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

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