Natrelle INSPIRA Breast Implants TRF-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10888628008366), received between Oct 20, 2017 and May 4, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "exchange from textured to smooth as well as Capsular Contracture Baker Grade III". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25074153 ↗
• InjuryMay 4, 2026Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25073757 ↗
• InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE IMPLANT IS "PAINFUL¿. PATIENT ADDITIONALLY REPORTED CONCERN ABOUT THE PAIN ON LEFT SIDE IMPLANT AND IS A LITTLE ANXIOUS SINCE THE IMPLANTS ARE PART OF THE RECALL. PATIENT LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21358041 ↗
• InjuryDec 4, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "TEXTURED" AGAINST LEFT DEVICE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED VIA IMAGING ¿1.2 CM OVAL ENHANCING MASS¿ WHICH IS NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 15912644 ↗
• InjuryOct 20, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE ¿RECALL/RUPTURED." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15643059 ↗
• InjuryJul 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15108339 ↗
• InjuryJul 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15105751 ↗
• InjuryJun 29, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TEXTURED AND RUPTURE." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14856746 ↗
• InjuryJun 29, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 14856554 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "PATIENT WAS DIAGNOSED WITH ANAPLASTIC LARGE CELL LYMPHOMA(ALCL)." PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. THE LEFT SIDE DEVICE WAS EXPLANTED.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Lymphoma; Seroma

  MAUDE report 13237254 ↗
• InjurySep 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 12510718 ↗
• InjurySep 20, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 12496934 ↗
• InjuryAug 31, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "PAIN, SWELLING, POSSIBLE RUPTURE, AND REMOVAL OF TEXTURED BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". PATIENT ALSO REPORTED BEING "19 YEARS OLD WHEN IMPLANTED" AND THAT IT WAS "FOR COSMETIC REASONS ONLY". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12391374 ↗
• InjuryApr 26, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11729334 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "FLUID," PAIN AND IMPLANT EXCHANGE DUE TO CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 11688690 ↗
• InjuryOct 27, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 10743750 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT'S CONCERN WITH THE PRODUCT." ADDITIONALLY, PATIENT REPORTED "BECAME TOO INFLAMED," "THERE WAS INFLAMMATION," AND "THE IMPLANT MOVED." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Inflammation

  MAUDE report 10436625 ↗
• InjuryApr 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND PAIN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9970135 ↗
• InjuryApr 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND PAIN". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9969426 ↗
• InjuryApr 10, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "DEVELOPED AN INFECTION IN BREASTS SHORTLY AFTER IMPLANTS WERE IMPLANTED" AND "THAT ONE IMPLANT FELL OUT". DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 9950281 ↗
• InjuryApr 10, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED THAT "THEY DEVELOPED AN INFECTION IN BREASTS SHORTLY AFTER IMPLANTS WERE IMPLANTED AND HAD TO HAVE THEM REMOVED." PATIENT ALSO REPORTED "THAT ONE IMPLANT FELL OUT." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 9948477 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED, "3 CAPSULES REMOVED" AND "300CC OF FLUID ASPIRATED FROM THE RIGHT BREAST AND SENT FOR CYTOLOGY." DEVICE HAS BEEN EXPLANTED. THIS IS THE RIGHT SIDE RECORD.

  Patient problems: Seroma

  MAUDE report 9899492 ↗
• InjuryMar 27, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "HARDENING", PAIN, AND "FLUID-FILLED SAC". DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 9889259 ↗
• InjuryFeb 13, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE, PAIN, AND "EXCHANGE DUE TO CONCERNS WITH THE PRODUCT". DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9705366 ↗
• InjuryFeb 7, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTH PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9683356 ↗

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-