NATRELLE Silicone-Filled Breast Implants 15-158Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628001381), received between Dec 11, 2025 and Mar 18, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Material Rupture

  HEALTHCARE PROFESSIONAL VIA COMPANY REPRESENTATIVE REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627471 ↗
• InjuryDec 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES, BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23786189 ↗
• InjuryDec 11, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES, BAKER GRADE III" AND "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23786145 ↗

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-