PELLET INSERTION CONSENT FOR FEMALES

Name*

First NameLast Name

Date of birth*

Date

Today's Date*

Date

My physician/practitioner has recommended bioidentical hormone therapy delivered by a pellet inserted under my skin for treatment of symptoms I am experiencing related to low hormone levels. The following information has been explained to me prior to receiving the recommended therapy.

OVERVIEW
Bioidentical hormones are hormones that are biologically identical to that made in my own body. The levels of active estradiol and/or testosterone made by my body have decreased, and therapy using these hormones may have the same or similar effect(s) on my body as my own naturally produced hormones. The pellets are a delivery mechanism for estradiol and/or testosterone, and bioidentical hormone replacement therapy using pellets has been used since the 1930’s. There are other formulations of estradiol and testosterone replacement available, and different methods can be used to deliver the therapy. There are no commercially available forms of testosterone, however, that are formulated specifically for use in women. The risks associated with pellet therapy are generally similar to other forms of replacement therapy using bioidentical hormones.

RISKS/COMPLICATIONS OF PELLET INSERTION:
Risks associated with pellet insertion may include: bleeding from incision site, bruising, fever, infection, pain, swelling, pellet extrusion which may occur several weeks or months after insertion, reaction to local anesthetic and/or preservatives, allergy to adhesives from bandage(s), steri strips or other adhesive agents.

RISKS/COMPLICATIONS OF TESTOSTERONE:
Some individuals may experience one or more of the following complications with testosterone: acne, abnormal bleeding or a change in menstrual cycle (if patient has a uterus), anxiety, breast or nipple tenderness or swelling, insomnia, depression, mood swings, fluid and electrolyte disturbances, headaches, increase in body hair, fluid retention or swelling, mood swings or irritability, rash, redness, itching, lack of effect (typically from lack of absorption), transient increase in cholesterol, nausea, retention of sodium, chloride and/or potassium, weight gain or weight loss, thinning hair or female pattern baldness, hypersexuality overactive libido) or decreased libido, overproduction of estrogen (called aromatization) or an increase in red blood cell formation or blood count erythrocytosis). The latter can be diagnosed with a blood test called a complete blood count (CBC). This test should be done at least annually. Erythrocytosis can be reversed simply by donating blood periodically, but further workup or referral may be required if a more worrisome condition is suspected.

FERTILITY AND TESTOSTERONE:
IMPORTANT: Testosterone may affect the ability to conceive. If you are planning to start or expand your family soon, please talk to your provider about other options.

RISKS/COMPLICATIONS OF ESTRADIOL (ONLY APPLICABLE IF RECEIVING ESTRADIOL IN THE PELLETS)
The side-effects of estradiol are similar to those listed above for testosterone. Additionally, there is some risk, even when using bioidentical hormones, that estrogens may cause existing cases of some breast cancers to grow more rapidly. This risk may also apply to some undiagnosed forms of breast cancer. Using estrogen-alone (without progesterone) may increase the chance of getting cancer of the uterus. Endometrial sampling (biopsy) or surgery may be required if abnormal bleeding occurs.

ABNORMAL UTERINE BLEEDING

Do you have a uterus?*

YesNo, my uterus was removed (hysterectomy)

Important: The risk of abnormal uterine bleeding when starting or changing hormone therapy is between 30-50%. The risk is higher at the start of treatment, especially if a patient has not had their period for many years. Usually the bleeding resolves once the hormone levels have stabilized. Sometimes dose adjustments are needed for the progesterone and/or estradiol. However in cases of persistent bleeding, additional investigations may be required such as ultrasound or endometrial biopsy. Progesterone is important for balance as it protects the uterus from excessive estrogen stimulation. Not taking progesterone could increase the risk of abnormal uterine bleeding and may also increase the risk of getting uterine cancer. Progesterone is prescribed as oral medication (capsules or sublingual), and it's important to remember to take it regularly. Please initial below to indicate that you understand and agree to take progesterone as prescribed, and to report any abnormal uterine bleeding to our clinic promptly. Initial below:*

CONSENT FOR TREATMENT

I agree to immediately report any adverse reactions or problems that may be related to my therapy to my physician or health care provider’s office, so that it may be reported to the manufacturer. Potential complications have been explained to me, and I acknowledge that I have received and understand this information, including the possible risks and potential complications and the potential benefits. I also acknowledge that the nature of bioidentical therapy and other treatments have been explained to me, and I have had all my questions answered. I understand that follow-up blood testing will be necessary four to six (4-6) weeks after my initial pellet insertion and then at least one time annually thereafter. I also understand that although most patients will receive the correct dosage with the first insertion, some may require dose changes. I understand that my blood tests may reveal that my levels are not optimal which would mean I may need a higher or lower dose in the future. Furthermore, I have not been promised or guaranteed any specific benefits from the insertion of estradiol or testosterone pellets. I accept these risks and benefits, and I consent to the insertion of estradiol and/or testosterone pellets under my skin performed by my provider. This consent is ongoing for this and all future insertions in this facility until I am no longer a patient here, but I do understand that I can revoke my consent at any time.

I have been informed that I may experience any of the complications to this procedure as described above. I have read or have had this form read to me completely. I have had the opportunity to discuss this treatment fully with my physician and any questions or concerns have been answered to my satisfaction.

Patient Name*

Signature*

Witness name*

Witness Signature*