Natrelle INSPIRA Breast Implants TRM-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628008113), received between Jun 14, 2019 and Mar 16, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED A "RUPTURED" AND "CAPSULAR FIBROSIS". LATER THROUGH MEDICAL REPORT HEALTHCARE PROFESSIONAL REPORTED "IMPLANT INVERSION", "DOUBLE CAPSULE FORMATION" AND CONFIRMED "CAPSULAR FIBROSIS III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24608233 ↗
• InjuryJul 7, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE DEVICE. LATER, PATIENT REPORTED RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17282959 ↗
• InjuryFeb 20, 2023Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16403604 ↗
• InjuryJan 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16275036 ↗
• InjuryNov 4, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CHANGE IN SIZE OF IMPLANT," "SUSPECTS LEAKING OR RUPTURE," PATIENT "HAS TEXTURED MAMMARY IMPLANTS" AND "WISHES TO HAVE THE IMPLANTS REMOVED." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15728661 ↗
• InjurySep 6, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT'S CONCERN WITH THE PRODUCT. PATIENT REPORTED RIGHT SIDE RUPTURE AND HEALTHCARE PROFESSIONAL LATER CALLED TO CONFIRM. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15364514 ↗
• InjuryJan 28, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "PATIENT¿S CONCERN WITH THE PRODUCT" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13388830 ↗
• InjuryMar 25, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "JOINTS ACHE ALL OVER HER BODY, SPECIFICALLY HER BACK AND FEET" WHICH WAS NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTS LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, "RECALL ALLERGAN TRM-TEXTURED IMPLANTS" AND ¿CONCERNS ABOUT IMPLANT RELATED ILLNESS." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED ¿SIGNS OF SYSTEMIC INFLAMMATION¿ WHICH WAS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 11570827 ↗
• InjuryFeb 1, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 11259937 ↗
• InjuryNov 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10878238 ↗
• InjuryOct 12, 2020Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "IS ALMOST COMPLETELY EMPTY" AS "LEFT IMPLANT HAS AGAIN RUPTURED, PAINFUL BEFORE SURGERY, DROPPED," AND "UPSET AT THE WAY SHE LOOKS." PATIENT ADDITIONALLY REPORTED HAVING "A LOT OF COLDS;" THIS EVENT IS NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10662468 ↗
• InjuryAug 19, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10425873 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "DOUBLE CAPSULE."

  Patient problems: Seroma

  MAUDE report 9962356 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, "PSEUDOMONAS INFECTION FROM OPEN WOUND UNDER THE RIGHT BREAST", BILATERAL REVISION SURGERY WITH LEFT SIDE IMPLANT RELEASED DUE TO DEVICES "SITTING HIGH LIKE "MAN PECTORALS", LUMPY, BULGING, AND DEFORMED, AS WELL AS 4 SURGERIES WITH DEVICES. PATIENT ALSO REPORTED "IT FEELS AS IF THE IMPLANT IS PUSHING ITS' WAY THROUGH TOWARDS THE STERNUM." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 9772081 ↗
• InjuryJan 16, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV, REMOVAL DUE TO VOLUNTARY MARKET WITHDRAWAL AND RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9597622 ↗
• InjuryDec 18, 2019Material Rupture; Material Rupture

  PATIENT REPORTED A RIGHT SIDE RUPTURE, "PAIN," AND "SWELLING." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9490008 ↗
• InjuryDec 17, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, AND "PATIENT¿S CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9481999 ↗
• InjuryOct 31, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPRESENTATIVE REPORTED "PATIENT WOULD NOT HAVE HAD THE RECALLED BIOCELL PRODUCT IMPLANTED HAD SHE KNOWN PRIOR TO HER SURGERY THAT THE BIOCELL TEXTURED IMPLANTS INCREASED HER RISK OF CONTRACTING BIA-ALCL, IN ADDITION TO THE COSTS ASSOCIATED WITH SURGICAL REMOVAL OF THE IMPLANTS AND MEDICAL MONITORING." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes

  MAUDE report 9261885 ↗
• InjuryOct 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPRESENTATIVE REPORTED "PATIENT WOULD NOT HAVE HAD THE RECALLED BIOCELL PRODUCT IMPLANTED HAD SHE KNOWN PRIOR TO HER SURGERY THAT THE BIOCELL TEXTURED IMPLANTS INCREASED HER RISK OF CONTRACTING BIA-ALCL, IN ADDITION TO THE COSTS ASSOCIATED WITH SURGICAL REMOVAL OF THE IMPLANTS AND MEDICAL MONITORING." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes

  MAUDE report 9255316 ↗
• InjurySep 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED A UNKNOWN SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9068494 ↗
• InjurySep 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED UNKNOWN SIDE "CAPSULAR CONTRACTURE," BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9064973 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "RECURRENT SEROMA". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 8745967 ↗
• InjuryJun 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, "FLUID AROUND THE IMPLANT", "SWELLING", "PAIN", LOOKING "STRANGE AND SHAPED DIFFERENTLY." DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 8714016 ↗
• InjuryJun 14, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8699806 ↗

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-