Natrelle Inspira SoftTouch Breast Implants TSM-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888628033948), received between Oct 30, 2018 and Jun 7, 2025 — classified as 7 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 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.

• InjuryJun 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22162459 ↗
• InjuryJun 7, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE, TEXTURED DEVICE, AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22162303 ↗
• InjurySep 5, 2022Gel Leak; Material Rupture; Gel Leak; Material Rupture

  EXPLANTING SURGEON REPORTS "RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE II ON THE LEFT SIDE, SILICON PERSPIRATION ON THE LEFT SIDE, PAIN, INFLAMMATION AND SEROMA-LATE". THE IMPLANTS HAVE BEEN REMOVED.

  Patient problems: Seroma

  MAUDE report 15358800 ↗
• InjurySep 5, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  EXPLANTING SURGEON REPORTS RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT SIDE, INCREASE VOLUME ON THE RIGHT SIDE, PAIN, INFLAMMATION AND SEROMA-LATE. THIS RECORD IS FOR THE RIGHT SIDE. THE IMPLANTS HAVE BEEN REMOVED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 15358799 ↗
• InjuryMar 30, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "CHRONIC PAIN, AND SWELLING." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. PATIENT ALSO REPORTED "COGNITIVE ISSUES, DIZZINESS, INSOMNIA AND OVERWHELMING ANXIETY"; THESE EVENTS ARE NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED THE EVENTS OF ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿, ¿PAIN¿, ¿INFLAMMATION¿, ¿FIBROSIS¿, AND ¿SHORTNESS OF BREATH¿ DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11593516 ↗
• InjuryMar 30, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "CHRONIC PAIN, SWELLING AND SHORTNESS OF BREATH." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. PATIENT ALSO REPORTED "COGNITIVE ISSUES, DIZZINESS, INSOMNIA AND OVERWHELMING ANXIETY"; THESE EVENTS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11589843 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTING PHYSICIAN REPORTED LEFT SIDE CAPSULE SEROMA DEVELOPED APPROXIMATELY 3 YEARS AFTER IMPLANTATION. AFTER NEGATIVE TESTING, PATIENT RETURNED FOR EXPLANTATION OF IMPLANT APPROXIMATELY 8 MONTHS LATER. LEFT SIDED SEROMA FLUID SENT FOR CYTOLOGY AND LEFT SIDED CAPSULE SENT FOR HISTOLOGY AT TIME OF SURGERY. HISTOLOGY ALSO NOTED A COLLAPSED OPEN CYST. THE EVENT WILL BE CAPTURED AS ALCL LYMPHOMA AS PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE BEEN RECEIVED.

  Patient problems: Anaplastic Large Cell Lymphoma; Cyst(s); Seroma

  MAUDE report 8019668 ↗

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-