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NATRELLE Saline-Filled Breast Implants 68LP-600Recalls & reported problems

Allergan, Inc. · NATRELLE Style 68LP-600 Low Projection |smooth|round|saline · Class 3 · Implant

All models of Natrelle Breast Implants (1167) · NATRELLE Saline-Filled Breast Implants (103)

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

Adverse event reports
5
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628000674), received between Sep 20, 2018 and Aug 8, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

5 other recalls cover devices cleared under the same FDA submission (P990074); 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

  • Fluid/Blood Leak5

Patient problems

  • Failure of Implant4
  • No Patient Involvement1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

    DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Patient problems: Failure of Implant

    MAUDE report 17481819 ↗
  • InjuryNov 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

    HEALTH CARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 12872270 ↗
  • InjuryOct 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

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

    Patient problems: Failure of Implant

    MAUDE report 10764558 ↗
  • InjurySep 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

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

    Patient problems: Failure of Implant

    MAUDE report 10481514 ↗
  • MalfunctionSep 20, 2018Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED "THAT DURING IMPLANT SURGERY, WHERE THE VALVE IS, THE VALVE COVER HAS A LITTLE PUNCH OUT IN THE TOP OF IT, AND THAT SILICONE PUNCH OUT CAME OUT AND GOT STUCK TO THE SIDE OF THE IMPLANT, AND IS NOW PART OF IT, IT IS STICKING OUT, IT LOOKS LIKE A LITTLE BUTTON [ON THE IMPLANT]." PATIENT CONTACT WITH THE DEVICE DID NOT OCCUR. THE SURGERY WAS COMPLETED WITH A BACK UP DEVICE.

    Patient problems: No Patient Involvement

    MAUDE report 7895364 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990074. One submission often covers many models, so check the product and lot details in each record.

  • Z-0699-2020 · Nov 6, 2019 · Terminated
    Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 108886280
  • Z-2451-2019 · Jul 24, 2019 · Open, Classified
    Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-7
  • Z-0337-06 · Dec 14, 2005 · Terminated
    McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
  • Z-0336-06 · Dec 14, 2005 · Terminated
    McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
  • Z-0851-05 · May 5, 2005 · Terminated
    Style 363 Saline-Filled BIOCELL textured Breast Implants

Other Prosthesis, Breast, Inflatable, Internal, Saline devices

All Prosthesis, Breast, Inflatable, Internal, Saline devices →

Sources and updates

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