Natrelle INSPIRA TRF-770Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628008427), received between Jun 19, 2019 and Jul 28, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED FOR RIGHT SIDE "INFLAMED LYMPH NODES IN THE RIGHT ARMPIT". ALSO REPORTED "ELECTRICUTION PULSES OUT OF EYEBALLS, SHARP PAIN UP AND DOWN BONES, AND NIPPLE DISCHARGE AND MIGRAINES" WHICH IS NOT RELATED TO THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 22637589 ↗
• InjuryJun 21, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 17173573 ↗
• InjuryMar 22, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "DROPPING CLOSE TO MY RIB." HEALTHCARE PROVIDER ADDITIONALLY REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED

  Patient problems: Failure of Implant

  MAUDE report 11542446 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "CONCERN WITH THE PRODUCT" AND "BODY REJECTED IMPLANT." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10732796 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "HAD TEXTURED BIOCELL IMPLANTS REMOVED ABOUT 3 YEARS AGO", "HAD TWO SETS WITHIN 6 MONTHS OF EACH OTHER BUT STATED [THEIR] BODY REJECTED BOTH SETS." THIS IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10683773 ↗
• InjuryApr 10, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT LATER REPORTED RIGHT SIDE RUPTURE AND AUTOIMMUNE TYPE SYMPTOMS (NOT DEVICE RELATED) DUE TO THE RUPTURE.

  Patient problems: Capsular Contracture; Cellulitis; Unspecified Infection

  MAUDE report 9949995 ↗
• InjuryApr 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DOCUMENTATION RECEIVED FROM PATIENT REPRESENTATIVE NOTING THAT APPROXIMATELY ONE MONTH POST IMPLANT THE FOLLOWING EVENTS WERE EXPERIENCED: SEROUS CLOUDY DRAINAGE; VIA ULTRASOUND MODERATE EFFUSION SURROUNDING PATIENT¿S SILICONE IMPLANT WAS NOTED; FLUID WAS SEEN SURROUNDING NEARLY THE ENTIRE IMPLANT; US BREAST GUIDANCE NEEDLE PLACEMENT YIELDED 180 ML OF CLOUDY YELLOW FLUID, LEFT BREAST DRAIN HAS CONTINUED... DRAINAGE, CENTRAL BREAST ON BOTH SIDES REVEAL A DERMATITIS WITH FEWER VESICLES, LESS WEEPING, AND A DRYING RASH, LEFT BREAST IS CONSISTENT WITH EARLY POST INFECTION CAPSULAR CONTRACTION AT THIS TIME; LEFT BREAST TIGHTNESS; FIRMNESS, MEDIAL BREAST INDURATION; LEFT BREAST FIRM BUT SOFTENING, AND LEFT LUMP. THE FOLLOWING EVENTS HAVE BEEN DEEMED NOT RELATED TO THE DEVICE: ACUTE BRONCHITIS/WHEEZING (COUGH, FEVER, CHEST CONGESTION, FATIGUE), INSOMNIA, DECREASED EXERCISE TOLERANCE, ASTHMA, WEIGHT GAIN, FATIGUE, AND ANXIETY. AFFECTED SIDE IS LEFT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 9949965 ↗
• InjuryApr 10, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DOCUMENTATION RECEIVED FROM PATIENT REPRESENTATIVE NOTES THAT THE PATIENT CONTACTED THE PRIMARY CARE PHYSICIAN APPROXIMATELY TWO MONTHS POST IMPLANT CONCERNED ABOUT INDICATIONS OF AN INFECTION. THE PRIMARY CARE PHYSICIAN SUGGESTED THAT THE PATIENT GO TO THE ER WHERE THEY WERE ADMITTED. THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY FIVE DAYS DURING WHICH TIME THE DEVICE WAS EXPLANTED AND REPLACED. THE EVENTS REPORTED TO OCCUR ARE AS FOLLOWS: RUPTURED IMPLANT, OUTWARD SIGNS OF INFECTION, FEVER, CHILLS, PRESENTED WITH FEVER, CHILLS -- SEPSIS WAS SUSPECTED, CHEST PAIN, SWELLING TO LEFT BREAST, INFECTED WOUND, LEFT BREAST RED, EDEMATOUS APPEARANCE, ERYTHEMA/REDNESS, MEDIAL EDEMA, VIA ULTRASOUND -- EDEMA WITHIN THE INFERIOR ASPECT OF THE LEFT BREAST SUGGESTS UNDERLYING MASTITIS, LEFT BREAST INFECTED, PAIN, CELLULITIS AND SKIN INFECTION, PAIN AND REDNESS, FEVER, CHILLS, CELLULITIS OF BREAST, LEFT BREAST EDEMA/CELLULITIS WITH A SMALL WOUND POSITIVE FOR (B)(6), VIA ULTRASOUND -- PERI-IMPLANT FLUID COLLECTION MEASURING AT LEAST 4 CM IN SIZE AND POSSIBLY LARGER. LEFT BREAST LARGE SEROMA; LEFT BREAST INFECTED SEROMA, 150 ML OF CLOUDY SEROUS

  Patient problems: Cellulitis; Seroma; Unspecified Infection

  MAUDE report 9949910 ↗
• InjuryDec 19, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 9498426 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL).

  Patient problems: Anaplastic Large Cell Lymphoma; Lymphoma; Seroma

  MAUDE report 8714004 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE BEEN PROVIDED.

  Patient problems: Anaplastic Large Cell Lymphoma; Lymphoma; Seroma

  MAUDE report 8713914 ↗

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-