Natrelle INSPIRA Breast Implants TRX-420Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628008519), received between Jun 4, 2019 and Sep 22, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Material Rupture

  Healthcare professional reported "Capsular contracture" Baker Grade I and "rupture". This record is for the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854602 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50782263 ↗
• InjuryMay 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. PATIENT ALSO REPORTED, ¿PAIN AND ABNORMALITIES IN MY BREASTS¿, ¿INCREASING PAIN¿ AND ¿HARDENING IN MY BREASTS¿, ¿FEELING FATIGUED¿, ¿LIGHT HEADED¿ AND ¿AT TIMES GENERALLY UNWELL¿, ¿FOUND A LUMP IN MY BREAST¿ AND ¿THESE FAULTY IMPLANTS¿, ¿DUE TO THE FACT THERE HAVE BEEN SO MANY ISSUES WITH THESE SPECIFIC IMPLANTS THAT THEY HAVE HAD TO BE RECALLED¿. THE DEVICE HAS BEEN EXPLANTED WITH A COMPLETE CAPSULECTOMY AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 19311989 ↗
• InjuryJul 6, 2022Material Rupture; Material Rupture

  A HEALTHCARE PROFESSIONAL REPORTED RUPTURE OF THE DEVICE. THIS RECORD RELATES TO UNKNOWN SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14933549 ↗
• InjuryDec 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED HAS COMPLICATIONS LIKE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND WANT THE DEVICE EXPLANTED. RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 10992357 ↗
• InjuryDec 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED HAS COMPLICATIONS LIKE CAPSULAR CONTRACTURE AND WANT THE DEVICE EXPLANTED. LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 10987621 ↗
• InjuryOct 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE "JOINT INFLAMMATION IN THE KNEES, SCAR TISSUE, PAIN¿ AND ¿BURNING SENSATION.¿ HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10621113 ↗
• InjuryJun 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE IMPLANTS OUT OF HEALTH CONCERNS REGARDING TEXTURED IMPLANTS." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8668665 ↗

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-