Wednesday, November 28, 2012

Ovarian Conservation, Ethics, and Informed Consent

by Dr. Margaret Aranda




“Ovarian Conservation” refers to the practice of keeping the ovaries at the time of surgical menopause, or hysterectomy for a benign cause.  Specifically, in this case, to ‘conserve’ the ovaries, one does not take the ovaries out at the same time as a hysterectomy for a noncancerous uterus or ovary.  Please bear in mind that removing the normal ovaries equates to castration of the female. While this may seem to be a severe word, it is nonetheless a word that would be equally applied if we were talking about surgically removing the testes out of a man. And I just want you to get a picture of what we are talking about here. It's not a simple thing. It's not an easy thing. It is removing the ovaries. I think that is a big deal.  That's my opinion and I'm sticking to it. 

So how many women in America are castrated?  Well, if 40% of American women over age 45 have had a hysterectomy, and 60% of those had the ovaries removed in an oophorectomy, that means that millions of women are castrated.  It is important to know what an oophorectomy means to you.

In general, whenever any surgical procedure is to be considered, a written Informed Consent must be obtained.  Competency, or decision-making capability, is implied, and is a legal term.  Informed Consent is based on the ethical premise that you, as a patient, have autonomy.  This means that in the end, it is your body and you have the innate right to decide what you want done (or not done) to it. 

I have noticed that if a patient agrees to do what the doctor wants, then all is well and everything proceeds normally.  But having autonomy means that sometimes, a patient will not make a ‘good’ decision according to the doctors, and will instead opt for an alternative, or a non-treatment.  It is usually when the patient does not want to do what the doctors advise, that the issue of Competency comes into play.  This is an ethical issue that has long been discussed.  But the law presumes that most patients will consent to procedures that will save life or personal disability.  In case you are not able, an Advanced Directive would spell out what you did and did not want to be done if injury or illness prevented you from making your own decisions.

Failure to provide Informed Consent before performing an operation is a legal term that is called battery.  It is a form of assault, so these matters are pretty serious.  In fact, battery is not usually within the scope of medical malpractice insurance liability, as it is considered to be a wrong against society.  Punitive damages may be sought.

In cases of Medical Emergencies or legal Incompetence, the right for the patient to have Informed Consent is waived, and the physician may proceed within the boundaries of legal and medical Standards of Care.

The components of the Surgical Informed Consent as a legal document can be divided into five components:

1. It must be “informed” in that you have the capacity and ability to make the decision;
2. Risks and Benefits must be discussed in general, and
3. The Likelihood of each Risk and Benefit must be described for you as an individual;
4. You must exhibit comprehension after issues are explained;
5. Your Consent must be voluntary, without coercion, duress, or negative pressure.

The Informed Consent document will have the following parameters:
1. The patient’s full and legal name;
2. The diagnosis or reason why the procedure is indicated
3. The name of the procedure in both (a) layman’s language and in (b) surgical language;
4. The purpose or benefits of the surgery;
5. The risks of the surgery, including the risks of not having the procedure;
6. An explanation of the alternatives to the surgery, together with the risks and benefits thereof;
8. The document should be signed, dated, and Witnessed by an impartial Witness.


Older surgeons may be more prone to remove the uterus together with the entirety of the Fallopian tubes, ovaries, and cervix.  Although the risk of ovarian cancer is less than 1% (perhaps it is 0.45%), up to 60% of hysterectomies remove the ovaries.  Some cite the lifetime risk of ovarian cancer as low as 0.25%, with normal ovaries (Natural 2012). 

The sequelae of surgical menopause must be considered for the woman to have adequate Informed Consent of risks and benefits. If you are having a hysterectomy and the surgeon is taking out the ovaries too, And you don't know what "surgical menopause" is, ask your doctor.

So what is a woman to do?  The American College of Obstetricians and Gynecologists “encourages women to educate themselves about their midlife health issues and to talk with their ob-gyn about their concerns”  (ACOG Website, 2012). On this note, women should be aware that laproscopy and ultrasound of the pelvic floor and uterus are available as diagnostic tools to help assess whether hysterectomy and/or oophorectomy (removal of ovaries) is indicated.  A second opinion is valuable and warranted when hysterectomy is considered. 

With a hysterectomy and oophorectomy, the ovaries are removed and abruptly, the woman is in Surgical Menopause.  She does not have the benefit of gradual hormone loss through years of menopause, like her older counterparts who do not have surgery.  The symptoms of surgical menopause can be more severe and more prolonged. 

With loss of the ovaries, a woman’s cholesterol increases, particularly the low-density liproproteins (LDL).  I like to think of the “L”DL’s as being “Lethal”, not just “bad”.  With an increase in LDL, the surgical menopausal state makes the woman at increased risk of a cardiovascular event like a heart attack.  Heart disease is already the number one killer of women in America, leading breast cancer as the most common cause of death. 

Additional symptoms of Surgical Menopause include depression, hair loss, and osteoporosis.  The subsequent loss of endogenous testosterone production may also result in decreased libido, loss of assertiveness, decreased appetite, diminished lean body mass, decreased muscle strength.  All of these factors may be associated with a significant decrease in Quality of Life.

To boot, I tried to find one scientific reference that proved that removal of normal ovaries at the time of hysterectomy decreases the rate of ovarian cancer, versus women who did not have their ovaries removed.  One can imagine that a statistical analysis can be done, projecting the sequelae if every woman over 40 who has a hysterectomy also gets her ovaries removed.  The theoretical study suggested that over 1000 cases of ovarian cancer/year could be prevented.  Let’s put that in comparison with another study, which was actually performed.

There was a study that compared women up to age 65 for hysterectomy, looking at those who kept their ovaries, and those who had them removed.  They found that in women under age 55 who removed their ovaries, there was an increased mortality of 8.6% by age 80 (Shapiro 2006).  Also, it is thought that because the uterus no longer “talks” to the ovaries after hysterectomy, leaving the ovaries in results in less ‘uterine stimulation’.  Thus, hysterectomy without ovary removal actually does decrease the incidence of ovarian cancer by up to 50%.   This concludes the matter in the respect of cardiovascular risk and ovarian cancer, because the ovaries can still produce small amounts of estrogen, progestin, and testosterone for up to 10 years past the onset of menopause. So even a small amount of hormone production appears to be beneficial to coronary artery disease, bone density, and sexual libido.  Up to age 65, leaving the ovaries in with a benign hysterectomy has been a general recommendation since 2005 (Parker 2005). So this thought of "ovarian conservation" is not new, but why is it that it seems so new?  Perhaps it is because we are increasing awareness, and ladies, that is a good thing.

Bear in mind that if you have a history of ovarian cancer in your family, these results do not matter.  It is recommended that you undergo oophorectomy, or removal of the ovaries.  Hands down, no one wants you to keep your ovaries.  Also, if you have had breast cancer or have a family history of breast cancer, getting your ovaries out will decrease your incidence of breast cancer recurrence.

In my studies of this issue, I gained perspective of the surrounding issues that once again, focus on this decision being individual and based on the family history, age, and particulars of each woman. 
The lifetime risk of ovarian cancer can be 1 in 70.  But here's one thing you may not know: Over age 40, the risk of ovarian cancer decreases to 1 in 100 women (Reichman 2006).  This is a significant decrease, so that Age is an important factor in determining lifetime risk. Put this in comparison with the studies that show that every 37 seconds in America, some one is dying from cardiac disease.  Women without ovaries who are not on hormone replacement therapy are at risk of dying from heart disease and this is not acceptable. 

So this is what I learned:



Age
Family History
Risk Factors
Number of Childbirths
Breastfeeding
Increases Risk
Decreases Risk
Over 40





X

Hx of Ovarian Cancer



X


Several Relatives have Colon or Breast Cancer



X



You used fertility drugs for > 6 mo and they did not work


X



Never using birth control pills


X



Never having a full-term pregnancy


X



Obesity


X



Diet high in animal and milk fat


X




2 or more


X




Breastfed your children

X


Positive Genetic Testing, BRCA Gene


X









Figure.  Risk of Ovarian Cancer for Women.  Ovulating over and over again, with eggs released over and over again…this is what is thought to increase the risk of ovarian cancer.  If you have used OCs for 2 years, you decrease your risk by 40%.  If you have used OCs for > 10 years, you decrease your risk by 80%.  BRCA gene mutations may place a woman at an increased 40% risk of ovarian cancer.  The risk of “hormonal shock” with ovary removal at the time of hysterectomy has to be weighed into this major Quality of Life decision. Hx = history; OC = Oral contraceptives. 


The decision to take or leave the ovaries at the time of hysterectomy is based upon ‘absolute’ reasons for removal, such as a history of ovarian cancer in the family, history of breast cancer in the patient (see Table).   Without an absolute reason for removal, it is suggested that each patient discuss the issues with her surgeon, looking at absolute risk factors and quality of life factors.  Additionally, a second opinion is recommended for hysterectomy due to non-cancer, and perhaps any major surgery.


Here is an excerpt from a 2005 Abstract summary of research, by WH Parker, et al:

Approximately 78% of women between the ages of 45 and 64 years have prophylactic oophorectomy when hysterectomy is performed for benign disease to prevent the development of ovarian cancer. However, after menopause, the ovary continues to produce androstenedione and testosterone in significant amounts and these androgens are converted in fat, muscle, and skin into estrone. Evidence suggests that oophorectomy increases the subsequent risk of coronary heart disease (CHD) and osteoporosis and whereas 14,000 women die of ovarian cancer every year nearly 490,000 women die of heart disease and 48,000 women die within 1 year after hip fracture. PubMed and the Cochrane database were used to identify studies that examined the incidence of disease and mortality from 5 conditions that seem to be related to ovarian hormones: CHD, ovarian cancer, breast cancer, stroke and hip fracture, and also data for death from all other causes. The data were applied to a Markov decision analytic computer model to calculate risk estimates for mortality from these conditions until the age of 80. The model shows for a hypothetical cohort of 10,000 women undergoing hysterectomy and who chose oophorectomy (vs. ovarian conservation) between the ages of 50 and 54 [without estrogen therapy (ET)], that by the time they reach age 80, 47 fewer women will have died from ovarian cancer, but 838 more women will have died from CHD and 158 more will have died from hip fracture. Therefore, the decision to perform prophylactic oophorectomy should be approached with great caution for the majority of women who are at low risk of developing ovarian cancer.”

I am aware that the articles referenced and the practice of hysterectomy and taking out the ovaries, too...well, those are two different stories. I am not here to upset the cart but to inform.  In informing, I realize that there are many, many women who may have had their normal ovaries out during a 'routine' hysterectomy. And I'm fairly certain that this article has the potential to create a lot of emotion. 

We are speaking about an emotional topic. It's not just anatomy. It's not just physiology. It is a representation of womanhood, and surgical menopause is not a simple thing to undergo. For many women, it is traumatizing and it leaves more than just little permanent scars from the laparoscope. 

For many women with surgical menopause, there is hair loss, bone decay, cardiac disease, depression, hot flashes, insomnia, weight gain, and a myriad of other symptoms. We can't change the fact that you have had your ovaries removed. No one can change the past, and we can't contemplate the 'what if's' for too long or else it is counterproductive.

Don't beat yourself up if circumstances are beyond your control and even if mistakes were made. For our own good, we have to move forward, persevere, and gain something today and tomorrow.  

So what is a woman to do? Well, you can start by leaving a comment. Let's take it one step at a time and see where it leads us.  We are women. We are together.


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Dr. Margaret Aranda's Books:

No More Tears en Espanol
Face Book Page: Stepping from the Edge
Little Missy Two-Shoes Likes to go to School
From Menarche to Menopause: A Journey through Time



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References:
ACOG Website, 2012.  http://www.acog.org/

National Cancer Institute.    A guide to understanding informed consent. National Cancer Institute. 03/24/2006.  http://www.cancer.gov/clinicaltrials/learningabout/patientsafety/informed-consent-guide/Page2

Natural-Progesterone-Advisory-Network.  The role a woman’s ovaries play after menopause. 2012.  http://www.natural-progesterone-advisory-network.com/the-role-a-womans-ovaries-play-after-menopause/

Parker WH, et al.  Ovarian conservation at the time of hysterectomy for benign disease.  Obstet Gynecol.  2005 Aug;106(2):219-26.  http://www.ncbi.nlm.nih.gov/pubmed/16055568

Raab, Edward L.  The parameters of informed consent. Trans Am Ophthalmol Soc.  2004; December 102:225-232.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1280103/

Shapiro S.  Does retention of the ovaries improve long-term survival after hysterectomy?  The validity of the epidemiological evidence.  Climacteric.  2006 Jun:9(3):161-3.  http://www.ncbi.nlm.nih.gov/pubmed/16766428


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Age 31: The Color Blue




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Dr. Margaret Aranda's Books:

No More Tears en Espanol
Face Book Page: Stepping from the Edge
Little Missy Two-Shoes Likes to go to School
From Menarche to Menopause: A Journey through Time


To Pre-Order the official book, No More Tears, Click Here

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Full Disclosure: Margaret A. Ferrante, M.D. receives no monetary compensation for hosting this website you are on, which is independent and not affiliated with Cenegenics. The information presented is for education and awareness.  Dr. Ferrante used to see patients out of the Cenegenics office in Beverly Hills, CA. 

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