Medical management of hormonal disturbances is clinically challenging. Many patients benefit from subcutaneous implanted pellet therapy that provides continuous, predictable release of supplemental hormones that cannot be taken orally or that are not otherwise easy to manage.
Hormone pellets are time-release capsules of synthetic and bioidentical hormones for replacing deficient hormones in men and women.
Conventional medicine makes extensive use of testosterone pellets for hormonal disturbances in persons designated as male at birth. Testosterone pellets are medically indicated for delayed puberty in males, and for primary or hypogonadotropic hypogonadism, when low testosterone levels are laboratory-verified. Testosterone pellets such as Testopel are FDA-approved for the treatment of gender dysphoria in the treatment of patients who are capable of making informed decisions about hormone therapy.
Insurers usually regard the use of implanted testosterone pellets for idiopathic hypogonadism in men (hypogonadism not associated with disorders of the testes, pituitary gland, or brain), male menopause, female menopause, and pain syndromes in women as investigational, not covered.
Progestin and progesterone pellets are sometimes used to treat dysmenorrhea and erythema nodosum. Because they are not FDA-approved for these indications, insurance companies usually do not reimburse them.
There are also issues with estradiol pellets for treating estrogen deficiencies in women. Implanted estradiol pellets have been associated with fluctuating and unpredictable estrogen levels in women, so the FDA has not approved them for this purpose, and insurance companies usually will not pay for them.
Issues with synthetic hormones, however, do not preclude the use ofhormone pellet therapy for treating hormone-related disorders in both men and women. Doctors can work with compounding pharmacies to create reliable, easily administered bioidentical hormones to replace testosterone, estrogen, or progesterone.
Bioidentical hormones are chemicals extracted from plants that bind to some of the same cell receptors as natural or synthetic hormones, but have a very different chemical structure. Because these plant chemicals can be chosen to bind to some of the receptors activated by a hormone, but not all of them, they do not cause the side effects common to synthetic hormone therapy. There are bioidentical equivalents of testosterone, estradiol, estrone, and dehydroepiandrosterone.
The prescribing doctor sends an order to a compounding pharmacy for a specific dosage of a specific bioidentical hormone, or, sometimes, in the treatment of menopause-related complaints, a combination of bioidentical hormones. The compounding pharmacy creates hormone pellets that are about the size of a grain of rice.
The doctor then implants the hormone pellet into the abdomen or gluteal muscle of the patient with an instrument known as a trocar. The trocar creates an opening through the skin and underlying fascia large enough for the pellet to be inserted into muscle, but small enough that no stitches are needed. The pellet provides a steady titer of bioidentical hormone for four to six months, at which time the patient will need new hormone treatment.
Bioidentical hormones are tailor-made to the patient, so they cannot be tested through the usual FDA-approved process of giving the candidate drug and a placebo to hundreds of patients. For this reason, bioidentical hormones are not FDA-approved, and because they are not FDA-approved, insurance companies do not pay for them.
Even the FDA., however, recognizes the value of bioidentical hormone therapy. Here are some of the justifications submitted to the FDA through the National Academies of Science, Engineering, and Medicine in favor of bioidentical hormone therapy.
Compounding pharmacies authorized under Section 503A of the FD&C Act can manufacture customized, patient-specific bioidentical hormone products that patients administer to themselves. Products made by 503A pharmacies are not time-sensitive, and can dispense products directly to patients.
Only compounding pharmacies authorized under Section 504A of the FD&C Act are allowed to manufacture hormone pellets. Pharmacies make hormone pellets "just in time" for the exclusive use of the prescribing physician, who is responsible for administering them to the patient.
There is never a concern about patient compliance when doctors prescribe bioidentical hormone pellets. Patients will not forget their medications. They do not have to learn how to take them.
Bioidentical hormone pellets do not have to be used to the exclusion of other forms of treatment. Bioidentical hormones are one more tool physicians can use to provide patient-centered, effective relief of symptoms of hormonal imbalance.
Men often seek bioidentical testosterone replacement to recover lost libido and to remedy unreliable erectile function. Slow, predictable release of bioidentical testosterone restores natural sexual response without the need of taking PDE5 inhibitors at the beginning of a romantic interlude.
Enhanced testosterone levels also help find more energy to power through their day. They encourage the production of muscle, reduce weight gain, lift mood, and mitigate hypercholesterolemia, diabetes, obesity, and peripheral artery disease, all associated with diminished testosterone levels.
Some women benefit from bioidentical testosterone for the restoration of libido, increased energy, prevention of weight gain, and relief from sleep disturbances. Although bioidentical estrogen can be delivered in many different forms, sometimes women seek bioidentical estrogen replacement in pellet form for conditions associated with declining estrogen levels.
Bioidentical estradiol replacement can accomplish the same therapeutic goals as any other estrogen replacement therapy, including relief from dry skin, vaginal dryness, painful intercourse, brain fog, night sweats, headaches, and depression. Hormone pellets may be indicated for women who have an unusual reaction to some component of an oral medication, or who need to achieve more predictable estrogen levels than are possible for them with mainstream treatments.
Trocar Supplies specializes in providing trocars for the insertion of extended-release pellets for hormone treatment. We feature products that minimize the risk of herniation, reduce the risk of infection, and leave patients with minimal post-procedural discomfort.
Trocar Supplies sells disposable medical tray kits and trocar wrap kits. We offerdisposable trocars just 3.5 mm wide, for either shallow or deep insertion. We also sell a reusable 3.5 mm stainless steel bevel tip, to be autoclaved between uses.
