Natrelle INSPIRA Breast Implants TRX-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10888628008632), received between Oct 28, 2019 and Aug 26, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22901016 ↗
• InjuryMar 17, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "ITCHING, BREAST PAIN, BREAST CANCER AND RUPTURE". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Breast Cancer

  MAUDE report 21627505 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A RIGHT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED "RASHES FATIGUE (NOT DEVICE RELATED), LUMPS, NODULES, TINGLING PAIN, BLURRY VISION (NOT RELATED TO THE DEVICE), FLUID ON BREASTS, AND HAIR LOSS (NOT RELATED TO THE DEVICE)." DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 17763544 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE VOLUNTARY RECALL. PATIENT REPRESENTATIVE REPORTED "THE PLAINTIFF UNDERWENT PAINFUL REMOVAL PROCEDURES AS WELL AS TREATMENT, THERAPY, RECOVERY, AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS DUE TO FEAR OF ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL INCLUDING: MENTAL ANGUISH, INCREASED RISK OF ALCL, EVALUATION FOR ALCL, EXPLANT, RECONSTRUCTION, SEROMAS, PHYSICAL PAIN, SCARRING AND DISFIGUREMENT. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE, PTSD, AND DEPRESSION; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Seroma

  MAUDE report 16726073 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE VOLUNTARY RECALL. PATIENT REPRESENTATIVE REPORTED "THE PLAINTIFF UNDERWENT PAINFUL REMOVAL PROCEDURES AS WELL AS TREATMENT, THERAPY, RECOVERY, AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS DUE TO FEAR OF ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL INCLUDING: MENTAL ANGUISH, INCREASED RISK OF ALCL, EVALUATION FOR ALCL, EXPLANT, RECONSTRUCTION, SEROMAS, PHYSICAL PAIN, SCARRING AND DISFIGUREMENT. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE, PTSD, AND DEPRESSION; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. " DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Seroma

  MAUDE report 16725829 ↗
• InjuryFeb 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16390266 ↗
• InjuryDec 20, 2022Material Rupture; Material Rupture

  HEALTHCARE REPORTED "RUPTURE/DEFLATION" FOR A SILICONE DEVICE VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16018204 ↗
• InjuryDec 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE, BAKER GRADE-4, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16018158 ↗
• InjuryNov 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN AND "RECALL". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15749300 ↗
• InjuryNov 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN AND "RECALL". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15749296 ↗
• InjuryNov 7, 2022Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE, EXCHANGE FROM TEXTURED DUE TO CONCERN WITH PRODUCT, AND "ACHY". PATIENT ALSO REPORTED THE NON DEVICE RELATED EVENTS OF "HAND TINGLING", "SINUS PROBLEMS, HAIR LOSS", AND "ALLERGIES". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15744313 ↗
• InjuryAug 29, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15312462 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED PATIENT UNDERWENT ¿REMOVAL OF IMPLANTS DUE TO FEAR OF ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL INCLUDING: MENTAL ANGUISH AND FEAR OF ALCL, INCREASED RISK OF ALCL, EVALUATION FOR ALCL,¿ ¿SUFFERS FROM SERIOUS EMOTIONAL DISTRESS INCLUDING ANGUISH, FRIGHT, HORROR, NERVOUSNESS, GRIEF, ANXIETY, AND WORRY OF BIA-ALCL,¿ "POST-OPERATIVE COMPLICATIONS INCLUDING INFECTION", ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO ANXIETY,¿ ¿TISSUE DAMAGE,¿ ¿PAIN,¿ ¿SWELLING¿ AND ¿RASHES.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ ¿OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING¿ ¿DISFIGUREMENT,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO GERD¿ ¿CHRONIC INSOMNIA,¿ ¿PANIC DISORDER,¿ ¿WEIGHT LOSS AND GAIN, IRRITABLE BOWEL, CHRONIC GI UPSET/REFLUX, DIARRHEA ON AN ONGOING BASIS,¿ ¿POST-OPERATIVE COMPLICATIONS INCLUDING INFECTION,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO DEPRESSION,¿ ¿VOMITING ON AN ONGOING BASIS¿ AND ¿NAUSEA ON AN ONGOING BASIS;¿ THESE EVENTS ARE NOT RELATED TO THE DE

  Patient problems: Unspecified Infection

  MAUDE report 14597469 ↗
• InjuryMar 4, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED PATIENT UNDERWENT ¿REMOVAL OF IMPLANTS DUE TO FEAR OF ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL INCLUDING: MENTAL ANGUISH AND FEAR OF ALCL, INCREASED RISK OF ALCL, EVALUATION FOR ALCL,¿ ¿SUFFERS FROM SERIOUS EMOTIONAL DISTRESS INCLUDING ANGUISH, FRIGHT, HORROR, NERVOUSNESS, GRIEF, ANXIETY, AND WORRY OF BIA-ALCL,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO ANXIETY,¿ ¿CONTRACTURE,¿ BAKER GRADE UNKNOWN, ¿TISSUE DAMAGE,¿ ¿PAIN,¿ ¿SWELLING¿ AND ¿RASHES.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ ¿OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING¿ ¿DISFIGUREMENT,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO GERD¿ ¿CHRONIC INSOMNIA,¿ ¿PANIC DISORDER,¿ ¿WEIGHT LOSS AND GAIN, IRRITABLE BOWEL, CHRONIC GI UPSET/REFLUX, DIARRHEA ON AN ONGOING BASIS,¿ ¿POST-OPERATIVE COMPLICATIONS INCLUDING INFECTION,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO DEPRESSION,¿ ¿VOMITING ON AN ONGOING BASIS¿ AND ¿NAUSEA ON AN ONGOING BASIS;¿ THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE WAS

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 11418046 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "LARGE POCKET OF FLUID BUILD UP", "SOME SWELLING AROUND THE NIPPLE", "A LARGE AMOUNT OF PUSS COMING OUT OF THE LINING OF HER PREVIOUS SCAR DUE TO A MASTOPEXY" AND EXCHANGE DUE TO CONCERN WITH TEXTURED PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Abscess; Seroma

  MAUDE report 10103448 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "LARGE POCKET OF FLUID BUILD UP" AND EXCHANGE DUE TO CONCERN WITH TEXTURED PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 10102032 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ADDITIONALLY REPORTED RASHES, FATIGUE, NODULES, TINGLING PAIN, BLURRY VISION, AND HAIR LOSS. HEALTHCARE PROFESSIONAL LATER REPORTED EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. THE EVENTS OF FATIGUE, BLURRY VISION, AND HAIR LOSS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 10020611 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "INFECTION". THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9606704 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE "LARGE SEROMA AND INFECTION." THE IMPLANT WAS REMOVED BUT RUPTURED DURING THE PROCESS; THIS IS NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 9520894 ↗
• InjuryOct 28, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 9246898 ↗

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-