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Morcellation Media Monitoring 4/27/2015
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One couple's strategy for waging a personal, public health campaign
Apr 24, 2015 | Newsworks
By Taunya English
In 2013, Reed had surgery in Boston, for what was supposed to be an uncomplicated hysterectomy to treat fibroids. Noorchashm said the surgeon assumed his wife was cancer-free and used a medical device called a power morcellator to divide up and remove the uterus. *Note: The article also contains a radio interview of Dr. Hooman Noorchashm and Dr. Amy Reed from the radio program The Pulse. -
No “best” treatment for common uterine fibroids
Apr 23, 2015 | Harvard Health Publications
By Urmila Parlikar
Laparascopic hysterectomy has historically been accompanied by a procedure called power morcellation. It uses a device to cut the uterus into fragments so it can be removed through the small incisions. But the FDA recently recommended limiting the use of power morcellation because of the small chance that a woman having surgery to remove fibroids may have undiagnosed uterine cancer. If power morcellation is performed in these women, there is a risk that the procedure will spread the cancer throughout the abdomen and pelvis. This is precisely what happened in the much-publicized case of Dr. Amy Reed, an anesthesiologist at Boston’s Brigham and Women’s Hospital. -
FDA Holds Public Meeting on Postmarket Risk for Medical Devices
Apr 23, 2015 | Medical Design Technology
By AAMI
Amy Reed, a patient advocate and cancer survivor, told her deeply personal story of undergoing a hysterectomy with a power morcellator, a device whose safety has been under intense scrutiny after it was linked to spreading a particularly aggressive form of uterine cancer in women. According to a study published by the Journal of the American Medical Association, undetected uterine cancers were present in 27 per 10,000 women undergoing a minimally invasive hysterectomy using power morcellation. The FDA has advised against using the device in most women and put a boxed warning stating uterine tissue may contain unsuspected cancer. Reed noted that most patients would not even think to ask about warnings associated with devices used in their care. She laid out a four-pronged approach to postmarket surveillance: recognition, reporting, analysis, and action.
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One couple's strategy for waging a personal, public health campaign
Apr 24, 2015 | Newsworks
By Taunya English
What does it take to challenge the U.S. Food and Drug Administration and get your personal story heard—and repeated—across the nation? Answer: unapologetic persistence--and maybe 7,000 emails to reporters, lawmakers and public health officials.
That's just part of the strategy that Bucks county couple Hooman Noorchashm and Amy Reed use in their campaign to transform the way medical devices are approved in the United States.
In 2013, Reed had surgery in Boston, for what was supposed to be an uncomplicated hysterectomy to treat fibroids. Noorchashm said the surgeon assumed his wife was cancer-free and used a medical device called a power morcellator to divide up and remove the uterus.
But what the doctor and the couple didn't know was that that Reed had a hidden cancer--leiomyosarcoma--on her uterus.
"We knew if you break up a sarcoma it's like ink, you can't just go back and undo that breaking up, it spreads," Reed said.
The device indiscriminately minces up both healthy tissue and tumors, Noorchashm said.
"My immediate question for the surgeon was 'Did you get it out in one piece at least?'" Noorchashm said "And at that point she told me 'no, we morcellated this.' For me the translation was almost immediate, it meant that they spread the cancer."
Ever since, Noorchashm and Reed have been pushing the FDA to ban morcellators for fibroid surgery, and change the regulation of medical devices.
The husband and wife team are vocal, but it's Noorchashm who takes the lead emailing and pressuring anyone who he thinks can help the cause.
The couple—parents to six children--writes a blog, there's a Facebookpage, and a Change.org campaign.
The national press took notice, and that reporting has garnered recognition from the Pulitzer Prize committee.
When a reporter shows interest in the story, Noorchashm forwards emails and copies lawmakers to let them know that news coverage is on the way.
"You—meaning the press--scare the hell out of them," he said.
The U.S. Food and Drug Administration issued a warning about power morcellators last year.
Lawmakers are speaking out too.
In a press statement, Rep. Mike Fitzpatrick, from Pennsylvania's 8th congressional district, said he looked into the issue after Noorchashm contacted him.
"... what I found were some very troubling facts and disturbing real-life examples."
Noorchashm is a cardiothoracic surgeon. Reed is an anesthesiologist. Having that insider knowledge of the health system has been helpful in their effort.
"We knocked on everybody's door," Noorchashm said. For example, he wrote to CEOs at Aetna because he says insurance companies are the "bloodline" for morcellation.
In recent months, the couple's fight has pivoted and expanded beyond power morcellators to focus on the way the FDA regulates medical devices. Reed says the government's approval path is more rigorous for drugs when compared to the 510(k) process allowed for some medical devices.
"Until you fix the loopholes," Reed said. "It's inevitable. This will come up again."
"I felt that I had to get increasingly vocal and my language had to get increasingly aggressive, that's not where I started," Noorchashm said.
Noorchashm has the stamina of a crusader or activist but said those terms don't apply to him.
"We're definitely patient advocates, now for sure," Noorchashm said. "I think we are fulfilling our responsibility as physicians to public health. The term activist implies someone from the outside doing something they perhaps aren't supposed to be doing--to buck the establishment. But we are part of the establishment. We aren't really activists, I'm a surgeon, there's a mistake happening. When there's a mistake happening you point it out."
Reed says it hasn't always been easy watching her husband's advocacy tactics.
"The tendency has been for me to at times say: 'Oh, oh, just stop.'"
But on consideration Reed said she doesn't think their success could have happened any other way.
"I compare it to, you walk past a car on a hot day and there's a kid inside. You could call the cops or a locksmith meanwhile that kid is baking and you've got to break the window," she said.
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No “best” treatment for common uterine fibroids
Apr 23, 2015 | Harvard Health Publications
By Urmila Parlikar
The other night, I sat in a restaurant with a group of girlfriends. We shared laughter, good conversation and some great wine. As I looked around, I realized that we were likely to share something else: uterine fibroids. Of the ten women sitting at the table, there was a good chance that seven of us would have uterine fibroids at some point in our lives.
Fibroids are noncancerous tumors that grow in the uterus. They may be smaller than a seed or bigger than a grapefruit. A woman may have only one fibroid or she may have many. Depending on their size, number, and location, fibroids can cause heavy bleeding and long menstrual periods (which can, in turn, cause anemia), pelvic pain, frequent urination, or constipation. Fibroids can also cause infertility and repeated miscarriages.No “best” treatment
Given how common uterine fibroids are, you’d think there would be a lot of research comparing treatment options. In fact, there are only a few randomized trials to guide treatment. In a clinical practice article in today’s New England Journal of Medicine, Dr. Elizabeth A. Stewart, professor of obstetrics and gynecology at the Mayo Clinic, lays out the options and discusses the factors that women and their doctors should consider when making treatment decisions.
First, are the fibroids causing symptoms? If not — which is often the case — no treatment is needed.
Next, what are the symptoms? These can be broadly divided into two categories: heavy menstrual bleeding and “bulk” symptoms. Bulk symptoms, like pelvic pain and frequent urination, are caused by the presence of large fibroids in the abdomen.
“I consider the severity of symptoms and the impact of those symptoms on a woman’s quality of life to be the foundation of treatment decision making,” says Dr. Aaron Styer, an obstetrician-gynecologist at Harvard-affiliated Massachusetts General Hospital. “For example, is the woman missing work, requiring frequent hospitalizations, or missing out on normal, daily life? If so, that information will guide the treatment I recommend.”
Whether a woman would like to have children, her age, and how close she is to menopause can also ninfluence the treatment decision. Once a woman enters menopause, fibroids often shrink or even disappear. But until menopause, they may continue to form or reappear after they are removed.Hysterectomy, hold the power morcellation
Removal of the uterus (hysterectomy) is a popular option for women who are done having children. With the uterus gone, new fibroids can’t form. But traditional hysterectomy, in which a surgeon makes a large incision in the abdomen, is major surgery.
In laparascopic hysterectomy, the surgeon removes the uterus through three or four small incisions in the wall of the abdomen. Recovery is quicker and there are usually fewer complications than with a traditional hysterectomy.
Laparascopic hysterectomy has historically been accompanied by a procedure called power morcellation. It uses a device to cut the uterus into fragments so it can be removed through the small incisions. But the FDA recently recommended limiting the use of power morcellation because of the small chance that a woman having surgery to remove fibroids may have undiagnosed uterine cancer. If power morcellation is performed in these women, there is a risk that the procedure will spread the cancer throughout the abdomen and pelvis. This is precisely what happened in the much-publicized case of Dr. Amy Reed, an anesthesiologist at Boston’s Brigham and Women’s Hospital.Treatment options for heavy bleeding
Women with heavy bleeding who do not want to have a hysterectomy can turn to both medical and surgical options. Some medications reduce heavy bleeding by helping blood clot. Hormonal birth control works by thinning the endometrium. This is the nutrient-rich lining of the uterus that is shed during a woman’s period. Medications can relieve symptoms, but they don’t treat the underlying problem.
A surgical option to treat heavy bleeding is hysteroscopic myomectomy. In this procedure, a thin tube called an endoscope is passed through the cervix and into the uterus. The fibroid is shaved and removed, but the uterus is left intact. If a woman does not want to have children, she can opt for endometrial ablation. In this procedure, the endometrium is destroyed, often with heat or cold.Treatment options for bulk symptoms
When fibroids cause pelvic pain or frequent urination, the goal of treatment is to reduce the size of the fibroids. Medications called GnRH agonists effectively shrink fibroids. However, fibroids grow back once the treatment is stopped, and these drugs are not intended for long-term use.
Myomectomy — this time done through a larger incision in the abdomen — can reduce the size of the fibroids while preserving a woman’s ability to have children. However, fibroids can recur after myomectomy. Another option is uterine artery embolization. This procedure blocks the blood supply to fibroids, causing them to shrink and die. Women are significantly more likely to have a successful pregnancy and delivery after myomectomy than after embolization.
A treatment option that is increasingly being used to treat uterine fibroids is MRI-guided ultrasound surgery. It uses ultrasound waves to shrink fibroids and reduce heavy menstrual bleeding.Which treatment is right for you?
While there are many treatment options for uterine fibroids, there is no clear winner. That means you and your doctor can choose a treatment based on your preferences and reproductive plans along with other medical considerations.
As you decide, ask your doctor:
Which treatment gives me the best chances of having a healthy pregnancy?
Which treatment is most likely to offer permanent removal of fibroids?
What are my personal risks and benefits of medical versus surgical treatment options?Let your doctor know:
whether you plan to have more children, if you’d prefer to keep your uterus, even if your childbearing days are over, which symptoms you find most bothersome and how they affect your quality of life.There may be no “best” treatment for uterine fibroids. But there is a best treatment for you.
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FDA Holds Public Meeting on Postmarket Risk for Medical Devices
Apr 23, 2015 | Medical Design Technology
By AAMI
How can the medical device industry best manage risk when it comes to products that are already on the market and in use in hospitals and other healthcare facilities?
That was the focus of a public workshop Tuesday organized and hosted by the U.S. Food and Drug Administration, which said it was trying to promote a better understand of risk in the postmarket setting and bolster an open line of communication between the agency and industry.
"Risk is everywhere," said Jean Cooper a senior staff fellow within the FDA’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health. But, she added, it is viewed in different ways. "It is colored by individual values, as well as society’s values," she said. The FDA and industry need to bridge these differences and develop a common terminology to advance the cause of effective risk management, Cooper said.
To that end, AAMI, in collaboration with CDRH, convened an informal working group this past fall to develop a white paper that articulated "a shared view of risk." The draft paper isavailable online, and interested parties are urged to comment by May 20.
AAMI President Mary Logan spoke about the paper at the workshop.
“We can’t eliminate all risk,” she said, but we can do a better job.
Ginger Glaser, vice president of global regulatory affairs at American Medical Systems, echoed the need for better alignment among all stakeholders—from regulators, to manufacturers, to patient groups. She also urged the audience not to look at the postmarket in isolation. "I want to encourage everyone to look at the entire product life cycle," to help assess whether the harm was caused by a predicted threat or a new risk.
Offering a hospital perspective, Jeff Natterman, the risk manager and associate senior counsel at Johns Hopkins HealthCare, said that he is not the only risk manager at his facility. "Everyone in a hospital who uses technology is a risk manager," he said. The rapid pace of technology change is concerning, and even seemingly small issues can lead to larger problems. He cited an example from 2001, when a recall notice was sent by regular mail. The notice was sent to the loading dock, where it remained for weeks. As a result, a recalled piece of medical equipment remained in use. It is essential to ensure there is a system that effectively communicates recalls and other safety information so that healthcare facilities can ensure recalled devices are not in use.
Putting the Patient First
Patient advocates had an opportunity to present a human face to this complex problem. Karen Smith of the Parkinson’s Disease Foundation described some of the struggles she has faced. Diagnosed with Parkinson’s at age 42, Smith was surprised to learn that the gold standard treatment was the same as it was when her grandmother developed the disease in her early 40s. However, she later learned of a newer treatment option, deep brain stimulation, which utilizes a lead implanted into the brain and a neurostimulator placed below the clavicle.When her healthcare provider asked whether she wanted treatment on one or both sides of her brain, she didn’t know how to answer. She opted for treatment on one side, and only learned a year later that she needed treatment on both. This episode only confirmed that healthcare is complex, she said, “leaving patients in a vulnerable position.” She urged manufacturers to provide more education to patients and their families. Patients have been forced to become experts about their devices, and they may not know about all of the risks.
"Risk management can only be enhanced by patient involvement," she said.
Amy Reed, a patient advocate and cancer survivor, told her deeply personal story of undergoing a hysterectomy with a power morcellator, a device whose safety has been under intense scrutiny after it was linked to spreading a particularly aggressive form of uterine cancer in women. According to a study published by the Journal of the American Medical Association, undetected uterine cancers were present in 27 per 10,000 women undergoing a minimally invasive hysterectomy using power morcellation. The FDA has advised against using the device in most women and put a boxed warning stating uterine tissue may contain unsuspected cancer. Reed noted that most patients would not even think to ask about warnings associated with devices used in their care. She laid out a four-pronged approach to postmarket surveillance: recognition, reporting, analysis, and action.
Reed’s message was echoed by Rep. Mike Fitzpatrick, R-PA, who has backed Reed and her husband in encouraging the FDA to take faster action on medical devices that could pose patient safety problems. "The focus must and always be on patient safety," said Fitzpatrick, who also is a cancer survivor. He urged the FDA to work with closely with Congress on this issue.
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