We at OB/GYN Reform are demanding a Congressional investigation into the decades-long practice of removing healthy ovaries in women without proven increased risk of breast or ovarian cancer. We believe the government's failure to regulate a multi-billion dollar industry has left room for that industry's judgment to spiral out of control, resulting in serious health crises in women of an age, where health issues are not considered or addressed, who have become a profit center for this specialty. The 740,000 annual elective hysterectomies 242-244 in this country (those not to treat diagnosed cancer, source: AHRQ & CDC) cost an average of $33,130 per surgery according to the AHRQ. That's $24,516,200,000 a year.

Can 40% of a 160 million person population (source: HHS) truly require an elective major surgery? Why is no one asking this question?

Why does removal of healthy ovaries matter? Because, despite the fact that only 2% of all women are able to be diagnosed with a genetic predisposition to breast or ovarian cancer and might benefit from this surgery, the OB/GYN medical specialty removes the ovaries at time of hysterectomy for benign conditions like fibroids or endometriosis a staggering 55% of the time. (This percentage may be higher, but the CDC stopped publishing this data in 2000. We know it is very unlikely to be lower because it has risen from 25% in 1965 to 40% in 1984 to 55% in 1999.)  It is also done in an additional 300,000 women who have benign ovarian cysts, which brings the number to at least 700,000 women a year.

In fact, this year, scientists finally began to ask how helpful this surgery has been in the reduction of BRCA 1/2 breast cancer. The answer? It has not been. (Read more here.)

The ovaries are not, as commonly believed outside of medicine, part of a hysterectomy. Hysterectomy only includes the uterus, and possibly, cervix. The ovaries are part of both the exocrine (ducted, in this case, egg-producing) and the endocrine systems. It's proven that their endocrine function does not stop working at menopause, and many studies published in the American Congress of Obstetricians & Gynecologists' own medical journal detail the fact that this surgery leads to significantly increased risk of significantly premature mortality resulting from diseases including up to 7x risk of heart disease, 2x lung cancer, fracture due to severe osteoporosis, Alzheimer's and other forms of dementia, Parkinson's, and many more. Removing the ovaries does not result in "early menopause"; it results in sick women who die prematurely. The practice makes no sense and must stop immediately.

Under Section 1557 of the Affordable Care Act, women should be protected from disparate treatment in hospitals, the majority of which receive federal funding. Ovaries and testes are both gonads. They have homologous functions in the body's HPG axis. 1,000 healthy sets of ovaries are removed each day "to prevent cancer." Removing testes is the "gold standard" in preventing prostate cancer, which kills twice as many men each year as ovarian cancer kills women. How many preventative testis removals take place each day? Each year? It's never done. Though the mortality rate is double, the surgery is never performed in men without diagnosed cancer who've tried hormone suppressant treatment first.

We must thank Senator Mark Warner, who wrote on Aug. 6 to say, "Thank you for contacting me regarding issues with the professional judgment of OB/GYN doctors. I've taken the liberty of contacting the Food and Drug Administration on your behalf asking that they review your concerns and get back to me with a detailed and appropriate response. As soon as I receive a reply, I will again be in touch with you. To sign up for my newsletter please visit www.warner.senate.gov. Sincerely, MARK R. WARNER United States Senator"

However, we wrote to the FDA also, and they don't think they're the right agency since the issue is unrelated to pharmaceuticals and devices.

We must also thank Virginia Governor Terry McAuliffe for sending the issue to the Virginia health department for a response on August 28, and Congressman Gerry Connolly for writing to Dr. Nancy Lee, head of Women's Health within the Department of Health & Human Services on September 1, 2015.

These are important steps, but the most important is a Congressional hearing. Why? Because there is no possibility that any health advisory group can come back with the opinion that disassembling healthy endocrine systems is ever ok. Because there is no question that the removal of healthy ovaries, which is done a staggering 1,900 times a day, is harmful. The OBGYN specialty has things to answer for. We need access to a forum to share the harm these surgeries have done to millions of women, and to put an end to these types of surgery once and for all.

www.gynreform.com

Hysterectomy has been done vaginally since 120 A.D., and through a laparotomy, as with a c-section, since the mid 1800s, centuries before the advent of the morcellator. 92% of hysterectomies are elective surgeries for benign conditions: fibroids, heavy bleeding, endometriosis. Though these conditions are painful without question, none represent conditions we'd risk upstaging cancer to an incurable level for - agreed?

As far as the way the surgery is performed goes, there are no circumstances under which a morcellator, a stick blender-like device used to chop up the uterus so it fits out the holes of a laparoscopic surgery, is required. More women agree to surgery when it is referred to as "minimally-invasive," sure, but the question is whether they would agree to this if they knew it increased their risk of death.

An even better question is why doctors would propose it, given how obvious it is that grinding up potential cancer inside the body can never be preferable to removing it intact. Yet, that's what's been done for a couple of decades now, and that's what continues, even after the well-covered case of Dr. Amy Reed, brought to light through her tireless advocacy and that of her husband, Dr. Hooman Noorchashm, as she fights her upstaged cancer and they continue to work and to raise their 6 children.

Because they pressed the issue, the FDA reworked the ACOG's math. The ACOG had been saying that the risk of a fibroid turning out to be cancer was 1 in 10,000. In fact, the FDA concluded, the risk is 1 in 352. The ACOG hadn't been using the right denominator to arrive at the risk. They'd been using "all women in the U.S." versus "all women who presented for surgery with fibroids."

Even according to the ACOG's own guidelines for when to perform a hysterectomy, this surgery is performed far too often. Other types of surgeons, those who are trained in general surgery (OBGYNs are not), remove illness, not entire organs. In the cases where women's fibroids turned out instead to have been sarcoma (cancer), had the cancer been removed in place ("in situ"), it certainly would not have been upstaged in the manner in which it is when a morcellator is used.

As you're reading these notes, which are directly quoted from the ACOG's May 2015 Annual Meeting, it's helpful to be aware that Dr. Keith Isaacson was a member of the panel that heard women's testimony to the FDA in 2014 about the fact that the women's cancer had been rendered incurable through the use of morcellation. Dr. Isaacson was allowed to remain on the panel despite the fact that he had a known financial conflict, having received money from robotic surgery device makers. You can read about that here.

The original ACOG meeting notes can be found here.

Directly quoted from the ACOG's May 2015 Annual meeting:

"Mathers Lecture to Focus on Power Morcellation Concerns Posted By: ACOG on: May 03, 2015 This year’s John and Marney Mathers Lecture will consider the risks and rewards of power morcellation.

“Morcellation Debate,” coming on the heels of last year’s FDA safety communication about the procedure, takes place at 3:15 pm today in Hall D and features Keith B. Isaacson, director of minimally invasive gynecologic surgery and infertility and Newton-Wellesley Hospital in Boston, and Javier F. Magrina, MD, professor of obstetrics-gynecology at the Mayo Clinic in Arizona. They will debate power morcellation’s benefits, concerns, sequelae, prevention of complications and the use of alternate techniques.

The communication, first released in April 2014 and updated in November, warned against using laparoscopic power morcellators in most patients undergoing hysterectomy or myomectomy for uterine fibroids because of a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, outside the uterus. Contraindications include suspicion of cancer, menopause and small uterus.

The risk of sarcoma in a fibroid exists, and morcellation of that fibroid may spread and upstage the disease, Dr. Isaacson said, but the treatment decision should rest with the patient and her health-care provider.

“We just don’t have enough additional information to say that this is considered bad medicine because there are many advantages to a smaller incision, depending upon the patient’s preferences and her lifestyle and priorities, she may elect to do that,” said Dr. Isaacson, who was on the FDA panel that looked into power morcellation but didn’t work on the final document.

The FDA document lists several contraindications. But for many younger or perimenopausal women, the procedure has great benefits that must be considered.

The FDA and physician statements from ACOG, the AAGL and other organizations that have examined existing data still provide an opportunity for the informed patient to make the final call.

“I don’t care what number you pick. Let’s say the risk of cancer is 1 in 10 instead of 1 in 8,000,” he said. “I still think the patient should be involved in the decision-making process after a discussion of the benefits vs. the risks.”

Dr. Magrina opposes any morcellation that takes place outside an endobag. He will argue that morcellation safety will improve with use of endobags to contain the morcellated material.

“Stopping only power morcellation doesn’t stop the problems that happen with morcellation by other means, such as using a regular cold knife if what you’re morcellating is exposed to the intraperitoneal cavity,” he said.

Dr. Magrina said that the FDA missed an opportunity in its safety communication by not addressing the use of endobags. More companies are working with contained morcellation concepts that will improve patient safety.

“I’m actually con and pro depending on how you do it — contained or uncontained,” he said. “The point that I’m making has never been discussed at the FDA level.”

While concerns about spreading and upstaging cancer have grabbed most of the attention, Dr. Magrina said that more people develop benign conditions such as endometriosis and peritoneal leiomyomatosis that spread into the peritoneal cavity during morcellation done without an endobag.

“The problem is not only with cancer,” he said. “And it makes no difference whether the morcellation is by knife or power morcellator.”

In this 2014 video, you can hear the doctors explain that they would all perform morcellation.  "The current situation with morcellation has not changed my practice in any way."

So, what are these OBGYNs saying about endobags to contain the pieces and what are they saying about screening beforehand?

Dr. Reed was carefully screened before her surgery.

Any use of an endobag is an experiment at the patient's own risk, designed only to allow OBGYNs to keep using unsafe devices.

According to the ACOG's own May 2014 Morcellation special report, endobags can tear or block the surgeons view: "Use of a Bag During Morcellation in Gynecologic SurgerySome investigators have suggested that the use of an intra-peritoneal bag during manual or power morcellation may be helpful in reducing intraperitoneal tissue dissemination (8, 30). However, power morcellation performed within a bag is not well studied and has several limitations that potentially increase the risk of the procedure. For example, currently available bags were not designed specifically for use in conjunction with power morcellation. The bags often have size limitations and have not been adequately constructed to prevent tearing by the morcellator. Further, the use of bags limits simultaneous visualization of the tissue being morcellated and the surrounding tissue that must be protected from the sharp morcellator blade."

The third doctor in the video says that if a patient is at "low risk" of cancer, he would "absolutely" use a morcellator. Is that good enough for you? In Boston, hospitals disagree as to policy.

Now imagine if, instead of figuring out better ways of dealing with uterine sarcoma, surgeons were sitting around constructing studies about how much it would cost not in lives, but in money, not to keep doing it? At Northwestern, that's exactly what they did. Is that how you imagine residents and surgeons spending their time?

"Conclusions:
Eliminating morcellation hysterectomy as a treatment for myomas is not cost-effective under a wide variety of probability and cost assumptions. Performing laparotomy for all patients who might otherwise be candidates for morcellation hysterectomy is a costly policy from a societal perspective."

This isn't the first study of its kind, either. The device manufacturer, Ethicon, sponsored this one in 2011 before the doctors broke their story.

Some OBGYN device advocates think it's ok to argue that we can't let go of technology. Though hospitals have invested heavily in these robots, that's not an excuse to keep using them if they're unsafe.

In terms of policy, who makes policy if not the FDA? Their conclusion was to put a warning on the device, but they chose not to ban it.

What about the ACOG? The ACOG's advice to its 58,000 OBGYN members was to continue to use the device, but, as usual, to put the onus back on patients. Their Committee Opinion in May 2014 was to inform patients of risk and to create a national registry of women made ill by the device. Does that make sense to you, as a patient?

Once a physician suggests performing a surgery a certain way, doesn't that bias a patient even if only by making the patient consider that option? Would a patient imagine that something being offered could take something bad and make it worse?

So, again, Dr. Keith Isaacson from Newton-Wellesley Hospital, who "doesn't care if 1 in 10 fibroids is sarcoma," is in favor of morcellation.

As with study results, it's important to follow the money:

Dr. Javier Magrina of the Mayo Clinic was less enthusiastic. He'll do the surgery, but only using an endobag. He was also paid less by morcellation manufacturers.

Read more at Drs. Reed and Noorchashm's page, here.

First question, always, when reading about a "new study" is, who paid for this? This one is based on an NIH and a Finnish grant, so the question of big pharma influence is a bit opaque, but because this one has been released in all the major publications at the same time, see picture at left, that's a good tip-off that pharma has a hand in there somewhere. Normally-financed studies that aren't reporting a major breakthrough don't get this kind of wide release.

The headline in the ACOG's Facebook post says, "ACOG recommends women and their health care providers work together..." This is something I have only seen the ACOG do. They suggest something to patients that may, in fact, not be beneficial at all, but if their suggestion of it to patients increases patients' likelihood to bring it up with their OBGYNs, well, that's just their choice. It's not readily obvious, but the ACOG is actually using the language they learned when talking about pro-choice issues.

How many of us will read past that headline? According to a 2014 survey by the American Press Institute, only 4 in 10 of us will click through and read the article. http://www.americanpressinstitute.org/publications/reports/survey-research/rational-attentive-news-consumer/

So, what would the ACOG's readership miss if they're among the 59% who don't click on this article? Let's join the 41% and find out.

The article, itself, is hard to get to. It's not the link within the copy above the picture. You have to click on the copy under the photo to get to it. Here's the study.

“Our findings provide evidence that taking these antidepressants is associated with a lower risk of preterm birth and Caesarean section and further confirm the results from previous research of a higher risk for several neonatal problems,” noted Brown. “Given these divergent findings, the decision whether to prescribe these medications during pregnancy should be individualized to the mother’s medical and psychiatric history.”

Well, no. This is only true if this study were all the data available to us, but that's far from the case. Instead, it looks like the vast majority of data about women who take SSRIs indicates that they are increasing the risk of their babies being born with birth defects. I don't know too many pregnant women who would be comfortable with that risk.

In fact, babies are born addicted to SSRIs, and with a host of birth defects. http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/content/tags/breastfeeding/use-selective-serotonin-reuptake-inhibitors-during-pre?page=full

The study results are really very negative. "...women who took an SSRI during the second or third month of pregnancy had nearly twice the risk of having children with congenital malformations as women who took no SSRI during pregnancy" http://www.bmj.com/content/333/7573/824.5

In Finland, the study indicates that the percentage of pregnant women taking an SSRI is 4%. In the US? 10%.

Are alternatives are tried first? Hormonal fluctuations can lead to depression, but is there a better, safer answer than SSRIs? Yes, of course. Even altering diet can have a beneficial effect. Wouldn't that be a better place to start? These are, after all, steroid hormones made by the ovaries that we're talking about, and the ovaries do link to the brain (the hypothalamus and pituitary) via the HPG axis. Can those steroid hormone levels be influenced by diet? Yes.

So, what about the information the ACOG links to on its own site through that little link in the copy above the picture?

At the ACOG's own site, linked to from the article, we learn:

1) The tiny print along the top indicates that the content on the page is not about the study, but an advertisement. See the tiny print at the top, there? That's pretty important.

2) There's no indication of who paid for the ad.

That doesn't stop people from taking it all at face value.

But, wait, why is the ACOG advertising on its site at all? Isn't this a professional organization's site with unbiased information for patients and medical professionals? Nope. Far from it. Though I can't find any other physician organizations selling themselves in this way on their site, the ACOG has all kinds of ways you can pay to play.

If I click on that little word "Advertisement" at the top of the Depression ad page, I'm brought here: http://www.acog.org/About_ACOG/Advertising.aspx

And if I click on the first link, Annual Meeting, and then Rate Card.pdf, I'm brought here. http://www.acog.org/-/media/Departments/Annual-Clinical-Meeting/acog2015ratecard.pdf?la=en

Holy crap. Even I am shocked.

That's all I have for today because I am speechless.