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NATRELLE Silicone-Filled Breast Implants 10-800Recalls & reported problems

Allergan, Inc. · NATRELLE Style 10-800 Moderate profile |smooth|round|silicone · Class 3 · Implant

All models of Natrelle Breast Implants (1167) · NATRELLE Silicone-Filled Breast Implants (128)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628001374), received between Oct 15, 2019 and Jul 19, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

4 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.

Most reported problems

Device problems

  • Material Rupture2
  • Device Appears to Trigger Rejection1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • Failure of Implant2
  • Capsular Contracture1
  • No Patient Involvement1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.

    Patient problems: Capsular Contracture

    MAUDE report 17354909 ↗
  • InjuryJul 18, 2023Material Rupture; Material Rupture

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 17346931 ↗
  • MalfunctionOct 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    HEALTHCARE PROFESSIONAL REPORTED "DAMAGED DURING PROCEDURE." SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

    Patient problems: No Patient Involvement

    MAUDE report 10725809 ↗
  • InjuryOct 15, 2019Material Rupture; Material Rupture

    PATIENT REPORTED RIGHT SIDE "RUPTURE." DEVICE REMAINS IMPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 9192983 ↗

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-2453-2019 · Jul 24, 2019 · Open, Classified
    Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR
  • 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-

Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices

All Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page