Natrelle INSPIRA Breast Implants TRF-695Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628008403), received between Nov 15, 2019 and Dec 1, 2022 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "SUSPECTED/ACTUAL RUPTURE/DEFLATION" OF A SILICONE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15895218 ↗
• InjuryAug 8, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV, PAIN, SEROMA, THE PATIENT¿S CONCERN WITH THE PRODUCT," AND "RUPTURES.¿ HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED ¿BRAIN CANCER¿ NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 15182391 ↗
• InjuryJun 14, 2022Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "RUPTURE, PAIN AND ENCAPSULATED." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14689970 ↗
• InjuryJun 13, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE, PAIN AND ENCAPSULATED. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14681669 ↗
• InjuryApr 5, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE RUPTURED". DEVICE REMAINS IMPLANTED. RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 14017416 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCESSIVE FLUID BUILD-UP AND EXCHANGE OF A TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 11454600 ↗
• InjuryJul 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10225265 ↗
• InjuryApr 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "CONSTANT THROBBING PAIN" AND THE IMPLANT IS "PHYSICALLY DROPPING". HEALTH PROFESSIONAL ADDITIONALLY REPORTED IMPLANT EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT, AND ¿BILATERAL FLUID SURROUNDING MORE ON THE LEFT SIDE¿ DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 9999569 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO PATIENT¿S CONCERN WITH THE PRODUCT AS WELL AS "CONSTANT THROBBING PAIN." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED ¿BILATERAL FLUID SURROUNDING MORE ON THE LEFT SIDE AND PAIN.¿ DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 9975990 ↗
• InjuryMar 17, 2020Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE AND "CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9841954 ↗
• InjuryFeb 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO CONCERN WITH THE PRODUCT AND A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9687717 ↗
• InjuryNov 18, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9335458 ↗
• InjuryNov 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9330451 ↗

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-