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Life Extension Magazine July 2014
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When A Common Gynecological Procedure Turns Deadly

By Drew Hofmann
When A Common Gynecological Procedure Turns Deadly  

Morcellation is a procedure used as a means of extracting a woman’s uterus, largely as a treatment for uterine fibroids. It may also be used to remove other organs.1 The process leaves only a small scar, while reducing hospital lengths of stay and potential surgical complications.2

This so-called “minimally-invasive” procedure has been found to cause the potentially lethal spread of cancer to unsuspecting women.

Amy Reed, MD, PhD, is an accomplished anesthesiologist at Beth Israel Hospital in Boston who treated many of the victims of the Boston Marathon bombing. She has tragically experienced the risks of morcellation firsthand.

Dr. Reed’s supposedly benign morcellation procedure at Boston’s Brigham and Women’s Hospital to treat her fibroids ended up splattering cancerous cells throughout her abdomen and pelvis, leading to an advanced stage IV cancer diagnosis.3

Life Extension® is publishing this story in the hopes that it will speed action amongstdoctors, hospitals, manufacturers, and patients to stop this needless loss of life.

A Routine Procedure Gone Bad

Dr. Reed and her
husband Dr. Noorchashm
Before: Dr. Reed and her
husband Dr. Noorchashm
before the morcellation.

Last October, Dr. Reed had a routine hysterectomy at Boston’s Brigham and Women’s Hospital in Boston to remove her uterine fibroids using the morcellation procedure.4 Dr. Reed was not informed about the risks that accompany this procedure.5,6 She was given no information about the morcellator, nor about the known risk regarding the spreading or upstaging of a hidden malignancy. Overwhelmingly, most women are not told that they will undergo morcellation. It is simply done at the discretion of the physician.7

A few days after the procedure, Dr. Reed and her husband Dr. Hooman Noorchashm, a cardiothoracic surgeon at the Brigham and Women’s Hospital and a lecturer on surgery at Harvard Medical School, were devastated to discover that she had developed a rare form of uterine cancer. They subsequently learned that, likely due to the morcellation procedure, the cancer cells had spread and Dr. Reed had stage IV cancer.

Yet the risks of spreading cancer cells through morcellation were indeed known, and had been clearly raised in numerous articles and editorials published in prestigious gynecological and cancer journals long before Dr. Reed’s procedure.8-11 In fact, an article published by a team at Brigham and Women’s Hospital in Boston, where Dr. Reed’s surgery was done, reported on the risks of spreading an existing cancer by morcellation. The article recommended “…review of current surgical protocols to prevent future seeding of the pelvic region with tumor particles.”11 That article’s publication preceded Dr. Reed’s surgery by three years. Indeed, the senior gynecological oncologist who authored the manuscript was the same individual who referred Dr. Reed for an operation he knew would likely involve the use of a morcellator after reassuring her in writing that “this is a clearly benign process.”

How could a procedure with a known risk of disseminating a malignancy not only be cleared by the FDA, but also become a standard gynecological procedure undergone by hundreds of thousands of women annually?2,9 Why did so many gynecologists close ranks to defend a flawed procedure and deny the clear and present danger posed by morcellation?12 Why, after Drs. Reed and Noorchashm drew both professional and public attention to the problem, was the procedure not put on at least a temporary moratorium? And why has Dr. Noorchashm been chastised and isolated, rather than praised and supported, by his peers and colleagues in his effort to make medicine safer?4

For many in the medical profession, Dr. Reed may be seen as just another statistic, but as a mother of six young children and a highly respected medical doctor with decades of life and medical practice ahead of her, her illness is catastrophic and beyond calculation.13

What Is Morcellation?

Agatston
After: Dr. Reed underwent surgery and five
cycles of chemotherapy to control her stage
IV cancer caused by morcellation. She is
pictured here with her husband, Dr.
Noorchashm, who shaved his head to emulate
his wife’s chemo-induced hair loss.

Physicians performing hysterectomies, often to remove uterine fibroids, frequently use a tool called a morcellator, a small device with a sharp blade attached to a handle. The tool is inserted into the body to cut and shred fibrous tissue in order to ease its removal. The problem is that the tissue that’s being shredded may contain hidden cancer cells that are then scattered throughout the abdomen where they can take root and quickly spread. Additionally, the rotating blades can injure nearby organs and blood vessels.8-10

Imagine taking a morcellator to an undetected malignant tumor in the abdomen, under the impression that it is a benign fibroid. Among the pieces of material freely scattered about are bits of cancerous tissue. These bits of tissue make the pathologist’s job even more challenging because the tissue’s highly mutilated state makes it very difficult to spot the presence of a malignancy.1-3,14

The result, in oncologic terms, is called “upstaging,” or worsening, of the cancer. And this upstaging may happen as a direct result of the procedure chosen by the gynecologist. A uterine malignancy is ominous even at its lowest stage (stage I), with five-year survival hovering around 60%. Upstaging the cancer to stage III drops survival to 22% at five years, and only 15% of women with stage IV cancers survive that long.5,15

What You Need To Know
Morcellation

Morcellation

A technique for “minimally invasive hysterectomy” known as morcellation threatens the lives of as many as one in 350 women.48 With more than 600,000 hysterectomies performed in the US annually, that is the equivalent of two jumbo jet crashes each year.

When such a tragedy struck a physician couple in Boston—and left a vibrant, 40-year-old mother of six struggling with stage IV uterine cancer—the couple spoke up and took their case to hospital administrators and leading gynecologists.

Yet the medical community and its regulatory bodies have remained largely silent, and in fact, have pushed back hard, refusing for the most part to alter their procedures and defending their practice.49

At the root of this completely avoidable catastrophe lies poor physician training, immovable administrators, a “too-big-to-change-now” mentality, and substantial corporate financial interests.

Do not succumb to a “minimally invasive hysterectomy” that puts your life at unnecessary risk; demand to know your physician’s intent long before you enter the operating room, and if morcellation is scheduled, ask for an alternative.50

Join the public crusade to remove this unsafe and needless procedure from our hospitals: write to your legislators asking for hearings on the subject and sign the petition at http://www.change.org/petitions/women-s-health-alert-deadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellating-the-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy.

Hysterectomy

Hysterectomy (removal of the uterus) is one of the most common surgical procedures in the United States, with roughly 600,000 done annually.5 The most frequent indication for hysterectomy is uterine fibroids, also called uterine leiomyoma (lie-oh-my-oma).5

Uterine fibroids are clusters of abnormal, but not cancerous, cells in the thick, muscular walls of the uterus. They commonly affect women in their 40s and 50s. Fibroids may occur singly or in clusters. Studies have shown that, while these tumors are not malignant, they often contain abnormal genetic material that predisposes them to growing rapidly and in an uncoordinated fashion. By age 50, between 20 to 80% of women develop fibroids.16-20

Over time uterine fibroids may grow in size and number.21 Women with fibroids may have no symptoms at all, but in many women the symptoms become intolerable, and often include:18

  • Heavy and irregular vaginal bleeding (possibly to the extent of producing anemia),
  • A feeling of fullness in the lower abdomen, with eventual abdominal swelling,
  • Frequent urination if the fibroids press down on the bladder,
  • Low back pain, and/or pain during sex,
  • Complications of pregnancy and labor, often leading to a higher risk for Caesarean section.

Most women with significant or persistent symptoms wind up with a hysterectomy, or removal of the uterus, which is curative.16

A standard hysterectomy is considered major surgery, requiring hospitalization and a recovery period that lasts several weeks.16,22 Naturally, patients and their gynecologists have sought easier, less painful, shorter operations.

The rise of so-called “minimally-invasive surgery” has led to many improvements in general surgery procedures, as well as in gynecological surgeries,23 although it remains unclear whether these techniques genuinely offer long-term advantages.24-27

Minimally-invasive surgery has been available to women requiring hysterectomies for over two decades.28,29 Like all minimally-invasive procedures, the technique involves inserting a laparoscope—a tube with a camera and channels through which to pass surgical instruments—into the abdomen, then performing the procedure either manually or robotically using inputs on a monitor screen.14,30,31

But since an entire uterus, especially one laden with large masses such as fibroids, is too big to pass intact through the endoscope, a morcellator is first used to slice and mince the tissue into pieces fine enough to draw out.8 Just as one would expect, bits of morcellated tissue inevitably fall away into the woman’s abdominal cavity.9

And for as many as one out of every 350 women undergoing morcellation in America, that’s where the nightmare begins. While the vast majority of uterine masses are indeed benign fibroids, an estimated one in 350 women instead has a uterine cancer.32 However, women with malignant tumors may not be identified before morcellation since symptoms and imaging findings in patients with benign fibroids and uterine sarcomas can be identical.5

Morcellation Of Hidden Cancers: A Systemic Failure

Morcellation Of Hidden Cancers: A Systemic Failure  

To understand this systemic failure, one needs to look at how physicians are educated, how inaccurate or thoughtless use of statistics produces false or misleading conclusions, and how medical devices are approved by regulatory agencies and marketed by manufacturers.

In an interview with Life Extension, Hooman Noorchashm, MD, PhD, took pains to reach thoughtful and objective conclusions about these areas, despite his personal grief and pain.

Regarding medical education, Dr. Noorchashm noted that gynecologists, unlike every other surgical specialty, have no extended exposure to general surgical practices and techniques. That means they learn in a “silo,” deprived of the opportunity to share with, and learn from, surgeons in all other fields.33

Physicians who later become cardiac surgeons, orthopedists, neurosurgeons, and such spend at least a full year of residency training in a general surgery environment. There, they learn to embrace certain standard techniques and shun others, including, says Dr. Noorchashm, the notion of chopping up an unknown mass and scattering its debris throughout the surgical field. In a letter to the American Association of Gynecologic Laparoscopists, he describes “the meticulous care that is taken by other surgeons not to disrupt tissues inside the body, especially when there is a possibility of cancer lurking,” and wonders why there is not greater interchange of information between gynecologists and other surgical specialties.

During our discussion, Dr. Noorchashm also provided insight into the statistics that have been used by both gynecologists and device manufacturers to reassure themselves and their patients about the safety of morcellation in the face of hidden uterine cancer. It has been pointed out that women preparing for fibroid surgery are typically quoted a figure of “one in 10,000” as the risk of having an undiagnosed malignancy.5 But that number simply represents the risk of uterine cancers in the entire general female population.5 For women with symptom-producing uterine masses, the figure is in fact believed to be as frequent as one in 350—a much greater risk.3,5

Why is the risk consistently downplayed?

That is a more difficult question to answer, says Dr. Noorchashm. It seems likely it has to do at least in part with the ways morcellators are marketed to physicians. Glossy ads appear in trade journals read by gynecologists, touting the device’s “safety, control, and simplicity,” saying it’s an “efficient and time-saving alternative” compared to other techniques, and describing the “simple, fast, and safe morcellation of even large amounts of tissue.” Note that most of the concerns in these promotional materials focus on the surgeon, not the patient. They have to do more with efficiency and speed than they do with patient outcomes.

Another factor is the surprisingly lax oversight of medical devices by the FDA. Medical devices must only demonstrate that they are “substantially equivalent” to existing devices for similar purposes, a surprisingly circular definition.34 Shockingly, no clinical data at all were deemed necessary for the 2010 FDA approval of a common morcellator.35,36

“Entrepreneurial medicine could be great, if the primary focus is to keep the patient 100% safe. However, if the primary object is to protect the practice of minimally invasive hysterectomy, defend or distract from a severe error in surgical judgment and practice, or to profit from a danger, such entrepreneurship in medicine is ethically suspect.”

—Hooman Noorchashm, MD, PhD

Finally, Dr. Noorchashm points to the intense pressure felt by physicians in today’s “industrialized” medical system to perform at maximum productivity, as measured in hospital lengths of stay (they should be short), numbers of patients seen daily (they should be large), and return on investment in expensive equipment (naturally it should be great). These factors prejudice doctors and hospitals against choosing any procedure that might take longer, use more resources, and cost the for-profit hospital system any additional money.

Taken together, says Dr. Noorchashm, the combination of inadequate, isolated training of gynecologists, the use of inappropriate statistics, shoddy FDA oversight, and intense financial pressure on physicians all sustain the use of this technology, despite the known risks to which it exposes patients.

No one is suggesting an actual conspiracy in this connection; far from it. Rather, this tragic situation arises from the same kind of institutional inertia, resistance to change, and narrow vision that continue to plague healthcare systems around the world.37-43

Medical Damage Control

Medical Damage Control  

In an ideal medical environment where patient care is held to be of paramount importance, where the Hippocratic Oath’s injunction “ primum non nocere,” or “first do no harm” is held sacred, and where genuine evidence is used to inform and revise policies and procedures, Drs. Reed and Noorchashm’s personal experiences and professional campaign for change would have led to an immediate halt to morcellation, at least while the issue was being more closely examined. Device manufacturers would rapidly issue warnings on their own, and if they didn’t, regulatory agencies like the FDA would step in to enforce such steps. And clinicians would fully explain to women why an apparent time-saving, scar-reducing procedure was unwise and unsafe.

But sadly we live in a world where profits take precedence over patient outcome. Dr. Noorchashm’s efforts to alert the medical community about the very real life-threatening dangers of morcellation have been met with denials and attempts at corporate “damage control” by hospital administrators and chiefs of gynecology. His persistent letters to manufacturing executives such as those at Intuitive Surgical who manufacture the da Vinci® robot have been met with silence rather than ethical and immediate action in issuing warnings on the device. According to Dr. Noorchashm, “This medical specialty’s leaders and the companies involved have known about the hazard and have blindly accepted the collateral damage to their patients for many years.”

The medical community does not appreciate when one of its own raises a red flag about a dangerous medical practice: it ruins business and halts the steady flow of dollars to device manufacturers, hospitals, and doctors. Dr. Noorchashm’s attempts to point out, in a reasoned fashion, where and how morcellation increases patient risks have been aggressively met with insults, push back, and even the suggestion that he is acting irrationally due to grief over his wife’s condition, and that it would be much wiser for him to remain quiet to protect his career.

Dr. Reed and her
husband Dr. Noorchashm
Surgeon looking into console viewer
when the da Vinci® robot is used to
morcellate. The da Vinci® Si™ patient
cart with Single-Site™ instruments.
©2014 intuitive surgical, inc.

“Thanks for sharing. As we have repeatedly said, nothing is going to create any ‘peace’ in this man.”

— Gerald F. Joseph, MD, Vice President for Practice Activities at
the American College of Obstetricians and Gynecologists (ACOG),
in response to Dr. Noorchashm’s request for ACOG support in
changing morcellation practices.

In effect, once the notion of patient safety is raised by a physician, that physician is seen as a traitor, and colleagues, hospitals, and other institutions quickly close ranks, isolating the whistleblower and protecting their own financial self-interests.

Thanks to Drs. Noorchashm and Reed’s relentless efforts there has been some minor progress. Four medical centers have now modified their position on open morcellation. Rather than totally discontinue or at least issue a moratorium until a thorough review has been conducted, Temple University Medical Center, University of Rochester Medical Center, Brigham and Women’s Hospital, and Massachusetts General Hospital now require that all morcellation be conducted using an “isolation bag” intended to prevent spillage of tumor or tissue. However, this is not a satisfactory solution. Isolation bags can tear during morcellation, spilling their potentially hazardous contents back into the patient. Additionally, bags are cumbersome and doctors cannot always see what they are morcellating, resulting in organ damage. This change in policy fails to ban morcellation entirely, so a certain amount of risks continues. Therefore, patients will continue to undergo this risky procedure.

Other institutions have not been willing to go even that far. Incredibly, after accurately describing the risk of spreading malignant cells throughout the abdomen, and after noting that “Morcellation-induced sarcomatosis (the spread of a type of cancer) will worsen the prognosis for the patient and necessitate additional surgery and chemotherapy,” a medical staff note to the OB/GYN Department at Brigham and Women’s Hospital in Boston (where Dr. Reed’s procedure was done) concludes, anticlimactically, that informed consent forms should make patients aware of the risks of morcellation.44 In reality, informed consent does little to protect the patient, but superbly protects the surgeon and hospital.

But the memo does not require that physicians even tell patients that they will use a morcellator. Instead, the memo only suggests it by saying: “Doctors sometimes use a mincing process called ‘morcellation’…mincing the tissue into small pieces may spread the tumor around the abdominal cavity…this may sometimes reduce the patient’s chances of being cured.” It goes on to suggest that spreading cancer this way is thought to occur “infrequently”—and then cites a range of one in 400 to one in 1,000 to support this claim. These statements are repeated in a position statement by the Society of Gynecologic Oncology (SGO) in 2013.3

Not surprisingly, this tepid approach has been strongly criticized by physicians and researchers in other countries. In an editorial, the British journal Lancet Oncology wonders “why the SGO [Society of Gynecologic Oncology] has taken such a soft line,” and recommends cracking down on device manufacturers and regulators to assure warning labels and accurate advertising for morcellators.3 And the National Institute for Health and Care Excellence in the UK, the equivalent of the US FDA, has issued provisional guidelines aimed at reducing the use of power morcellators and improving patient consent procedures.45

Dr. Noorchashm is cautiously encouraged by these changes, but he feels that they go nowhere near far enough. In letters and op-ed pieces to major US newspapers, in a barrage of letters to medical journals and professional organizations, and in approaches to state and federal legislators, he advocates for an immediate moratorium on morcellation.46 He and Dr. Reed have also founded a petition on the www.change.org website which reads: “Place an immediate moratorium on intracorporeal uterine morcellation during minimally invasive hysterectomy, on all gynecological tissue morcellation devices and any devices, used to morcellate the uterus intracorporeally in the United States and Abroad. It is your high duty to first, do no harm.”

 
Non-Surgical Ways To Manage Uterine Fibroids

Non-Surgical Ways To Manage Uterine Fibroids

Life Extension® has published an integrative protocol for
the management of uterine fibroids. This updated protocol
can be accessed at lef.org/fibroids

 

Almost daily, Drs. Reed and Noorchashm hear from other couples whose lives and loved ones have been irreparably harmed by morcellation, each couple telling their own version of an eerily similar story: they were not told that morcellation would be used, they were not informed of the risk, alternatives were not discussed, and cancers, when discovered, were at advanced stages. Yet doctors continue to use morcellation on legions of women day in and day out.

Despite a flurry of articles in the gynecologic and general medical literature questioning or condemning the practice, morcellation continues to be used on women daily at hospitals throughout the country. Its proponents have not backed down. In an email received shortly before press time, Dr. Noorchashm repeated his pleas, and directed them to readers of this magazine: “I again ask for your help in keeping this hazard in the public eye until it is resolved.” The gynecological associations have not acted to stop this dangerous procedure.

Due to Drs. Noorchashm and Reed’s herculean efforts, the Food and Drug Administration has finally issued a safety communication on the use of laparoscopic uterine power morcellation in hysterectomy. Yet according Dr. Noorchashm, “…the FDA advisory on morcellation is definitely insufficient in protecting women. In fact, given the extensive analysis performed by the FDA public health specialists revealing a one in 350 mortality hazard, we are astonished that this equipment was not pulled from the marketplace. Functionally, the FDA has left this hazard in the hands of the patient to inform themselves…This is not an acceptable response from a Federal agency entrusted with protecting the public effectively—particularly because these devices are regulated by the FDA.” Yet as we go to press, morcellation and its very real risks continue to be used on uninformed patients.

There is still much work to be done to stop this dangerous procedure from bringing deadly cancer into the lives of even more innocent women.

Summary

Modern technology has delivered some genuinely miraculous techniques capable of relieving suffering, reducing costs, and minimizing complications of surgical procedures. But sometimes newer and faster is not better, and may even be harmful.

Morcellation, chopping up a fibroid-laden uterus for easy removal through a laparoscope, held the promise of shorter operations, smaller scars, and faster returns to everyday activities. But its proponents overlooked, downplayed, or concealed the risk of spreading deadly uterine cancer in a small, but by no means minuscule, proportion of cases.

Morcellation continues to be used in the US, driven by inadequate physician training, institutional inertia, and corporate greed. Even now, few hospitals require that the technique, and associated risks, be revealed to, much less discussed with, patients prior to an elective hysterectomy.47

If you or someone you care about is facing a hysterectomy, it is essential that you know whether morcellation is being contemplated in your case. Ask your physician long before you are faced with signing an informed consent form and the operation is imminent. Demand to know your options. The wisest choice, if you agree that a one in 350 chance of dying from upstaging a hidden malignancy is unacceptable, is to choose an alternate procedure. And if this article has moved you, please consider signing Dr. Noorchashm’s online petition at www.change.org.

If you have any questions on the scientific content of this article, please call a Life Extension® Health Advisor at 1-866-864-3027.

Morcellation: News Update

Efforts to stop the use of morcellation to remove uterine fibroids and perform hysterectomies remains a rapidly evolving story. The Wall Street Journal, New York Times, Boston Globe, Washington Post, and nightly news continue coverage of this story.

As we approach press time, Johnson & Johnson announced it will suspend worldwide sales of its power morcellator device. Note that Johnson & Johnson is not removing the device from the market, but rather stopping further sales until there is clarity in the medical community about the safety and use of this device.

Additionally, Dr. William Maisel of the FDA stated on April 17, 2014, “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

This summer, the FDA will convene a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss laparoscopic power morcellation and hear from patients, physicians, and manufacturers.

Changing medical thinking, practice, and regulation is too often a painfully slow process that allows years of needless suffering for far too many patients. Until Dr. Noorchashm tirelessly and courageously began to sound the alarm morcellation was performed on too many women without concern for the lethal risks perpetuated. Specific hospitals, medical professions, device manufacturers, and the FDA are beginning to respond, albeit somewhat cautiously, to Dr. Noorchashm’s warnings. In the space of several months, Dr. Noorchashm has created a vital awareness to change a harmful medical practice that normally takes thousands of deaths and years of fighting bureaucracy and manufacturers. His is a remarkable accomplishment. While there are still massive obstacles to overcome—such as medical societies, physicians, and hospitals who continue to endorse morcellation—Dr. Noorchashm has brought a powerful light onto a harmful business-as-usual medical practice. His hopes and ours is that going forward, no woman should unnecessarily be exposed to the life-threatening risk of cancer through morcellation.

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