NATRELLE Silicone-Filled Breast Implants 10-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628001190), received between Jul 25, 2019 and Sep 17, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Material Rupture

  Healthcare professional reported "possible rupture". This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802845 ↗
• InjuryJun 25, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620976 ↗
• InjuryJan 2, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE RUPTURE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23952516 ↗
• InjuryDec 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IT WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23865377 ↗
• InjuryDec 22, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. THE DEVICE WILL BE RETURNED UPON EXPLANATION.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861913 ↗
• InjuryJun 25, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22333801 ↗
• InjuryJul 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8829402 ↗
• InjuryJul 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8826590 ↗

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-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-
• 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