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Informed Consent for Female Estradiol & Testosterone Hormone Insertion


This consent form provides written confirmation that a discussion regarding bio-identical hormone insertion has occurred, and I agree to proceed.


General Bio-identical hormone pellets are comprised of naturally derived concentrated hormones. These hormones are designed to be biologically identical to the hormones a woman makes in her own body prior to menopause, including estrogen and testosterone which are made in the ovaries and adrenal glands. Bio-identical hormones have the same effects on the body as one’s own estrogen and testosterone did when the woman was younger, without the monthly fluctuations (ups and downs) of menstrual cycles.


Birth Control Patients who are pre-menopausal must continue reliable birth control while participating in pellet hormone replacement therapy. Testosterone is listed as category X (will cause birth defects) and cannot be given to pregnant women.

My birth control method is:

Benefits I consent to having testosterone inserted under my skin to achieve a steady delivery of natural testosterone hormone into my blood system. The potential benefits of testosterone include a possible increase in my bone density, short term memory, protection against Alzheimer’s, increase in my energy, my libido, and my sense of well-being. Testosterone may also decrease the frequency and severity of my headaches. I also consent to having estradiol pellet(s) inserted under my skin to also achieve a steady state of estradiol in my body. The potential benefits of estradiol include possible elimination of my mood swings, anxiety and irritability, cardiovascular protection and protect from developing colon cancer and brain dysfunction. I understand that none of these potential benefits are guaranteed.


Risks I understand that the above potential benefits come with some risks and that some hormone replacement therapy is not FDA approved. These risks include, but are not necessarily limited to the following: bleeding, infection and pain at the insertion site; lack of effect (from lack of absorption) infection due to patient noncompliance, pellet expulsion, indentation, scarring nerve injury, bruising and / or discomfort and/ or prolonged pain. Estrogen effects may include: breast tenderness and swelling especially in the first three weeks; water retention; increased growth of estrogen dependent tumors (fibroids endometrial cancer, breast cancer). Results may vary as not everyone is the same and this may not work for you.


Testosterone risks include: birth defects in babies exposed to testosterone during their gestation; increase in hair growth on the face; body hair, thinning of scalp hair, growth of liver tumors, if already present: change in voice and/or clitoral enlargement.


Other potential risks of testosterone therapy include but are not limited to: heart disease, stroke, thrombosis (blood clots), weight gain, and the possibility of unknown long-term risks.


In a small number of patients, the body may convert testosterone to DHT which can cause acne or hair loss. The estradiol dosage that I may receive can aggravate fibroids or polyps, if they exist, and cause bleeding. If I have a uterus, I must take progesterone or risk abnormal endometrial cells or in rare cases endometrial cancer.

Charges I understand there is a charge which varies depending on the number of pellets I receive. The precise amount is to be determined by my medical provider. I understand payment is due in full at the time of service.


By signing below, I certify that I have read and understood the above and that I have been encouraged to ask any questions regarding pellet therapy and all of my questions have been answered to my satisfaction. I also acknowledge that the risks and benefits of this treatment have been explained to me and that I may experience one or more of the complications listed above. I accept these risks and benefits and consent to the insertion of hormone pellets under my skin.

 

Patient Name:  


Patient Date of Birth:


Consent for Hormone Implantation


1.I hereby authorize a treating provider at Tutera Medical Provider(s)*


to perform the following operation or procedure: STERILE SURGICAL PLACEMENT OF HORMONE PELLETSUNDER THE SKIN.


2.I understand the reason for the procedure is: hormone replacement therapy using Estradiol and/or Testosterone.


3.RISKS: Risks that may be associated with this procedure include but are not necessarily limited to the following as somehormone replacement therapy is not FDA approved: bleeding, infection due to patient noncompliance, pellet expulsion,indentation, scarring, nerve injury, bruising and/or discomfort and/ or prolonged pain, pain at the insertion site, lack of effect(from lack of absorption). Bloating, moodiness and/ or assertiveness; growth of existing cancers.


     a.Estrogen side effects may include breast tenderness and/ or swelling especially in the first three weeks; water retention;increased growth of estrogen dependent tumors (fibroids endometrial         cancer, breast cancer).


     b.Testosterone side effects include: increase in hair growth on the face and/ or body, thinning of scalp hair; birth defectsin babies exposed to testosterone during their gestation, growth of liver         tumors, if already present: change in voiceand/or clitoral enlargement. Thickening of the blood. Decreased sperm count. In a small number of patients, the bodymay convert testosterone to             DHT which can cause acne or hair loss.


     c.Other potential risks of testosterone therapy include but are not limited to: heart disease, stroke thrombosis (bloodclots), weight gain, and the possibility of unknown long-term risks.


     d.The estradiol dosage that I may receive can aggravate existing fibroids or polyps, if they exist, and cause break-thrubleeding requiring a pelvic ultrasound and/or endometrial biopsy. If I have       a uterus, I must take progesterone or riskabnormal endometrial cells or in rare cases endometrial cancer.


4.LOCAL ANESTHESIA: The administration of anesthesia also involves risks; most importantly, a rare risk of reaction tomedication causing death. I consent to the use of such anesthetics as may be considered necessary by the medical professional,physician or practitioner responsible for these services.


5.I understand that no guarantee or assurance has been made as to the results of the procedure and that it may not cure anycondition I may have.


6.PATIENT’S CONSENT: I have read and fully understand this consent form and understand I should not sign this form if allitems, including all my questions, have not been explained or answered to my satisfaction or if I do not understand any of theterms or words contained in this consent form.

Patient Name:  


Patient Date of Birth:


*Providers on staff: Jeffrey Dean, NMD, Mel Schottenstein, NMD, Dr. Stuart Fowler, MD, FACOG, ISSVD, Steve Nunn, MPAS, PA-C, DFAAAPA, Melanie Ferrier FNP-C

Use by Permission, ©2011 Tutera Medical, Inc

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Signature Certificate
Document name: Informed Consent for Female Estradiol & Testosterone Hormone Insertion
lock iconUnique Document ID: 15dbcc0745d91c8cc7025ea1fd04d62418aae945
Timestamp Audit
February 9, 2022 11:17 am MSTInformed Consent for Female Estradiol & Testosterone Hormone Insertion Uploaded by CarolAnn Tutera - info@tuteramedical.com IP 52.144.111.70