A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy

Inclusion criteria

• 18 years of age or older
• Scheduled for bilateral mastectomy with two-stage (tissue expander) reconstruction at UCM
• Bilateral mastectomy for unilateral in situ or T1to T2, clinically, N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk. (Note - 19-34% of women choosing mastectomy for small unilateral breast cancer elect bilateral mastectomy.)40 We will enroll from this cohort.
• Agrees to have breast tissue expander removed within 12-20 weeks of implantation.
• Has access to a cell phone and willing to provide the research interviewer with the cell phone number
• Agrees to receive text messages from the study
• Able to speak and understand English or Spanish
• Able to participate in the informed consent process

Exclusion criteria

• Requires adjuvant chemotherapy
• Single stage mastectomy and reconstruction procedure
• Clinical evidence of bilateral breast cancer
• Clinical evidence of lymph node involvement
• Prior history of mastectomy or other major breast surgery
• Prior history of radiation to the chest area (e.g., mantle radiation for Hodgkin's disease)
• Prior history of injury (e.g., trauma, surgery, burn) that the participant perceives to have had an effect on the sensation of the breast
• Pregnant or intending to become pregnant during the study period
• Pacemaker, defibrillator or other implanted electrical stimulation device that may be affected by the implanted electrodes
• Complex regional pain syndrome or other pain syndromes or a history of a neurologic condition like multiple sclerosis, degenerative neurological disease, cognitive impairment or dementia
• Uncontrolled diabetes
• History of poor wound healing or chronic skin ulcerations
• History of uncontrolled infection or active infection at time of consent
• Expectation that MRI will be required while the devices are implanted
• Inability or unwillingness to follow verbal instructions and comply with study procedures
• Untreated or poorly managed physical or mental health condition that may pose additional risk according to clinical judgment of the patient's breast surgeon or surgeons
• Unwillingness to undergo psychological evaluation to determine study eligibility, if requested or required by surgeons or investigators