Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.
Female breast cancer patients aged 18 to 70 years.
Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines.
Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.
ECOG performance status of 0-1.
Age >70 years.
Metastatic breast cancer (Stage IV) at initial diagnosis.
Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.
Tumor involvement of the nipple-areolar complex.