Natrelle Inspira Cohesive Breast Implants TCM-445Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628030930), received between May 14, 2019 and Dec 14, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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.

• InjuryDec 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED A LEFT EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT WITH "ANXIETY, CHANGES IN HOW THEY FEEL AND HOW THEY LOOK, LEFT IS LARGER THAN THE OTHER, HAD A COUPLE OF SPOTS LOOKS LIKE PRECANCEROUS SPOTS ON MY CHEST ABOVE MY BREAST. I HAD THEM BURNED OFF 6 MONTHS AGO AND GETTING MORE BURNED OFF IN JUNE, PAIN UNDERNEATH THEM IN THE TISSUE AROUND THEM, MAINLY THE LEFT, SCARED BECAUSE I ALREADY HAD CANCER ONCE AND DON'T WANT TO GET IT AGAIN". THE EVENT OF ¿HAD A COUPLE OF SPOTS LOOKS LIKE PRECANCEROUS SPOTS ON MY CHEST ABOVE MY BREAST¿ IS NOT DEVICE RELATED. PATIENT ALSO REPORTED BILATERAL RASHES, REDNESS, EXTREME SWELLING, PAIN, AND IS VERY STRESSED ABOUT THE TEXTURED IMPLANTS SHE HAS. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18324250 ↗
• InjuryFeb 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED "¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN, "WASN'T HEALING RIGHT," AND ¿ANXIETY BECAUSE OF THE IMPLANTS." PATIENT ADDITIONALLY REPORTED "RAYNAUD'S SYNDROME;" THIS EVENT IS NOT DEVICE RELATED. THE DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 9688661 ↗
• InjuryJan 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE "WASN'T HEALING RIGHT", "HARDENING" AND "CAPSULAR CONTRACTURE", BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Impaired Healing

  MAUDE report 9582080 ↗
• InjuryDec 26, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN, ¿ANXIETY BECAUSE OF THE IMPLANTS." PATIENT ADDITIONALLY REPORTED "RAYNAUD'S SYNDROME " WHICH IS CONSIDERED NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9519942 ↗
• InjuryMay 14, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND "DEVICE HAS NOT "DROPPED." DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8609531 ↗

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-