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Natrelle Inspira SoftTouch Breast Implants SSL-460Recalls & reported problems

Allergan, Inc. · Natrelle Inspira SSL 460cc Low profile|smooth|round|silicone · Class 3 · Implant

All models of Natrelle Breast Implants (1167) · Natrelle Inspira SoftTouch Breast Implants (195)

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888628032590), received between Feb 12, 2020 and Feb 14, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility2

Patient problems

  • Capsular Contracture2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

    HEALTHCARE PROFESSIONAL REPORTED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED. THIS IS THE RIGHT SIDE RECORD.

    Patient problems: Capsular Contracture

    MAUDE report 9711380 ↗
  • InjuryFeb 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

    Patient problems: Capsular Contracture

    MAUDE report 9703291 ↗

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-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