📊 Evidence-Based Reference
Cpx 4 Breast Tissue Expander with Smooth Surface
Mentor Worldwide
Summary: The CPX 4 breast tissue expander by Mentor Worldwide is used for breast reconstruction. It is FDA 510k cleared. Key evidence includes studies on expansion limits in obese patients and surface roughness effects on fibrosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K182335 ↗
Decision Date ?
September 25, 2018
Product Code ?
LCJ
Device Class ?
—
Evidence ?
0 studies
The CPX 4 breast tissue expander was cleared via the FDA 510k pathway on September 25, 2018. It is manufactured by Mentor Worldwide and does not have a specific regulatory classification.
What It Is
The CPX 4 breast tissue expander is a medical device designed for temporary implantation to aid in breast reconstruction. It features a smooth surface and is used to gradually expand breast tissue to accommodate a permanent implant.
FDA-Cleared Indications
- Temporary implantation for breast reconstruction after mastectomy or other breast surgery.
- Gradual expansion of breast tissue before placement of a permanent breast implant.
Clinical Applications
- Two-stage breast reconstruction after mastectomy.
- Expansion of breast skin and soft tissue before exchange for a permanent breast implant.
- Staged reconstruction when the available breast skin envelope is not large enough for immediate implant placement.
Evidence Summary
The available literature includes two studies: one published in 2019 and another with unspecified publication year. These studies explore the limits of tissue expansion in obese patients and the impact of implant surface roughness on early-stage fibrosis.
Reported Outcomes
Published studies report that the CPX 4 expander is effective in achieving desired tissue expansion in patients with a history of breast radiation. The research highlights the importance of considering flap thickness in obese patients to avoid complications during expansion.
Safety Profile
Reported complications include challenges in port localization due to flap thickness, which can lead to inadvertent puncture during expansion. No other specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcomes and safety data. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The expander is available in different shapes, dimensions and fill volumes; selection depends on the patient's chest anatomy, skin envelope and reconstructive plan.
- It is a temporary device and is generally removed or exchanged for a permanent implant after adequate tissue expansion.
- Expansion is performed gradually through an integrated fill port by the reconstructive surgeon or care team.
- Patients with active infection, inadequate soft-tissue coverage or conditions that impair wound healing may not be candidates; the treating surgeon evaluates these risks.
- MRI safety and scan conditions should be confirmed using the current manufacturer labeling and implant documentation before an MRI examination.
Frequently Asked Questions
What are the clinical indications for CPX 4 breast tissue expander?
The CPX 4 is indicated for use in breast reconstruction, particularly in patients post-mastectomy and those who have undergone radiation therapy.
What outcomes have been reported in clinical studies?
Studies report effective tissue expansion and highlight the importance of managing flap thickness in obese patients to prevent complications.
What complications have been reported?
Safety data indicate potential complications with port localization and inadvertent puncture during expansion, especially in patients with thick flaps.
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.