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Robert C Wright, MD, PS – Puyallup, Washington Informed Consent – Sentinel Lymph Node Biopsy for Breast Cancer (right / left / both sides) You have been diagnosed as having breast cancer, which usually demands surgical treatment. Part of the treatment demands knowing if tumor has spread to the lymph nodes. The sentinel lymph node biopsy is a new technique, which allows the doctor to identify the lymph nodes in your arm pit, which would be immediately in the path of spreading cancer (the sentinel lymph nodes). If the sentinel lymph nodes do not contain cancer, an axillary dissection, with its possible complications, may be avoided It is possible, that following the operation the pathologist may find deposits of cancer in the sentinel lymph node. If the deposit of cancer is present, a return trip to the operating room will be necessary to complete the axillary dissection. Should this be the case, your surgeon will discuss with you the risks and benefits of further surgery, to allow you to decide the best options for you. Description of the Procedure Several hours before your surgery is scheduled, the area around the tumor is injected with a special radioactive material—this will, drain into the lymphatic system and collect in the lymph nodes. Just before surgery, the surgeon will also inject a special blue dye around the area of the tumor to further assist him in finding the sentinel lymph nodes. During surgery, a “Geiger-counter” type machine is used to identify these sentinel lymph nodes, and these nodes are removed for close inspection. If there is a suggestion of tumor in the lymph node(s), or if we are unable to find any appropriate sentinel lymph node, we will then do a formal axillary dissection, cleaning out the rest of the lymph nodes in the arm pit. Concomitant with the sentinel node biopsy, you may also be having a mastectomy or lumpectomy for the treatment of your breast cancer. These procedures, as well as the possible axillary dissection, are explained elsewhere. Risks/Complications of Treatment Treatment risks fall into two categories; those that could happen during any operation under anesthesia, and those that are specific for a sentinel lymph node biopsy. In any sort of medical treatment, it is impossible to predict all the things that could go wrong. Fortunately, complications are the exception rather than the rule. Every reasonable effort is made to avoid complications. The most common possible complications are as follows: Possible complications of major surgery 1. Bleeding – this is a problem that could happen any time the skin is cut. The need for a blood transfusion is rare. 2. Infection – we take special care to prevent an infection, but it is always a possibility. An infection can delay further treatment and prolong healing. 3. Reactions to medications – this could be many things, from a minor rash, to possible death. 4. Reactions to anesthesia and surgery – this could show up as a heart attack, blood clots, pneumonia, sore throat, or, in rare cases, death. 5. Poor wound healing – breakdown of the incision. Possible complications of sentinel node biopsy 1. Inability to identify the sentinel lymph nodes(s) – a complete axillary dissection is then done. 2. Paralysis/atrophy of some of the shoulder muscles. 3. Numbness on the inside of the arm. 4. Swelling (lymphedema) in the arm on the side of the operation. (see other side) 5. Seroma formation – This is a collection of fluid beneath the wound. 6. Recurrence of the cancer – this could occur either within the area of the breast operation or somewhere else in the body. Cure cannot be guaranteed. Anticipated Recovery/Expected Rehabilitation Recovery is quite variable, depending on the individual. You should start moving your arm within days following the surgery. With diligence, you should gain complete motion in your arm within a few months. Most people are able to go home the day of surgery or the next day. The amount of time it takes before you will be able to return to work will partly depend on the type of work you do, and the speed at which you heal. Most people with light job duties can return within two weeks; if you do heavy lifting, you might want to wait up to one month before returning to work. Most people do not require special rehabilitation in order to get function back in their arm. Further treatment of the breast cancer may be required, including chemotherapy and possibly radiation therapy. The final pathology report after surgery will influence this decision. Consent for Treatment I understand my condition to be a breast cancer and am aware of its risks if untreated. I have read and understand the above explanation of the procedure being proposed. My surgeon has answered my questions, and I choose to proceed with surgery. I understand that every operation may yield unexpected finding. I give the surgeon permission to act on his best judgment in deciding to remove or biopsy tissues that appear to be diseased, understanding that complications may arise from that action. I understand that while most people with breast cancer benefit from this operation, I may not. My condition may not improve, and it may worsen. No absolute guarantee can be made. HIPAA: Before and after surgery, unless otherwise requested in writing by you, visitors whom you invite to attend the surgery will be informed of the surgical finding, your surgical status, and anticipated recovery issues for effectiveness of communications. Because of the anesthetic, you may or may not remember these important details. PRINT NAME OF PATIENT __________________________________________________________________ SIGNATURE __________________________________________________________ DATE _________________ WITNESS ____________________________________________________________ DATE _________________ SURGEON ____________________________________________________________ DATE _________________ RELATIONSHIP TO PATIENT IF SIGNATURE OF LEGAL GUARDIAN ___________________________________ I waive the right to read this form, and do not want to be educated and informed of treatment risks; nonetheless, I understand the need for this surgery and grant permission to the surgeon to proceed on my behalf. SIGNATURE _____________________________________________________ DATE _________________ 06/03ljb