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Morcellation Media Monitoring 5/4/2015
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Controversy surrounds gynecologic device known as morcellator
May 1, 2015 | KCTV
By Bonyen Lee
It's a procedure most Kansas City metro hospitals won't do because of FDA warnings, but the University of Kansas Hospital says there are benefits to using a gynecologic device called a morcellator. *Note: Article contains an embedded video of the segment and an interview with patient activists Amy Reed and Hooman Noorchashm, it is available at http://www.kctv5.com/story/28957304/controversy-surrounds-gynecologic-device-morcellator#ixzz3ZB5cVm00 . -
New Orleans woman alleges surgical product caused her cancer
Apr 30, 2015 | The Louisiana Record
A New Orleans woman has sued two major pharmaceutical companies for allegedly giving her cancer through a morcellation device that was used during her hysterectomy. -
Two Congressmen Turn Up Heat on Power Morcellators
May 1, 2015 | MedScape
By Robert Lowes
Amy Reed, MD, PhD, and her husband, Hooman Noorchashm, MD, PhD, have waged an often lonely campaign to end the use of cancer-dispersing power morcellators in gynecologic procedures and subject all medical devices to tougher safety standards. -
Industry’s Unofficial Training Ground
Apr 30, 2015 | Medical Device and Diagnostic Industry
By Jim Dickinson
It was over in less than a minute, at the midway point in the Senate Health, Education, Labor, and Pensions (HELP) committee’s April 28 hearing on the future of U.S. medical innovation leadership—CDRH director Jeffrey Shuren let slip FDA’s dirty little secret: it is, and has long been, industry’s unofficial training ground.
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Controversy surrounds gynecologic device known as morcellator
May 1, 2015 | KCTV
By Bonyen Lee
It's a procedure most Kansas City metro hospitals won't do because of FDA warnings, but the University of Kansas Hospital says there are benefits to using a gynecologic device called a morcellator.
It's used in a minimally invasive surgery to remove fibroids or perform a hysterectomy.
“It allows us to do all the surgeries through smaller incisions which means patients have a faster recovery time, decreased wound infections, decreased complications. They can get back to life much quicker than if they needed a bigger incision,” said Dr. Kimberly Swan, gynecologic surgeon at the University of Kansas Hospital.
That's why Swan's patient Heather chose the morcellator. Her fibroid was causing painful symptoms and she needed surgery, but it came at a busy time in her life.
“I'm finishing up school. I had surgery at the beginning of my semester,” said Heather, who didn't want her last name used.
Fibroids are rarely cancerous, affecting one in 350 women, according to the FDA. But one Philadelphia family said that one case was them and the morcellator made Amy Reed sicker.
“We opted for a complete hysterectomy, but the way they did the surgery, they cut it up rather than removing my uterus whole. They spilled the tissue all over,” Reed said.
Reed and her husband Hooman Noorchashm are Harvard trained doctors - Reed, an anesthesiologist, and Noorchashm, a thoracic surgeon.
The two didn't know she had cancer before the hysterectomy two years ago. They say as soon as they learned about her aggressive form of cancer and found out the doctor had morcellated the uterus, they immediately knew it would spread.
“The FDA is essentially approving devices for marketing which have not undergone stringent enough safety testing, which means there will be other examples like the morcellator out there hurting people being used by licensed physicians in standards of care,” Noorchashm said.
The couple has spent the past two years fighting the FDA to pull the device. The FDA didn't.
Instead, it issued the most serious alert called a “Black Box Warning,” and urged doctors using a morcellator to use a containment system to keep particles from flying inside the body.
Noorchashm said he's now focused on changing the system in which medical devices are monitored after approval. He just returned last week from a round table discussion with the FDA about ways to improve it's unenforced self-reporting laws.
“It's that minority subset that are blowing through the system because of lack of oversight and found to be unsafe and causing great harm. The cost of it is to the families and to the insurance infrastructure,” Noorchashm said.
The bag used to contain fibroids at the University of Kansas Hospital is generally used for tissue removal. It isn't FDA approved for this particular use.
Swan carefully stuffs the bag into the patient's belly before placing the fibroid inside the container. Once the bag is secured, the morcellator breaks up the growth, all tissue is then contained inside the bag.
Noorchashm fears the morcellator blades could puncture the bag and leave holes the tissue can leak through.
“We comply with every one of the guidelines that the FDA puts forth as a selection process for which patients are appropriate,” Swan said.
Swan said women who are menopausal, have known cancers or someone who has small enough growths that can come out whole through small incisions should not be considered for morcellator use.
“I'm very up front with them. I say, ‘Here's the procedure, I think you're a candidate for it, here are the risks, here are the benefits,'" Swan explained.
For Reed, a mother of six, her cancer was under control until last year when doctors discovered cancer on her spine. They successfully removed it and she has undergone radiation to keep it from spreading.
“Even if you think you don't have cancer, it's still a bad tool. I mean, it still hurts people. People have chronic conditions from healthy tissue sprayed all over,” Reed said.
In Kansas City, doctors at St. Luke's hospitals no longer use the device. A morcellator manufacturer says HCA-Midwest hospitals have also stopped using them, but HCA would not comment when KCTV5 asked about its policy.
You can read the full FDA warning at this link.
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New Orleans woman alleges surgical product caused her cancer
Apr 30, 2015 | The Louisiana Record
A New Orleans woman has sued two major pharmaceutical companies for allegedly giving her cancer through a morcellation device that was used during her hysterectomy.
Nidra L. Phillips filed a lawsuit filed April 22 in U.S. District Court for the Eastern District of Louisiana, against Ethicon Endo Surgery Inc., Urology Ethicon Inc., Johnson and Johnson, Johnson and Johnson Services Inc., ABC Corporations1-10, John Does 1-10 and Jane Does 1-10.
According to the complaint, on April 2, 2014, Phillips had a hysterectomy and uterine mass removal with a uterine morcellation at Ochsner Baptist Medical Center in Orleans Parish. At the time, the suit states, “there was no evidence of disseminated and/or metastatic cancer/disease but very shortly following this procedure, the plaintiff was informed she had cancer of the uterus. Sometime later, at least several weeks later, plaintiff had reason to suspect that the defendant’s morcellator surgical product caused and/or accelerated the spread of cancer in her body.”
The plaintiff cites “severe and permanent damages due to the injuries caused by the defendants’ product.”
Phillips seeks: past and future medical expenses; pain and suffering; loss of earnings; loss of services; loss of enjoyment of life; other undisclosed non-economic damages; increased risk or death and/or spread of cancer; attorney fees; and court costs.
She is represented by attorneys Maury A. Herman, James C. Klick, Joseph A. Kott and Aaron Z. Ahlouist of Herman, Herman and Katz in New Orleans.
U.S. District Court for the Eastern District of Louisiana case number: 2:15-cv-01310-CJB-MBN.
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Two Congressmen Turn Up Heat on Power Morcellators
May 1, 2015 | MedScape
By Robert Lowes
Amy Reed, MD, PhD, and her husband, Hooman Noorchashm, MD, PhD, have waged an often lonely campaign to end the use of cancer-dispersing power morcellators in gynecologic procedures and subject all medical devices to tougher safety standards.
Lately, however, the couple has gained some influential supporters in the form of two congressmen from their home state of Pennsylvania as well as America's Health Insurance Plans (AHIP), a trade association. The physicians hope that these allies will nudge Congress to hold hearings on medical-device safety.
Sen. Robert Casey Jr (D-PA) and Rep. Michael Fitzpatrick (R-PA) have recently fired off letters to the US Food and Drug Administration (FDA) questioning how the agency has responded to reports of power morcellators spreading occult uterine cancer during laparoscopic hysterectomy and myomectomy. And in a letter to Casey, the head of AHIP called attention to "serious gaps in the current approval and post monitoring process for medical devices" that have allowed problems with morcellators to escape the notice of regulators for years.
Although the devices have been on the market since 1991, and the problem of dispersed occult cancer had surfaced in the medical literature, the FDA did not receive a report on this adverse event until December 2013, according to Dr Noorchashm. That report detailed how Dr Reed, an anesthesiologist, underwent a laparoscopic hysterectomy 2 months earlier to remove fibroid tumors only to discover that morcellation had spread a previously undetected uterine leiomyosarcoma. The mother of six has since had two cancer operations.
Dr Reed and Dr Noorchashm, a cardiothoracic surgeon, have tried to persuade the FDA to ban these devices that shred tissue for easy removal through laparoscopic incisions, and they likewise have called on gynecologic surgeons to drop this procedure. The FDA has recommended that surgeons stop using the devices for hysterectomy or myomectomy in most women with uterine fibroids and has slapped a boxed warning on the devices saying that they may spread unsuspected cancer. An estimated 1 in 350 women undergoing hysterectomy or myomectomy for fibroid removal have an unsuspected uterine sarcoma, according to the agency.
One manufacturer of morcellators — Johnson & Johnson's Ethicon division — has voluntarily withdrawn its products from the market, and a number of insurers have stopped paying for the procedure or have placed restrictions on it.
This backlash against power morcellators has found its way into the operating room, according to Karen Ignagni, AHIP's president and chief operating officer. "Our chief medical officers report that there has been a major reduction in the use of laparoscopic power morcellators in today's market," Ignagni wrote in her letter to Casey. She attributed the downturn in part to actions by the FDA and health insurers as well as cautionary statements from the American College of Obstetricians and Gynecologists.
So why not go all the way and ban the use of power morcellators outright? Fitzpatrick asked this question in a February 19 letter to then FDA Commissioner Margaret Hamburg, MD. He noted "the avoidable nature of this potentially deadly hazard and unwillingness of industry advocates and many gynecologists to abandon this practice." Power morcellators, he wrote, "may have caused the unnecessary or premature deaths of many hundreds (if not thousands) of American women for over two decades."
Casey's letter of March 2 to Dr Hamburg posed additional questions:
When and how did the agency first learn about safety concerns surrounding the devices?
What data are the FDA collecting about adverse events?
Has the FDA linked adverse events to a particular make of morcellator?
When Medscape Medical News asked the FDA what answers it has given, if any, to the two congressmen, an agency spokesperson said it was "responding directly to Rep. Fitzpatrick and Sen. Casey." Press secretaries for the two congressmen did not respond to repeated requests for an interview.
"Sick People Hurt by This Industry — They Don't Lobby"
Another cause celebre of Dr Reed and Dr Noorchashm, who live in the Philadelphia area, is overhauling the FDA's approval process called 510(k) that has been used to bring power morcellators to market. Under 510(k), a manufacturer need only establish that its product is substantially the same as a device already approved by the agency. Dr Reed and Dr Noorchashm say this expedited process endangers patients because it lacks premarket safety testing and mandatory postmarket monitoring for adverse events. They criticize the FDA for catering to device makers that in their opinion want easy sailing through regulatory waters.
Casey and Fitzpatrick also pressed the FDA on the subject of medical-device safety and the 510(k) approval process in their recent letters. Casey asked what the consequences are for a device manufacturer that fails to report adverse events to the FDA in a timely manner. He also asked how the agency determines whether it should recall a faulty product or let the manufacturer do so voluntarily.
In his letter, Fitzpatrick asked the FDA how it responded to a 2011 report by the Institutes of Medicine that recommended an overhaul of the 510(k) process to ensure patient safety.
Fitzpatrick doubled down on the issue when he addressed FDA officials earlier this month at a workshop on postmarket surveillance of medical devices. The story of Dr Reed, he said, made it clear that "we can do more to catch unsafe devices quickly and prevent further devastation to families."
Dr Reed and Dr Noorchashm also spoke at the workshop. Dr Noorchashm contended that the FDA's Center for Devices and Radiological Health was allowing unsafe devices to reach the marketplace as a result of "mission corruption" — that is, putting the interests of manufacturers at the same level as those of patients. He said that the FDA rarely enforces regulations requiring manufacturers to voluntarily report medical device mishaps.
In her testimony, Dr Reed urged FDA officials to consider the victims of faulty medical devices. "Sick people hurt by this industry — they don't lobby," she said. "They go home and die."
AHIP also wants 510(k) reform.
"We urge discussion around strengthening the 510(k) process and post-marketing assessment of medical devices, including power morcellators," Karen Ignagni said in her recent letter to Casey. "Requiring post-marketing review will greatly improve our ability to identify adverse events and act more rapidly when safety issues are identified.
"Had this been required for morcellators, safety issues would have been identified much sooner."
To spur Congressional action, Dr Noorchashm has been peppering members of both the House and Senate with a steady stream of emails. At this point, he considers Fitzpatrick his strongest supporter. He also would like to win over Rep. Joe Pitts (R-PA), chair of the health subcommittee of the House Energy and Commerce Committee, all for the sake of a congressional hearing.
"If this problem that has happened to my family doesn't trigger a hearing," Dr Noorchashm toldMedscape Medical News, "there's something seriously wrong with our Congress."
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Industry’s Unofficial Training Ground
Apr 30, 2015 | Medical Device and Diagnostic Industry
By Jim Dickinson
It was over in less than a minute, at the midway point in the Senate Health, Education, Labor, and Pensions (HELP) committee’s April 28 hearing on the future of U.S. medical innovation leadership—CDRH director Jeffrey Shuren let slip FDA’s dirty little secret: it is, and has long been, industry’s unofficial training ground.
The admission came during casual questioning by ranking member Patty Murray (D–WA), harking back to a conversation she’d had with outgoing commissioner Margaret Hamburg about how difficult it has been for CDRH to attract and keep top-notch staff. Uncompetitive salaries make this a general problem across government.
But in CDRH’s case, Shuren blurted out: “We are the training ground for industry. Once trained, they become more marketable and they leave for salaries twice as high as they are making at the agency. A high workload combined with less pay makes it hard to get people and this also leads to high turnover.”
That, in turn perversely “hurts companies because in the middle of a review and your lead reviewer or medical officer leaves and I don’t have a deep bench in my Center.”
Murray: “So industry steals your employees but they need you?”
“That is exactly right,” Shuren answered, “and we have to change that because it best serves not just industry, it ultimately serves patients and that is what this is all about.”
Murray then turned to a previous FDA witness, Center for Drug Evaluation and Research director Janet Woodcock, asking “I assume you see the same thing?”
Woodcock: “Absolutely. Our scientists need to go toe to toe with the best industry scientists. And yet when my people leave either to academia or to industry they typically double their salaries.”
Then it was over. The hearing moved on to other topics.
The senators, their staffs, and their witnesses took it all in stride, seemingly unaware that FDA’s unplanned and undesired service as a “training ground for industry” isn’t widely known outside the Beltway, where patient activists are increasingly unhappy with CDRH.
“This is a blatant admission to how closely aligned the CDRH is with industry,” stormed heart surgeon Hooman Noorchashm, who is campaigning for a power morcellators-motivated CDRH makeover that puts patients first, instead of industry. He was venting in an email to his extensive list of activists, FDA leaders, lawmakers, and their staffs.
“Where is the patient’s voice?” he demanded. “Where is the public voice? Where are the real representatives of the harmed? ‘A training ground for industry’???!!! Mission corruption, indeed! The CDRH and its leadership have strayed far away from their public health mission.”
Seemingly not suspecting that his words might evoke such a response beyond the Beltway, Shuren actually built upon the “service to industry” theme that Noorchashm and others find so offensive, in his 33 page prepared testimony to the HELP committee.
“In the early part of this decade,” his testimony reads, “many policymakers and FDA stakeholders called for reform of FDA’s device program, arguing that FDA regulation was driving companies to relocate overseas or market their devices abroad before introducing them in the United States.”
These complaints were backed up by surveys of device manufacturers, an influential and sobering Pew Charitable Trusts research report on FDA staffing in 2012, and even FDA’s own data. These all led to programmatic and policy changes at CDRH, as well as to increased funding by Congress that has now “significantly improved” the Center’s performance, Shuren’s testimony says, before plunging into two-and-a-half pages of improvement details across every type of product submission.
“Our experience also suggests that there is marked improvement in the medical device industry’s perception of FDA,” the testimony says. “In 2014 CDRH made providing excellent customer service a strategic priority and launched an effort to improve customer service that included staff training, surveys to assess interaction with customer and measure customer satisfaction, and, based on feedback from customers, actions to improve the quality of CDRH actions and services. CDRH’s 2014 results show 86 percent satisfaction.”
There was a time, not too long ago, when official use of the word “customers” to describe regulated industry was decried as unseemly by the general run of FDA employees. It evoked a well-known and popular catch-phrase in commerce: “The customer is always right”—even when he’s wrong.
Accordingly, most FDA leaders adopted the more neutral term “stakeholders”—until Shuren’s prepared, and presumably vetted, HELP testimony.
Shuren’s happiness with the new industry happiness with CDRH was shared by former FDA Office of Chief Counsel medical device specialist Nathan Brown, now with Akin Gump Strauss Hauer & Feld, in an interview published in Metropolitan Corporate Counsel.
Brown told the publication that the medical device industry is emerging from a period of significant frustration with FDA and entering into an improved regulatory environment following the injection of more resources and “more formalized procedures.”
“There are still refinements to be made to the premarket review process,” Brown told his interviewer, citing the de novo program as an example. It’s “very challenging legally because it requires creation of a brand new classification; these reviews tend to take longer and, so far, the de novo process hasn’t been subject to the types of negotiated performance goals that other submission types have.”
In his prepared testimony to the HELP committee, Shuren hailed a final decision time reduction for de novo requests from 992 days in FY 2010 to 300 days in FY 2014. And over the past five years, the decision time for 510(k)s has fallen from 116 days to 105 days while PMA decision times have come down during this period from 320 days to 236 days.
Shuren’s happiness and industry’s happiness are reciprocal benefits of an intensely close relationship that has strong economic and political foundations since the advent of user fees.
The strident unhappiness of certain patient constituencies such as morcellator, duodenoscope, dental amalgam, and LASIK victims, owes much to the absence of a comparable relationship with CDRH.
Meanwhile, as Brown observes in his online interview, later this year user fee negotiations will resume, leading to a 2017 reauthorization that he expects will help continue the focus on how to accommodate new technology from the medical device industry.
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