Target Therapeutic Levels
Note: If testosterone levels are suboptimal after TPI, it is possible to augment with cream or injections until the reimplantation date (3 or 4-months post-implantation for men and 3-months post-implantation-for women).
Men
For saliva, blood spot, and venous bioavailable testosterone the goal is mid to high-end of normal range or until clinical effects are achieved and an adequate duration of benefits are seen. If adverse reactions are absent and negative metabolites are not elevated, clinical response trumps testosterone levels. If levels are above the normal range no reduction in dose is needed if there are no adverse reactions and metabolites (E2 and DHT) are in range.
Women
Target therapeutic levels for women are mid to high-end of normal levels (or above normal if needed) on salivary or blood spot testing. Again, clinical response trumps testosterone levels, so for women we are looking for good clinical benefits, ideally without acne, hair growth, or aggressiveness. Therefore the main reason for testing post-implantation levels in women is to detect lower than optimal levels if symptoms of deficiency still exist. Many women with high levels on repeat testing show none or only minor symptoms of acne or facial hair growth and usually no change in dosing is required, unless doctor and patient both agree that it is appropriate.
The Procedure
1.Prepare then anesthetize area halfway between iliac crest and gluteal crease. Men: 4 ml 2% lidocaine with epinephrine, 4 ml. 2% without epinephrine, or 4 ml 0.5% Marcaine®. Women: Use 1/2 to 2/3 of the above doses. (Fig. 2).
Figure 2. Prepare and anesthetize the area
2.Find the plane of subcutaneous fat (requires physician training and practice). This is more difficult in men with low body fat, and is easy to find on obese people. You may encounter fibrous septae requiring a twisting motion (like a screwdriver, clockwise/counterclockwise). Avoid overly traumatizing subcutaneous tissue and fat to minimize post-procedure bleeding. The approximate angle of anesthesia and trocar insertion is 15-30°. If needle is too shallow, the patient will experience a sharp or burning pain. If the needle is too deep the patient will feel muscle twitching (with anesthesia). If the angle is correct needle insertion should be pain-free as long as it is done slowly. (Fig. 3).
Figure 3. Getting the angle of insertion correct (15-30°) is important
Figure 4. The pellets are inserted with a blunt probe
3.It is now time to insert the pellets. These are pushed in with a blunt probe (Fig 4.). If implanting several tracts, redirect the trocar after implanting 3-4 pellets and implant 3- 4 more to avoid having them clumped all together. Then remove completely, create a new tract in a different direction (within the zone of anesthesia) and repeat. Men: Implant up to 4-5 x 100 mg pellets per tract. Women: Usually one 100 mg. pellet or one plus a smaller pellet (can cut or order smaller sized pellets, depending on the lab). With practice, cutting 100 mg pellets is easy and fairly precise (a few mg discrepancy does not affect outcomes). Progressive cutting of pellets can be done if one needs 50 mg, 25 mg, or 12.5 mg in order to yield a dose of 150 mg, 125 mg, or 112.5 mg.
4.After pellet insertion is complete the insertion site should be dressed (Fig. 5). In our office we use a large Band-Aid placed over a gauze pad folded in half 3-times. We then use waterproof plastic tape around the edges so that patient can shower the next morning.
Figure 5. Dressing the insertion site
5.After dressing, 8 minutes of pressure (with ice pack) should be applied (Fig. 6). For aspirin users I advise a 10 full minutes or pressure. However, ideally aspirin users should refrain from using aspirin for at least 3-4 days before procedure to avoid post procedure hematomas.
Figure 6. Pressure should be applied for 8 minutes after dressing
Possible Complications
Hematomas are the most common complication associated with TPI, and occur in approximately 10% of cases, although they are usually quite small. They are more common in aspirin in aspirin users. If they are very painful you can inject 7.5-10 mg of dexamethasone with lidocaine into the site (remembering sterile prep!).
Infections are another potential complication, however I have never experienced this even after carrying out more than 1800 procedures. Of course it is vital to use the sterile technique when carrying out TPI in order to minimize the risk of infection.
Traumeel® cream is very useful after TPI for minimizing pain and bruising. It is also available in an injectable form, which can be injected mixed with anesthetic or after implantation of the pellets (or the next day).
Signs and Symptoms of Testosterone Excess
It is important to look out for signs and symptoms of testosterone excess, these include:
•Aggressiveness (usually abates after a few weeks. Vigorous exercise helps greatly);
•Unexplained fatigue (usually caused by negative feedback causing a drop in ACTH);
•Hypoglycemia (rare);
•Salt and sugar cravings (uncommon);
•Facial hair;
•Acne/oily skin;
•Irregular menses (obviously in women only, very uncommon);
•Infertility (in men, caused by suppression of spermatogenesis);
•Fluid retention.
RECOMMENDATIONS
Recommendation 1
Evaluate adrenal function prior to starting testosterone, ideally with a circadian rhythm test (4 saliva samples). If patient is in Stage 3 adrenal fatigue, consider deferring testosterone until the adrenals have been corrected because of concerns about negative feedback.
Caution adrenal deficiency patients about the symptoms of adrenal shutdown – orthostatic lightheadedness and standing fatigue (caused by a drop in blood pressure), and excessive thirst (due to low aldosterone levels). Adrenal shutdown can be immediately corrected with oral or injectable corticosteroids.
Recommendation
