Natrelle Inspira Cohesive Breast Implants TCM-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628030879), received between Mar 31, 2020 and Jul 6, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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.

• InjuryJul 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED PATIENT WAS EXPERIENCING SWELLING, DEFORMITY, PAIN, HARDENING, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND "BOTH IMPLANTS WERE TEXTURED FROM INFORMATION AND BELIEF, WHICH FROM INFORMATION AND BELIEF WERE ALSO RECALLED IN THE LATER RECALL BY THE FDA." FURTHER REPORTED WERE LUMPS, FEVER, AND BODY ACHES WHICH HAVE BEEN DEEMED NOT RELATED TO THE DEVICE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 14931390 ↗
• InjuryJun 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED PATIENT EXPERIENCED "GRADE III CAPSULAR CONTRACTURE" AND "INCREASED RISK." PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "PERSONAL INJURIES" AND "BREAST IMPLANT ILLNESS"; THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 14603788 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "WAS ENCAPSULATED." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT SIDE "MACROMASTIA, BILATERAL BREAST DOUBLE CAPSULES WITH LEFT BREAST SEROMA 75 CC. INFLAMMATORY NODULES TO BILATERAL CAPSULES NOTED". DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 13831040 ↗
• InjuryApr 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT EXPERIENCED THE EVENTS OF ¿PAIN¿, AND ¿THERE WAS MORE FLUID ON THE LEFT SIDE THAN THE RIGHT SIDE¿. HCP ALSO REPORTED CAPSULAR CONTRACTURE, BAKER GRADE, UNKNOWN, AND ASYMMETRY. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9931621 ↗
• InjuryMar 31, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED "THERE WAS FLUID AND CAPSULE WAS IRRITATED AND INFLAMED ON THE LEFT BREAST. ON THE PATIENT'S LEFT BREAST, THERE WAS A BLISTER ON THE INNER POLE AND IT WAS INFLAMED AND RED." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED IMPLANT EXCHANGE FROM TEXTURE TO SMOOTH AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Inflammation; Irritation

  MAUDE report 9905556 ↗

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-