NATRELLE Silicone-Filled Breast Implants 40-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628001954), received between Dec 19, 2019 and Jul 10, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25781810 ↗
• InjuryNov 17, 2025Material Rupture; Material Rupture

  SALES REPRESENTATIVE REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL, NO COMPLAINT AGAINST THE DEVICE. LATER THE HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. IT WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23576901 ↗
• InjuryNov 13, 2025Material Rupture; Material Rupture

  SALES REPRESENTATIVE REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL, RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. IT WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23544251 ↗
• InjuryFeb 21, 2025Device Appears to Trigger Rejection; Material Rupture; Migration; Device Appears to Trigger Rejection; Material Rupture; Migration

  HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND RUPTURE. HEALTHCARE PROVIDER PROVIDED MRI AND CLINICAL EXAM WHICH NOTED "NORMAL BREAST PARENCHYMA, BREAST IMPLANT, AND AXILLARY LYMPHADENOPATHY. AXILLARY ULTRASOUND INTERROGATION REVEALED ¿SNOWSTORM¿ IMAGES, WHICH IS A TYPICAL APPEARANCE FOR SILICONE LYMPHADENOPATHY. THE REPORT INDICATED THAT THIS WAS COMPATIBLE WITH THE PATIENT¿S HISTORY OF PRIOR IMPLANT RUPTURE. PATIENT IS ESSENTIALLY ASYMPTOMATIC FROM THE LYMPHADENOPATHY. PATIENT THOUGHT THAT IT WAS RELATED TO A COLD THAT THEY MIGHT HAVE BEEN HAVING (NOT DEVICE RELATED). THERE IS NO COMPLAINT OF DEFINITE PERSISTENT TENDERNESS IN AXILLA. PATIENT DOES COMPLAIN OF TIGHT AND HIGH RIDING IMPLANT. THEY ARE UNCOMFORTABLE AND DEFORMING. PATIENT HAS BAKER GRADE IV CAPSULAR CONTRACTURE WITH TENDERNESS AND DEFORMITY. THERE IS NO DEFINITE LYMPHADENOPATHY. THERE IS NO DISTINCT TENDERNESS IN THE AXILLA. THERE IS NO PARENCHYMAL NODULE. PATIENT CAPSULES DO NOT HAVE NODULES. ULTRASOUND RESULTED WITH EVIDENCE OF SILICONE WITHIN PATIENTS ENLARGED LYMPH NODES INDICATING LIKELY PRIOR IMPLANT RUPTURE. MAMMOGRAM WAS NEGATIVE FOR EVIDENCE OF MALIGNANCY. THE PATIENT¿S LYMPH

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 21438639 ↗
• InjuryFeb 21, 2025Device Appears to Trigger Rejection; Material Rupture; Migration; Device Appears to Trigger Rejection; Material Rupture; Migration

  HEALTHCARE PROVIDER REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND RUPTURE. HEALTHCARE PROVIDER PROVIDED MRI AND CLINICAL EXAM WHICH NOTED "NORMAL BREAST PARENCHYMA, BREAST IMPLANT, AND AXILLARY LYMPHADENOPATHY-RIGHT AXILLARY LYMPHADENOPATHY WAS REPORTED TO HAVE BEEN SEEN ON A RECENT CT SCAN FOR LUNG CANCER SCREENING DUE TO A SIGNIFICANT HISTORY OF SMOKING IN THE PAST. AXILLARY ULTRASOUND INTERROGATION REVEALED "SNOWSTORM" IMAGES, WHICH IS A TYPICAL APPEARANCE FOR SILICONE LYMPHADENOPATHY. THE REPORT INDICATED THAT THIS WAS COMPATIBLE WITH THE PATIENT'S HISTORY OF PRIOR IMPLANT RUPTURE. PATIENT IS ESSENTIALLY ASYMPTOMATIC FROM THE LYMPHADENOPATHY. EVERY NOW AND THEN PATIENT THINKS THEY MIGHT HAVE FELT A LITTLE TENDERNESS IN THE RIGHT AXILLA. PATIENT THOUGHT THAT IT WAS RELATED TO A COLD THAT THEY MIGHT HAVE BEEN HAVING. THERE IS NO COMPLAINT OF DEFINITE PERSISTENT TENDERNESS IN AXILLA. PATIENT DOES COMPLAIN OF TIGHT AND HIGH RIDING IMPLANTS. THEY ARE UNCOMFORTABLE AND DEFORMING. PATIENT HAS BAKER GRADE 4 CAPSULAR CONTRACTURE WITH TENDERNESS AND DEFORMITY. THERE IS NO DEFINITE LYMPHADENOPATHY. THERE IS NO DISTINCT TENDERNESS IN THE AXILLA. THERE IS NO PARENCHYMAL NODU

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 21438167 ↗
• InjuryApr 25, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19188148 ↗
• InjuryJun 16, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED RUPTURE ON UNKNOWN SIDE AND "ENCAPSULATION" BAKER GRADE UNKNOWN ON UNKNOWN SIDE. HEALTHCARE PROFESSIONAL CONFIRMED RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17145393 ↗
• InjuryJun 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17131764 ↗
• InjuryDec 19, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND "ANY CREASES". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9495216 ↗

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