501 19th Street, Trustee Towers FORT SANDERS WOMEN’S SPECIALISTS 1924 Pinnacle Point Way Suite 401, Knoxville Tn 37916 P# 865-331-1122 F# 865-331-1976 Suite 200, Knoxville Tn 37922

Dr. Curtis Elam, M.D., FACOG, AIMIS, Dr. David Owen, M.D., FACOG, Dr. Brooke Foulk, M.D., FACOG Dr. Dean Turner M.D., FACOG, ASCCP, Dr. F. Robert McKeown III, M.D., FACOG, AIMIS Dr. Steven Pierce M.D., Dr. G. Walton Smith, M.D., FACOG, Dr. Susan Robertson, M.D., FACOG

In-Office Biopsy Consent Form for Fort Sanders Women’s Specialists

Please read the following consent form. Only sign the form when you feel that you completely understand the In-Office procedure that is to be performed and after you have asked all of your questions. If you have any further questions or concerns, please discuss these with your provider prior to your procedure so that we may clarify any pertinent issues.

Procedure: Cervical Biopsy, Skin Biopsy, Endometrial Biopsy

Layman’s Description: Remove tissue in an attempt to diagnose a medical problem or to cure a medical problem.

Diagnosis/Indication: ______

Expectations of Outcome: 1) Making a definitive diagnosis or potentially ruling out certain medical problems. 2) To obtain tissue for a Pathologist to evaluate in hopes of making a diagnosis. 3) To attempt to decrease the risk of occurrence of certain medical problems such as Cancer. Occasionally the biopsy does not provide any helpful information or has to be repeated.

¨ Colposcopy and Cervical Biopsy: Colposcopy involves the visual evaluation of the Cervix, or the Vagina, or the external Vulvar tissues utilizing a microscope after the application of a vinegar solution. This is commonly performed due to either an abnormal Pap smear, bleeding after intercourse, abnormal appearing tissue or due to symptoms that suggest an underlying pathology. The biopsy may be painful and may cause bleeding. If a biopsy is performed than you should expect the results of the biopsy within 4-5 days. Additional treatment may be recommended. ¨ Skin Biopsy: If your provider identifies abnormal appearing skin during your exam, if your Pap smear is abnormal, or if you have symptoms that might suggest an underlying pathology then a skin biopsy may be recommended. The biopsy may or may not be associated with a microscopic exam called Colposcopy. The biopsy may be painful. If a biopsy is performed then you should expect result within 4-5 days. ¨ Endometrial Biopsy: If you have abnormal bleeding, bleeding after menopause, or you have symptoms that might suggest an underlying pathology then your provider may recommend an endometrial biopsy. If an endometrial biopsy is recommended then your cervix will be cleansed with an iodine solution. Your cervix may be grasped with a tenaculum to hold it steady. Your provider may measure the depth of the uterine cavity with a metal instrument called a sound. Sometimes the cervix will need to be stretched (dilated) in order for the instruments to be passed into the uterus. A small plastic, or metal, catheter will be passed into the uterus in order to obtain a sampling of the uterine tissue. Either the tenaculum or the biopsy may cause cramping and pain. If a biopsy is performed you should expect results in 4-5 days.

Possible Complications of the Procedure: All procedures, regardless of complexity or time, can be associated with unforeseen problems. They may be immediate or even quite delayed in presentation. While we have discussed these and possibly others in your consultation, we would like you to have a list of some specific complications so that you may ask questions if you are still concerned. A list of possible complications, would include, but are not limited to:

•Organ Injury: This is extremely rare for in-office procedures. During any part of the procedure, any organ in the pelvis (intestine or bladder) that is near the surgical site can be inadvertently injured. Often the injury is minor and can be treated with relative ease; however if the injury is major or the repair is complicated then surgery may be necessary. •Infections: Post-procedure infections can occur but are rare. They most common symptoms to suggest infection are fever, unusual discharge, or pain several days after the biopsy.

•Vascular Injury: Any of the vessels near the surgical site are at potential risk for injury during any procedure. Occasionally stitches are required to stop bleeding from a biopsy. Rarely bleeding will occur several hours after a biopsy and may require returning to the office or to the emergency room for treatment.

* Anesthesia: Sometimes a local anesthetic (numbing medicine) may be injected prior to a biopsy. An allergic reaction to the medication is possible even if you are not aware of any prior reactions. Most allergic reactions are very limited if they occur but in rare instances an allergic reaction can cause breathing problems or a life-threatening reaction called anaphylaxis. If you experience wheezing, shortness of breath, or confusion after a local anesthetic injection then call 911 or go to your nearest emergency room.

•Blood Loss/Transfusion: The vaginal region is vascular. Usually the blood loss in this procedure is minimal. In rare cases blood loss can be significant enough to necessitate a blood transfusion. If a transfusion is necessary, there is a small risk of blood related infections such as Hepatitis or HIV.

•Chronic Pain: With any procedure, a patient can develop chronic pain from scarring in an area that has undergone a biopsy. Typically, the pain disappears over time, although some feeling of numbness may persist. In rare instances the pain can be permanent.

Additional Procedures/Consultations: If there are unanticipated findings, difficulty during the procedure, or a situation where your doctor does not believe that he has the expertise to accomplish all of your case then a consultation may be necessary. A consultation is when another physician or surgeon is asked to give recommendations, assist or take over a procedure. This occurs at your doctor’s discretion for your safety and without regard to whether you have met the other physician or whether they are on your insurance panel. Photographs/Recordings: Still photographs and digital recordings of your procedure may occur for documentation of findings or for educational purposes.

Consent: I, Dr.______, have counseled ______regarding her planned procedure. In my professional opinion I believe that the procedure is reasonable and most likely will result in a beneficial outcome. It is my belief that the patient has considered her options and fully weighed the risks of procedure.

Signed______Date______Time______

I, ______, believe that the procedure listed above is the best option for me. My situation is not an emergency and I understand that I have other options, including not having the procedure. I understand that complications, bad outcomes, and unanticipated events will occur occasionally. I understand that my doctor and his team are not perfect and at no point have I been guaranteed any outcomes or results. I have been given the opportunity to ask all my questions and I believe that I have all the information necessary to make a reasonable decision. Therefore, I elect to give my consent and proceed with the above procedure, as witnessed by my signature below.

Patient Signature______Date______

Witness Signature______Date ______