Pellet Insertion Consent For Females

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 TESTOSTERONE
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.

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.

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.
Please initial if you are postmenopausal, have a uterus, and are getting estradiol

RISKS/COMPLICATIONS OF ANASTROZOLE
(ONLY APPLICABLE IF RECEIVING ANASTROZOLE
IN THE PELLETS)
Anastrozole is a type of medication called an aromatase inhibitor.
Aromatase inhibitors limit or prevent the conversion of testosterone into
estrogen. Aromatase inhibitors can be used for a variety of conditions
but are most commonly used in patients with a history of estrogen
receptor positive breast cancer.

Anastrozole should not be used in pregnant women and should be
used with caution in women with pre-existing ischemic heart disease.
Anastrozole in pellets should not be given to premenopausal women nor
to women taking oral aromatase inhibitors (anastrozole or letrozole) or
selective estrogen receptor modulators (tamoxifen or raloxifene).

The amount of anastrozole used in pellets is very low. The most common
side-effects for women taking anastrozole are hot flashes, joint pain, and
muscle pain. Because of the low dose in the pellet, these effects are not
usually seen with this type of therapy, however

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 (4) 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 testosterone pellets.

I accept these risks and benefits, and I consent to the insertion of
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.