Compounding, and Its Importance to Me
by Debbie Braaten
Compounding (medical) – In the field of pharmacy, compounding is preparation of a custom formulation of a medication to fit a unique need of a patient that cannot be met with commercially available products. – Wikipedia
It is difficult to put into words the all-encompassing life changes induced by hysterectomy and ovary removal. Here I will only describe the loss of ovarian hormones. A term for the removal of the uterus and both ovaries is “surgical menopause” and leads one to believe it is just like the menopause entered naturally, the only difference being that it is brought about by the hand of the surgeon. This couldn’t be further from the truth. Another medical term for the surgical removal of both ovaries is “female castration” and describes the surgery more accurately. Ovaries function throughout a woman’s life providing her with the hormones her body needs to maintain health. The effects of surgery are generally more pronounced if surgery is performed prior to menopause and for those with higher levels of testosterone. So, if both conditions are met, the effects of surgery can be devastating, not only physically but mentally and spiritually. Women, however, are expected to go on with their lives without replacement of basic hormones lost due to surgery. Regardless of the misguided publicity following the HERS and WHI studies, our hormones or their bio-identical equivalent are good for us and protect us from osteoporosis, Alzheimer’s, and heart disease. The results of these studies were based on the synthetic hormones manufactured by pharmaceutical companies which are structurally unlike anything in the human body. Humans are not horses.
After surgery was performed on me, I felt like the living dead. I lived like that for nine years, and the only thing that brought me back to life were the bio-identical hormone pellets of estradiol and testosterone. The bad press in the United States regarding testosterone replacement in women is contrary to worldwide research. The benefits have been documented in medical journals for over 100 years. Women need lower doses of testosterone than men. However, these doses can only be obtained from a compounding pharmacy and must be prescribed by a medical practitioner. The hormones I use have had an excellent safety record prior to the Massachusetts tragedy. However, this tragedy happened not because of the hormones themselves, but because of the ineffective oversight by the FDA who had been warned multiple times of the condition of the compounding laboratory and did nothing to stop it. Women should not be punished for the inaction of the FDA.
The only thing the new compounding rules do is reduce the competition for pharmaceutical companies who manufacture hormones. Because of restrictions regarding FDA oversight and the ridiculous rules regarding the geographical distance between compounding pharmacies and prescribers’ offices, I have not had access to the hormones my body needs: bio-identical hormone pellets, compounded with the proper amount of fillers my body can tolerate and balanced correctly for me. The effects of castration are beginning to re-emerge. I don’t know how I will survive. Did I mention my survival depends on these pellets? There is nothing in the human body that can compensate for the loss of ovarian hormones. When these organs are removed, hormones must be replaced from a source outside of the body. These hormones affect every single cell and organ in the body.
I want to express my gratitude for all I have learned from Elizabeth Plourde, Ph.D. and NAMS Certified Menopause Practitioner. From her, I learned more about hysterectomy, ovary removal, and the only hormone replacement that ever worked for me, bio-identical hormone pellet therapy.
More information can be found through the HERS Foundation fact page.
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Letter referenced in Part I:
From the Office of Delegate Sid Saab
Dear Ms. Braaton,
Sorry for the delay, however, there are no statutory or regulatory requirements specific to any specific type of procedure, whether elective or not. Advising a patient of all potential risks of a procedure is a standard of care issue. Standard of care is not legislated because it is so variable and depends on many factors.
Generally, a provider obtains consent from the patient to perform a procedure and in doing so informs the patient of the risks and benefits. In many situations where medical care or treatment is provided to an individual, medical professionals obtain the patient’s “informed consent.” Although there is no specific definition of informed consent, it means essentially that the patient has made a knowing decision about a medical treatment or procedure after a doctor or other health care professional discloses all the information a reasonably prudent medical provider would give to a patient regarding the risks involved in the proposed treatment or procedure. If the health care provider fails to obtain informed consent, a patient may have cause to file a complaint at the Board or a legal claim for damages.
If you would like, the Board can conduct a preliminary investigation if you file a complaint. Complaint forms are available on the Board’s website at the following link: [link no longer functions].
Can I assume that no signed consent was obtained?
In an effort to further assist you, I have also reached out to the DHMH Office of Health Care Quality (OHCQ) to see if there is a facility requirement to have documented informed consent. OHCQ is the state agency that surveys and inspects facilities.
I hope this is helpful.
(This is the second part of a series by Debbie Braaten sharing her experience with the challenges navigating the emotional and medical labyrinth which followed her 1996 hysterectomy and the revelations that followed. Read Part 1 here.)