PLACE LABEL HERE
INFORMED CONSENT FOR
WIRE LOCALIZATION
(This form is designed to comply with the Georgia Informed Consent Law O.C.G.A. 31-9-6.1)
PATIENT NAME: ______DATE: ______
TIME: ______
The diagnosis or clinical history requiring this procedure is: right
left breast abnormality______
______
The nature of the procedure is: to use imaging guidance (mammogram, ultrasound or MRI) to place a wire into the_
breast area of concern.______
______
The purpose of this procedure is: To localize area of abnormality to guide in surgical excisional biopsy. ______
______
______
THIS PROCEDURE INVOLVES THE MATERIAL RISK OF INFECTION, ALLERGIC REACTION, SEVERE LOSS OF BLOOD, LOSS OR LOSS OF FUNCTION OF ANY LIMB OR ORGAN, PARALYSIS, PARAPLEGIA OR QUADRIPLEGIA, DISFIGURING SCAR, BRAIN DAMAGE, CARDIAC ARREST OR DEATH.
ADDITIONAL RISKS: In addition to the material risks listed above, there may be other potential risks involved in this procedure including, but not limited, to the following: bleeding, infection, lung collapse, implant rupture.______
______
The likelihood of success of this procedure is: good fair poor
THE PRACTICAL ALTERNATIVES TO THIS PROCEDURE ARE: Clinical/imaging follow-up, surgical biopsy without localization, image guided core biopsy.______
______
If I choose not to have the above procedure, my prognosis (future medical condition) is: unknown.______
______
I understand that during the course of the procedure described above, it may be necessary or appropriate to perform additional procedures which are unforeseen or not known to be needed at the time consent is given. I consent to and authorize the persons described herein to make the decisions concerning such procedures. I also consent to and authorize the performance of such additional procedures as they deem necessary or appropriate.
I consent to diagnostic studies, tests, x-ray examinations and any other treatment or courses of treatment relating to the diagnosis or procedures described herein.
I consent to the use of IV sedation and/or anesthesia and understand the risks are those associated with the procedure itself as listed above. The options have also been explained to me.
I consent to the use of blood and blood products as deemed necessary. The risks of exposure to AIDS, hepatitis or other infectious diseases as well as the need for and available alternatives have been explained to me.
*2-22209* FORM 2-22209 REV. 04/2014 Page 1 of 2
PLACE LABEL HERE
INFORMED CONSENT FOR
WIRE LOCALIZATION
I consent that any tissues, specimens, organs or limbs removed from my body in the course of any procedure may be tested or retained for scientific or teaching purposes and then disposed of within the discretion of the physician, facility or other health care provider.
I understand that the physician, medical personnel and other assistants will rely on statements about myself, my medical history, and other information in determining whether to perform the procedure or the course of treatment for my condition and in recommending the procedure which has been explained.
I understand that the practice of medicine is not an exact science and that NO GUARANTEES OR ASSURANCES HAVE BEEN MADE TO ME concerning the results of this procedure.
BY SIGNING THIS FORM, I ACKNOWLEDGE THAT I HAVE READ OR HAD THIS FORM READ AND/OR EXPLAINED TO ME IN GENERAL TERMS, THAT I FULLY UNDERSTAND ITS CONTENTS, THAT I HAVE BEEN GIVEN AMPLE OPPORTUNITY TO ASK QUESTIONS AND THAT ANY QUESTIONS HAVE BEEN ANSWERED SATISFACTORILY. ALL BLANKS OR STATEMENTS REQUIRING COMPLETION WERE FILLED IN AND ALL STATEMENTS I DO NOT APPROVE OF WERE STRICKEN BEFORE I SIGNED THIS FORM. I ALSO HAVE RECEIVED ADDITIONAL INFORMATION, INCLUDING, BUT NOT LIMITED TO THE MATERIALS LISTED BELOW, RELATED TO THE PROCEDURE DESCRIBED HEREIN.
I hereby voluntarily request and consent for Dr.______, as my physician, and any other physician(s), and such associates, assistants or other medical personnel involved in performing such procedure(s), to perform the procedure(s) described or referred to herein. I further consent to the presence of device or supply manufacturer’s representatives in the operating room as may be deemed appropriate by my physician.
Additional materials used, if any, during the informed consent process for this procedure include: ______
______
______
Date Time Person giving consent Relationship to patient
Patient unable to sign because of ______
Witnessed by: ______
Date Time Signature of person obtaining consent
Responsible Practitioner’s Statement:
I have reviewed the contents of this form, including the risks, benefits and alternatives to the proposed procedure, with the patient or the patient’s decision-maker, and have provided the patient/decision-maker with an opportunity to ask questions.
______
Date Time Physician Signature PID Number
FORM 2-22209 REV. 04/2014 Page 2 of 2