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artoura breast tissue expanders with smooth surface
Mentor Worldwide
Summary: The Artoura Breast Tissue Expanders are used in breast reconstruction to create a breast pocket. They are typically used by plastic surgeons in reconstructive procedures.
FDA Clearance Information
Pathway
510K
Number
K161176 ↗
Decision Date
May 23, 2016
Product Code
LCJ
Device Class
—
Evidence
0 studies
The Artoura Breast Tissue Expanders by Mentor Worldwide were cleared through the FDA 510k pathway on May 23, 2016. The device does not have a specific class but falls under product code LCJ.
What It Is
The Artoura Breast Tissue Expanders are medical devices used in breast reconstruction surgeries. They work by gradually stretching the skin and tissue to create space for a breast implant. This process involves periodic saline injections to incrementally increase the expander's volume, allowing the skin to stretch naturally over time.
Clinical Applications
These expanders are commonly used in post-mastectomy breast reconstruction. Plastic surgeons employ them to prepare the chest wall for permanent breast implants. The device is typically used in hospital settings or specialized surgical centers, primarily for patients who have undergone mastectomy due to breast cancer.
Indications for Use
The Artoura Breast Tissue Expanders are indicated for patients undergoing breast reconstruction following mastectomy. They are designed to help form a natural breast pocket by stretching the skin and tissue gradually.
Practical Considerations
The expanders come in various sizes to accommodate different patient anatomies. They are compatible with standard saline solutions used for expansion. Surgeons should consider the patient's skin elasticity and overall health when planning the expansion process.
Related Literature
The study titled 'The Best Under Stress' analyzed how breast tissue expanders respond to external forces during reconstruction. It highlighted the challenges of undesired changes to the chest wall and lateral plane. The study found that while expanders are effective in creating breast pockets, they may cause changes in the surrounding anatomy. Limitations include a focus on mechanical response without long-term patient outcomes.
Frequently Asked Questions
What is Artoura Breast Tissue Expanders used for?
They are used in breast reconstruction to create a space for a breast implant after mastectomy.
What specialties typically use this device?
Plastic and reconstructive surgeons primarily use this device.
What are the FDA-cleared indications?
The device is indicated for breast reconstruction following mastectomy to help form a natural breast pocket.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.