NATRELLE Silicone-Filled Breast Implants 45-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628002050), received between Jan 26, 2023 and Jul 2, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25695522 ↗
• InjuryJan 21, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "rupture". Patient later reported "Capsular Contracture Baker grade Unknown". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 24137336 ↗
• InjuryDec 29, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL VIA SALES REPRESENTATIVE REPORTED "GRADE 3 CAPSULE RIGHT SIDE" AND "RUPTURE" VIA MAGNETIC RESONANCE IMAGING. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23905252 ↗
• InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23403777 ↗
• InjuryOct 24, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿ DIAGNOSED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23379201 ↗
• InjuryJun 12, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE LEAKING, DENTS IN THE BREASTS, IMPLANTS ARE DEFORMED AND EXCHANGE DUE TO CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22194481 ↗
• InjuryMay 21, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE LEAKING, DENTS IN THE BREASTS, IMPLANTS ARE DEFORMED, AND EXCHANGE DUE TO CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED

  Patient problems: Failure of Implant

  MAUDE report 22061474 ↗
• InjuryMay 6, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21973689 ↗
• InjuryApr 28, 2023Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE ¿LEAKING¿ OF GEL DEVICE, ¿DENTS IN THE BREASTS¿, ¿IMPLANTS ARE DEFORMED¿, AND ¿EXCHANGE DUE TO CONCERN WITH THE PRODUCT¿. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16830975 ↗
• InjuryApr 28, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE ¿LEAKING¿ OF GEL DEVICE, ¿DENTS IN THE BREASTS¿, ¿IMPLANTS ARE DEFORMED¿, AND ¿EXCHANGE DUE TO CONCERN WITH THE PRODUCT¿. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16830925 ↗
• InjuryJan 26, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16246560 ↗

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-