The patient has a history of breast cancer resulting in a double mastectomy.Patient is undergoing breast reconstruction and has tissue expanders in place as part of her post mastectomy breast reconstruction.Patient was diagnosed with lymphedema in her right arm and trunk in the past 6 months and was prescribed the device as part of her lymphedema treatment.Patient received the device on (b)(6) 2016 and was trained on (b)(6) 2016.The training was uneventful.Patient had one treatment with the device post training and within 24 hours she noticed increased swelling and erythema in her non affected left breast area.She reported no pain or warmth in the breast tissue.Patient reported that her physician did not believe she had an infection but prescribed antibiotics as a precaution.Patient left for a business trip.Upon her return 2 weeks later, her swelling and erythema remained.She was seen by her surgeon who conducted a ct scan and it was determined that the tissue expander had partially deflated and fluid had leaked into the left breast area.There was no infection.Patient states that the surgeon indicated that her prior radiation may have weakened the surrounding breast tissue.The expander was left in place and patient was monitored for the duration of her phase one reconstruction with no other reported complications.She is scheduled to undergo reconstructive surgery as planned in early (b)(6).
|