There is currently no consensus on the "gold standard" for Implant-based Breast
reconstruction. In the United States, more than half of all breast reconstructions are
performed using acellular dermal matrix (ADM). However, based on the findings of
literature and systematic reviews, it can be cautiously said that synthetic meshes cause
fewer complications with comparable aesthetic results and low cost. In our study, we
propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction.
This material has previously proven itself in cardiovascular, maxillofacial and
neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has
demonstrated comparable results in breast reconstruction with the literature, will be
used as a comparison. The purpose of this study is to evaluate the efficacy and safety of
a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based
breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater
technique will be used as a control.
Patients eligible for this study are classified according to the National Comprehensive
Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer.
The primary questions this study aims to answer are:
What are the rates of major and minor complications associated with these
techniques. Major complications will be defined as complications leading to
reoperation.
How effective are PTFE mesh and dura in maintaining the inframammary fold and
implant projection after breast reconstruction?
What is the patient satisfaction rate with the surgical results?
Patients will be randomly assigned to the study but will know which technique will be
used in their particular case. Patients included in this study will undergo subcutaneous
mastectomy or skin-sparing mastectomy using standard techniques with simultaneous
implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and
graft will stabilize the projections of the inframammary fold and breast implant.
After the surgery, all minor and major complications will be recorded for 6 months. For
this, both physical examination and radiological diagnostic methods will be used,
including breast ultrasound and MRI with contrast. Revision surgeries will be performed
if necessary.
Projections of the inframammary fold and breast implant will also be measured in order to
determine the effectiveness of the compared techniques.
Patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module
questionnaire to determine satisfaction with the surgical outcome.
The results of the study will help the professional community to determine the most
effective method of Implant-based Breast reconstruction and will be published in
peer-reviewed scientific journals.