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Safety of CPX4 Breast Tissue Expanders in Primary Reconstruction Patients
Daniel Maxwell1, Megan M Estes2, Jennifer McMillen Walcott2
1Artisan Plastic Surgery, LLC, Atlanta, Ga.
Plastic and Reconstructive Surgery. Global Open
|March 31, 2021
Summary
This study found that CPX4 Breast Tissue Expanders are safe and effective for two-stage breast reconstruction. Complications like delayed wound healing and infection occurred in 31.7% of patients.
Area of Science:
- Plastic Surgery
- Reconstructive Surgery
- Biomaterials in Medicine
Background:
- Two-stage expander-to-implant breast reconstruction is common in the US.
- Advancements in tissue expansion technology are ongoing.
- Limited data exists on CPX4 Breast Tissue Expanders' real-world outcomes.
Purpose of the Study:
- To evaluate the safety and effectiveness of CPX4 Breast Tissue Expanders in primary breast reconstruction.
- To assess real-world outcomes of the tissue expansion process using CPX4 devices.
Main Methods:
- Retrospective cohort study of 123 patients undergoing two-stage reconstruction.
- Single-site data collection from April 2013 to December 2016.
- Minimum 2-year follow-up with descriptive statistics for safety outcomes.
Main Results:
- 31.7% of patients (23.2% of implants) experienced at least one complication during tissue expansion.
- Most common complications included delayed wound healing (13.8%) and cellulitis/infection (9.7%).
- Average follow-up was 3.73 years.
Conclusions:
- Real-world data support the safety and effectiveness of CPX4 Breast Tissue Expanders.
- The study provides evidence for CPX4 use in two-stage expander-to-implant breast reconstruction.
