The Supreme Court Blocks Civil Rights of Medical Device Harm Citizens

Essure Harm Shielded by the Supreme Court

Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.

FRIDAY, JANUARY 8, 2016, 10:52 AM

One of the underlying tenets of our free-market is that consumers alleging harm should have legal recourse in our court system. And the 14^th Amendment of our Constitution guarantees citizens equal protection under the law.

So, if a product or service is unreasonably harming people, the court system usually provides feedback to the supplier and problems are removed.

But, if legal barriers prevent consumers from taking their cases to court, harmful products and services will persist in the market.

That’s the scenario playing out in the multi-billion-dollar medical device sector of our economy.

Most Americans do not realize that when the Food and Drug Administration (FDA) approves “high-risk” devices through its “Pre-Market Approval” (PMA) pathway, these devices are automatically shielded from litigation. This shield was created by the Supreme Court in the 2008 decision, Riegel v. Medtronic.

You can read about Riegel v. Medtronic here and here.

The presumption is that if and when a PMA device harms people, recourse will be provided through FDA review. But, unfortunately, FDA and, in particular, its Center for Devices and Radiological Health (CDRH) is a “captured” agency. What that means is that the FDA process is overly influenced by industry advocates, at the expense of patients.

Here is a clear example of why CDRH is considered a “captured” agency by prominent FDA watchdog groups.

When the federal government, on the one hand, blocks consumers’ access to state courts and, on the other, takes on the job of addressing allegations of harm outside of a courtroom, that’s not the free-market working - it’s Big Brother at work. And that’s the process protecting PMA-approved devices.

A specific example of this problem is playing out in the case of a device used to permanently sterilize women. This PMA-approved device is known as Essure, made by a German company, Bayer Health.

You can read about Essure here and here.

More than 25,000 women across the United States claim they have been harmed by Essure, but they do not have access to the state court system.

FDA did conduct a hearing on Essure in September 2015, but last I checked FDA is not an arm of the Department of Justice.

Pennsylvania Congressman Mike Fitzpatrick is fighting to overturn Riegel vs. Medtronic.

On Dec. 6, he introduced an amendment proposing the removal of all barriers to civil litigation in product liability cases against medical devices.

You can watch him introduce this amendment here at 41:50.

But Fitzpatrick’s amendment was rejected, based on technicalities, by the House Rules committee. So it will not come up for a vote in the House.

Incredibly, those voting against the amendment were Fitzpatrick’s Republican colleagues – the supposed guardians of “free-market” economics and vocal critics of federal government protectionism over the market.

Democrats are also rejecting rep. Fitzpatrick’s call to remove Essure from the market, despite many in that party who advocate for women’s health and patient safety. The party machine won’t support Fitzpatrick’s E-Free Act.

Meanwhile, Bayer is defending its product and claiming that the harm done to a relatively small group of otherwise healthy women is to be accepted given the product’s supposed benefits.  

But our country was built on protecting minority groups who are wrongly harmed.

Fitzpatrick’s position on Essure and Riegel offers Republicans an opportunity to live up to their free-market ideology and to claim women’s health as a real Republican platform – but many are failing to see this. 

Read more at http://www.philly.com/philly/blogs/healthcare/Essure-Harm-Shielded-by-the-Supreme-Court.html#ZJTeV8mB59FL1LhF.99

F.B.I. Investigates: Are Medical Device Adverse Events Reported?

F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored

By DENISE GRADY and KATIE THOMAS MAY 27, 2015

The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators.

The tool, called a morcellator, has rapidly spinning blades that cut tissue into pieces that can be removed from the body through the tiny slits made during minimally invasive surgery. Morcellators have often been used in surgery to remove the uterus, but in some women with undetected cancers they have sprayed malignant cells around inside the abdomen like seeds, speeding the progression of the disease.

The inquiries were first reported on Wednesday by The Wall Street Journal, which said the agents worked out of the F.B.I. office in Newark, N.J.

Celeste Danzi, a spokeswoman for the F.B.I.’s Newark office, declined to confirm the inquiry. “We just don’t comment on the existence or nonexistence of any investigation,” she said.

In an interview with The New York Times, Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, was harmed by the device, confirmed that they had spoken a number of times to an F.B.I. agent from Newark. A retired pathologist from Pennsylvania, Dr. Robert W. Lamparter, also said he had spoken to investigators. Both men declined to name the agent, saying they had been warned that disclosing too much information could interfere with the investigation.

Dr. Reed, 42, an anesthesiologist, had a hysterectomy because of fibroid tumors in her uterus in October 2013 at Brigham and Women’s Hospital in Boston. Fibroids are benign, but they sometimes hide cancer. A biopsy after Dr. Reed’s surgery found a hidden sarcoma, an aggressive type of cancer. The tumor spread, resulting in advanced Stage 4 cancer. Dr. Reed underwent numerous rounds of chemotherapy and radical surgery, but the cancer recurred in March of this year, near her spine, requiring still more surgery.

The couple, who have six children, have conducted a ceaseless nationwide campaign to ban morcellation. Gynecology groups have resisted, saying that sarcomas are uncommon and that morcellation makes surgery less invasive and safer for the majority of women.

In November, the Food and Drug Administration said that morcellators should no longer be used in “the vast majority” of women. But the agency did not take the devices off the market or ban their use.

Dr. Noorchashm said he contacted an agent from the Newark F.B.I. office last fall, because he suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the F.D.A. He said that he and his wife spoke with the agent a number of times over a few months, and that the F.B.I. seemed increasingly interested.

Dr. Lamparter said that he had also recently spoken to the F.B.I., and that the conversation had focused on his 2006 correspondence with Ethicon, the unit of Johnson & Johnson that sold power morcellators. At that time, he warned Ethicon of the potential for the morcellators to spread undetected cancer, according to email correspondence he provided to The Times and other news outlets. Johnson & Johnson withdrew its morcellators from the market last July.

Johnson & Johnson has said that after Dr. Lamparter raised his concerns, it added new language to the instructions for use of the device, and that the company had already recommended that, in patients where a cancer was suspected, doctors should use a special bag to remove the tissue.

In a telephone interview Wednesday, Dr. Lamparter said that he considered the change a “legal fig leaf” and that the gynecologists at his hospital, Evangelical Community Hospital in Lewisburg, Penn., reported that the training they received from the company in using the device did not substantially change after he raised his alarm.

Dr. Lamparter said he initially believed that the morcellator could still be used, but not on women at high risk for cancer. However, he added, “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.”

Ernie Knewitz, a Johnson & Johnson spokesman, said it was unaware of any investigation.

Kate Zernike contributed reporting.

http://www.nytimes.com/2015/05/28/business/fbi-investigates-whether-harm-from-surgical-power-tool-was-ignored.html?emc=edit_tnt_20150527&nlid=50639700&tntemail0=y&_r=0

Harm by "innovation" and irrational exuberance: a home grown threat.

“Irrational Exuberance”: A homegrown threat to our nation’s health

Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.

Check Up

Posted: Friday, March 20, 2015, 9:56 AM FiDA highlight added

Our prevailing model of medical progress, innovation and research centers on the concept of "benefit". Doctors, in both academic and corporate medicine, are focused on developing novel therapies to benefit our patients beyond the existent standards of care. This noble intent has evolved from our profession's desire to heal our patients and to create a healthy society.

Once the benefit of a novel approach is either demonstrated (or agreed upon) by expert consensus, new standards of care are established and funded by our health insurance infrastructure. This is the awesome power of American healthcare and our insurance infrastructure in the 21st century.

However, a very serious and insidious deficit also plagues our optimistic, "benefit-oriented" outlook on innovation and progress in corporate medicine. We do not always place sufficient emphasis on the concept of "harm". That is, in our quest to save lives and innovate, the cost to those who do not benefit is often disregarded or minimized.

We do not focus enough on whether the harm brought about by our 'beneficial advances' could have been avoided - nor do we evaluate the tangible and intangible costs of advancement when we construct our new standards of care.

This tendency to downplay the harm done by innovation, in favor of marketing real or perceived benefit, has turned our healthcare establishment into a self-congratulatory and “irrationally exuberant” one.

So on the backs of those harmed without consideration, we may be on an “irrationally exuberant” path to financial and spiritual ruin in medicine, despite our best intentions. Our financial markets have demonstrated this phenomenon repeatedly over the past three decades in America. As it is said, "the road to hell is paved with good intentions".

Of course, this irrational exuberance in American medicine stands to be dramatically worsened by medicine's corporate nature today. After all there is a lot of money to be made in saving lives. And our health insurance infrastructure is designed to pay for benefit-driven, "life-saving" interventions. Most individuals are willing to pay a high price for the promise of staying alive - no one wants to die.

Of course, our corporations capitalize on this fact. They market and advertise increasingly sophisticated, expensive and "beneficial" therapies. The harm done and its cost is not part of the corporate marketing label - at best, it is a footnote and at worst it is censored.

Corporate forces in medicine are only too willing to use the banner of benefit and safety to acquire revenue and profit. And when there is money to be made, dwelling on the cost of harm, especially if it is to a minority subset of patients, is downplayed and even ridiculed - because it gets in the way of lucrative business and cash flow.

Most tragically, our federal government, whose responsibility it is to protect the forgotten minority of people in harm’s way, seems to have lost its existential purpose. Congress, and our public health agencies, are increasingly influenced by corporate lobby power and special interest groups – not patients and their advocates. Because most of those harmed go home, go bankrupt or die – they very certainly do not lobby lawmakers and federal agencies in any effective manner. And while healthy, most people never imagine themselves being in harm’s way. So not enough people rally behind solid patient safety initiatives and legislative actions proposed by cogent politicians.

Instead of being true to their constitutional mission to protect every American citizen from harm, our federal public health agencies, notably the FDA, have accepted corporate America as being an equal stake-holder to individual citizens and residents of our land. This is a massive regulatory error that has resulted in very notable failures – and these will recur until citizens and legislators of reason and courage drive necessary improvements to our flailing federal system.

As a prominent example, the 510(k) legislation governing approval of the majority of medical devices by the United States Food and Drug Administration does not require any definitive pre-market safety testing and it provides no consistent “risk assessment” mechanism; nor does 510(k) definitively require active surveillance or consistent reporting of adverse outcomes by doctors, hospitals or manufacturers to FDA.

Of course most Americans find these lax safety standards in the medical device industry hard to believe. Some even think our critique is too much of a "blanket statement" about a very complex regulatory process. But it really is that simple: corporate forces have breached the FDA and have deviated its public health and patient safety mission in the medical device space. Most citizens have no idea that this is the case. In fact, most of us trust that our government and our healthcare establishment is there to protect us from harm – but that is simply not a guarantee, especially on issues and practices that are not clearly in the public eye.

Unless, as patients and doctors, we shed our irrational exuberance about medical benefit and the infallibility of our healthcare establishment, and instead empathetically focus on the possibility of harm and its systemic and personal costs…Unless, as citizens, we demand that our federal government realign itself with the people’s interests instead of corporate and special interests…we will continue to accept the unacceptable from the medical establishment and from our federal government.

We may even manage to drive our society’s health and healthcare establishment into irrecoverable bankruptcy - both financial and ethical.

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed’s unsuspected uterine cancer was spread by the device during a routine hysterectomy.

http://mobile.philly.com/blogs/?wss=%2Fphilly%2Fblogs%2Fhealthcare%2F&id=297014051

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Social Media and Patient Activists: Read this!

510(k) Under Attack

Created 02/18/2015 - 17:36

Posted in Regulatory and Compliance [1] by MDDI Staff on February 18, 2015

Regulatory and Compliance

The most common pathway to market for medical devices is coming under fire from a social media campaign led by activists determined to get FDA to ban power morcellators used in hysterectomy procedures. 

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) [3]”—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 [4]” 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 [5] 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 [6].

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 [7] 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 [8] promoted them. He also credits FDA associate commissioner for policy and planning Peter G. Lurie [9]’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 [10] 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.

Jim Dickinson is MD+DI's contributing editor. 

Update: Sign this petition to ban uterine morcellation device.

FiDA UPDATE:
http://www.cancerletter.com/articles/20141126_1?utm_content=buffera6f9c&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer

Urgent FDA Action Turns Power Morcellation Into Rarely Used Gynecological Procedure

A Karl Storz power morcellator, one of the devices that will be affected by FDA's latest guidance. This model was used in a Brigham & Women's Hospital study testing the ability of containment bags to reduce the risk of cancer dissemination. That study has been halted.

By Matthew Bin Han Ong  

The power morcellator should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures, FDA declared in a highly anticipated guidance document Nov. 24.

Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use in the following manner:

• The agency placed a “black box” label on the device, warning that the use of power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. The boxed warning is FDA’s sternest warning for significant risk of serious or life-threatening adverse effects.

• The agency’s guidance decreed that power morcellators are contraindicated for removal of uterine tissue in menopausal and post-menopausal women, and in women who are eligible for surgeries that remove uterine tissue intact i.e. through the vagina or mini-laparotor.

• Similarly, power morcellators are now contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

Categorized as a Class II moderate-risk surgical device by FDA, the power morcellator is used to cut tissue into small fragments for removal through small incisions. When used in patients with undetected or missed uterine cancers, the device spreads malignant tissue in the patient’s abdominal cavity, rapidly upstaging the disease (The Cancer Letter, July 4).

FDA’s move is expected to adversely impact minimally invasive surgical gynecologists, who made power morcellation a routine procedure, which is performed in a subset of an estimated 50,000 to 100,000 women who undergo laparoscopic procedures for hysterectomy each year in the United States.

Class II devices are cleared through the 510(k) process, which applies to new devices that are based on comparability to predicate devices already in use. Only Class III high-risk devices require an FDA premarket approval application.

Here, semantics mean a lot: the standards for Class II clearance aren’t as rigorous as for Class III approval.

This week’s FDA guidance does not reclassify the power morcellators. It is unclear whether FDA intends to re-categorize power morcellators or require manufacturers to resubmit the devices for approval as Class III devices.

In its decision, the agency cited its earlier estimate that one in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. The American Association of Gynecologic Laparoscopists disagrees with the estimate, citing international data reporting lower prevalence rates.

“The FDA decision today is based on what we believe is best for patients,” William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said at a press call Nov. 24. “The contraindications cover the vast majority of women who would undergo morcellation during myomectomy or hysterectomy, which should reduce the use of the device in patients at greatest risk.”

The contraindications are so broad that they make morcellation appropriate only for young women who may choose, after a consent process, to undergo the minimally invasive procedure to preserve their ability to bear children.

The agency’s decision comes nearly a year after former Harvard physicians Amy Reed and Hooman Noorchashm launched a vigorous campaign that drew FDA’s attention to the issue (The Cancer Letter, July 4).

“I think it’s a good first step, or second step after the April advisory,” said Rick Kaitz, a Boston attorney whose wife, Erica, died after her leiomyosarcoma was upstaged by power morcellation performed at Brigham & Women’s Hospital, a Harvard-affiliated institution (The Cancer Letter, Nov. 21).

“In most circumstances, I can’t imagine that this industry is going to continue to survive at the moment. I think FDA’s decision is strong enough to significantly impact the nature of the practice,” Kaitz said.

“Drs. Reed and Noorchashm should be really saluted for the amount of progress they’ve made within a relatively short period of time. I know for all of us it seems like forever, but I’m very encouraged.”

Immediately in Effect

This is the first time FDA has used an authority, called the “Immediately In Effect” guidance.

According to Maisel, the IIE was created by CDRH to act swiftly on issues that the agency would normally respond to with a routine guidance.

“We didn’t feel that issuing this guidance in draft form, and waiting for a comment period, and then finalizing it, is in the best interests of the public health,” Maisel said at the press call.

Bill Vodra, a former FDA associate chief counsel for drugs, said the agency’s rapid response is extraordinary.

“The timeframe of this is pretty astoundingly fast, for me at least,” Vodra said to The Cancer Letter. “If you get people who understand the system i.e. doctors who become patients, they can push much more aggressively than the ordinary consumer can. What I’m most impressed by here is how quickly they’ve done this.”

Vodra helped draft many agency regulations still in use, including those implementing the Controlled Substances Act and FDA’s rules for Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, bioequivalency and the Orange Book.

“Compare how long it took FDA to address this issue, with, let’s say, the surgical mesh that was being used a couple of years ago—that took years for FDA to finally get around to do something about it,” Vodra said.

The American College of Obstetricians and Gynecologists, a 58,000-member professional society, said it would seek additional clarification of the agency’s guidance.

“We are pleased that the FDA’s action takes steps to enhance patient safety while allowing the appropriate use of power morcellation in gynecologic surgery for select women,” Hal Lawrence, executive vice president and CEO of ACOG, said in a statement. “The FDA’s clarification of contraindications for morcellation will help to ensure that only women at low risk for an occult malignancy will undergo laparoscopic hysterectomy or myomectomy with morcellation.

“However, we look forward to working with the FDA to provide additional clarification regarding certain language within the contraindications that could be confusing to patients and physicians.”

AAGL, another professional society, characterized FDA’s action as a setback.

“Abandoning power morcellation technology for many patients undergoing minimally invasive myomectomy, supracervical hysterectomy, or hysterectomy for a large uterus will be a setback in the care of patients with gynecologic conditions,” Franklin Loffer, AAGL medical director, said in a statement.

Observers: FDA “Severely Restricts” Device Use

FDA-watchers said the agency’s decision would likely eliminate power morcellation as a routine surgical procedure in gynecology.

“FDA’s statement is going to discourage a significant amount of use, assuming that most of these procedures are being done in post-menopausal and menopausal women. That’s a pretty clear statement. They want this to drop substantially,” said Vodra, a retired partner of Washington, D.C., law firm Arnold and Porter. “If 80 percent of the women who undergo power morcellation are peri- or post-menopausal, then 80 percent of these procedures shouldn’t be done anymore.”

“The contraindication means no rational person would use the product this way. So that’s really saying, ‘No doctor out there should use this. If a doctor goes ahead and uses it, it’s not malpractice per se, but, in many or some jurisdictions, it shifts the burden of proof from the patient to the doctor.’”

Normally, in a medical malpractice case, the patient has to show that the doctor did not follow the standards prevailing in his or her community at the time that a procedure was done or a drug was used.

“Now, any physician that continues using power morcellators, and any device company which still wishes to sell and promote these devices will be taking a huge risk in the liability arena, both medical and otherwise,” said David Challoner, emeritus vice president for health affairs at the University of Florida. “It’s de facto, not de jure.”

Challoner chaired the Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) process that clears Class II devices such as the power morcellator based on predicate devices.

“I see FDA’s action as severely restricting the use of morcellation in the treatment of uterine fibroids,” Challoner said. “That’s a very desirable outcome, and it’s only slightly second-best to just banning the instruments from the market completely.”

More insurance companies may refuse to pay for power morcellation as a result of FDA’s guidance. Several companies have ended payments for the procedure prior to the guidance (The Cancer Letter, Nov. 21).

“It would be up to the insurance company and the laws governing insurance,” Vodra said. “Clearly, they could refuse to pay for any procedure that is contraindicated. But normally, a boxed warning would not be disqualifying from reimbursement.”

FDA said it would continue to consider other steps that may further reduce the risk of spreading unsuspected cancer, including preoperative cancer detection methods, or containment devices, such as bags, that can prevent dissemination of malignant tissue.

The Brigham & Women’s Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during gynecological surgery.

Key Advocates Call for Ban

Reed and Noorchashm, the couple who led the campaign against morcellation, called FDA’s decision a “failure.”

“This is a massive and monumental failure in federal regulation,” Noorchashm said to The Cancer Letter. “From a scientific, clinical, surgical and common sense perspective, it’s very clear that you don’t mince up tissues that have any degree of malignant potential inside a patient’s body.

“The FDA was confronted with this problem. They chose to not definitively regulate this problem, and that is clear demonstration of regulatory incapacity. They were given a binary decision to make and they failed. This should tell anyone with a remote understanding of the issue that the FDA is a captured agency—beholden to industry interests over patient safety.”

Reed said banning the device is the only appropriate action.

“People say we should be thankful that we’ve gotten as far as we have, that it moved as it did and we raised the level of awareness,” Reed said. “But I have to say, overall, I’m overwhelmingly disappointed with the whole decision. There is no question in my mind that they should have outright banned it, and I’m not sure what they thought they were overreaching if they did.”

FDA’s Maisel said that banning power morcellators would require doctors and patients to choose other options—typically more invasive surgery.

“Banning laparoscopic power morcellators would completely remove them from the market for all patients in all indications,” Maisel said. “We recognize that there are risks associated with all fibroid treatment options, and we believe there is a very small population in whom the benefits for this procedure.

“When the patients are appropriately informed of the potential risks, and that the potential benefits may outweigh the risks, the individual women may choose to have their procedure done, knowing the potential benefits and risks.”

Maisel said the key to preserving fertility in some women is to minimize the damage to the uterus.

“We recognize that some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risk, may be candidates for this procedure,” Maisel said at the press call. “Younger women present a lower risk of having underlying cancer than older women.

“Doctors and patients should determine if the patient is in an appropriate patient, together, and the agency believes that women should have this option available to them should they wish to preserve their fertility and they are informed of the risk.

“Being able to remove the fibroid and reduce the risk of adhesions that might be associated with a traumatic surgery can help preserve fertility,” Maisel said. “Some clinicians specialize in this area, and believe that it is an important tool that needs to remain available.”

Reed and Noorchashm disagree.

Reed said no data exist to show that fertility is adversely affected in laparotomies vs. laparoscopic removal of fibroids with power morcellation.

“Firstly, I would like to see the data that mini-laparotomy versus full laparoscopy for fibroids has a detrimental impact on fertility,” said Reed, formerly an anesthesiologist at Beth Israel Deaconess Medical Center. “That’s what they are saying, that adhesions by mini-laparotomy would negatively impact the fertility of women, so they should be allowed to opt for it. I know of no data that supports that claim.”

“For such a data heavy driven argument I want to know who said that this was a problem and based on what? Because the adhesions caused by spraying a huge fibroid around likely are as significant as a laparoscopic dissection and mini-laparotomy.”

“And I think that is the important point: it’s power morcellation vs. laparoscopic dissection and mini-laparotomy, not full laparotomy.”

Reed underwent power morcellation at Brigham & Women’s Hospital in October 2013. The procedure upstaged her previously undiagnosed leiomyosarcoma, which was then aggressively treated. The disease is now in remission.

“Because of the wording of the FDA, women will still be on that table having power morcellators used at the discretion of the physician,” Reed said to The Cancer Letter. “Secondly, I would like the FDA to clarify what its intentions are in regards to studying containment devices. Knowing the potential for harm is great, is this something they intend to support human experimentation on? They clearly state that this is an area that they will watch closely. Will this be done in animals, or will they permit this to be done in humans? Surely one would think not.

“I think the FDA has some serious explaining to do.”

Noorchashm said that alternative uterus-sparing surgeries are available.

“You don’t need to use a morcellator to do a myomectomy, which is what is meant by a ‘uterine sparing’ operation. Morcellators are only used to extract the tissue from small incisions,” said Noorchashm, a cardiothoracic surgeon who formerly practiced at Brigham and who is now at Thomas Jefferson University. “To perform a uterine sparing operation, these surgeons can dissect out the problematic myomas they’ve ascertained are not malignant using intra-op or pre-op biopsies. Then, they take out the bagged myomas through a small incision. It’s really that simple. There is absolutely no need to use a morcellator.”

“You can, perfectly well, either by using laparoscopic or robotic devices, do a myomectomy and remove the myoma from the body without power morcellation through a small incision at the end of the operation. I think the concept that a uterine sparing myomectomy requires a morcellator is a smokescreen created by device advocates and gynecologists—it’s hogwash.”

Several members at an FDA advisory committee hearing in July expressed a desire to avoid any kind of morcellation of tissues (The Cancer Letter, July 25).

“Myomectomy, in and of itself, isn’t an oncologically safe procedure. There is a conundrum there,” Reed said. “But you don’t have to make it worse by spreading everything all over the abdominal cavity with power morcellation.”

Vodra: 510(k) Does Not Necessarily Protect Consumers

Pre-menopausal young women who elect to undergo power morcellation could be waiving the ability to claim medical malpractice against their physicians, if they are harmed by the surgery.

“If a woman is pre-menopausal and elects to undergo power morcellation, then if she has been warned by the doctor that these are the risks and benefits, and she then chooses the procedure, she probably has no claim whatsoever against the doctor,” Vodra said. “When a doctor uses the normal standard of care, in which you’d advise a patient before a surgery on what the risks are, the patient can opt to have it or not have it.”

However, doctors can be vulnerable in these situations if they fail to exercise due diligence.

“I could see situations in which, for example, the doctor did not do any medical history to determine whether the patient was at risk of uterine cancer, and did nothing to check or test whether this patient could have a cancer,” Vodra said.

“If there is a blood test available at some point and he didn’t run the blood test before he did the procedure, that could lead to malpractice.

“The doctor cannot say, ‘What do you want me to do?’ The patient’s not an expert, the doc is, and has an obligation to exercise due diligence according tothe standard of care in the community before surgery is done.”

Young women should not be subject to the risks of power morcellation when there are alternatives, Reed said.

“I had some degree of health literacy, but what do you do with somebody with a third grade education? What do you with somebody with prejudices against the medical establishment, and there are issues with fertility and management?” Reed said. “There are entire subsets of population who look at all this very differently than Hooman and I do.

“There are a lot of women who’d say, ‘I don’t want you to be taking my fertility away,’ even if they have no intention of having children. That’s a touchy subject, but again, you can do without morcellation.

“FDA is very quick to trash drugs that do not meet safety and efficacy criteria, but on the other hand, here’s a dangerous device, and it’s not banned. What’s the hold up?”

Vodra said the premarket requirements for drugs, and for Class II devices such as the power morcellator are very different.

“In the drug arena, drugs have to be shown to be safe and effective for a specific use in order to get them into the marketplace,” Vodra said. “In the device arena, you don’t have to.

“The 510(k) process means you simply have to show that you’re substantially equivalent to another device that’s in the marketplace. You don’t have to show that you’re effective at doing anything, and in a lot of products—like the scalpel—you don’t need to.

“If I read the history of the power morcellator right, it was cleared for one purpose, and doctors started using it for a different purpose, so that’s where the problem arose.

“That’s where drugs and devices differ. Almost all drugs have to be shown to be effective for a specific use before they can get to the market for any use, whereas devices don’t have to do that.

“That’s what the 2011 IOM report on the 510(k) is about. The 510(k) is not protecting the consumer in the way people think it is.

“People thought that the devices that were cleared are safe, but they are not approved. FDA approves products that are safe and effective, but it clears devices that can prove to be equivalent to something else.”

Copyright (c) 2014 The Cancer Letter Inc.

 http://petitions.moveon.org/sign/campaign-against-morcellatio.fb49?source=s.fb&r_by=10266987

PLEASE SIGN THIS PETITION AND SHARE !!

courtesy of American Recall Center

Dr. Hooman Noorchashm has spearheaded this effort because his wife, Dr. Amy Reed is one of the victims of this FAILED and essentially unregulated device that spreads and upgrades undetectable cancerous tissue in the uterus.  There are other alternatives for hysterectomy that do not expose women to this PREVENTABLE catastrophic and irreversible danger.  

Other references:

http://www.democratandchronicle.com/story/all-about-health/2014/07/11/couple-put-real-people-into-fda-hearing/12517557/

http://www.fda.gov/advisorycommittees/calendar/ucm400221.htm

http://www.recallcenter.com/power-morcellator/lawsuit/

https://www.facebook.com/pages/American-Recall-Center/576580039088552

http://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226

http://newbrunswicktoday.com/article/jj-paid-over-150k-doctor-who-sat-fda-safety-panels#.U_vVyL4bhzw.facebook

http://www.prevention.com/health/health-concerns/morcellation-surgery-when-cutting-edge-kills?cid=social_20140603_25180366&cm_mmc=Twitter-_-Prevention-_-health-healthconcerns-_-morcellationsurgery

http://boston.cbslocal.com/2014/04/25/local-couple-makes-push-to-ban-morcellation/

http://www.usatoday.com/story/news/nation/2014/02/18/hysterectomy-laparoscopic-morcellation-amy-reed/5347093/

http://www.medscape.com/viewarticle/829476

http://blogs.wsj.com/corporate-intelligence/2014/09/23/jjs-exit-from-morcellator-sales-leaves-opportunities-for-others/