informed consent

The FDA Legacy: A Dereliction of Duty

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informed consent

 

“Meet the new boss. Same as the old boss.” 

– The Who (Pete Townsend, Songwriter), 1971

The FDA recently finalized its ruling to ease informed consent requirements for “Minimal Risk Clinical Investigations.”

As you might expect, legacy media turned a blind eye. Admittedly, “easing requirements” and “minimal risk” do not readily inspire hard-hitting headlines, but this is precisely the type of ruling that should, at the very least, give us pause.

The entirety of our faith in the medical system relies on two tenets. First, we assume the precepts of informed consent provide a guaranteed layer of protection for both patients and test subjects of scientific research. Second, we assume that doctors take an oath to “first, do no harm.”

So, before we simply dismiss this new ruling as inconsequential, let’s first look at the system in which we have placed such great trust.

Is it Hippocratic or Hypocritical?

We will begin with the latter since it is easier to tackle. Most of us outside the medical industry still tend to think that the Hippocratic Oath is as much a part of becoming a doctor as spending time in a residency program. However, that is not the case, and a recent survey of over 2,800 physicians and medical students confirmed an alarming trend for those of us who may take a bit of comfort in the oath.

Among doctors 65 and older, 70% said the oath was very meaningful, while less than 40% felt that way among those physicians under the age of 35. Of the younger group, nearly one out of every five said the oath was not meaningful at all.

Does this mean the young doctors and medical students lost faith in the oath? Not necessarily. One doctor’s comment suggests he may have lost faith in the system. He wrote that the oath is “sadly, irrelevant. Medicine has evolved from a profession into a huge service industry that involves many other players. These players, like health insurance, hospital employers and pharmaceuticals, do not pray to the same god as the medical profession. Their priority is financial profit ― within or without the Hippocratic Oath.”

The Evolution of Informed Consent

The dubious state of medical oaths means our safety depends much more on informed consent.

The concept of informed consent began to evolve very slowly after the creation of the Food and Drug Administration (FDA) in the early 1900’s. At first, a smattering of landmark lawsuits began to highlight the need for greater protections for patients and test subjects. Some of the lawsuits revolved around doctors going rogue, while others delved into the intricacies of health illiteracy and a patient’s need for more complete information delivered in layman’s terms.

As so often happens within bureaucracy, the FDA recognized the need for better regulations, but potential solutions floated around nebulously in the ether until things reached a breaking point on the global stage.

A Serious Catalyst

Nothing could have demonstrated the need for informed consent in medical research more than the atrocities committed by Nazi doctors in World War II. The subsequent Nuremberg Trials put the world on high alert. Across the globe, citizens were horrified to witness the depths of depravity that human souls could engage.

At the conclusion of the trials in 1947, the judges issued what is now known as the Nuremberg Code, a document outlining ten essential points necessary for any medical trial to be permissible. The first principle of that code states, “The voluntary consent of the human subject is absolutely essential.”

The authors added further context to reinforce the absoluteness of their statement, “…before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.”

In No Hurry

The FDA followed this up with an amazing display of inertia. In fact, it would be another decade before a judge (once again, it was the judicial system rather than congress or the agency) coined the term “informed consent” in a ruling against a doctor who paralyzed a patient with a procedure after not properly warning him of the risks.

It took two and half more decades, 1981 to be exact, for informed consent to be codified in U.S. federal law through coordinated policies of the FDA and the U.S. Department of Health and Human Services.

The most devilish of Devil’s advocates might argue that the war crimes occurred under a despot in Germany. So, why would a federal agency in the U.S. feel any pressure to react?

Well.. it is precisely what did happen on this soil that makes their lethargic approach to patient protection all the more jarring.

Lesson Learned

Around the same time a judge in California gave “informed consent” its name, the Merrell drug company pressured a young Pharmacology Ph.D. at the FDA  to approve a new drug, but she refused, citing a lack of evidence. Despite their repeated attempts to strong-arm her, Dr. Frances O. Kelsey never signed off on thalidomide. Her tenacity likely saved tens of thousands of Americans from suffering horrific birth defects and earned her distinguished recognition from President John F. Kennedy. I wrote about these events in greater detail in my book, In the Name of The Pill.

The close call with Thalidomide left many in Congress more concerned than ever about ineptitude at the FDA. The resulting legislation, the Kefauver-Harris Drug Amendments, gave the FDA more control over the approval process and required the drug companies to report adverse reactions. The amendments also put a greater emphasis on proving the efficacy of a drug during clinical trials.

Not So Much 

Undoubtedly, when Congress approved Kefauver-Harris, they recognized that the thing that made Dr. Kelsey’s story unique was not that she was being strong-armed by a drug company, but that she stood her ground. 

In fact, the similarities (which would not become public until much later) are eerie when compared with the details of the approval of another potent drug, hormonal birth control. Dr. John Rock went on record to boast about how he browbeat the FDA into approving The Pill despite insufficient safety data.

Ironically, when the FDA later assembled a committee to investigate whether The Pill had ever been proven safe, it would be the greater emphasis on efficacy imposed by Kefauver-Harris that the committee chairman would contort to give a friendly nod to The Pill.

When Dr. Louis Hellman was appointed chairman of this FDA advisory board, his cozy relationship with the drug companies was not yet obvious. However, by the time the Nelson Pill Hearings rolled around in 1970, it was clear that Sen. Gaylord Nelson held a level of contempt for Dr. Hellman’s lack of ethics as a shill for the drug companies.

During the hearings, Sen. Nelson pointed out that, despite having issued a chairman’s statement that The Pill was “safe within the intent of the law (Kefauver-Harris),” Dr. Hellman had previously lamented that the committee had to come up with the “right” statement. They had to issue an opinion, but if they stated that the drugs were not safe, the FDA Commissioner might have to take them off the market. They needed some way to affirm that The Pill was safe enough, although their “scientific data did not really permit that kind of statement.”

Coordinated Entropy

There is a basic law of entropy, which states that any spontaneous process will tend toward greater entropy (disorder) over time. But, that is a spontaneous process. When it comes to medical research, the entropy seems to be engineered as a direct affront to law and order.

Anytime Congress or a regulatory agency tries to define a suitable order for their practices, the drug companies skate right up to the newly drawn line and begin testing it – first sticking a hand over the line and then a foot. Before you know it, they have Hokey Pokey’ed their way back into business as usual.

Consider that in the wake of Nuremberg, Dr. Gregory Pincus conducted hormonal birth control trials in Puerto Rico, in which the women were not told they were participating in a trial. Five of those healthy, young women died and were buried without autopsies because the doctors believed their little miracle pill could not have been a factor. And, when 65% of the women complained about the side effects, Dr. Pincus dismissed the complaints as psychological in nature because of the “emotional super-activity of Puerto Rican women.”

The history of shameful trials do not end with Dr. Pincus. In 1966, Dr. Henry Beecher cited dozens of examples of dubious medical practices to highlight the need for stronger protections. Shockingly, many of his colleagues ostracized him, calling his accusations a “gross and irresponsible exaggeration.”

Mounting Evidence

Examples from Beecher’s Bombshell, as it became known, included instances of doctors transplanting melanoma into healthy patients, withholding penicillin from soldiers, and infecting disabled children with hepatitis to study the disease.

Other well-known instances of less-than-ethical medical practice and research include:

Mississippi Appendectomies, where minority women were surgically sterilized without their consent.

Tuskegee syphilis study, a 40-year non-therapeutic “study” that documented the affects of untreated syphilis on black men in the deep south.

Milgram Experiment, a troubling study of obedience to authority where subjects believed they were administering shocks to people they had just met, potentially to the point of death, in order to satisfy the commands of an authority figure.

Whether these examples are the exception, the rule, or somewhere in between, they do confirm one thing. Medical professionals with no moral compass pose a threat from which we, the public at-large, need to be protected. The only solution is informed consent, without mitigation.

Same Difference

History shows us we need to be concerned about doctors who would push back against informed consent – even if their language says it is only relevant to matters of “minimal risk.”

Doctors developing The Pill were convinced they were only affecting ovulation, and would have, no doubt, argued it posed minimal risk.

Somewhere in the USA, a doctor injected hepatitis into children because, oh well, they’re already disabled.

Somewhere in the USA, doctors performed full hysterectomies on black women because they were deemed unfit.

Somewhere in the USA, a doctor intentionally transplanted cancer into healthy patients.

Dr. Beecher ultimately ended up with hundreds of examples of research gone wrong. He struggled to understand how these “men of science” could willingly “cause harm to patients with no possibility of benefit.”

It would be foolish to assume that doctors like this no longer exist. They personify the reason we should not be chipping away at the policies that protect us. Where will these “little” changes end? And that question is precisely why this new ruling is indeed newsworthy. The legislation was already amended to allow for an exception to informed consent in life-threatening situations, when “it is not feasible to get the consent of the subject or the subject’s representative.”

The new ruling also suggests that the FDA will be taking a very hands-off approach to defining what constitutes “minimal risk.” The power to waive informed consent requirements based on minimal risk now resides in the hands of Institutional Review Boards (IRBs), meaning that a board designated by the very institution wishing to perform the study will be interpreting the meaning of “minimal risk.” Conflict of interest much?

Maybe it is no big deal that they already eliminated protections for the most extreme cases, and now they are eliminating protections for the least extreme cases. Maybe it is no big deal that we are going to have to trust researchers to define what falls into that still-protected middle ground. But, maybe it is a big deal.

On another note, the quote at the beginning of this article comes from a song titled, Won’t Get Fooled Again.

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Hysterectomy Experiences: Misinformation and Lack of Consent

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Gynecologic surgeries, namely hysterectomy (uterus removal), oophorectomy (ovary removal) and C-sections, are the top overused procedures in the U.S. Only 10%, at most, of hysterectomies (and probably fewer oophorectomies) are considered necessary as cited in the “Hysterectomy Facts” section of this article. The 90% “elective” rate would indicate that these surgeries are “restorative” or at least harmless, but medical literature and women’s experiences prove otherwise.

A few years ago, I began writing for Hormones Matter about the consequences of hysterectomy and oophorectomy. Year after year, these posts generate tens of thousands of views and hundreds of comments. The comments inevitably follow the same pattern. The surgery was recommended or sometimes forced on a woman for reasons that are not typically medically warranted suggesting that many gynecologists use unethical and fraudulent tactics, such as those discussed here and here.

Worse yet, after the surgery any negative effects are dismissed by the doctors as unrelated or untreatable. This leaves women fending for themselves. With the internet, she finds us and discussions ensue. We thought it was time to highlight those comments, to show what women are saying about their experiences. For the next several weeks, we’ll be re-publishing some of the most telling stories of declining health and profound feelings of betrayal after female organ removal.

Deceit and Bullying

The following comments are the most striking examples of “fraud in the inducement” which is defined as “the use of deceit or trick to cause someone to act to his/her disadvantage” as defined here. This definition goes on to say that “The heart of this type of fraud is misleading the other party as to the facts upon which he/she will base his/her decision to act.” My article here explores the con of female organ removal. The HERS Foundation wrote a blog on “fraud in the inducement” which can be found here and has 100 comments. Here is my personal story of how I was scammed. Other women who’ve written for Hormones Matter have also been given hysterectomies without (informed) consent. Their stories can be found here, here and here.

The first comment listed below is the most glaring example of fraud, as the doctor fabricated the woman’s fibroids and was deceitful about her ovarian cyst. Thankfully, the woman sensed that she was being played and did not fall into his trap. It’s so important that women get their medical records and do their own research. But, unfortunately, medical records cannot always be trusted either so we can’t count on them to protect us from fraudulent tactics as evidenced in this first comment. This woman’s gynecologist lied in her medical records to protect himself. My medical records from both my gynecologist and my gyn oncologist contained lies as did those of many women with whom I’ve connected.

Donna writes:

“When I was 41, I had a couple of irregular periods but otherwise I had never had any gynecological problems…. So, I went to an OB/GYN who was VERY well known and popular in my city… he examined me and said my uterus was the size of someone at 3 mos. pregnancy. A couple of days later, I was back in his office to discuss the results. As soon as he walked in, the first words out of his mouth were, “You need a hysterectomy.” I was taken aback, but thought to myself, okay–maybe. I said, “Is it fibroids?” And he said, “Yes! Multiple fibroids. And a cyst on your ovary.” I still couldn’t really believe it, but went on with the visit. He asked for permission to “go ahead and take out my ovaries if during surgery he sees that they’re bad.” What? I said, “okay—I guess.” But I wasn’t really buying all of this. He told me to plan on “a nice six-week vacation,” and he proceeded to set up the surgery for the following Wednesday, just five days from then. I left being very skeptical…So I called his office the next day and told the nurse that I was not going to have the surgery and the doctor called back almost immediately asking why. I asked him some questions (based on my reading) that he should know: What kind of cyst was on my ovary? I had read that most women have functional cysts on their ovaries during every menstrual cycle, then they dissipate. The doctor can tell what kind of cyst it is on the sonogram. What options are there besides surgery? He was agitated and said he didn’t know what kind of cyst it was until he got in there (lie) and “there are no other options”! (another lie). He said that if I wanted a second opinion, then go get one. So I did. I went to… saline sonogram of my uterus, which would give an even better picture. Imagine my surprise when the results were NO FIBROIDS whatsoever! And, it was indeed a functional cyst. The former doctor outright lied about the whole thing. I wrote him a letter and told him my results that I had no fibroids and to let him know that I know he lied. I asked for my medical records, and on them on the date of my exam, he had written his recommendation for surgery and “all options discussed with patient.” Another horrible lie. Unfortunately, just about every person I know who goes to him has had a hysterectomy. And none of them had cancer or anything very serious. It’s chilling, too, to hear them tell the story because the doctor uses the same phrases that he used on me. That was 15 years ago; today I’m 56 and have gone through menopause naturally, and I never had any other issues. It was simply irregular periods in the beginning perimenopause stage. My doctor at… told me this. The former doctor never once mentioned that it could be perimenopause. I’m hoping more women will question and stand up against a diagnosis that just doesn’t seem right or make sense, just because a doctor is telling them it’s so. Always get a second or even third opinion!”

Marie writes:

“This was never what I wanted. I went for medical attention…. After an MRI, the next day my family and I were told that I had to have an emergency hysterectomy and possibly my colon…. PLEASE help STOP this modernized form of sterilization of woman!!!!”

From Marlo:

“Oh wow. I feel so duped. I had no idea about all these problems after having a total hysterectomy…. I thought everything would be so much better after this. That is what my new OBGYN made me feel like.”

Rachel:

“I had numerous promises and scare tactic talk used on me. I would give anything to not have the surgery. I am slowly dying from… and no doctor will help me.”

Jacqueline:

“I had the same disgusting lied to procedure done to me two years ago. Why do doctors castrate woman. Why. It makes no sense at all. Why do they cut out our sex organs? Why do they disable us?… Every woman who has this done has been harmed and brutilized…. Even rapists are treated better.”

Donna:

“I am truly horrified to read these stories…. They all say the same thing (especially if you’re over 40), that “you don’t need your reproductive organs anymore if you’re done having children.” This is an absolute lie… the doctors are very intimidating and we find it hard to question what should be their expert opinion that’s in the patient’s best interests (not their wallet’s).

Robin:

“I refused to sign a consent for a ‘complete’ hysterectomy and was promptly knocked out so one could be performed regardless of what I needed or wanted or even agreed to! So, I knew immediately upon waking up in recovery what had been done to me…. I didn’t begin to understand how drastically my life would change from that moment on….”

Amanda:

“I too was told more likely than not you have cancer. …gyns are so quick to just to yank everything out…. Additionally, they don’t fully explain options nor explain how serious the surgery will be….”

Shanda:

“I was told I would feel better… but unfortunately… I do not… the worse I have ever felt….”

Elissa:

“I too had a hysterectomy and was told how great I would feel.”

Sunny:

“I had robotic Laproscopic hysterectomy on 10/15/15…. I was told “you will feel like a new person after the hysterectomy.” They were so wrong! I feel 10 times worse…!”

Elaine:

“Surgeon basically told me I had to have a hysterectomy, I had gone through menopause so I was not using it anyway.… I feel I was not thoroughly informed and this surgery was the biggest mistake!”

SG:

“… it is too late for me.… I had a hysterectomy 4 years ago… the gyno decided it was necessary… and later told me he found a few nasties down there… I never received any pathology results to indicate this….”

Rebecca:

“Was advised the only option was a total hysterectomy had it on 6th February 2014.… I can’t cope anymore.”

KME:

“Looking back I remember my OB matter of factly telling me that surgery was really my only option and cheerfully started to schedule the procedure right then and there during the initial exam.”

Elissa:

“I too had a hysterectomy and was told how great I would feel… my bones hurt! My whole body hurts! I have more spider veins in my legs now than I remember my grandma having when she was 70.”

Convenient Omissions

More frequently than not, it appears physicians fail to inform women of the potential side effects.

F D:

“I feel very angry that I was never told of these very debilitating side effects.”

Gail:

“My life changed the day I went to a women doctor who did not disclose everything when she recommended a total hysterectomy for me due to a bladder prolapse.… Doctors seem ill equipped or unwilling to spend time to explain thoroughly the consequences of having your lower organs removed. Somebody do something!!!!!!!!!…please.”

Nicole:

“I wish I would have known about all of this prior to the surgery so I could have passed on having a complete hysterectomy….”

Sharon H:

“Oh how I wish I knew all this before my surgery. I would NEVER have had it done.…”

Irene:

“I was never advised about the negative. MY BIGGEST REGRET IN LIFE IS HAVING This TOTAL HYSTERECTOMY.”

Theresa:

“Like others my gynecologist never explained all the side symptoms to me. Had I known I would’ve just removed my fibroids ONLY.”

Elizabeth:

“I had a partial hysterectomy several years ago…. If I had known all this before the hysterectomy I wouldn’t have had it.”

Nora:

“I had a TAH in December. The surgery shortened my vaginal canal by 3 inches. After 27 years of marriage I am unable to have sex. I feel castrated. Can this be reversed? I never knew this could happen.”

Pat:

“I had total hysterectomy 7 years ago due to fibroids. I still regret having it…. I feel duped because the doctors never mentioned the sex disadvantage. I wish someone had told me.”

S M:

“Can’t believe what I have read – I match your situation entirely. I feel so let down by my consultant, these changes to my sexuality were never suggested to me…. I feel numb, panic stricken and so very sad.”

KME:

“I was never told about ANY possible adverse short or long term complications from the surgery, especially long term anatomical changes. Nor was I offered any other choice than the surgery or an unwieldy and painfully uncomfortable pessary….”

Barracuda:

“Oh and you’re totally right about patients not being informed, I went in blind! Went home blind too. I had a short, vague pamphlet that didn’t really answer anything directly about what to expect….”

Julia:

“Again, none of the potential problems, nerve damage and prolapse are not mentioned in the usual hysterectomy surgical blurb. I asked specifically about hormones etc and was assured my remaining ovary would be doing the work of both but in the off chance it didn’t hrt would do the job. Of course I know now that one form of hormone can never replace the delicate balance of multiple hormones….”

Marlo:

“I feel like I am 90 years old when I sit for a while and then get up I cant even walk because the hip joint pain is so bad…. I did not have any idea about the physical changes that are now going to take place.”

Sharonj:

“So I trusted my Doctor and didn’t search on the internet for the side effects of a hysterectomy. I wish I would have… I wouldn’t be where I am today. I guess that means I’m twice the moron.”

Yvonne:

“I came across [sic] this site while once again researching all my post op problems from my recent hysterectomy…. I wish I would have know before how I was going to feel.”

Dismissal of After Effects

When women question their doctors before surgery about various negative effects, they are typically told that the negatives they’ve heard or read about are “nonsense” or rare. When they experience these after surgery, they are typically dismissed as unrelated.

Sharonj:

“My doctor and her nurses told me to avoid the internet so I wouldn’t be scared with any horror stories. The thing is, 4 years post-op and my story is darn near identical to the ones I found here. The endometriosis I had my whole life (I’m now 46) was a cake walk compared to the hell I’m in now!”

Sunny:

“your symptoms do not sound like they are from your surgery… maybe you should see a neurologist.”

DM:

“This is a fantastic piece. So much detail and so much supporting data…. Only wish I’d seen it before my surgery… though I suspect my doctor would’ve told me it was all nonsense.”

Marie:

“I have severe pain I am dealing with, especially on my spinal cord. The surgeon claims it has NOTHING to do with the surgery, but I did NOT have it prior to the surgery. PLEASE help STOP this modernized form of sterilization of woman!!!!”

Post-Surgery Medical Abandonment

Consistently, women express that once after effects emerge post-surgery, their doctors are less than helpful.

Sunny:

“My surgery date was 10/15/15. Felt really great up until last week of January 2016…. Noticed drastic, sudden sharp pain from my lower back shooting around the sacrum, up into my spine, all the way to my neck and head. I am in so much pain all day everyday and nothing helps whatsoever. Naturally my GYN got his money out of me and conveniently he is all booked and per his nurse… ‘your symptoms do not sound like they are from your surgery in October 2015– maybe you should see a neurologist.’”

WS:

“It became clear very quickly that I had become a different person. I felt like my HEART and SOUL were removed in that operating room. Despite being prescribed estrogen, everything fell apart. I quickly spiraled into a suicidal depression… with a lengthy list of symptoms of hormonal deficiency and endocrine havoc…. Yet a call to my gynecologist/surgeon resulted in being told ‘we’ve never heard of those problems before’ followed by the phone being hung up. He’d now abandoned me as his patient despite having been under his care for 20 years….”

Suz:

“… Doctors don’t seem to want to help and didn’t explain all this beforehand.’

Rachel:

“I would give anything to not have the surgery. I am slowly dying from worse pelvic pain, new severe symptoms, adhesions and no doctor will help me.”

Robin:

“I contacted my gynecologist and told him. I begged him to help me…. I was told to find another doctor since I had so many problems.”

ATH:

“I went back to my obgyn (more than once) and was blown off and told pain was common and would go away on its own.”

When Will it End?

These surgeries have been largely unnecessary since their inception in the late 1800’s. There have been efforts by various organizations as well as Congressional hearings, one in 1978 and one in 1993 but still the problem persists. About half of all women will end up having a hysterectomy. And 55% to 73% of them will also have a healthy ovary or ovaries removed. Those are shocking statistics! You can hear the desperation in some of the aforementioned comments. Unfortunately, our voices are also silenced on some of the hysterectomy forums such as the hysterectomy “sisters” site, the UK Patient.Info site and a Surgical Menopause site. The many women’s health organizations seem to only care about women’s “reproductive choice” (access to birth control and abortion). (They probably don’t want to alienate the gynecologists.) The following comment sums it up:

Someone Who Cares:

“After 40 years of enduring this “disabled” existence, it breaks my heart that no matter how many of us try to warn other women, in various ways, the number of these destructive surgeries continues to increase, not decrease.”

A complete list of my articles can be found here. The HERS Foundation is a good resource for understanding the life long functions of the female organs. It also has a lot of information about gynecologic conditions and treatment options. These two sites, Gyn Reform (especially the studies/citations link) and Ovaries for Life, are excellent resources about the gross overuse and harm of ovary removal or loss of ovarian function after hysterectomy.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter.

This article was first published on October 13, 2016.

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Endometrial Ablation – Hysterectomy Alternative or Trap?

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Endometrial ablation seems to be the latest “bag of tricks” in the treatment of women’s gynecological problems. It is an increasingly common procedure used to treat heavy menstrual bleeding. The procedure is premised on the notion that if the endometrial lining is destroyed – ablated – bleeding can no longer occur. Problem solved. But is it? Does endometrial ablation work? Does it resolve the heavy menstrual bleeding and prevent the “need” for a hysterectomy as it is marketed, or does endometrial ablation cause more problems than it solves? The research is sketchy, but here is what I found.

Short-term Complications Associated with Endometrial Ablation

For any surgical procedure there are risks associated with the procedure itself. Here are the short-term complications for endometrial ablation reported in PubMed: pelvic inflammatory disease, endometritis, first-degree skin burns, hematometra, vaginitis and/or cystitis. A search of the FDA MAUDE database included complications of thermal bowel injury (one resulting in death), uterine perforation, emergent laparotomy, intensive care unit admissions, necrotizing fasciitis that resulted in vulvectomy, ureterocutaneous ostomy, and bilateral below-the-knee amputations. Additional postoperative complications include:

  1. Pregnancy after endometrial ablation
  2. Pain-related obstructed menses (hematometra, postablation tubal sterilization syndrome)
  3. Failure to control menses (repeat ablation, hysterectomy)
  4. Risk from preexisting conditions (endometrial neoplasia, cesarean section)
  5. Infection

Long Term Complications of Endometrial Ablation

Endometrial ablation to block menstruation. In order to understand the long-term risks of endometrial ablation, one must understand the hormonal interaction between the uterus and ovaries. The endometrial (uterine) lining builds and sheds in response to the hormonal actions of the ovaries. Ablation scars the lining impeding its ability to shed. But ovaries continue to send the hormonal signals necessary for menstruation and the uterus attempts to function normally by becoming engorged with blood. The problem is, the blood has nowhere to go. It is trapped behind the scar tissue caused by the ablation. This causes all sorts of problems.

Retention of blood in the uterine cavity is called hematometra. If the blood backs up into the fallopian tubes it’s called hematosalpinx.  Hematometra and hematosalpinx can cause acute and chronic pelvic pain. Some data suggest that about 10% of the women who have had endometrial ablation suffer from hematometra. The pelvic pain in women who’ve undergone both tubal sterilization and ablation has been coined postablation-tubal sterilization syndrome.

“Any bleeding from persistent or regenerating endometrium behind the scar may be obstructed and cause problems such as central hematometra, cornual hematometra, postablation tubal sterilization syndrome, retrograde menstruation, and potential delay in the diagnosis of endometrial cancer. The incidence of these complications is probably understated because most radiologists and pathologists have not been educated about the findings to make the appropriate diagnosis of cornual hematometra and postablation tubal sterilization syndrome.”  Long term complications of endometrial ablation. 

So although ablation can have the desired effect of reduced or even absent bleeding, it can be a double-edged sword. This relief from heavy bleeding may, in the long-term, be overshadowed by chronic, debilitating pain caused by the ongoing, monthly attempts by the uterus to build and shed the lining.

Ablation leads to hysterectomy in younger women. The younger a woman is at the time of ablation, the greater the risk of long-term problems that can then lead to hysterectomy. A 2008 study in Obstetrics & Gynecology found that 40% of women who underwent endometrial ablation before the age of 40 years, required a hysterectomy within 8 years. Similarly, 31% of ablations resulted in hysterectomy for 40-44.9 year old women, ~20% for 45-49.9 year old women and 12% of women over the age of 50 years required a hysterectomy after the endometrial ablation procedure.

Another study, reported a similar link between endometrial ablation and hystectomy. “On the basis of our findings one third of women undergoing rollerball endometrial ablation for menorrhagia (heavy menstrual bleeding) can expect to have a hysterectomy within 5 years. If the linear relationship noted during the first 5 years is extrapolated, theoretically, all women may need hysterectomy by 13 years.”

Post ablation tubal sterilization syndrome. A 1996 study of 300 women who underwent ablation found an array of pathological changes in the uterus including: hematosalpinx, endometriosis, chronic inflammation of the fallopian tubes, and acute and chronic myometritis. Eight percent of the women developed intense cyclic pain that necessitated a hysterectomy within 5-40 months post endometrial ablation.

Informed Consent That Isn’t

Recently, Hormones Matter has begun to explore the legalities of the medical informed consent, here and here. With all the adverse effects associated with endometrial ablation, especially the need for hysterectomy later, one must question whether women are informed about those risks. As I have found when investigating this topic, there are few long term studies on endometrial ablation. Many of the articles cited for this post come from paywalled journals that are not readily available to either the patients or the physicians – the costs are prohibitive for both. So it is not clear whether the physicians performing these procedures are aware of the long-term risks associated with ablation. And as one physician suggests, neither the pathologists nor radiologists responsible for diagnosing post ablation pathology are trained to recognize these complications. Without data or access to data and without training, one wonders whether it is even possible to have informed consent for a procedure like ablation.

You know the sayings “never mess with mother nature” and “you never know what you’ve got ’til it’s gone?” We need to heed those words at least when it comes to treatments that can’t be reversed or stopped! At the very least, we have to become thoroughly educated about the risks and benefits of any given medical procedure.

This post was published originally on Hormones Matter in May 2013.

 

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Risk Communication and Hormonal Contraceptives

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birth control pill risk label

When it comes to the dangers associated with hormonal contraceptives, how is risk communicated to women? Back in the 1960s when the pill first came out, only the doctors and pharmacists received the information pamphlet included with birth control pills. The burden was on them to decide what information to share with women and what information to omit. This was a central theme of the 1970 Nelson Pill Hearings. What are the risks of the birth control pill and how do we inform women of these risks? Here is testimony from several experts about the issue of informed consent.

Dr. Hugh Davis (page 5928): “In many clinics, the pill has been served up as if it were no more hazardous than chewing gum. The colorful brochures, movies, and pamphlets which are used to instruct women about the pill say next to nothing about possible serious complications. The same can be said for the veritable flood of articles in popular magazines and books which have convinced many women that there are few satisfactory alternatives to these steroids and that careful studies have proved there is little or no risk to life or health in the pill… It can be argued that the risk benefit ratio of the oral contraceptive justifies their use under certain circumstances, but it cannot be argued that such a powerful medication should be administered without the fully informed consent of each woman.”

Dr. Roy Hertz (page 6039): “My view would be that the application of these medications in their present state of knowledge constitutes a highly experimental undertaking. That the individual called upon to take these materials, particularly for prolonged period of time, should be regarded as, in effect, a volunteer for an experimental undertaking. I think she should be so informed.”

Dr. John Laragh (page 6167): “I think we have to do everything we can to simplify communication, to use education, to use techniques of repetition, to simplify the package insert. We can only go ahead in this area, and with many other powerful drugs… by full disclosure.”

With so many doctors insisting that women be informed of the risks of using hormonal birth control, we now have concise, unbiased, and easy-to-read risk information that comes with every package. Or do we?

Modern Risk Communication for Hormonal Birth Control

Because of my experience of having a stroke caused by hormonal birth control, I used my master’s thesis to investigate how drug manufacturers communicate the risks of taking birth control pills with respect to blood clots. Specifically, I was interested in determining whether the package inserts fully disclosed the risks for blood clots and whether/how women were informed of these risks by their physicians. The first part of my research assessed the risk communication, provided by the manufacturers, for three different types of hormonal birth control. This included reviewing the warning materials included with each packet of pills and determining whether the following information was included:

  • Did the information state that blood clots are a risk of taking this medication?
  • If so, did the information state that genetic disorders can increase the risk of blood clots?
  • Did the information list symptoms of a blood clot?
  • Did the information tell women with symptoms of a blood clot what to do in that situation (i.e. go to the emergency room, etc.)?

In addition to these questions, each insert was given a general overview of content, design, and language. Language and design play important roles in the understanding of risk and benefit. “Risk information typically is presented in often-ignored smaller print; as part of a large, undifferentiated block of text… or simply hidden in plain view… Even when found and read, risk information often is missing key pieces of information that consumers need to evaluate drug risks” (Davis). Unfortunately for women, this is the case with oral contraceptives.

How are Risks Communicated?

  • All of the inserts were text heavy, used extremely small font, and were designed in such a way that the paper would need to be rotated at least twice to access all of the information.
  • All three inserts had a larger portion and a smaller, perforated portion (presumably for a woman to tear off the larger section and keep the smaller) which means a woman would have to thoroughly read both sections of the inserts fully for all of the risk information (something that is unlikely due to the redundancy of much of the rest of the information).
  • Technically, each of the inserts lists all four points of information that were examined in this study, however, clotting disorders are only mentioned in the smaller sections, while symptoms of blood clots are only listed in the larger sections.
  • Each insert has statistical information about the risks involved with taking the medication but without the disclaimer that it is based on studies run by the very company who makes the medication. (Research has shown that studies funded by pharmaceutical companies that make oral contraceptives produced more favorable results than independent studies of the same medications.)

In general, the most highlighted information on any risk communication for birth control pills is a version of this:

Do not use [pill type] if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack. This risk increases with age and number of cigarettes smoked.

I didn’t smoke and I was only 28 when I had my stroke from birth control pills. But the way this is worded leads women to believe that they are only at risk if over 35 and smoke. Which is patently false. All women who use hormonal contraception are at risk for blood clots. In fact, “the reality is that the estrogenic effects of combine hormonal contraceptives increase the risk of a potentially life threatening blood clot (venous thromboembolism or VTE) by between 400% – 700% for ALL women at any age including those that don’t smoke and those that do smoke. (Comparing Annual VTE Impact across 2nd-4th Generation CHC’s in the U.S. 2013).”

As Joe Malone points out in Five Half-truths of Hormonal Contraceptives, these types of warnings (being over 35 and a smoker) infer that if you are neither, hormonal contraceptives are perfectly safe for you. They are not. They weren’t safe for me and they weren’t safe for his daughter.

Another problem with these warnings is the conditional language stating that serious side effects “can be life-threatening.” A stroke, a heart attack, a blood clot—these things ARE life threatening. But as the research shows, conditional language like that helps give the patient confidence in the medication. After all, something like that can’t happen to me…

Would women feel as confident in their choice to use hormonal birth control if the warning accurately read: “This medication increases your risk of life-threatening blood clots by 400-700%”? Doubtful.

The Right To Know

Over 40 years ago, Dr. Edmond Kassouf testified at the Nelson Pill Hearings (pg 6121) about the information the drug companies were providing about birth control pills:

“Some of the pamphlets mislead and misinform, others are frankly dangerous, but all have one thing in common—they all seem to disparage the reader’s right to know.”

I wonder, how much has really changed?

By creating documents that are so text heavy, with dense language couched in conditional terms, in font barely large enough to read, pharmaceutical companies are clearly not designing for their audience, or any audience for that matter. But perhaps that is their intention.

 

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

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Insurance Liability and Medical Adverse Events

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medical adverse events lawsuits

In reading a blog the other day, I was reminded how little many people understand about their health insurance (or any insurance), particularly how personal insurance works when injuries or damages are caused by a person or company with legal responsibility for those injuries or damages. Insurance is a subject that for most of us, causes great pain and consternation; we don’t get it, our eyes roll back in our heads and our brains go into explode mode if we have to read an insurance contract. More often than not, we just rely on the agent or claims person to explain to us. (I understand that- because that is how I felt before I actually went to work in the insurance industry.)

Who Pays What and When

Most of us think that if we get sick or injured, we go to the doctor or hospital, pay our co-pay or deductible, and are good to go. For your average illness, or accidental injury, that is the case. However, in certain circumstances, this does not hold true. For example, if you are injured as a result of your job, you may be covered under Workman’s Compensation, and your health insurance is not responsible for your medical care and bills. Or, if you are in an auto accident and if you did not cause the accident, then the auto insurance of the person who caused it is responsible for your medical expenses. Your health insurance is only responsible for any cost above the amount of the limits that driver’s insurance policy, and/or any amount that is paid under your own uninsured/underinsured motorist coverage on your own auto policy, if you have one.

Medical Adverse Events or Injury Claims

In the case of injury/damage from a medical device or a negligent physician, your personal health insurance is not responsible for the cost of your medical care that results from that damage. And that is the issue I’d like to discuss today- the medical/negligence issues. If you suffer from injuries that are the result of a faulty device, a reaction to a medication, a negligent doctor, etc., your insurance company will generally initially cover your bills, but if you go to court, and it is determined that another person or manufacturer are actually at fault in causing your injuries, and therefore legally responsible for what happened to you, then your health insurance policy is not responsible for any of your care that is a result.

So, how does it work?  In most cases, the actual cause of the injury/damage is not known at the time you begin to seek medical treatment, and your insurance is covering those expenses. But once it has been determined in court that there is a party that is legally responsible for the injuries, then your health insurance company is not held responsible. Even though they did pay at first, the party that has been found responsible, whether a company or an individual, is now responsible for all of the medical costs associated with the cause of the injury/damage. As a result, the insurance company must be reimbursed for the payments they made on your behalf.

This is covered under the law by what is called “Double Indemnity”. This means that one cannot be recompensed twice for the same loss.  So, for example, in a car accident, if you are not at fault, you can’t get payment of the cost to replace your car from both your insurance company and the insurance company of the other party. You can’t have the same medical bill paid by both your insurance and the other party’s insurance.   You can’t purchase 2 insurance policies to cover the same item, or risk (such as health insurance). And in the case of product liability or negligence, you cannot be paid twice for the cost of your medical care. When settlement is paid, it includes the cost of the medical care.  If you were the one who originally paid the full amount for the medical care, you keep the money.

If your insurance company paid for the medical care. You must pay them back.

Now in settling these cases, there may be multiple types of payment ordered to the injured party, which can include medical expenses, lost wages, cost of any home health or general care required as a result of the injury, and there can also be additional payments for pain and suffering, loss of companionship suffered by one’s spouse, loss of care to one’s children, etc. On top of that, depending on the individual case, there may be punitive damages that the party responsible must pay. (This is most frequent in a case against a corporation found to have been willfully negligent).

Usually, you will receive a check from the company/individual for the full amount of the settlement, and you are then responsible for reimbursing the insurance company from the settlement amount you received. In a few cases, the court may direct the responsible party to make payment directly to the insurance company for the portion of the award that covers those expenses, with the rest to the injured party, but most often, the injured party receives the entire sum and must reimburse the insurance companies themselves. Here is where it sometimes gets confusing for the injured party.

Class Actions are Different

Now, a caveat is in order here. The above describes what will generally happen in the case of an individual personal lawsuit. Levels of responsibility and damages awarded will vary in individual cases, but will generally address the actual expenses of the individual plaintiff, and settlements are awarded on that basis. There is, however, another type of case that many victims of medical malfeasance may become involved in, and that is the “Class Action Lawsuit”. Unfortunately, in a class action lawsuit, the amount of the award that goes to any individual plaintiff may not cover all of the individual’s medical expenses. In a class action suit, each individual agrees to accept a specific percentage of the aggregate award, after attorney’s fees are deducted from the award, regardless of their individual expenses.

An individual plaintiff’s award may not be enough to cover either real expenses or pain and suffering, yet due to the finding of liability on the part of the third party, the plaintiff may still be held responsible for reimbursement of the insurance company.

This is actually a subject for a more in-depth article in the future, but in the mean time, you should know that participating in class action suit may not yield a financial award sufficient to cover your medical expenses.

How Insurance Rates Are Determined

I would just like to add a note regarding the determination of the cost of individual health insurance policies and how rates are determined. (This actually applies to all catastrophic insurance policies as well, including auto and homeowner liability). Rates are set based on projections of how much an insurance company can be expected to pay for casualty losses of  ALL their customers in a given time frame, and for losses that are not the result of negligence or intent by a third party. This is because of the liability laws that can hold a third party financially responsible for damage to another that is the result of negligence or malice. If the insurance companies were required to pay for losses to their customers that were caused by a third party, either intentionally or due to negligence, then rates would have to be factored to include those costs as well, and costs would skyrocket to the customer.

What This Means For You and Yours

The cause of illness or injury may not always be clear when it first occurs. And of course, the initial action taken should be to consult your physician, or in the case of emergency get to a hospital. Your personal health insurance will generally be the first source of payment. Should it turn out to be the potential liability of a third party, whether a person or a company, when consulting an attorney regarding a lawsuit, it is important to discuss with them the specific details regarding what sort of judgment is expected. Some basic questions to consider may include the following:  Can you expect that all of your actual expenses (medical losses, loss of wages, any home health or household assistance, loss of future income if one is long-term or permanently disabled, etc.) will be covered? Can you ask for punitive damages? How will attorney fees and other legal fees be charged (Can the defendant be expected to pay, or will they deducted from your award)? This can help prevent surprises, and unexpected costs once the case is settled.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter. 

Image by LEANDRO AGUILAR from Pixabay.

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Hysterectomy in America

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Margaret Aranda, MD

Women suffer in childbearing, many women suffer during their periods, and many more women suffer from various methods of birth control. They also suffer from fibroids, leiomyoma, uterine prolapse, immobilizing pain, bleeding, migraines, endometriosis, uterine cancer, and are immobilized, squirming in bed, and crying out for mercy before they die or  sadly seek suicide as what they see as the only definitive option. After seeing doctor after doctor, after immeasurable doctor, hysterectomy is offered as an escape for each and every of these problems. After Cesarean Section, hysterectomy is the second-most popular surgery in American women, providing 600,000 procedures per year, and 20 million procedures to date (Keshavarz, 2012), with 55% having both ovaries removed.

Given that an astounding 40% of American women have had a hysterectomy by age 45, and about one-half have had both normal ovaries removed, if you are a woman, and you have had menstrual problems, it is likely that you have talked to your doctor about hysterectomy. You may even have considered scheduling it, particularly if the pain persists as so often it does.

Gynecologists and Hysterectomy

For many women, the gynecologist drives conservation. He thinks you’re ready for the hysterectomy now. It’s the only solution to your problems. There’s an ever-so-subtle pressure for you to pick a date for your hysterectomy already.  And so, you pick the date, and he practically stumbles out of the room to go get it on the Schedule.

As he’s leaving and just before the heavy door closes, he says his nurse will give you the details. Not knowing any better, you sit in your blue, stiff paper garb, freezing cold and still bleeding from your fibroids. You feel like he just told you that all your problems will melt away, and your life will start over again.

Did I Consent to this?

You are just too busy smelling the roses to stop and ask yourself, “Wait. What does this mean?” But really, it nags at you. You further contemplate: what’s wrong with this picture? Several huge and glaring things suddenly hit you like a smack in the face. It’s like you just heard the buzzing of a bee in the middle of the rose you are about to sniff.

No Informed Consent was given, and you don’t even know the risk: benefit ratio (Aranda, 2013).

Hysterectomy Second Opinion

You haven’t had a Second Opinion from another surgeon (eHow, 2014; Cornforth, 2014). Big Boo-Boos, because maybe you don’t need the surgery at all. “C’mon me. Get a hold of ourself.”  “I have to know that getting a hysterectomy isn’t like getting my tooth pulled out.” It is this author’s personal opinion is that surgery should be used as a ‘last’ resort, not a ‘first’ resort. Additionally, alternatives should be sought and tried before resorting to any surgery that requires general anesthesia. I was an anesthesiologist. My opinion. Take the time to get a second opinion and maybe even a third before finalizing the hysterectomy.

In my case, my second opinion Ob/Gyn was female, had two children of her own, the last one by C-section. She knew the drill, and gave a detailed analysis of the algorithm she would use; it led to my decision to have an open hysterectomy. I agreed, and scheduled it with her, later cancelling with the first doctor.

She told me that the risks of surgery are about 10% for complications related to infection, inability to see structures and a need to operate with an “open” (large) incision, bleeding, transfusion(s), adverse drug reactions, death, etc. Informed consent includes (a) the general risks of the procedure, and (b) the specific risks for me. If the doctor does not discuss the risks of the surgery specific to you run, don’t walk, out the door and find another doctor. For more information on what an informed consent should include: Informed Consent is the Law: Stop, Talk and Show Should be the Standard.

I should note that this conversation has to be between patient and the surgeon, not the patient and a nurse, not the patient and a doctor-in-training.

In my case, I happen to be both a patient and an anesthesiologist. I know the general and the specific risks of anesthesia; most women do not. We’re talking general anesthesia, a breathing tube down the windpipe, anesthetic gases breathed in from a ventilator, a high chance of vomiting afterwards; the whole shebang.

I knew that I would be bloated and blown up like a 7 month old pregnancy for a matter of days. Or could it be it weeks? Or…could it be months?  Most women do not know this and sadly many surgeons do not discuss this with the patients either.  She reminds me to bring gym pants with an elastic waist.

About the Hysterectomy: In the Operating Room

The doctor will fill her belly up with CO2 gas, and will leave it blown up for the duration of the surgery. She will be in ‘extreme’ lithotomy and ‘extreme’ Trendelenburg position. Legs wide open, head down, feet to the sky. The anesthesiologist will have to add positive airway pressure (PEEP) to push her lungs opened to fill with oxygen, and sometime the surgeon argues saying, “Hey, anesthesia, I can’t see anything.” Then a classic argument ensues: lungs for the patient vs. visibility for the surgeon. So they both work together, sometimes screaming, to get it done for the patient. Anesthesia always wins. No one wants a pneumothorax, a popped lung on the O.R. table. Then it will become a blame game and both of them are responsible. Sometimes the poor patient needs a chest tube and an ICU stay instead of going home.

Some people get shoulder blade pain that hurts like the dickens, and she already knew that if your shoulder blade hurts afterwards, it is ‘referred’ pain coming from your belly. Most of my patients had not been told that information by their surgeon, but if they are lucky, a good anesthesiologist will give her the down low.

Who will be Performing the Hysterectomy and How?

The types of hysterectomy procedures themselves aren’t always explained to the patient (Aranda, 2012). Admit it. You were so eager and desperate to have your uterus out, that you didn’t really even care how it came out; as long as it was gone by the time you woke up. You didn’t care if a medical student, resident, intern, Fellow, or Attending did it with or without a morcellator. Oh. A morcellator. What’s that (Fulton, 2014) ? Or the daVinci robotic hysterectomy robotic machine ~ Are they using that on me? Uhm. Each of these technologies carries with it discrete risks. You should know those risks to make the decision most appropriate for your health.

The Morcellator Problem

It wasn’t generally known until recently, but in order to get the ball of the uterus out of the large straw of the laparoscopic instrument, Ob/Gyn surgeons have been using, for the last 20 years, what is called a power morcellator once you are good and asleep. It pretty much goes into the laparoscopic scope and into the uterus to churn and blend it up like a garbage disposer, so it can be sucked up the tube.

Problem is…no one can possibly know if you have uterine cancer or not, until after the whole uterus is out. It is simply undetectable until then. Some women, like Amy Reed, M.D., an anesthesiologist and internist at Harvard, got her uterus, along with undiagnosed uterine cancer, splatted all over the abdomen at the same time (Reed, 2014). Now that was a big Oops.

As it turns out, they’ve been doing it to our mothers, aunts, and sisters for decades, and even invented the daVinci robot to do the hysterectomy instead of a surgeon. What do you think the Ob/Gyn Associations have let their surgeons do? No one knows if it’s 1:1000, or 1:500, or 1:400, or 1:315 women that actually does have uterine cancer, but splat!splat!splat! There it all goes! All over the woman’s abdomen, it is upstaged from a Stage I to a Stage IV cancer because the doctor has now iatrogenically done the bad deed. Never should have happened. Never should have been allowed. Ethics Committee should have been involved. One woman in the same hospital as Dr. Reed had also been upstaged to uterine Stage IV cancer, one year before. “Hush! Hush!” There was no need for Dr. Reed to be placed in this position. But “Hush! Hush!” She was. An “n” of 1 is too much. We don’t want one woman to ever suffer this known fate.

No one knew this was really happening until Dr. Amy Reed’s husband, Dr. Hooman Noorchasm, and his love for his wife and family of six children, that he took this to Change.org, then the Senate, then to the FDA.

The July 10-11, 2014 FDA Hearing where Dr. Noorchasm spoke, resulted in these conclusions by the FDA:

  1. Little to no evidence that morcellation can be performed without spreading cancer to other parts of the body;
  2. Informed consent, including the risk of spreading an unknown cancer, should be included from now on;
  3. There is no evidence that the bags…prevent the outcome we are trying to prevent.”
  4. “There is at present no safe way to offer morcellation as part of gynecological surgery.”

Watch the video of Dr. Noorchasm’s testimony to the FDA.  Now, he has accomplished the seemingly impossible for all women: he has all but put a ban on most uses of the morcellator. ROCK ON, Dr.Hooman Noorchasm! There’s always more work to be done, but once the people have a heart, a Movement has started.

What about the Ovaries?

Are they planning to keep your ovaries in? And the Fallopian tubes? If they take the ovaries out, you will not only have your uterus out when you wake up, but you will be in surgical menopause.  Surgical menopause sounds benign enough, but really it isn’t. The rapid depletion of hormones can cause serious mental health issues, along with a compilation of physical health issues that will be with you for the rest of your life. And although hormone replacement is available, hormone management is never as easy as popping pill or pasting a patch on your abdomen.

If the ovaries are removed with the hysterectomy, women enter surgical menopause overnight, leaving them with huge fluctuations in the estrogens, progesterone and the androgens. There’s no ‘gradual’ menopause for them over the course of 1-10 years, as other women naturally have. They hit the menopause wall POOF! When they wake up and oh! Eeeh! Was surgical menopause part of the Informed Consent? These ladies are ready to throw in the towel by now, as they are living in “hell”.

Symptoms range from precipitous drops in hormones if the ovaries were taken out: hot flashes, night sweats, they can’t sleep with their husbands any more, thinning hair, pain on intercourse, insomnia, disturbance in day/night cycles, depression, irritability, and with the uterus gone. Hormones need to be tested and hormone replacement is used on an individual basis, in light of lab results, contraindications to hormones, family history, and other risk factors.

It is important to note that surgical menopause also means faster aging, increased risk of heart attack, cognitive dysfunction, osteopenia, osteoporosis, a fractured hip from a fall.  Ask any woman who has had her ovaries removed about the complications and health issues she has faced. It might just change your mind.

Making the Hysterectomy Decision

Weigh the pros and cons and above all realize that your health matters. Whatever you do, speak up! Ask questions. You are expected to ask questions, like ordering food at a restaurant. So ask them.

Your body belongs to you. It is your temple, meant to be treated with respect and care. Ask if the if the daVinci robotic and morcellator will be used. Make sure you understand. The choice is yours, and no one can take it away from you.

Hysterectomy Research

Hormones Matter is conducting research on hysterectomy outcomes. If you have had a hysterectomy, please take a few minutes to complete The Hysterectomy Survey.

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Informed Consent is the Law: Stop, Talk and Show Should be the Standard

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A lot of us think of “informed consent” as just a form the doctor’s office has us sign. The forms are usually full of really broad, overreaching phrases like “all reasonable medical alternatives were fully and completely explained to me, and I understand that this surgery/ procedure has the following risks . . . .etc. etc.”  And too often, patients are given the forms and expected to sign them without really having any idea what they are signing and what the forms mean.

This sort of “dotting the  I’s and crossing the T’s” approach does little to form a complete sentence, and it does little for the patient or the medical profession. So before you ever sign an informed consent, you should have had a thorough, two-way dialogue with your doctor.  And you should push for a STOP, TALK, and SHOW approach to understanding your condition, your diagnosis, your options, and the risks associated with each and every option—including the option to get a second opinion or forego any medical treatment at all.

Most people don’t know that they actually have specific legal rights that entitle them to have a thorough and informed discussion prior to any non-emergency medical procedure.  Just from an ethical standpoint, doctors should be eager to have that discussion too since that discussion really is the backbone of a meaningful doctor-patient relationship.  But regardless of whether the doctor is eager to have the discussion or is eager to march forward with the procedure, most states have a statute specifically requiring health-care professionals to obtain informed consent, and most states set forth standards that the medical profession should meet in order to show that the patient was informed about the procedure, its risks, and the alternatives to the procedure when he/she consented.  Some states look at these talks from the viewpoint of the doctor: Would other doctors in the same position say the doctor gave adequate information to inform the patient? Other states take a more patient-centric view: Did the doctor tell the patient the things a prudent patient would want to know?

Regardless of where you live and regardless of the standard that particular state sets, I suggest you adopt a “STOP, TALK, and SHOW” requirement yourself before you consent to any medical procedure.  And if you are like me, you’ll want to be heavy on the SHOW part of the discussion.

STOP – As soon as the doctor suggests a plan of treatment, stop the doctor right there, take out your notepad, and get ready to jot down everything the doctor says so that during the next section, the TALK section, you can make sure you talk about everything the doctor just breezed through.  (And understand, I don’t say “breezed through” to indicate a lack of concern or rigor on the part of the doctor. This is his/her area, and it’s not uncommon for people with highly specialized sets of knowledge to sail through a topic that we ordinary people don’t fully understand).

TALK – Once the doctor has finished with his “plan of treatment” discussion, it’s your turn. You have to look at this conversation for what it is: your best opportunity to make the best decision for your health. So talk to the doctor until you understand the following things:

  1. What is the condition the doc thinks is creating your symptoms/complaints?
    1. This one requires that the doc explain what condition/injury/or disease process is, how it works, and why it is the most likely cause for your symptoms and complaints.
    2. This one also requires the doc to tell you how he ruled out other possible causes of your symptoms/complaints.
    3. If the condition is one that was diagnosed by x-ray or MRI, it might be a good opportunity for the doctor to SHOW you what the condition is.
  2. What are ALL of the available treatments for this condition, and what are their concordant risks?
    1. For most conditions there are multiple accepted ways of treating the condition.  You’re entitled to (and the doc is required to give you) an explanation of these alternative treatments.
    2. You are also entitled to know the risks of the alternative treatments.  The doc may have ruled out an alternative treatment because it is less effective, but if it has lower risk, you might want to try that treatment first.
    3. When the alternative treatments are surgical in nature, the doctor can often draw out the procedure so they can SHOW you what is being proposed.  Despite their infamous handwriting, most doctors can draw out a simple surgical process so that you can see what you’re getting into.
  3. Which treatment does the doc recommend and why?
    1. You should have gotten this information along with the alternatives, but since this is the proposed treatment, you are likely going to hear more about its strengths than its weaknesses.  This is a good time to fully understand how the procedure works.  Many times a surgeon will draw out his proposed approach—ask for the drawing.
    2. This part of the conversation should be clear enough that you can intelligently compare the alternatives.  If you feel like you’re in a car dealership making choices before the “boss in the back” leaves, you aren’t having the proper interaction.
  4. What are the risks of the proposed treatment?
    1. I separate this part out because the informed consent forms generally lay these risks out in black and white and they might be vastly different from the conversational risks you were told about.
    2. I ask the doctors to go ahead and SHOW me the informed consent form at this stage so that I can compare the written risks with the risks we’ve discussed.
  5. What are the risks of the alternative treatments?
  6. What are the risks of foregoing any treatment at all?

If this seems like a lot, it is. But remember, you are entitled by law to be fully informed before you have a medical procedure.  Some doctors and hospitals are so focused on meeting quotas and “staying on schedule” that they will try to satisfy that right by giving you a piece of paper and expecting you to just go along with their expert decision about how to manage your health.  The STOP, TALK, and SHOW approach will help you understand the procedure, but it will also help you gauge which doctors see the doctor-patient relationship as a profoundly important part of health care.  I submit that the doctors who take the time to explain the procedure well will also take the time to perform it well.

STOP, TALK, and SHOW, I’d love to hear how it works for you.

 

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Wide Awake: A Hysterectomy Story

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I’ve always considered myself to be someone who takes charge of her life and health. After all, we only get one body, one heart, one set of eyes, one uterus, one pair of ovaries and so on. I never smoked and always exercised. I went in for my yearly pap smears. I never took my good health for granted.

However, as it turns out, I had no idea how my body functioned or how I remained healthy. Not really. I didn’t understand how my female organs and hormones contributed to who I was. That is, I didn’t understand until my life fell completely apart after hysterectomy and ovary removal five years ago. Now, I’m wide awake.

On September 27, 2007, I woke up in recovery after undergoing a complete hysterectomy I didn’t need or consent to. I was coerced into agreeing to removal of my uterus after experiencing a distended abdomen. I looked six or seven months pregnant and was wearing maternity clothes. Only after surgery did I learn that my distended abdomen had nothing to do with my uterus. At no time did I agree to removal of my cervix, tubes or ovaries. Even my doctor agreed that I should keep my healthy ovaries.

When I arrived at the hospital the morning of my surgery, I was presented with a consent form which listed the wrong surgical procedure. According to the new consent, all of my healthy female organs were to be removed. I explained to the nurse that this was not the surgery I agreed to and I refused to sign the consent. As I waited to speak with my doctor about this, another nurse came into my room and said he was going to give me something to relax me. I explained that I didn’t want to be given any medication since I had not signed the consent and was waiting to speak with my doctor.  As I was protesting, he injected my IV with Versed.

That was my last waking memory.

My next memory was that of seeing a nurse I didn’t recognize. I asked her if my doctor was on his way to talk with me and she told me that I had already had surgery. In disbelief, I began to sob and asked what type of surgery. I wanted to know what organs had been removed. She matter-of-factly said “You have nothing left.” I cried out that I wanted to die, a curious fact that is noted in my medical record. Everything seemed to be happening in slow motion. Although I lost a lot of blood and had to be taken back to surgery, I was released the next morning with a prescription for hormones and iron pills.  I had no idea just how much my life was about to change.

I went back to my apartment but everything seemed different. It wasn’t that the apartment had changed. It was me. I felt like a different person. I also felt an emptiness I’ve never known. I assumed this was only temporary and would pass as I healed. I remembered researching hysterectomy and reading about how some women feel emptiness afterward because they can no longer have children. Eventually, I healed from the outward surgical wounds, but the emptiness remained. It was an emptiness that transcended far beyond not being able to have any more children.  I suddenly found myself in a body that didn’t feel like mine. Every bone, muscle and joint cried out in pain. I felt as if I had aged twenty years. My abdomen never did return to normal size. My sexuality vanished. My emotions were blunted. I didn’t know what was happening to me but I was afraid – very afraid. I cried for no reason and for every reason.  I did not want to live in the body I’d been left with.

Not knowing what else to do, I went out to a local bookstore and bought every book I could find on the topic of hysterectomy and hormones. One of the first books I read was “Hysterectomy Hoax” by Stanley West M.D. By the time I finished reading Dr. West’s book, I was finally wide awake. I had been castrated and there was no turning back. Finally, I realized I did not feel like the same woman because I wasn’t the same woman.  I felt a deep sense of betrayal. I became desperate to find a way to “fix” myself.

The truth is that there are over 400 estrogen receptor sites in a woman’s body. Every organ depends on an estrogen type hormone to function properly (there are three main estrogens: estrone, estradiol and estriol along with many more we’re only now beginning to understand) . Estrogens protect the heart, brain, lungs, bladder and more. The thyroid gland has estrogen receptors. When the ovaries are removed, the body often attacks the thyroid. Many women who’ve undergone hysterectomy go on to develop thyroid anti-bodies and/or thyroid disease. I developed thyroid problems almost immediately after surgery. I was first diagnosed with Hashimoto’s disease and then Hypothryroidism. I’ll have to take thyroid medication for the rest of my life. A woman’s brain has estrogen receptors too. Without estrogens, the brain develops diseases such as Dementia and Parkinson’s Disease. Memory and concentration are very real problems I face almost daily. Heart disease is a much greater risk for woman once their female organs are removed due to the loss of heart protection via the loss of estrogens.

The hormone replacement therapy (HRT) my doctor prescribed was not helping and was, in fact, making me feel much worse.  I was taking Premarin – an estrogen made from pregnant mare’s urine. The chemical structure of Premarin is nothing like a woman’s own natural estrogens. Because my body wasn’t tolerating Premarin, I began to research hormones — especially, bioidentical hormones. After I met with a hormone doctor, blood tests confirmed that all of my hormone levels were nearly non-existent. I was prescribed bioidentical estradiol and testosterone crèmes and compounded oral progesterone. Additionally, I was prescribed supplements such as DHEA, Calcium, Vitamin D, etc.  The creams were very messy and didn’t seem to help. I tried wearing a bioidentical estrogen patch (Vivelle Dot) but the adhesive made my skin break out with a blistery rash. Nothing was working.

Finally, I found a hormone doctor who uses bioidentical hormone pellets.  I decided to give the pellets a try even though they are quite expensive. They seem to work better for me than anything else I’ve tried.  My doctor inserts estrogen and testosterone pellets about every three months and I still take a compounded oral progesterone by mouth each night. Many doctors don’t prescribe progesterone for women who have undergone hysterectomy, but I learned through my own research that progesterone is critical for proper hormone balance. Nothing works like a woman’s own natural hormones but for a woman who has undergone hysterectomy and ovary removal, hormone “replacement” is a must.

As the days turned into weeks and the weeks turned into months, I realized that I was not getting back to my old self. In fact, I was getting further and further away from myself. Within the first year of surgery, I was diagnosed with severe vaginal atrophy and third degree bladder prolapse. The pelvic organs I had left, drifted down into the open space left from removal of my uterus. Chronic constipation became a huge problem. I experienced nerve damage that often prevented me from standing or walking. I developed problems with my eyes and was eventually diagnosed with severe dry eye disease. Due to corneal ulcers, I’m now legally blind in my left eye and can no longer see to drive.

Sadly, the aftermath of hysterectomy is filled with a lot of losses. There’s no turning back. Hysterectomy is final. For the woman who undergoes hysterectomy, life is forever changed. I lost my health, my career and then my home. I was engaged to be married at the time of surgery but never did marry. Unfortunately, it’s not uncommon for women to end up divorced and alone after hysterectomy. There have been more times than I’d like to admit that I felt all alone in my devastation. I felt as if I had stepped into some alternate world where I could no longer communicate. Hysterectomy impacts every facet of a woman’s life.  Every single cell is impacted.  And yet, nobody is talking about it.

For this reason, I decided to create a blog site and web site. I knew there must be other women who felt as alone and devastated as I did. Since creating my sites, I’ve heard from women all over the country, and sadly, their stories are all pretty much the same.  The names are different but the stories are the same. Many of their stories are posted on my web site. Most women share the feeling of betrayal. Once they awaken to the many adverse consequences of hysterectomy, they feel deeply betrayed by their doctor for not telling them about the true impact of the removal of their female organs. The trauma can’t be overstated. Women deserve better than this. They deserve to be told the consequences of hysterectomy and informed about the alternatives to hysterectomy. My goal is to make this a reality. I testified in both Indiana and Kentucky regarding hysterectomy informed consent laws and I created a petition on Change.org insisting ACOG (American Congress of Obstetricians and Gynecologists) inform women of the many consequences of hysterectomy and ovary removal (castration).  I support Hormones Matter and their research on hysterectomy. If you have had a hysterectomy, take The Hysterectomy Survey. Your data could save the life of another woman.

My Websites and Social Media

Website: Hysterectomy Consequences

Blog: Hysterectomylies

Twitter: www.twitter.com/jiggaz31

Facebook: www.facebook.com/hysterectomyconsequences

change.org petition: Help Stop Unnecessary Hysterectomy and Castration

 

 

 

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