Natrelle INSPIRA Breast Implants TRF-345Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10888628008304), received between Jun 20, 2019 and Sep 8, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Material Rupture” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Material Rupture

  Patient reported "implant rupture", "cysts", "small avascular cysts", "fibroadenoma", "fibroadenomatosis", "shallow folds", "integrity of the endoprosthesis impaired in the projection of the inner quadrant", "heliomas", "silicogranulomas", "capsule is unevenly thickened", double circuit of the endoprosthesis, "axillary lymph nodes on the sides are increased" and "axillary lymph node hyperplasia". Later healthcare professional reported "pain", "changes in shape", "density" and "implant rupture". Healthcare professional later reported Capsular Contracture Baker grade II. This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667882 ↗
• InjurySep 7, 2026Gel Leak; Malposition of Device

  Patient problems: Fluid Discharge

  MAUDE report 50648802 ↗
• InjurySep 2, 2026Material Rupture

  Patient reported "exchange from textured to smooth" and "ashy dermatosis.". Healthcare professional then reported "Rupture/contour" and "Exchange of textured devices to smooth". Helathcare professional then reported "Breast Density: Extremely dense". This record is for the left side. Device remains implanted.

  Patient problems: Rash

  MAUDE report 50569017 ↗
• InjuryJun 9, 2026Material Rupture

  PATIENT REPORTED THROUGH COMPANY REPRESENTATIVE "RUPTURED", "DEFORMATION AREA", "CHANGES, SAGGING OF THE BREAST", "POSSIBLE VIOLATION OF IMPLANT INTEGRITY" AND "SIGNS OF DIFFUSE FIBROADENOMATOSIS OF THE FIBROUS TYPE". HEALTHCARE PROFESSIONAL LATER REPORTED "CHANGE IN THE SHAPE OF THE BREAST". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445767 ↗
• InjuryAug 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PROVIDER ADDITIONALLY REPORTED TEXTURED EXCHANGE DUE TO THE PATIENT'S CONCERNS WITH THE DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22843590 ↗
• InjuryJun 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. DEVICE HAS BEEN EXPLANTED. PATIENT REPRESENTATIVE REPORTED LEFT SIDE "BREAST PAIN", "PAINFUL REMOVAL PROCEDURES 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.", "DOUBLE ENCAPSULATIONS," "ASYMMETRY, INDENTATIONS TO CHEST", "SEVERE PAIN FROM RIGHT SHOULDER/NECK TO RIGHT HAND, EXCRUCIATING PAIN IN JOINTS", "DEPRESSION", "CHRONIC AND DEBILITATING HEADACHES,", "THICK SCARRING NEAR RIGHT UNDER ARMPIT AND BILATERAL BREASTS, MUSCULAR TWITCHING IN RIGHT BREAST AND SHOULDER, RINGING IN EARS, CHRONIC BLOATING AND STOMACH DISCOMFORT, COGNITIVE DYSFUNCTION AND MEMORY LOSS, STUTTERING, LIMITED PHYSICAL MOBILITY, DIFFICULTY IN DAILY ACTIVITIES SUCH AS SHOWERING, SITTING, AMBULATING, WORKING, AND EXERCISING, AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND ANXIETY, OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE

  Patient problems: Capsular Contracture; Seroma; Unspecified Infection

  MAUDE report 14880913 ↗
• InjuryApr 12, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE DIAGNOSED VIA MRI. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14088562 ↗
• InjuryMar 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III AND TEXTURED IMPLANTS" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13868769 ↗
• InjuryMar 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III AND TEXTURED IMPLANTS" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13866497 ↗
• InjuryDec 16, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND RIGHT CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED A RIGHT SIDE IMPLANT EXCHANGE FROM A TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN REPLACED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 13019418 ↗
• InjuryMar 18, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  LATER HEALTHCARE PROFESSIONAL REPORTED VIA PORTAL "TEXTURED IMPLANTS". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 11516292 ↗
• InjuryFeb 20, 2021Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 11356037 ↗
• InjuryNov 24, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE "RECALL LETTER RECEIVED" ,"KNOT UNDER ARMPIT", "IMPLANT FEELS HARD THAT COMES AND GOES". PATIENT ADDITIONALLY REPORTED CAPSULAR CONTRACTURE AND RUPTURE. PATIENT ADDITIONALLY REPORTED "LOW GRADE TEMP", UNRELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 10896476 ↗
• InjuryNov 24, 2020Gel Leak; Material Rupture; Patient-Device Incompatibility; Gel Leak; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE "RECALL LETTER RECEIVED" ALSO MENTIONED KNOT UNDER ARMPIT, IMPLANT FEELS HARD THAT COMES AND GOES, CAPSULAR CONTRACTURE AND RUPTURE. PATIENT ADDITIONALLY REPORTED "LOW GRADE TEMP", UNRELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 10895994 ↗
• InjuryMar 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND EXCHANGE DUE TO VOLUNTARY RECALL. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9847989 ↗
• InjuryJan 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED " RINGING IN MY EARS, SHORTNESS OF BREATH, AND GENERAL UNWELLNESS WHICH ARE UNRELATED TO THE DEVICE. ADDITIONALLY PATIENT REPORTED "DISCOMFORT, ANXIETY, AND CONTRACTURE", BAKER GRADE NOT SPECIFIED. THE DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 9587724 ↗
• InjuryDec 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED UNKNOWN SIDE "CAPSULAR CONTRACTURE," BAKER GRADE IV. PATIENT ADDITIONALLY REPORTED "FATIGUE, ANXIETY, RINGING IN EARS, VISION DECLINE, DECREASE IN LIBIDO, MEMORY, SLEEP DISTURBANCES, VERTIGO, MOOD CHANGES, TEMPERATURE INTOLERANCES;" THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9510980 ↗
• InjuryNov 20, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 9347652 ↗
• InjuryOct 18, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9206992 ↗
• InjuryJun 21, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "POSSIBLE RUPTURE." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8722105 ↗
• InjuryJun 20, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 8718920 ↗

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-