Female Pellet Consent form  Logo
  • FEMALE: Informed Consent for Hormone Pellets

  • Do NOT switch screens while completing this form as all information will be lost.

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  • Mammogram Recommendation:

    Women ages 42-44 should have the choice to start annual breast cancer screening with mammograms if they wish to do so. Women age 45 to 54 should get mammograms every year. Women 55 and older should switch to mammograms every two years or they continue yearly screenings. Screening should continue as long as a woman is in good health and expected to live 10 more years or longer. All women should be familiar with you known benefits, limitations, and potential harm is linked to breast cancer screening.
  • I understand the above stated recommendations for mammogram screenings. My treating provider it has discussed the importance of a mammogram, according to the guidelines from the American cancer society. Although evidence supports the many health benefits of estradiol, my treating provider has informed me that exposure to estradiol in any form, could possibly stimulate an undetected cancer, causing growth of and/or recurrence of cancerous tissue.
  • I have assess the risk on a personal basis, and my perceived value of the hormone therapy outweighs the risk. I voluntarily choose to undergo the implantation of subcutaneous hormone pellet therapy. I acknowledge that I therefore responsibility for any personal injury or illness, accident, risk, or loss (including death, and or breast, uterine, or any cancer issues) that may be sustained by me in connection with my decision to not have a mammogram and undergo hormone pellet therapy, including, without limitation, any cancer that could develop in the future, whether it be deemed a stimulation of a current cancer or new cancer.
  • I hear by releasing agree to hold harmless 4You LLC and any of their staff, nurses, officers, directors, owners, employees, and agent from any and all liability, claims, demand, and actions, arising or related to any loss, property, damage, illness, injury, or accident that may be sustained by me as a result of breast cancer diagnosis in conjunction with estradiol hormone pellet therapy.
  • I acknowledge and agreed that I have been given adequate opportunity to review this document, and to ask questions. The release and hold harmless agreement is, and shall be biting on myself and my heirs, assigns, and personal representatives.
  • Mammogram Waiver

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  • Preventative Healthcare Requirements:

    I understand I must complete required preventative healthcare measures including but not limited to:

    - Mammograms (annually or more frequent as required by my OBGYN or medical professional)

    - Medical/GYN exam (annually)

    - Bone Density scans (annually or more frequent as recommended by healthcare provider)

    - Pelvic ultrasound (as recommended by healthcare provider

    - Self screening breast exam

    - Healthy eating habits as recommended by staff at 4You LLC

    - Regular exercise including at least 150 minutes of cardio weekly 

    - Regular bowel movements daily

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  • Medical Conditions:

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  • Female Pellet Consent Form

  • Bio, identical, hormone pellets are concentrated, hormones, biologically, identical to the hormones you make in your own body. Estrogen, progesterone, and testosterone are derived from the female ovaries (primarily)and adrenal glands (secondarily)prior to menopause.

     

    Testosterone is a hormone produced by the ovaries, and adrenal glands and women. And medical research testosterone supplementation, and women has been shown to improve fatigue, exercise, and tolerance, muscle tone, leaving Diehl, Weight, decreased depression, anxiety, and mood disorders, and other conditions.

     

    The laboratory asses can support a diagnosis of testosterone deficiency. They should not be used to excluded as there are multiple problems in the measurement of testosterone (ex. Dietary intake , sexual activity, sample storage variables, circadian, variations). Greater reliance on clinical features, and consideration of symptoms is suggested as an appropriate tool in treating women with testosterone therapy. There is no generally accepted "normal" level of testosterone for women. It is reasonable to prescribe testosterone to women who has symptoms of low, and to expect total testosterone values that are supraphysiologic after treatment.

     

    All testosterone use in women is considered "off label". Off label use refers to the use of any medication for something other than its FDA approval. Any medication as prescribed in the US are prescribed her off label use. The awfully the use of testosterone therapy has not been evaluated by the FDA, and in any claims of benefit are purely educated opinions that come from considerations of fairies medical research studies. It is reasonable to expect a supraphysiologic testosterone laboratory value after pellet therapy is initiated.

     

    Hormone pellet production is highly FDA regulated; however, the pellet insertion procedure is not FDA approve procedure for hormonal replacement.

     

    Goals for treatment with this medication will be discussed at each appointment. If goals are met, then maintenance doses will be discussed. If treatment is not as effective as anticipated, it might be discontinued; at that time, alternative therapies will be discussed. You are welcome to six second opinion or a specialist cancel

     

    The safety of hormone therapy during pregnancy cannot be guaranteed. Notify your provider if you are pregnant, so expect that you are pregnant, or are planning to become pregnant during this therapy continuation exposure to testosterone during pregnancy may cause adverse effects of the fetus.

     

    Side Effects:

    Side effects of subcutaneous one pallet will be managed clinically and individually there have been no reported irreversible side effects of subcutaneous pellet therapy noted in the literature.

    Potential side effects of pellet insertion may include, but not limited to:

    Surgical risk are the same as for any minor medical procedure. Bleeding, bruising, spring, pain, extrusion of pellets; infection or abscess formation; seroma formation, scarring at the insertion site, keloid scar.

     

    Potential side effects of hormones may include, but are not limited to:

    Estradiol related: dysfunctional, uterine, bleeding: growth of estrogen, dependent, tumors, and breast tenderness,

    Testosterone unrelated: hyper sexuality (overactive libido),, increase, hemoglobin, and hematocrit, acne, increase in body/facial hair growth, abnormal menstrual cycles, hair loss/thinning and derealization, voice, changes, or abnormal growth of female genitals.

     

    IMPORTANT:

    17- data estradiol has not been shown in any clinical studies to date to increase breast, cancer, uterine, or ovarian cancer risk; however, if a patient has an undiagnosed estrogen, hormone dependent cancer a possible risk of accelerated growth may occur. For this reason, mammograms, according to the clinical guidelines are required as a baseline prior to initiation of hormone hormone cancer risk; however, if a patient has an undiagnosed estrogen, hormone dependent cancer a possible risk of accelerated growth may occur. For this reason, mammograms, according to the clinical guidelines are required as a baseline prior to initiation of hormone therapy. Every patient has a right to refuse diagnostic mammogram.

    I understand if I refuse a mammogram, I will be required to sign a mammogram waiver before I am to receive hormone therapy. I understand if I have a uterus and I am on estradiol therapy. I must take oral micronized progesterone daily for protection against uterine cancer.

     

    Consent for treatment:40

    I have been informed that I may experience any of the complications related to this procedure. Periodic adjustments are required to fine-tune the treatment with this type of medication. Periodic blood tests are necessary to determine if the dose needs to be adjusted. I understand the hormone therapies are, in other forms, including creams, and oral medication. I understand that I am consenting to testosterone therapy for treatment of my symptoms. I understand hormone pellet procedure is not FDA approved. 

     

    Aftercare:

    I agree to immediately report to my practitioners office any adverse reactions or problems that may be related to my therapy. Potential complications have been explained to me, and I agree that I have received information regarding those risk, potential complications, benefits, and the nature of the hormones and other treatments, and have all my questions answered. Furthermore, I have not been promised or guaranteed any specific benefits from the administration of hormone therapy. I accept the risk and benefits, and I can send to the insertion of hormone pellets with the dosage regime, discussed thoroughly by my hormone pellet provider. I have read and understand this document in its entirety, and have been given the opportunity to ask questions concerning my care. I can send to the subcutaneous hormone pellet insertion. This consent is ongoing for this, and all future subcutaneous hormone pellet insertion.

     

    Reference: 

    Carruthers, M. (2008). The paradox dividing testosterone deficiency symptoms and androgen assays; a closer look at the celllular and molecular mechanisms of androgen action. The journal of sexual medicine, 5(4), 998-1012. 

     

    Bachman, G., Bancroft, J. Braunstein, G., Burger, H., Davis, S., Dennerstein, L., ... & Traish, A.(2002). Female androgen insufficiency: the Princeton consensus statement on definition classification, and assessment. Fertility and sterility, 77(4), 660-665.

     

    Sufelt, C. L., & Braunstein, G. D. (2009). Safety of testosterone using women. Maturity's, 63 (1). 63-66.

     

    Panay, N., & Fenton, A. (2009). The role of testosterone in women.

     

    Maclaran, K., & Panay, N. (20012). The safety of postmenopausal testosterone therapy. Women's Health. 8(3) , 263-275.

     

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