ AND ¿BLEEDING FROM ONE OF THE INTERNAL MAMMARY ARTERY BRANCHES IN THE IMPLANT POCKET BETWEEN THE RIB CAGE AND PECTORAL MUSCLE LOWER POLE WAS DETECTED AND STOPPED.¿ TREATMENT OF ¿VACUUM DRAINAGE¿ WAS ADDITIONALLY PROVIDED, AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7357784 ↗

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-