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Morcellation Media Monitoring 1/30/2015
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A national security threat: Another Titanic and her fateful iceberg
Mar 30, 2015 | Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.
In October of 2013, a FDA cleared power morcellator upstaged an early stage cancer in our family. This device was a dangerous one that had made it into the marketplace unchecked. The human, psychological and spiritual cost of this complication to our entire family is immeasurable. And, as of March 2015, the dollar cost of care to our family and our health insurance infrastructure stands at near $400,000 – not to mention the hidden costs of dealing with illness. -
A national security threat: Another Titanic and her fateful iceberg
Mar 27, 2015 | Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.
In October of 2013, a FDA cleared power morcellator upstaged an early stage cancer in our family. This device was a dangerous one that had made it into the marketplace unchecked. The human, psychological and spiritual cost of this complication to our entire family is immeasurable. And, as of March 2015, the dollar cost of care to our family and our health insurance infrastructure stands at near $400,000 – not to mention the hidden costs of dealing with illness. -
Guidance Issued for Endometrial Cancer, Hints for Diagnosis
Mar 30, 2015 | MedScape
By Veronica Hackethal, MD
Minimally invasive surgery: Standard surgical approach for comprehensive staging. Do not use power morcellation in women with known or strongly suspected uterine cancer. -
Laparoscopic, Abdominal Hysterectomy for Fibroid Tumors Compared in Study
Mar 27, 2015 | Monthly Prescribing Reference
Laparoscopic hysterectomy with morcellation is associated with better outcomes than abdominal hysterectomy for women with presumed fibroid tumors, according to research published online March 24 in theAmerican Journal of Obstetrics & Gynecology. -
Google Takes on the Challenge of Making Robot Surgery Safer
Mar 30, 2015 | Wired
By Tim Moynihan
Given Google’s skill with software, it’s also tempting to hope that the company might actually make robot-assisted surgeries safer. These are incredible machines, but they’re still as fallible as the human controlling them. In 2013, the Colorado Medical Board charged physician Warren Kortz with malpractice after he injured several patients and left instruments inside them after robotic surgery procedures. And earlier this year, Johnson & Johnson stopped sales of its power morcellators—instruments used to cut up pieces of tissue for removal during a hysterectomy—after an FDA warning said morcellation could actually spread cancerous tissue during surgery. -
Health Insurance Provider Addresses Hysterectomy with Morcellation & Cancer Risks
Mar 27, 2015 | Injury Lawyer News
By Stephanie Reid
For many women, the stress of undergoing a uterine hysterectomy is enough to handle, and the notion ofcontracting deadly cancer of the reproductive organs as a result of the surgery is virtually unimaginable. However, dozens of women across the United States have endured this very result – and health insurance providers are starting to take notice.
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A national security threat: Another Titanic and her fateful iceberg
Mar 30, 2015 | Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.
The Titanic was a marvel of technological advancement. She was the “unsinkable” ship of her time.
But her crew and captain became complacent to safety concerns and confidently went for “speed”, ignoring the icebergs ahead.
The rest is history. The “unsinkable” ship sank, definitively.
Of course, the Titanic is a true story. But it serves as an allegorical paradigm and lesson for security threats to the welfare of our own nation - a nation, which is, without question, a Titanic.
America and her institutions are, indeed, as awesome and historic as the Titanic was in her time.
But we must learn from history and human experience. Because America cannot be allowed to sink.
We must take care and be vigilant of the proverbial icebergs in our path. Our congress, our president, our federal agencies and our fellow citizens must be on guard always – lest our Titanic be lost again.
We, and others, have identified one such iceberg in our nation’s path and it will not be small in its impact.
This national security threat is fully operational and it resides in our medical device regulatory space. This “iceberg” is on a direct collision course with our nation’s health insurance infrastructure and the very fabric of our society: American lives and their health.
The medical device industry in the United States is not regulated by the FDA in a risk based fashion. “Patient-safety” is not the primary goal of the FDA’s Center for Devices and Radiological Health (CDRH), where thousands of medical devices used in patients are being cleared for marketing annually.
Despite this dangerous safety deficit, medical device industry advocates, many congressional representatives and even the CDRH leadership at FDA, are confidently calling for even more speed and “streamlining” of medical device approval. They are calling for tax advantages to further stimulate this dysregulated industry.
Senator Lamar Alexander, Senator Bob Casey, Senator Elizabeth Warren, Senator Jeanne Shaheen, Senator Pat Toomey, Congressman Mike Fitzpatrick, honorable members of the United States congress, we ask you: Why?
Their rationale is that increasing the speed of marketing will deliver presumably “life-saving” devices to market faster. That the economy will boom and that innovation will be spurred because of this increased speed.
Indeed, the Titanic crashed into its fateful iceberg confidently and with great speed and efficiency.
Let us be clear, we grant that only a minority of medical devices in the repertoire of existing devices are dangerous and unrecognized. But each one of these minority subset of faulty devices triggers an enormous human and dollar cost to our society when it avoidably harms patients.
So, when the minority subset of dangerous devices present in the healthcare milieu do harm, the human and dollar cost to our nation is exponentially compounded.
Now imagine, further increasing the speed with which such devices get into the market-place without any real safety measures – and you have an iceberg on a direct collision course with one of the most robust and vigorous healthcare systems in the history of human civilization.
In October of 2013, a FDA cleared power morcellator upstaged an early stage cancer in our family. This device was a dangerous one that had made it into the marketplace unchecked. The human, psychological and spiritual cost of this complication to our entire family is immeasurable. And, as of March 2015, the dollar cost of care to our family and our health insurance infrastructure stands at near $400,000 – not to mention the hidden costs of dealing with illness.
We invite the reader to extrapolate the numbers. They are enormous.
And ours is only one of the families affected by a single faulty device. There are many more - hidden from view at home, in long-term acute care facilities, and dead.
Hidden from our society’s consciousness because they are harmed by devices bearing a seal of FDA clearance used in “standards of care” by licensed physicians - this is why it is an enormous iceberg, a National Security Threat, camouflaged by our irrational confidence and exuberance about our own healthcare system and its associated industries and federal agencies.
The “unsinkable” ship sank because her captains became complacent, arrogant, and comfortable in the luxurious glow of their ship. They failed to recognize their primary mission, which was to safely get the passengers and cargo to the other side of a perilous terrain.
In March of 2015, we are reiterating to you, the reader, a severe national security threat is looming in our own medical device regulatory space. It promises to devastate more families and blow an even bigger hole in our health insurance infrastructure. And our time is running out to reverse course.
Let’s hope that this time those on board the American Titanic awaken her captains from their ignorant slumber, to the looming hazard ahead.
This iceberg is not small. And we are all on the ship. -
A national security threat: Another Titanic and her fateful iceberg
Mar 27, 2015 | Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.
The Titanic was a marvel of technological advancement. She was the “unsinkable” ship of her time.
But her crew and captain became complacent to safety concerns and confidently went for “speed”, ignoring the icebergs ahead.
The rest is history. The “unsinkable” ship sank, definitively.
Of course, the Titanic is a true story. But it serves as an allegorical paradigm and lesson for security threats to the welfare of our own nation - a nation, which is, without question, a Titanic.
America and her institutions are, indeed, as awesome and historic as the Titanic was in her time.
But we must learn from history and human experience. Because America cannot be allowed to sink.
We must take care and be vigilant of the proverbial icebergs in our path. Our congress, our president, our federal agencies and our fellow citizens must be on guard always – lest our Titanic be lost again.
We, and others, have identified one such iceberg in our nation’s path and it will not be small in its impact.
This national security threat is fully operational and it resides in our medical device regulatory space. This “iceberg” is on a direct collision course with our nation’s health insurance infrastructure and the very fabric of our society: American lives and their health.
The medical device industry in the United States is not regulated by the FDA in a risk based fashion. “Patient-safety” is not the primary goal of the FDA’s Center for Devices and Radiological Health (CDRH), where thousands of medical devices used in patients are being cleared for marketing annually.
Despite this dangerous safety deficit, medical device industry advocates, many congressional representatives and even the CDRH leadership at FDA, are confidently calling for even more speed and “streamlining” of medical device approval. They are calling for tax advantages to further stimulate this dysregulated industry.
Senator Lamar Alexander, Senator Bob Casey, Senator Elizabeth Warren, Senator Jeanne Shaheen, Senator Pat Toomey, Congressman Mike Fitzpatrick, honorable members of the United States congress, we ask you: Why?
Their rationale is that increasing the speed of marketing will deliver presumably “life-saving” devices to market faster. That the economy will boom and that innovation will be spurred because of this increased speed.
Indeed, the Titanic crashed into its fateful iceberg confidently and with great speed and efficiency.
Let us be clear, we grant that only a minority of medical devices in the repertoire of existing devices are dangerous and unrecognized. But each one of these minority subset of faulty devices triggers an enormous human and dollar cost to our society when it avoidably harms patients.
So, when the minority subset of dangerous devices present in the healthcare milieu do harm, the human and dollar cost to our nation is exponentially compounded.
Now imagine, further increasing the speed with which such devices get into the market-place without any real safety measures – and you have an iceberg on a direct collision course with one of the most robust and vigorous healthcare systems in the history of human civilization.
In October of 2013, a FDA cleared power morcellator upstaged an early stage cancer in our family. This device was a dangerous one that had made it into the marketplace unchecked. The human, psychological and spiritual cost of this complication to our entire family is immeasurable. And, as of March 2015, the dollar cost of care to our family and our health insurance infrastructure stands at near $400,000 – not to mention the hidden costs of dealing with illness.
We invite the reader to extrapolate the numbers. They are enormous.
And ours is only one of the families affected by a single faulty device. There are many more - hidden from view at home, in long-term acute care facilities, and dead.
Hidden from our society’s consciousness because they are harmed by devices bearing a seal of FDA clearance used in “standards of care” by licensed physicians - this is why it is an enormous iceberg, a National Security Threat, camouflaged by our irrational confidence and exuberance about our own healthcare system and its associated industries and federal agencies.
The “unsinkable” ship sank because her captains became complacent, arrogant, and comfortable in the luxurious glow of their ship. They failed to recognize their primary mission, which was to safely get the passengers and cargo to the other side of a perilous terrain.
In March of 2015, we are reiterating to you, the reader, a severe national security threat is looming in our own medical device regulatory space. It promises to devastate more families and blow an even bigger hole in our health insurance infrastructure. And our time is running out to reverse course.
Let’s hope that this time those on board the American Titanic awaken her captains from their ignorant slumber, to the looming hazard ahead.
This iceberg is not small. And we are all on the ship. -
Guidance Issued for Endometrial Cancer, Hints for Diagnosis
Mar 30, 2015 | MedScape
By Veronica Hackethal, MD
The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncology have issued new guidance for endometrial cancer. The practice bulletin waspublished in the April issue of Obstetrics & Gynecology.
"A thorough understanding of the epidemiology, pathophysiology, and diagnostic and management strategies for this type of cancer allows the obstetrician–gynecologist to identify women at increased risk, contribute toward risk reduction, and facilitate early diagnosis," the bulletin states.
The practice bulletin reviews current knowledge about endometrial cancer and offers recommendations for diagnosis and management.
Endometrial cancer, the most common gynecologic malignancy, will affect about 54,870 US women in 2015, and 10,170 will die from it, the authors note. At diagnosis, more than 70% of women have stage I disease, which has a 5-year survival rate of 90%. Although white women have a slightly higher lifetime risk of being diagnosed with endometrial cancer, black women are more likely than white women to have higher-grade, more advanced disease at diagnosis.
Type 1 endometrial cancer, or endometrioid adenocarcinoma, causes about three quarters of cases. At diagnosis, most are low-grade and limited to the uterus. With conservative treatment, the precursor lesion (endometrial intraepithelial neoplasia) has a 19-year cumulative risk for progression of 27.5% (95% confidence interval, 8.6% - 42.5%). The precursor lesion coexists with undiagnosed endometrioid carcinoma in 30% to 50% of cases.
Type 2 has clear cell and papillary serous histologies. It carries a worse prognosis than type 1, with high-grade lesions and significant risk for extrauterine disease. Although uterine papillary carcinoma causes about 10% of uterine cancer cases, it accounts for 40% of deaths resulting from the disease. Endometrial intraepithelial carcinoma usually precedes type 2 uterine cancer.
Risk factors include prolonged exposure to unopposed estrogen, obesity, type 2 diabetes, hypertension, older age, nulliparity, infertility, tamoxifen use, early age at menarche, late age at menopause, smoking (increased risk for type 2, decreased risk for type 1), and genetic predisposition with Lynch syndrome and Cowden disease.
The recommendations address the following issues: diagnosis; metastatic evaluation in new diagnoses; the role of the gynecologic oncologist in initial management; comprehensive staging; initial surgical management; adjuvant therapy; cytoreduction, chemotherapy, and hormone therapy in advanced-stage or recurrent disease; fertility-sparing treatment and ovarian preservation; management of incidentally diagnosed endometrial cancer after hysterectomy for another indication; follow-up; and estrogen therapy for the management of menopausal symptoms in survivors.
The practice bulletin offers recommendations based on level A evidence ("good and consistent scientific evidence"), level B evidence ("limited or inconsistent evidence"), and level C evidence ("primarily consensus or expert opinion").
Recommendations based on level A evidence include:
Outpatient endometrial sampling with disposable devices: Method of choice for histological evaluation; usually reliable and accurate.
Hysteroscopy: Not required, although it is recommended along with directed dilation and curettage to include discrete lesions and background endometrium; it is the best way to confirm endometrial premalignancy and exclude associated endometrial carcinoma.
Routine preoperative imaging: Not necessary for evaluation of metastasis.
Initial management: Comprehensive staging (total hysterectomy, bilateral salpingo-oophorectomy, pelvic and para-aortic lymphadenectomy, and collection of pelvic washings). Exceptions only in consultation with a specialist in endometrial cancer.
Minimally invasive surgery: Standard surgical approach for comprehensive staging. Do not use power morcellation in women with known or strongly suspected uterine cancer.
Adjuvant radiation: Can decrease local recurrence rate in certain stage I or stage II tumors, but does not affect survival.
Adjuvant treatment of choice: Vaginal brachytherapy, preferred over pelvic whole irradiation in some patients with high-intermediate risk for recurrence.
Chemotherapy: Improves outcomes in advanced disease.
Estrogen therapy: Consider for menopausal symptoms in early-stage survivors, but only after comprehensive counselling about risks and benefits.
The article also includes a list of selection criteria for women who may be candidates for conservative treatment.
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Laparoscopic, Abdominal Hysterectomy for Fibroid Tumors Compared in Study
Mar 27, 2015 | Monthly Prescribing Reference
Laparoscopic hysterectomy with morcellation is associated with better outcomes than abdominal hysterectomy for women with presumed fibroid tumors, according to research published online March 24 in theAmerican Journal of Obstetrics & Gynecology.
Matthew T. Siedhoff, MD, from the University of North Carolina at Chapel Hill, and colleagues modeled outcomes for laparoscopic hysterectomy with morcellation vs. abdominal hysterectomy for the presumed fibroid uterus. Using a decision-tree analysis, outcomes were compared for a hypothetical cohort of 100,000 premenopausal women who underwent hysterectomy for presumed fibroid tumors over a five-year time horizon.
The researchers predicted fewer overall deaths for laparoscopic hysterectomy vs. abdominal hysterectomy (98 vs. 103 per 100,000). After laparoscopic hysterectomy there were more deaths from leiomyosarcoma (86 vs. 71 per 100,000), while more hysterectomy-linked deaths occurred after abdominal hysterectomy (32 vs. 12 per 100,000). The rates of transfusion, wound infection, venous thromboembolism, and incisional hernia were lower in the laparoscopic group, but the rate of vaginal cuff dehiscence was higher. There were more quality-adjusted life-years with laparoscopic hysterectomy (499,171 vs. 490,711 over five years).
"No decision analysis is ever the 'final word,' and this one in this month's AJOG is no different," Editor-in-Chief for Gynecology of the American Journal of Obstetrics & Gynecology Ingrid Nygaard, MD, of the University of Utah in Salt Lake City, said in a journal news release. "New data will continue to be added to the literature and the conclusions might stand as they are or change. But, most importantly, Siedhoff et al remind us to keep the big picture in mind, to balance risks and benefits of different procedures, and to work vigilantly to decrease the impact of risks to the extent possible."
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Google Takes on the Challenge of Making Robot Surgery Safer
Mar 30, 2015 | Wired
By Tim Moynihan
GOOGLE IS NO stranger to robotics or healthcare technology. The tech giant owns several robotics companies, including Boston Dynamics and its arsenal of robo-dogs and nimble-but-drunk bipedal bots. And the Google X Life Sciences division has created everything from contact lenses that measure blood-sugar levels to tremor-proof spoons for Parkinson’s patients.
Now, the search giant is teaming up with Johnson & Johnson’s Ethicon subsidiary to build what the two hope are the ultimate platform for robotic surgery.
Robot-assisted surgeries aren’t a new thing; in fact, they’ve been around in one form or another since 1985. And as tempting as the vision of a scalpel-wielding T-800 may be, in real life it’s a much more delicate process. In modern robotic-surgery systems, a doctor peers into a console to see a high-definition image of what the robot’s cameras are capturing. Using hand controls, the doctor operates the robo-surgeon’s arms.
Robotic surgery works best for operations that require small incisions and levels of precision that would be difficult for even the nimblest human. In this demo video from Intuitive Surgical, the multi-armed machine is dextrous enough to paint a tiny picture—while guided by a human, at least. Real-world applications include removing cancerous tissue, performing hysterectomies, and bypass surgery. The smaller incisions enabled by machines mean smaller scars and less bleeding for patients.
Of course, in that real world, robotic surgery has faced certain obstacles. Like, for example, the dozens of lawsuits around the US filed against Intuitive alleging that the da Vinci system has a higher rate of complications, including serious injuries and death. Even though the Food and Drug Administration eventually said that Intuitive had addressed all the agency’s concerns and approved a new version of the device, the company has continued to face allegationsthat its business practices allowed undertrained physicians to operate the devices, and that the devices themselves had critical problems.
So what is Google bringing to this ripe-for-disruption industry? A spokesperson wouldn’t talk in detail about the company’s partnership with Johnson & Johnson, but a few details are already available. And they don’t involve teaching Big Dog to play fetch with scalpels.
Existing robotic surgery platforms, such as Intuitive Surgical’s da Vinci robots, have high-definition, 3-D capable endoscopes. A video feed gives a surgeon a view of your guts. Google says its goal is to use algorithms to analyze those on-screen images and do things like highlight blood vessels and display critical information on screen. In other words, says the Google spokesperson, a new system would “help surgeons see better during surgery or help them more easily access information they rely on as they operate.” Similar technology powers the image-editing tools in Google’s photos app, as well as automated YouTube upload analysis that can recognize pirated content.
A Johnson & Johnson spokesperson says whatever the team comes up with might, for example, suggest the best places to make incisions based on the individual patient’s medical history—sort of a Google Maps for surgery. Google says it will not be involved in making the systems that actually control the surgical instruments.
Johnson & Johnson already works with Intuitive Surgical on components for the da Vinci system, and says it will continue to do so, but the Google partnership will be for an entirely different hardware-and-software product. A spokesperson says the company hopes the new system will be more cost-effective for hospitals in developing nations, and that it’ll have an interface that improves a surgeon’s access to information during a procedure.
Given Google’s skill with software, it’s also tempting to hope that the company might actually make robot-assisted surgeries safer. These are incredible machines, but they’re still as fallible as the human controlling them. In 2013, the Colorado Medical Boardcharged physician Warren Kortz with malpracticeafter he injured several patients and left instruments inside them after robotic surgery procedures. And earlier this year, Johnson & Johnson stopped sales of its power morcellators—instruments used to cut up pieces of tissue for removal during a hysterectomy—after an FDA warning said morcellation could actually spread cancerous tissue during surgery.
Whether the Google-J&J partnership can do all that remains to be seen. It needs to pass antitrust muster, first of all, and even then the project will have a long research and development phase. An actual product is still a year or two away. But one thing Google knows is how to build intuitive and straight-forward interfaces. Giving one of those to a surgeon controlling forceps- and scalpel-tipped robot arms poking around at a person’s innards seems like it would be a net win.
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Health Insurance Provider Addresses Hysterectomy with Morcellation & Cancer Risks
Mar 27, 2015 | Injury Lawyer News
By Stephanie Reid
For many women, the stress of undergoing a uterine hysterectomy is enough to handle, and the notion ofcontracting deadly cancer of the reproductive organs as a result of the surgery is virtually unimaginable. However, dozens of women across the United States have endured this very result – and health insurance providers are starting to take notice.
In January, 2015, the major private insurer known asUnited Health issued a Network Bulletin detailing changes in its coverage allowances for non-vaginal uterine hysterectomy procedures. Citing theincreasing risks of cancer in women following the use of the power morcellator device, the company opted to require prior authorization of all non-vaginal hysterectomies – which are minimally invasive and performed on an outpatient basis. Upon review, United Health has declared it will deny coverage for any non-vaginal procedures that are not medically necessary, and patients will be required to accept responsibility for the entire cost of the procedure.
The change comes on the heels of an FDA Safety Communication issued in November, 2014. The contents of that warning explained to both patients and healthcare providers that the power morcellator can spread undetected cancerous cells throughout the abdominal cavity. When this happens, undiagnosed uterine cancer cells are spread to other organs and tissue – allowing for continued growth and the development of aggressive and possibly untreatable cancer. Despite the stern warnings in the Communication, the FDA nonetheless declined to remove the power morellator from the American market, opting instead to require more disclosure on the warning label.
Basics of the power morcellation technique
A uterine hysterectomy is the surgical removal of the uterus, and over 400,000 women undergo this procedure annually. There are a number of reasons a gynecologist may prescribe a hysterectomy, including: Uterine fibroids, Endometriosis, Uterine prolapse, Pelvic pain, Abnormal uterine bleeding.
Uterine cancer
There are generally two ways for a gynecologist to remove the uterus: laparoscopically through the abdomen, and vaginally. In the latter, the physician accesses the uterine tissue through the vaginal cavity, while the former requires an abdominal incision. In a laparoscopic hysterectomy involving the use of a power morcellator, the uterine tissue is essentially obliterated in the pelvic region and removed in pieces. It is during this process that it becomes possible for unforeseen and undiagnosed uterine sarcoma cells to spread to other areas of the body, particularly targeting remaining reproductive organs (e.g., ovaries, cervix, or vagina). However, it is not unheard of for these malignant cells to migrate to other organ systems, requiring extensive treatment and additional surgeries in many cases.
Power morcellation litigation
A number of women have filed claims alleging they were not fully warned about hysterectomy with morcellation and risk of spreading cancer. This lack of informed consent, coupled with a resulting diagnosis of cancer, is considered by plaintiffs to be cause for legal action. Resulting power morcellator lawsuits bring claims of negligence, failure to warn and breach of warranties.
The FDA has endured increasing criticism for keeping the power morcellators on the market, despite the known correlation between use of the device and the resulting development of aggressive malignant cell growth.
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