3D-printed Biodegradable Breast Implants for Breast Restoration

The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is: Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction? Participants will: Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.

Sex

Female

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

* Female patients with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.
* Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material breast implants.
* Having indications for subcutaneous glandectomy that preserves the nipples and areolas.
* ECOG performance status score: 0-1.
* If receiving neoadjuvant chemotherapy, the interval between chemotherapy completion and surgery is less than 8 weeks.
* Good compliance with the planned treatment, ability to understand the study procedures, and willingness to sign the written informed consent form.

Exclusion Criteria:

* Age \> 70 years.
* Newly diagnosed stage IV metastatic breast cancer.
* Multicentric, extensive, or diffuse lesions; or inflammatory breast cancer.
* Tumor invasion of the papillary areola complex.
* Inability to accept/tolerate radiotherapy.
* Breast cancer during pregnancy.
* History of other malignant tumors within the past five years (except cured cervical carcinoma in situ and non-melanoma skin cancer).
* Abnormal functions of vital organs (heart, lungs, liver, kidneys), poorly controlled diabetes, or other conditions that preclude surgery tolerance.
* Patients deemed unsuitable for participation by the researchers.

• BACKGROUNDMu X, Zhang J, Jiang Y. 3D Printing in Breast Reconstruction: From Bench to Bed. Front Surg. 2021 May 20;8:641370. doi: 10.3389/fsurg.2021.641370. eCollection 2021. PMID 34095200