Preview Newsletter
Morcellation Media Monitoring 2/19/2015
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Two New Studies Add to Scrutiny of Gynecology Tool
Feb 19, 2015 | Wall Street Journal
By Jennifer Levitz and Jon Kamp
New research is adding to a debate over a surgical tool called the laparoscopic power morcellator that the Food and Drug Administration has warned against using in a vast majority of cases because of its potential to spread hidden cancer in common gynecological procedures. -
The medical device tax repeal: The good, the bad and the ugly
Feb 18, 2015 | Philadelphia Inquirer
By Dr. Hooman Noorchashm and Dr. Amy J. Reed
Recently we’ve been getting some feedback from medical device industry advocates. Ironically, this feedback did not come when we started to raise an alarm about the severe patient safety hazard the device industry’s federal regulations have caused. Rather, it came when we raised a significant concern about providing this unsafe industry a tax advantage – the so-called “medical device tax repeal”. -
Obamacare enrollment’s not quite over — Growing chorus for special tax season enrollment period
Feb 17, 2015 | Politco
By Natalie Villacorta
Debate over whether the power morcellator can spread cancer continues with news that one of its defenders was paid by the device maker, also in the Journal: http://on.wsj.com/1ALM9Ro. *Note: The link above directs to the Wall Street Journal article "How Suspect Device Got Surgeon Group’s Blessing" from February 17, 2015. -
510(k) Under Attack
Feb 18, 2015 | Medical Device and Diagnostic Industry
By Jim Dickinson
In February, the Philadelphia Inquirer published an article by Noorchashm in its Sunday health section headlined “A modern-day wolf in sheep’s clothing: FDA’s Center for Devices and Radiological Health (CDRH)”—just the latest salvo in the couple’s 18-month multimedia efforts to ban power morcellation devices used to perform hysterectomy procedures. The article opened a new front in the couple’s fight: to repeal or radically alter Section 510(k). -
Report recommending power morcellator devices to docs reveals conflict of interest
Feb 17, 2015 | Fierce Medical Devices
By Emily Wasserman
Amid mounting backlash over the use of power morcellator devices in women undergoing certain gynecological procedures, new evidence shows that a report issued last year by a professional association of surgeons recommending the tool to physicians may have been biased. -
Questions Raised About Report On Morcellator By Surgeons’ Group
Feb 17, 2015 | Kaiser Health News
The Wall Street Journal reports that an official of the group supporting the use of the controversial surgical device was also a paid consultant to a morcellator's manufacturer. In other news about the health care industry, the Journal also has a collection of articles about medical innovation, and KHN examines some difficulties for determining if a doctor is in an insurance network. -
Risk of unexpected sarcoma being discovered after hysterectomy appears fairly low
Feb 19, 2015 | University of Michigan Health System
By Beata Mostafavi
Authors say the findings, which appear in this month’s issue of Obstetrics and Gynecology, may have implications for the risks associated with morcellation – a minimally invasive procedure that cuts large tissue inside the body into smaller pieces so it can be removed through smaller incisions. The FDA recently issued new guidelines on power morcellators, an electrical device that is used by surgeons to help with morcellation, after concerns that it could potentially spread unsuspected tumors that appeared as benign fibroids. -
WSJ Sheds Light on Morcellator “Blessing” by AAGL
Feb 18, 2015 | The Legal Examiner
By Adrianne Webb
*Note: This site is sponsored by Anapol Schwartz Personal Injury Lawyers. A front-page article in the Wall Street Journal yesterday highlighted growing concerns from 2014 regarding power morcellators, a tool commonly used in gynecological laparoscopic surgeries to cut up and remove tissue. -
Why Surgeons Defend the Power Morcellator
Feb 17, 2015 | Injury Law Blog
By Pintas & Mullins Law Firm
*Note: This article is sponsored by Pintas & Mullins Law Firm. A surgical device used in hysterectomies, myomectomies and other gynecological procedures is now linked to aggressive and fatal uterine cancer. The device, called a power morcellator, has been banned my top hospitals throughout the country and subject to cancer lawsuits. A group of surgeons, however, continues to defend the power morcellator. Our team of uterine cancer lawyers explores why doctors are standing behind this device.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
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Two New Studies Add to Scrutiny of Gynecology Tool
Feb 19, 2015 | Wall Street Journal
By Jennifer Levitz and Jon Kamp
New research is adding to a debate over a surgical tool called the laparoscopic power morcellator that the Food and Drug Administration has warned against using in a vast majority of cases because of its potential to spread hidden cancer in common gynecological procedures.
The University of Michigan said Thursday that researchers at its health system had found that 1 in 368 women undergoing hysterectomies for uterine growths called fibroids instead had an undetected uterine sarcoma that is at risk of being spread by a morcellator. Their study, which was published in the journal Obstetrics & Gynecology, found risk numbers similar to those identified by the FDA. The study included 2,575 women undergoing surgery for presumed fibroids at a statewide group of hospitals in 2013.
The authors said patients should be advised of “the possibility of a poorer prognosis should an unidentified malignancy be morcellated,” and noted that there was no reliable way to distinguish a benign fibroid from a uterine sarcoma before surgery.
Meanwhile, another new study published online Thursday by the Journal of the American Medical Association Oncology found that women who have only fibroids removed with a power morcellator face a lower risk of undetected cancers than hysterectomy patients. But the study authors also said risk increases with age and that there is continued uncertainty about the device.
The morcellator, which is used to remove fibroid growths or the whole uterus through small incisions, can worsen cancers that go undetected before surgery, the FDA warned in November, calling for strict new language on device packaging. Many hospitals have since banned or curbed morcellator use, and former top manufacturer Johnson & Johnson has left the market.
The FDA stopped short of banning morcellators, saying it was leaving open a narrow band for women for whom the tool’s benefits may still outweigh its risks.
Most of the tens of thousands of morcellation procedures performed before controversy over the device erupted in late 2013 involved hysterectomies. But there is also a market for removing just fibroids in procedures called myomectomies, often in younger women who still want to have children.RELATED
How FDA Approved Hysterectomy Tools It Now DisfavorsThe Short Answer: How Medical Devices Like Morcellators Get to MarketHealth Canada Calls for Warning Label on Hysterectomy ToolA Medical Device Is Sidelined, but Too Late for One Woman
Myomectomies are most commonly performed without laparoscopic morcellators, although some gynecologists use the devices. The JAMA Oncology study found that 7.7% of 41,777 myomectomies performed between 2006 and 2012 involved power morcellation.
For those patients on whom morcellators were used, 62% of whom were under age 40, researchers found an overall 1-in-1073 rate of undetected uterine cancer. That rate is more than nine times higher than the 1 in 10,000 rate many doctors quoted patients before the morcellation controversy erupted.
The cancers in Thursday’s JAMA Oncology study included sarcomas, an aggressive kind the FDA focused on, as well as endometrial cancers many gynecologists argue are easier to detect preoperatively.
Younger myomectomy patients are “potentially an area where you may still consider morcellation,” Jason Wright, the lead author of the report and division chief of gynecologic oncology at the Columbia University College of Physicians and Surgeons. But patients should still carefully weigh possible hazards, he said.
“Some women certainly would not want to take the risk of having a potential cancer disseminated,” Dr. Wright said.
Study authors also said the myomectomy “should be approached with caution” in women over 50.
Doctors not connected with either study said they were carefully watching emerging research. Kimberly Kho, an assistant professor in Department of Obstetrics & Gynecology at the University of Texas Southwestern Medical Center, said the JAMA Oncology study would help doctors better counsel younger women. She said power morcellators aren’t necessary for minimally invasive myomectomies.
At Temple University Hospital, Enrique Hernandez, the hospital’s top gynecologist, said new studies support Temple’s decision to halt use of morcellators. “I think it’s too big a risk,” he said.
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The medical device tax repeal: The good, the bad and the ugly
Feb 18, 2015 | Philadelphia Inquirer
By Dr. Hooman Noorchashm and Dr. Amy J. Reed
Recently we’ve been getting some feedback from medical device industry advocates.
Ironically, this feedback did not come when we started to raise an alarm about the severe patient safety hazard the device industry’s federal regulations have caused. Rather, it came when we raised a significant concern about providing this unsafe industry a tax advantage – the so-called “medical device tax repeal”.
You see, giving a financial boost to an industry whose products have virtually no standardized guarantee of safety, is wrong. That’s just common sense – doesn’t matter if you are a democrat, a republican or an independent.
Of course, the reason we’ve raised this issue is not because we are die-hard supporters of the Affordable Care Act, where the proposed tax repeal is going to come from - far from it. Rather, we are die-hard activists for patient safety and medical ethics in our healthcare establishment –as all physicians ought to be.
The industry advocates who are approaching us are all kind and well meaning. They are doing a good job promoting the economic interests of their constituents. They are doing a good job trying to create more jobs. But they also feel suddenly threatened by our goal of linking this tax repeal to the severe patient safety deficit in the medical device realm. They know it’s real. Their message to us about these issues is: “Keep’em separated”.
Unfortunately, these are not separate issues. We do believe that a vast majority of medical devices in our country are designed to be ‘life saving’ – and to make a good profit for their manufacturers. We are not against industry or profits. But, a minority subset of these devices are faulty, in design or conception – as the power morcellator is. And no real federal safety checkpoints are in place to protect unsuspecting patients. Doctors and device reps are the only things that stand between the patient and this monster we call “harm” – and that’s just not acceptable.
When $30 billion dollars are injected into the device industry, it will stimulate the good, the bad and the ugly all the same. And when the bad and the ugly in the medical device realm have no real federal safety checkpoints and are stimulated to grow, they devastate unsuspecting patients’ lives in America.
The real problem in the medical device industry comes from the corrupted way in which the Food and Drug Administration is using the 510(k) law to clear the vast majority of medical devices in the United States. This legislation was never designed for this purpose and it was certainly not designed to ensure patient safety. But, with definitive certainty, the way to protect patients from an industry gone rogue due to defunct federal regulation, is not to boost it with a sizable tax advantage.
So, our response to our friends and colleagues in the medical device industry when they tell us to “keep ‘em separated” is: Help us drive a leadership overhaul of the FDA’s Center for Devices and Radiological Health by congress. Help us make a “Medical Device Safety Reform Act” a reality and the law of this land. Only then can we help you achieve your tax repeal, stimulate your industry and create your jobs.
Patient Safety is first and foremost in our healthcare establishment. An industry whose products have the capacity to damage and destroy lives without any real legislative standards guiding safety, has no business influencing our hospitals and practice patterns – much less getting a tax advantage from our federal government.
Our proposal to our friends in the medical device advocacy community: Secure patient safety first, and win your tax advantage next.
We hope our congressional leaders and the president of the United States are hearing us loud and clear - because real lives in America have been compromised and lost to this industry’s inadequate safety legislation and to FDA’s leadership failure. -
Obamacare enrollment’s not quite over — Growing chorus for special tax season enrollment period
Feb 17, 2015 | Politco
By Natalie Villacorta
Hurray! We made it through the second open enrollment season. Well, almost — it’s not over yet. While the official season ended Sunday night at midnight, people who encountered technical glitches on HealthCare.gov or faced long wait times at the call center over the weekend have until Feb. 22 to finish signing up. Most states have outlined similar policies.
Yes, there were glitches. An otherwise smooth enrollment season was blemished Saturday by a glitch in the technology that verifies income, which blocked consumers from filing new applications. That was fixed by Saturday night, and it’s unclear how many people may have been affected. Despite the glitch, there were signs of a last-minute surge. Sunday was the federal marketplace’s busiest day of the enrollment season other than Dec. 15, the deadline for Jan. 1 coverage. As of about 8:30 p.m. Saturday, the call center had fielded more than 250,000 calls, and there were more than 80,000 people using HealthCare.gov at once. The site’s traffic last week was a 37 percent increase over the prior week, for a total of 31 million visitors to the federal enrollment site since the start of the open enrollment period back in November.
The Massachusetts and Washington exchanges also experienced technical problems. In all, at least 40 states have issued some sort of extension, though the dates vary. For more details on enrollment this past weekend:http://politico.pro/1A12fGl
SPECIAL TAX SEASON ENROLLMENT PERIOD? — The chorus urging the Obama administration to create a special enrollment period around the April tax-filing deadline is growing. Federal lawmakers and consumer advocates say that some people won’t discover they owe a penalty for going without coverage until they file their 2014 taxes, but by then it’ll be too late to sign up for 2015 coverage. A special enrollment period would help such consumers avoid paying the penalty for two consecutive years and boost enrollment numbers further, supporters of the idea say. The Pro story:http://politico.pro/1AxbUGz
In an interview with Pro’s Jen Haberkorn, HHS Secretary Sylvia Mathews Burwell said that the Obama administration will decide within two weeks whether to hold the special enrollment period. On Monday, the Washington Health Benefit Exchange announced it’ll offer one that will last for two months. California and Minnesota are considering it.
A group of Democratic lawmakers, including Sen. Tammy Baldwin wrote Burwell Friday pushing for the tax season enrollment season. The letter:http://1.usa.gov/1CCudFq
BUT THERE ARE DOWNSIDES TOO — A special enrollment period could create adverse selection if people who fall sick in the interval take advantage of the opportunity to enroll, notes a paper released by the Urban Institute over the weekend. Plus, verifying that consumers faced tax penalties could be a headache and the new enrollment opportunity could muddle messaging strategies. The authors argue for shifting future open enrollment periods to early in the calendar year, which would make it overlap with tax season, eliminating the need for future special tax season enrollment periods. The paper: http://urbn.is/1Bi0176
ENROLLMENT INTEREST WANED — Health Pocket is also supportive of moving the enrollment period to coincide with tax season and while HHS is at it, the department might as well shorten the period. A Health Pocket analysis finds that consumer interest in Obamacare waned over the course of the open enrollment season, with shopping interest down by more than 50 percent in the second half. That’s why it’s no biggie if HHS eventually shortens the enrollment period to the length of Medicare Part D and MA plan enrollment — 54 days — Health Pocket says.
This year’s frontloading is a departure from last year when 73 percent of enrollees selected plans in the second half. Of course, HealthCare.gov’s technical problems had something to do with that. In addition, many existing enrollees were auto-enrolled, which occurred early in this year’s season. The analysis: http://bit.ly/1CCywkh
Welcome back to PULSE and happy snow day! We hope you enjoyed the long weekend, stayed warm and received loads of chocolates and flowers for Valentine’s Day. We suspect that Second Lady Jill Biden was secretly disappointed when she got a bunch of wellness and health from her hubbie and no adorable hand-drawn portrait like Michelle got from Barack. Vice President Joe Biden’s Valentine’s Day-themed Obamacare plug: http://bit.ly/1vJjRGX
“Let’s start over. I’ll try to do PULSE right this time around. It’s not over.”
BURWELL GOES DEEP IN THE HEART OF TEXAS — Pro’s Jennifer Haberkorn traveled down to Texas where Burwell spent two days before the close of the open enrollment period encouraging people to sign up. “While many of the politicians here may hate the law, the Obama administration's strategy is clear: If it can get upwards of one million Texans covered, it can prove the law is a success even in the most unfriendly climates. The more people who sign up, the harder it might be — even for the staunchest opponents — to justify killing Obamacare,” Haberkorn writes. Burwell spent her time talking with Texans who have gotten Obamacare and enrollment assisters, asking them what worked, what didn’t and what could be done better. With the closure of the enrollment season, Burwell plans to ensure new Obamacare enrollees actually use their coverage, to guarantee access to providers and to reform the delivery system. The Pro story: http://politico.pro/1FUGpFb
DEADLINES EXTENDED OFF-EXCHANGE — Consumers who missed the Feb. 15 deadline but still want coverage starting March 1 also have the option of purchasing Obamacare plans directly from insurers. Online private health insurance exchange eHealth says that insurers in at least 28 states are accepting applications for ACA plans beyond Sunday’s deadline — some until the end of February. But subsidies aren’t available off-exchange, only through the government-run exchanges. The states include both federal and state-run exchanges, and they include: Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Missouri, Nevada, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin.
STATE WEEK — Disgraced Oregon Gov. John Kitzhaber will leave several ambitious health-related goals unrealized when he steps down this week. Maine Gov. Paul LePage wants the Supreme Court to let him kick young adults off the Medicaid rolls, while a study in Kentucky quantifies the current and future economic benefits of Medicaid expansion. More news from the states: http://politico.pro/1va3QsX
While many in Wyoming think Medicaid expansion is dead there, House Speaker Republican Kermit Brown says the debate isn’t over, the AP reports. This week, members will bring up several amendments to a budget bill that seek to expand the program, he said. Republican Matt Mead is urging lawmakers to approve an expansion bill. The AP story: http://bit.ly/17jzLfl
CMS DELAYS RECONCILING COST-SHARING SUBSIDIES — CMS said Friday that it won’t start reconciling advance cost-sharing subsidy payments that it made to insurers in 2014 until April 2016. These subsidies reduce out-of-pocket expenses for Obamacare enrollees who earn less than 250 percent of the federal poverty level. CMS estimates payments with the intention of reconciling them later with data about actual cost-sharing that insurers provided to enrollees. According to a guidance document released Friday, CMS is delaying reconciliation because some insurers maybe incorrectly estimating how much they’re owed. The 2014 reconciliation was supposed to happen this April, but it will instead start April 30, 2016, CMS said. The guidance:http://politico.pro/1zjB2ee
IN TAX WARS, LITTLE KNOWN AGENCY IS KEY — Republicans are gunning to replace CBO Director Doug Elmendorf with someone more open to their ideas when it comes to taxes. The problem is, CBO doesn’t really do taxes. That’s the job of a different office, the lesser-known Joint Committee on Taxation. Tom Barthold, the guy who has been running that office since 2009, learned last month that his job’s safe. So while changing up CBO’s leadership will affect issues from Obamacare to immigration, JCT will still reign when it comes to taxes. Pro Tax breaks down the history of the twin offices and their distinct roles: http://politico.pro/1L5NB2d
WHAT WE’RE READING
The collapse of CoOpporunity Health, one of the 23 nonprofit co-ops created under the ACA, is raising questions about whether the co-op experiment is more broadly in trouble, reports the New York Times: http://nyti.ms/17KnBx7
Eric Segall and Jonathan Adler debate the merits on King v. Burwell in the University of Pennsylvania Law Review: http://bit.ly/1E0xEu4
After receiving complaints about misleading nursing home ratings, the government is making it difficult for nursing homes to score high on a public report card, Kaiser Health News reports in the Washington Post: http://wapo.st/1MsQL3I
New Jersey, New York and Connecticut are considering legislation that would allow doctors to help terminally ill patients end their lives, the Wall Street Journal reports:http://on.wsj.com/1ALLHTj
Debate over whether the power morcellator can spread cancer continues with news that one of its defenders was paid by the device maker, also in the Journal:http://on.wsj.com/1ALM9Ro
How Medicare was made, in the New Yorker: http://nyr.kr/19nMIGs
The FDA has twice rejected a drug that claims to boost women’s libidos over safety and effectiveness concerns. Is it sexism? NPR delves into that question:http://n.pr/1L6Ua6E
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Feb 18, 2015 | Medical Device and Diagnostic Industry
By Jim Dickinson
The main portal for admission of new medical devices to the market, Section 510(k) of the Food, Drug, and Cosmetic Act, is under attack again, this time from an unlikely quarter: an unconventional and social media-driven campaign led by Philadelphia cardiothoracic surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed.
In February, the Philadelphia Inquirer published an article by Noorchashm in its Sunday health section headlined “A modern-day wolf in sheep’s clothing: FDA’s Center for Devices and Radiological Health (CDRH)”—just the latest salvo in the couple’s 18-month multimedia efforts to ban power morcellation devices used to perform hysterectomy procedures. The article opened a new front in the couple’s fight: to repeal or radically alter Section 510(k).
Their campaign began after Reed’s hysterectomy with a Karl Storz power morcellator spread cancer throughout her abdomen, joining a general one-in-350 incidence rate in power morcellation, according to FDA.
Their efforts have been remarkably successful so far, attracting congressional as well as media support and culminating last November in an uncommonly rapid FDA “immediately in effect guidance” urging manufacturer adoption of a boxed warning and two label contraindications. FDA guidances by definition are nonbinding, however.
Even this small step was swiftly denounced by the American Association of Gynecologic Laparoscopists, which has renamed itself simply AAGL, at its annual meeting in Vancouver, where it declared power morcellation “an effective, lifesaving tool in gynecologic surgery when used appropriately” that “should not be abandoned despite recent concerns about the dissemination of occult cancers.”
FDA’s modest, voluntarism-based action wasn’t enough for Noorchashm and Reed, whose campaign for an outright ban so far has attracted more than 87,000 signatures on a cyber petition to end the devices’ use in all gynecological procedures.
They also want Section 510(k) itself repealed or amended to include a proof-of-safety requirement and a rigorous postmarketing surveillance requirement.
In February, their local Congressman, Republican Mike Fitzpatrick, was preparing a bill to do just that, according to Noorchashm (at press time, Fitzpatrick’s office had not responded to my request for confirmation).
FDA’s implementation of 510(k) has plenty of deficiencies. Five years ago, there was the memorable tumult over the collagen scaffold which, after two years of controversy and corrupt CDRH review allegations, the agency was forced to admit should never have been cleared for marketing.
As in the power morcellator case, a key and recurring theme is 510(k)’s gaping loophole on what “substantially equivalent” really means. Both devices were only vaguely similar to their predicates, and predicate-creep over years and even decades without any second look at safety documentation for new-technology products is a disconnect that should be obvious.
Not if there’s market millions to be made in that disconnect, and in user-fee funds (currently $5018 per submission) to be garnered at FDA. This combination understandably brings with it a certain degree of elasticity in “substantial equivalence” determinations by a CDRH that has come to regard product sponsors as “customers.”
When further combined with industry campaign support for candidates of both parties, this fiscal interdependency arguably enabled both Congress and FDA to ignore or dismiss a recommendation in the 2011 Institute of Medicine report on 510(k) that the agency’s 510(k) program be scrapped.
In its place, the report said, should be a new regulatory framework for Class II devices that is not based on “substantial equivalence” but rather on an “integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
The collagen scaffold and power morcellator controversies haven’t been the only storms to rock FDA’s 510(k) boat, and they likely won’t be the last. The IoM report cited safety issues with an artificial hip, surgical mesh, and medical-tubing connectors, among others.
In Noorchashm’s opinion, and that of former FDA medical device compliance director and noted device attorney Larry R. Pilot—a fierce defender of 510(k) which he helped write—a major issue is the quality of CDRH’s management, processes, and culture.
Noorchashm and other critics fault the center for “being in bed” with industry, while Pilot and others fault it for “incompetence” and failure to use the tools available to it to resolve problems.
These are legitimate issues, but they’re unlikely to be easily eliminated because they are deeply rooted in the very nature of government, across the board, in the American political system. Stakeholders have to be heeded, and the more money they have, the more they have to be heeded.
This is a dynamic that may be about to undergo radical change—something that Noorchashm and others representing injured patients are counting on.
Social media have given them potent tools they never had before. People-power is evolving as a key factor in government decisionmaking. FDA’s timid action on power morcellators came as swiftly as it did largely because of the effectiveness of Noorchashm’s skillful, even adroit multi-media efforts, especially after the Wall Street Journal promoted them. He also credits FDA associate commissioner for policy and planning Peter G. Lurie’s active cooperation.
Social media are changing everything. As mainstream media struggle to adjust, print yields to digital, and Twitter and Facebook replace the evening news, health activists representing injured patients and their families will eventually truncate FDA’s fossilized internal processes, gain seats at the table, and counter the heavy, hidden hand of the influence peddlers.
It’s coming faster than you might think. President Barack Obama’s widely reported initiative on precision medicine actually would enlist “a million or more Americans to volunteer to contribute their health data to improve health outcomes, fuel the development of new treatments, and catalyze a new era of data-based and more precise medical treatment.”
The million or more may be expected to become much more interested, if not activists, in patient care technologies and their governance.
The precision medicine initiative aims to recruit collaborative public and private efforts to “leverage advances in genomics, emerging methods for managing and analyzing large data sets while protecting privacy, and health information technology to accelerate biomedical discoveries.”
Whether or not a Republican-controlled Congress goes along with this initiative—and there are signs that it might—FDA and industry’s old ways of doing things in Washington, DC, and at grassroots are already undergoing seismic change.
A grassroots challenge to 510(k) could be just a beginning. For those with long memories, it was a gynecological device, the Dalkon Shield IUD, and injured patient activism that fueled much of the legal and public agitation that led to the 1976 Medical Device Amendments and the enactment of Section 510(k).
The new patient-powered insurgency could be at least that effective, this time around.
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Report recommending power morcellator devices to docs reveals conflict of interest
Feb 17, 2015 | Fierce Medical Devices
By Emily Wasserman
Amid mounting backlash over the use of power morcellator devices in women undergoing certain gynecological procedures, new evidence shows that a report issued last year by a professional association of surgeons recommending the tool to physicians may have been biased.
As The Wall Street Journal reports, the AAGL--formerly known as the American Association of Gynecologic Laparoscopists--said in a May 2014 report that power morcellation "remains safe when performed by experienced, high-volume surgeons." But an AAGL executive officer, New York-based surgeon Arnold Advincula, joined the final discussions of the report even though he had received consulting fees from a morcellator maker, violating the association's conflict-of-interest policies, Ceana Nezhat, the association's president at the time, said in a May 7 email.
"Given the importance of COI surrounding this topic, and the potential press involvement in dissecting COIs of our board members in relation to morcellation, I am shocked the organization would allow their own policies to be 'flexible,'" Nezhat said in the email, as quoted by the WSJ.
The AAGL started beefing up its conflict-of-interest policies in 2013, adopting a rule that forbid executive committee members from doing paid work for drug or device companies. But Advincula and other incumbents on the committee were exempted from the rule under a grandfather clause that Advincula lobbied for himself.
Advincula, chief of gynecological surgery at Columbia Medical Center, received at least $50,000 for speaking and other services in the last 12 months from Blue Endo, a morcellator seller. He said through an AAGL spokeswoman that his consulting relates to sharing clinical expertise and collaborating with scientists and engineers. Lenexa, KS-based Blue Endo did not comment to the WSJ.
The AAGL today maintains that power morcellation with "appropriate informed consent should remain available to appropriately screened, low-risk women," theWSJ reports.
Meanwhile, the FDA and industry is responding to public outcry over the devices. In July, Johnson & Johnson ($JNJ) pulled its related product from the global market, months after suspending sales for the device. In November, the FDA updated its safety guidance for the devices, recommending against using laparoscopic power morcellator tools in the "majority" of women undergoing a hysterectomy or the removal of uterine fibroids.
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Questions Raised About Report On Morcellator By Surgeons’ Group
Feb 17, 2015 | Kaiser Health News
The Wall Street Journal reports that an official of the group supporting the use of the controversial surgical device was also a paid consultant to a morcellator's manufacturer. In other news about the health care industry, the Journal also has a collection of articles about medical innovation, and KHN examines some difficulties for determining if a doctor is in an insurance network.
The Wall Street Journal: How Suspect Device Got Surgeon Group’s Blessing
Last May, as controversy mounted over a surgical device called the power morcellator, a professional association for surgeons issued a report defending the tool. A month earlier, the U.S. Food and Drug Administration had warned the device risked spreading cancer in surgeries such as hysterectomies. ... Doctors read the report closely for guidance on use of morcellators, which cut up and remove tissue through small incisions. What they didn’t know: An AAGL executive officer who received consulting fees from a morcellator maker had weighed in before publication. (Walker and Levitz, 2/16)The Wall Street Journal: In Image Guided Operating Suites, Surgeons See Real-Time MRI, CT Scans
Surgeons sometimes fly blind when operating on hard-to-reach anatomical parts or hard-to-see conditions. For visual references inside the brain or body, they often rely on images and scans taken before an operation. A growing number of hospitals are equipping operating suites with magnetic resonance imaging, CT scanners and other technology that enables surgeons to scan a patient in real time, without having to move them from the operating table. The resulting real-time 3D visuals—known as “intraoperative imaging”—help surgeons excise tumors and tissue with greater accuracy, reducing risks such as nicked nerves from an errant knife and the potential need for repeat surgery. (Landro, 2/16)The Wall Street Journal: Remote Patient Monitoring Lets Doctors Spot Trouble Early
[A] merging of wireless technology and medical care is still in its infancy, but health systems that began pilot programs with the technology in recent years say they see signs that it is keeping patients healthier. By enabling doctors to continuously monitor patients, they say, the systems can detect problems well before they grow serious. (Rockoff, 2/16)The Wall Street Journal: How To Make Surgery Safer
Surgery can be risky by its very nature, and the possibility of error or negligence makes it even more so. According to an analysis last year in the journal Patient Safety in Surgery, 46% to 65% of adverse events in hospitals are related to surgery, especially complex procedures. Despite years of prevention efforts, procedures are still performed on the wrong body part and surgical tools are sewn up in patients. Now the movement to make things safer is taking on new urgency, as advocates inside and outside the surgical community push for a range of changes, and the cost of mishaps mounts. (Landro, 2/16)The Wall Street Journal: Innovation Is Sweeping Through U.S. Medical Schools
Critics have long faulted U.S. medical education for being hidebound, imperious and out of touch with modern health-care needs. The core structure of medical school—two years of basic science followed by two years of clinical work—has been in place since 1910. Now a wave of innovation is sweeping through medical schools, much of it aimed at producing young doctors who are better prepared to meet the demands of the nation’s changing health-care system. (Beck, 2/16)The Wall Street Journal: How To Detect Infectious Diseases Like Ebola Faster
Now a handful of companies have received emergency clearance from the U.S. Food and Drug Administration to market faster diagnostic tools for Ebola that were in the works when the epidemic in West Africa erupted. One of the tools, from a company called BioFire Defense, uses the same kind of machine—polymerase chain reaction, or PCR—as the test that Ms. Meyler underwent. But BioFire’s system automates much of the process, so results are available in about an hour, instead of the usual four to six. ... Other companies are crafting machines to seek out common diseases. Alere Inc. of Waltham, Mass., has a flu test that delivers results in about 15 minutes, versus about 90 minutes for other tests. (McKay, 2/16)Kaiser Health News: Figuring Out If A Doctor Is In Your Network Is Harder Than You Think
“Is this doctor in my insurance network?” is part of the litany of questions many people routinely ask when considering whether to see a particular doctor. Unfortunately, in some cases the answer may not be a simple yes or no. -
Risk of unexpected sarcoma being discovered after hysterectomy appears fairly low
Feb 19, 2015 | University of Michigan Health System
By Beata Mostafavi
Uterine sarcoma – a potentially aggressive type of cancer that forms in tissues in the uterus – was found in 0.22 % of women following a hysterectomy for benign conditions, a new large-scale study by the University of Michigan departments of Obstetrics and Gynecology, and Surgery finds.
Authors say the findings, which appear in this month’s issue of Obstetrics and Gynecology, may have implications for the risks associated with morcellation – a minimally invasive procedure that cuts large tissue inside the body into smaller pieces so it can be removed through smaller incisions. The FDA recently issued new guidelines on power morcellators, an electrical device that is used by surgeons to help with morcellation, after concerns that it could potentially spread unsuspected tumors that appeared as benign fibroids.
“We found that there is a risk of unexpected cancer discovery at the time of a hysterectomy for what was presumed to be for a benign or non-cancerous indication, however, the risk is fairly small,” says senior author Sawsan As-Sanie, M.D., M.P.H, Assistant Professor in the Department of Obstetrics and Gynecology at the U-M Medical School.
“Caution is warranted in preoperative planning for a hysterectomy, but for a significant number of women, a minimally-invasive procedure may still be a very viable and beneficial option. Physicians need to balance optimizing technologies that have well-known patient-centered benefits while still being cognizant of the rare but true risk of undiagnosed cancer.”
Dr. Sawsan As-Sanie, U-M
Researchers analyzed 2013 data from a quality and safety database maintained by the Michigan Surgical Quality Collaborative, a statewide group of hospitals that voluntarily reports surgical outcomes. The study included 6,360 women who underwent a hysterectomy for benign conditions such as fibroids, pelvic pain, endometriosis or abnormal uterine bleeding. Benign hysterectomies account for more than 400,000 surgeries a year nationwide, and symptoms associated with uterine fibroids remain the most common benign indication for hysterectomy.
The study found a total 2.7 percent incidence of unexpected cancer in women who had undergone hysterectomy for benign indications, but the majority of cases – 1.02 percent – were unexpected endometrial cancer. The underlying reason for the risk of unexpected endometrial cancer is unclear since data was not available on whether these women underwent endometrial biopsy prior to surgery, which can detect most but not all cases of endometrial cancer. "Physicians need to balance optimizing technologies that have well-known patient-centered benefits while still being cognizant of the rare but true risk of undiagnosed cancer.” Dr. Sawsan As-Sanie, U-M
However, only 0.22% of hysterectomies performed for benign indications contained uterine sarcoma. Uterine sarcomas are a rare group of diverse and potentially aggressive uterine tumors. The risks associated with power morcellation have received significant attention in the media recently and have been primarily linked to sarcomas since there are no available methods to accurately distinguish sarcomas from otherwise benign uterine fibroids before surgery. This study also found that there were no reliable clinical predictors of uterine sarcoma before surgery.
As-Sanie notes vaginal surgery is always the preferred route for benign indications but some women are not candidates for that option. The minimally invasive laparoscopic hysterectomy—which may include morcellation techniques when the uterus is too large to remove from the laparoscopic or vaginal incisions – means smaller incisions, lower risk of infection and blood loss, and quicker recovery than the standard abdominal hysterectomy.
“The ultimate goal in the field is to eventually find more reliable ways to accurately distinguish between benign fibroids and uterine sarcomas,” As-Sanie says. “For now, this data confirms a very low incidence of unexpected uterine sarcoma and is valuable information to inform patients and physicians when considering treatment options for fibroid-related symptoms.”
“Our focus is on minimizing risks without taking choices with potentially better outcomes away from patients that are at low risk of an undiagnosed cancer.”
Additional Authors: Nichole Mahnert, M.D.; Daniel Morgan, M.D.; Darrell Campbell, M.D.; Carolyn Johnston, M.D.; all of U-M.
Funding: The Michigan Surgical Quality Collaborative database is funded by Blue Cross and Blue Shield of Michigan/Blue Care Network
Disclosure: None
Reference: “Unexpected Gynecologic Malignancy Diagnosed after Hysterectomy Performed for Benign Indications,” Obstetrics and Gynecology, February, 2015.
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WSJ Sheds Light on Morcellator “Blessing” by AAGL
Feb 18, 2015 | The Legal Examiner
By Adrianne Webb
A front-page article in the Wall Street Journal yesterday highlighted growing concerns from 2014 regarding power morcellators, a tool commonly used in gynecological laparoscopic surgeries to cut up and remove tissue.
In April 2014, federal regulators advised doctors to stop using power morcellator tools for hysterectomies, citing its potential to spread cancer. In July 2014, Johnson & Johnson, the company with the largest market share of power morcellators, pulled its product from hospitals; and in November 2014, the FDA strengthened its April 2014 warning and said doctors shouldn’t use morcellators on most women.
A month after the FDA warning in April, the AAGL—formerly known as the American Association of Gynecologic Laparoscopists— issued a report stating that morcellation “remains safe when performed by experienced, high-volume surgeons.” However, the WSJ article pointed out that the organization’s opinion supporting the use of power morcellator tools was influenced by an executive committee member who had done paid consulting for a manufacturer of power morcellators.
The executive member was New York surgeon Arnold Advincula, who serves as AAGL’s president. AS reported by the WSJ, his 2014 disclosure on Columbia’s website reports he received at least $50,000 for speaking and other services in the prior 12 months from Blue Endo, a morcellator seller.
The published report misleadingly stated that it was approved with “no commercial, proprietary, or financial interest in the product or companies described in the report.” While the minutes reflect that Dr. Advincula did not vote to pass the report, he was involved in the discussion that ultimately approved the report favoring the use of power morcellators.
Reports published by professional organization undoubtedly influence medical professionals and decisions regarding the care they provide patients. A seemingly unbiased report carries different weight than one published by professionals with financial ties to the product. In my opinion, reports published by professional organizations should clearly disclose any financial ties or potential conflict-of-interests of individuals involved in approving the report. I applaud the WSJ for shedding light on the AAGL’s report and conflict-of-interest rules.
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Why Surgeons Defend the Power Morcellator
Feb 17, 2015 | Injury Law Blog
By Pintas & Mullins Law Firm
A surgical device used in hysterectomies, myomectomies and other gynecological procedures is now linked to aggressive and fatal uterine cancer. The device, called a power morcellator, has been banned my top hospitals throughout the country and subject to cancer lawsuits. A group of surgeons, however, continues to defend the power morcellator. Our team of uterine cancer lawyers explores why doctors are standing behind this device.
The link between the morcellator and uterine cancer was publically exposed in 2013, when study after study confirmed the association. One of these studies, conducted by Columbia University, found that at least 1 woman out of every 370that undergo a hysterectomy using a power morcellator will have undetected cancer cells. During the procedure, these cancer cells are spread throughout the uterus, planting in previously healthy tissue and creating massive tumor cell spread.
This confirms the FDA warning, made in April 2014, discouraging the use of power morcellators in hysterectomies and myomectomies, or surgeries to remove uterine fibroids. Power morcellators work by shredding large masses of tissue inside the body, so the tissue can be removed through a minimally-invasive incision. It was recommended to patients who were looking for shorter recovery times and less scar tissue.
The problem with this method is the likelihood that the tissue will contain undetected cancer cells - specifically, the cancer uterine leiomyosarcoma. This is an extremely aggressive form of cancer, and many women have been diagnosed with Stage 4 uterine leiomyosarcoma just weeks after morcellation procedures. There is no test to detect these cancer cells before surgery.
During an FDA hearing on power morcellators in July 2014, however, many gynecologsts and surgeons said they still believed the benefits of morcellation surgery outweighed the risks. The American Association of Gynecologic Laparoscopists (AAGL) later released a report saying morcellation remains safe "when performed by experienced, high-volume surgeons."Conflicts of Interest
Like most other issues in healthcare, there were outside influencing factors at play here. One of the AAGL executive officers, Arnold Advincula, who had considerable say in the report, received"consulting fees" (or more simply, cash) from a morcellator manufacturer. Specifically, Advincula - who is now the AAGL president - has received at least $50,000 in the last year for consulting services with Blue Endo, which sells power morcellators.The former president of the AAGL, Andrew Brill, has also done considerable "consulting" for morcellator companies. He chose to step down from the FDA morcellator panel in July 2014. More than 7,500 gynecologists read reports from the AAGL closely for guidance on best practices.
Yet another former AAGL president, Ceana Nezhat, recused himself from the morcellator report due to his own financial ties with a morcellator manufacturer. He neither voted on nor discussed the report with the other AAGL members. He also requested that Advincula do the same, to no avail. After the report was published, Nezhat sent an email stating that it was misleading and that the AAGL needed a zero-tolerance conflict of interest policy.
Since its release, the AAGL report has been used to credit the use of power morcellators and even persuade hospital administrators to continue offering morcellation surgeries.
Despite this report, the FDA has repeatedly warned doctors not to use morcellators on women, and most hospitals have stopped using them in gynecologic procedures. Johnson & Johnson, a major maker of power morcellators, pulled its devices from global markets.Our team of uterine cancer lawyers is currently investigating cases of cancer development or progression from procedures using this device. We understand that women may not know whether or not morcellators were used during their hysterectomy or fibroid removal. We are able to order all medical records for you, investigate the procedural notes, and determine whether or not you have a case, all free of charge. We only get paid if we win you a settlement or verdict.
It is also important to note that these lawsuits are NOT against the doctors or hospital that performed your procedure; rather, these are product liability lawsuits, filed against the companies that designed, manufactured and sold power morcellators, such as Johnson & Johnson or Endo Blue.
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