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 usingbioidentical 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.

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.

WHAT MIGHT OCCUR AFTER A PELLET INSERTION (FEMALE)

A significant hormonal transition will occur in the first four weeks after the insertion of your hormone pellets. Therefore, certain changes might develop that can be bothersome.

• INFECTION:
  Is possible with any type of procedure. Infection is uncommon with pellet insertion and occurs in 0.5 to
  1%. If redness appears and seems to worsen (rather than improve), is associated with severe heat and/or pus, please contact the office. Warm compresses are helpful, but a prescription antibiotic may also be needed.
• PELLET EXTRUSION:
  Pellet extrusion is uncommon and occurs in 5% of procedures. If the wound becomes sore again after it
  has healed, begins to ooze or bleed or has a blister-type appearance, please contact the office. Warm compresses may help soothe discomfort.
  • ITCHING or REDNESS:
  Itching or redness in the area of the incision and pellet placement is common. If you have a reaction to the tape, please apply hydrocortisone 2-3 times per day to the rash. If redness becomes firm or starts to spread after the first few days, you will need to contact the office.
  • FLUID RETENTION/WEIGHT GAIN:
  Testosterone stimulates the muscle to grow and retain water which may result in a weight change of two to five pounds. This is only temporary. This happens frequently with the first insertion, and especially during hot, humid weather conditions.
  • SWELLING of the HANDS & FEET:
  This is common in hot and humid weather. It may be treated by drinking lots of water, reducing your salt intake, or by taking a mild diuretic, which the office can prescribe.
  • BREAST TENDERNESS or SWELLING:
  This usually occurs most commonly in the first round of pellets but does not usually continue thereafter.
  DIM 1 capsule daily is helpful in preventing this, but the dose may be increased to 2-3 daily, if needed. Evening primrose oil (available in our office) is helpful as is Iodine+ if this occurs.
• MOOD SWINGS/IRRITABILITY/ANXIETY:
  These may occur if you were quite deficient in hormones. These symptoms usually improve as hormone levels improve. 5HTP can be helpful for this temporary symptom and can be purchased at many health food stores.
  • ELEVATED RED CELL COUNT
  (most common in men):
  Testosterone may stimulate growth in the bone marrow of the red blood cells. This condition is called
  erythrocytosis. Erythrocytosis may also occur in some patients independent of any treatments or medications. If your blood count goes too high, you may be asked to see a blood specialist called a hematologist to make sure there is nothing worrisome found. If there is no cause, the testosterone dose may have to be decreased.
  • HAIR LOSS:
  Is rarely due to pellets but can occur in some patients who convert testosterone to DHT. Dosage adjustment generally reduces or eliminates the problem. Prescription medications may be necessary in rare cases. Workup for other causes may also be needed.
  • FACIAL BREAKOUT:
  Some pimples may arise if the testosterone levels are either too low or rise rapidly. This lasts a short period of time and can be handled with a good face cleansing routine, astringents and toner. If these solutions do not help, please call the office for suggestions and possibly prescriptions.
  • UTERINE SPOTTING/BLEEDING/IRREGULAR PERIODS:
  This may occur in the first few months after an insertion, especially if you have been prescribed progesterone and are not taking properly: i.e. missing doses, or not taking a high enough dose. Please notify the office if this occurs. Bleeding is not necessarily an indication of a significant uterine problem.
  • HAIR GROWTH:
  Testosterone may stimulate some growth of hair on your chin, chest, nipples and/or lower abdomen. This tends to be hereditary. Fine, vellous hairs or “peach fuzz” often occurs but is not thick nor coarse. You may also have to shave your legs and arms more often. Dosage adjustment generally reduces or eliminates the problem.

POST-INSERTION INSTRUCTIONS FOR WOMEN

• Your insertion site has been covered with two layers of bandages. Remove the outer pressure bandage any time after 24 hours. It must be removed as soon as it gets wet. The inner layer (usually a steri strip) should be removed in 3 days.
• Do not take tub baths or get into a hot tub or swimming pool for 3-4 days. You may shower, but do not remove the bandage or steri-strips for 4 days.
• No heavy lifting or major exercises for the incision area for the next 3-4 days, which includes running,
  elliptical, squats, lunges, etc.
• The sodium bicarbonate in the anesthetic may cause the site to swell for 1-3 days.
• The insertion site may be uncomfortable for up to 2 to 3 weeks. If there is itching or redness you may
  take Benadryl for relief (25 to 50 mg orally every 6 hours). Caution: this can cause drowsiness!
• You may experience bruising, swelling, and/or redness of the insertion site which may last from a
  few days up to 2 to 3 weeks. If the redness worsens after the first 2-3 days, please contact the office.
• You may notice some pinkish or bloody discoloration of the outer bandage. This is normal.
• If you experience bleeding from the incision, apply firm pressure for 5 minutes.
• Please call if you have any bleeding not relieved with pressure (not oozing), as this is NOT normal.
• Please call if you have any pus coming out of the insertion site, as this is NOT normal.
• We recommend putting an ice pack on the area where the pellets are located a couple of times for
  about 20 minutes each time over the next 4 to 5 hours. You can continue this for swelling, if needed. Be sure to place something between the ice pack and your bandages/skin. Do not place ice packs directly on bare skin.

REMINDERS:

• Remember to have your post-insertion blood work done 6 weeks after your FIRST insertion. If you are not
  feeling any better by 4 weeks, however, please call the office to have your labs drawn early.
• Most women will need re-insertion of their pellets 3-4 months after their initial insertion. If you experience
  symptoms prior to this, please call the office.
• Please call as soon as symptoms that were relieved from the pellets start to return to make an appointment
  for your next insertion.

Medical Waiver

I consent to the insertion of testosterone pellets in my hip or abdomen area. I have been informed that I may experience any of the complications to this procedure as described above. Surgical risks are the same as for any minor medical procedure.

I have read, and acknowledge these requirements, of my procedure to better assist with treatment adversities that can occur if a protocol is not taken seriously. I know that this is an elective service and my questions regarding services have been answered satisfactorily I understand this procedure and accept all risks and will notify Top Beauty Bar of any changes that could put my treatment at risk.

I take full liability and responsibility for all risks, undesired outcomes, or adverse events associated with the injections and will not hold the provider of Top Beauty Bar LLC liable for any unfavorable outcome or adverse event. I release Top Beauty Bar LLC, its owner, and medical staff from liability associated with the procedure. This consent form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal representatives, heirs, administrators, successors, and assigns. I hereby release Top Beauty Bar LLC, Tina Videtic, and staff from all liabilities associated with the indicated procedure. The procedures to be used to treat my condition have been explained to me. Any adverse reaction should be reported immediately to the office mobile at 920-678-7709.

I have read, and acknowledge these liability requirements of my procedure.