Consent for female pellet insertion


I wish to receive subdermal hormone pellet implants for the purpose of reducing symptoms that are at least in part due to low levels of estrogen and/or testosterone.  Even though subdermal bioidentical hormone implantation has been done for over 50 years by a large number of doctors around the world, I realize that it is not the usual and customary means of hormone replacement.  These pellets are a natural soy-derived bioidentical estradiol and testosterone inserted under the skin (subcutaneous) of my lateral buttocks to achieve a steady and consistent delivery of hormone into my bloodstream.  I realize that testosterone may increase my libido (sexual desire), energy, mental clarity, bone strength, and overall sense of well-being.  It may also help improve my mood.

I may receive 6-50 mg of 17-b-estradiol in pellet form inserted subcutaneously in my hip area.  Although results are usually favorable in reducing or eliminating the symptoms of estrogen deficiency, I have not been given any promises or guarantees of positive results in my individual case.  Estrogen replacement with bioidentical estradiol may cause transient breast tenderness, bloating, or swelling.  If my uterus is present, I may get some mild or moderate menstrual-type bleeding sometime after the insertion.  This is not unusual with any type of female hormone therapy such as birth control pills and is usually easily dealt with. If bleeding persists; however, it could indicate the need for a uterine ultrasound and/or endometrial sampling in the office.  I will need to take some form of regular progesterone to balance the effect of the estradiol upon my uterus.   If no progesterone is taken, I could develop endometrial hyperplasia, which in some cases can lead to a low-grade form of uterine cancer.

Occasionally, hormone implants have been associated with temporarily increased levels of anxiety, insomnia, depression, lethargy, increased sleeping, or fatigue. These events occurred in the first few weeks following implantation and are believed to be a response to rapidly rising hormone levels.

I may also receive 25-150 mg of bioidentical human testosterone. Taking large amounts of testosterone imitators has resulted in heart disease or high cholesterol. However, bioidentical subcutaneous testosterone pellets have NOT been associated with these problems.

I may experience transient tenderness of my nipples, probably due to the increased level of testosterone, increased oiliness of my skin or mild acne.  Rarely, some patients have experienced some increased hair growth or a slight deepening of the voice, if the testosterone level goes significantly higher than the desired target range.

Pellet extrusion (coming out) has been known to occur on rare occasions. Incidence in the literature is between 2-5%.  There is a very slight chance of a wound infection as there is with any type of surgical procedure. This would be easily treated with an antibiotic, or very rarely, incision and drainage.

Pellets should be considered irretrievable once they are inserted.  However; in extraordinary circumstances, pellets may be removed by a general surgeon via a minor outpatient surgical procedure.  Pellets may be added if needed to achieve desired results/blood levels. They dissolve completely in 4-12 months.

I understand that if I am still having periods and I want a testosterone implant, I will need to use a reliable form of birth control, as high levels of testosterone could harm a developing female fetus causing abnormal genitalia.  If I do accidentally become pregnant, I will need to see a surgeon immediately to have the pellet removed to reduce risk to the fetus.

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