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

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

Read more at http://www.philly.com/philly/blogs/healthcare/Irrational-Exuberance-A-home-grown-threat-to-our-nations-health.html#FtrFfIsWqQMVcurX.99

Read more at http://www.philly.com/philly/blogs/healthcare/Irrational-Exuberance-A-home-grown-threat-to-our-nations-health.html#qfiOq2L7FXx8VkU7.99

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/

J&J Morcellation Surgery Device May Unleash Deadly Cancer

 Morcellation Surgery: When CuttingEdge Kills

How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?

By Harriet Brown  Photograph by Jamie Young  FiDA Highlight

On good mornings, Hooman Noorchashm wakes early, a relic of the days when he rose at 4:30 am for surgical rounds at Brigham and Women's Hospital. He pads through the quiet house to pop a coffee pod into the machine, then heads for his home office, where, over the course of the day, he will calmly, deliberately compose and send dozens of emails.

Doctor. Mother of six. Stage 4 cancer patient. Amy Reed may not have much time to live, but she's making sure her death won't be in vain.

His wife, Amy Reed, sleeps till 6:30 am, when she slips on a red Phillies T-shirt, snugs a maroon jersey cap over her stubbled head, and begins the work of getting six children under 12 ready for the day. An anesthesiologist at Beth Israel Deaconess Medical Center, Reed was on the team that treated both the Boston Marathon bomber and his victims. She is by nature even-keeled. You'd want her as your anesthesiologist. You'd want her sharp intelligence and steady presence with you in the OR. She and her husband aren't people who "do drama," as they put it. They're experienced doctors who argue logically rather than raise their voices or yell or cry.

On good mornings, then, in the face of events that have devastated their family, this composure seems both a gift and a burden. Last fall, a routine hysterectomy seeded cancer throughout Reed's abdomen. The hysterectomy didn't cause the cancer, but it very likely transformed it from stage 1 disease, with a 60% 5-year survival rate, to stage 4 disease, with a grim prognosis. About 85% of women like Reed are dead 5 years after diagnosis.

Reed's surgeon, one of the best in the country, wasn't to blame for the catastrophe. Nor was this a random disaster, the kind of bad-luck bolt from the blue that can strike anyone—the brick falling off the building, the truck spinning on the icy highway. The cancer upstaging was a preventable consequence of a surgical technique, one that is still being used in operating rooms around the country.

And this is what Noorchashm and Reed can't bear. This is what keeps him doggedly online, in the research, on the phone, whether he's home or sitting by Reed's hospital bed or driving her to and from chemo. The effort has led to international attention, much of it critical. Noorchashm's incendiary question: When new technology makes medicine cheaper and more convenient, how many patients have to die to prove it's not worth it?

"People have faulted my husband's enthusiasm," Reed says of Noorchashm. "But women are having this surgery right now." 

On good mornings, his arguments land as powerfully as his wife's even gaze. "People have faulted my husband's enthusiasm," Reed says on one of those mornings. "But women are having this surgery right now. Today. And they're going to have their lives destroyed, just like ours."

This year, more than half a million women in the United States will undergo hysterectomies. The majority will be between 40 and 55 years old, and, like Reed, most will have the surgery for fibroids, benign growths in the uterus that can cause pain, bleeding, and other symptoms. Five years ago, only about 12% of these surgeries were performed laparoscopically, done through incisions just big enough to fit a scope and tiny camera. Last year, nearly 30% were done that way, and the numbers were considered likely to rise.

Compared with traditional open abdominal procedures, laparoscopic surgeries were said to result in shorter hospital stays (and, therefore, lower costs for insurers), faster healing, less pain, fewer infections, and smaller scars. Still, when Reed first discussed hysterectomy with her surgeon, she asked for an open operation, despite the larger incision and longer recovery time. "I said, ‘I'm an anesthesiologist. I know how they operate. I'd rather have them see what they're dealing with and not mess around with little holes,' " she recalls. "Laparoscopic surgery's not all it's touted to be sometimes."

She'd known about her fibroids for a while, but the bleeding and pain had ramped up dramatically during her last pregnancy. Her husband arranged a consult with a colleague, Michael Muto, who directs the gynecological oncology fellowship at Brigham and Women's, which is Harvard's teaching hospital and an industry standard-bearer. As Reed remembers, Muto reassured her that the problem was "a no-brainer"; she'd have her uterus removed, and that would be that. "He told me, ‘This is not cancer, it's not anything terrible, this is what fibroids do.' " She says this quietly, matter-of-factly, 3 months later, sitting in the sun-splashed living room of a white clapboard house on a narrow street in the Boston suburb of Needham. From time to time she reaches under her cap to rub at a spot where her hair is starting to grow back, white fuzz now laced through the dark.

Muto said no surgeon would do what she wanted. You're young and healthy, Reed remembers being told; there's no reason in the world to have this done as an open surgery. "Dr. Muto wears a nice white coat with the Harvard emblem on it," says Noorchashm, sitting across from Reed. "He's my colleague, and we trust our own establishment." He pauses, and then corrects himself. "I trusted the establishment."

So Reed had MRIs and biopsies to check for cancer, as is standard before a fibroid operation, and went ahead with the laparoscopic hysterectomy. She went home that afternoon, and everything was fine until the surgeon called 8 days later to say that the pathology report showed leiomyosarcoma, a cancer in her uterus. And nothing has been fine since then.

Imagine a hive filled with angry bees flying this way and that, buzzing, darting, stingers at the ready. Now picture that hive inside a woman's belly, where at any moment the bees could explode through the body, wreaking the deadliest kind of havoc. The hive, says Noorchashm, is a good metaphor for a sarcoma, a kind of cancer that can grow anywhere in the body. He's operated on sarcomas and knows that the way to handle them is to carefully remove them in one piece. Now imagine inserting a long spinning saw—something like a handheld blender—into the hive while it's still inside the woman's body and cutting it up into tiny pieces. "What's going to happen," says Noorchashm, "is a million bees are going to come out and you're dead."

That saw is called a morcellator, and over the past 10 years or so, it's become standard procedure in laparoscopic surgeries to remove fibroids, the uterus, or both. "Morcellation prevents you from having to make a larger incision," says Larry Kaiser, dean of the Temple University School of Medicine. "You couldn't take the uterus with fibroids out through these small ports used for the camera and instruments."

The trouble is, some cancers—like leiomyosarcoma—don't show up on biopsies or MRIs done before surgery. If a woman's uterus is morcellated inside her body, cancer cells are spewed around the abdomen, where they cling to internal organs and, inevitably, grow. Even benign tissue that's morcellated can implant in the abdomen and trigger pain, bowel obstructions, and other problems.

Morcellation is what Reed and Noorchashm want to stop, arguing that it's unacceptable if there's any chance of hidden cancer—and there's pretty much always a chance. "It's flawed surgical procedure," says Noorchashm. Some ob-gyn surgeons say morcellation is safe if it's done in a containment bag, something like the bag inside a vacuum cleaner. Noorchashm disagrees. Bags can break, he says, especially when you're using a rotating power saw. Instead, he and Reed want surgeons to remove the whole, unmorcellated uterus vaginally when they can, and do the old-fashioned open surgery when they can't.

On the day Reed got the bad news, Noorchashm was down at Duke, preparing for surgery. After he got the call, he scrubbed out, booked a ticket home, and left. In the cab on the way to the airport, he called Muto, who told him what he'd already told Reed: Leiomyosarcoma is so rare there are no protocols for treating it, no best practices, no good survival statistics. Some doctors do nothing, waiting to see if it comes back; some start chemotherapy to try to stave it off; some schedule surgery to clean out anything that's already growing.

Noorchashm was horrified, both by the stark reality of the facts and by the offhand way he felt they were being delivered. "In my mind, when I hear sarcoma, and the sarcoma has been broken up inside, that's a five-alarm fire," he says. "And here's a surgeon thinking, We have three options, including watching and waiting. That's like taking a water gun and shooting at a five-alarm fire."

That day in the Raleigh-Durham airport, an advocate was born. Noorchashm began researching, making phone calls, and sending hundreds of emails to anyone he thought might make a difference—family, friends, colleagues, doctors, researchers, journalists, editors of medical journals. He and Reed (who at the time felt physically fine despite the cancer inside her) created a petition on Change.org calling for a ban on the practice.

Doctors and administrators maintained that what happened to Reed was unfortunate but incredibly rare and that it didn't make sense to abandon morcellation—a convenient and widely usable technique—because of such an unusual occurrence. The largest professional organization for ob-gyn surgeons, the American Association of Gynecologic Laparoscopists, issued an official statement disagreeing with putting limits on the procedure.

Some ob-gyns pointed out that the alternative laparoscopic techniques (removing tissue vaginally or morcellating in a bag) aren't an option for women with large fibroids—and worried that restrictions would lead to thousands of unnecessarily invasive open surgeries. These can cause more blood clots and infections, both of which can be lethal, says Joseph Ramieri, an ob-gyn surgeon and professor at Mount Sinai School of Medicine. "I'm not defending morcellation—as a technique, it leaves an awful lot to be desired," he says. "But it needs further study before we put limitations on it."

Noorchashm and Reed were asking for a huge shift in medical practice, and physicians, especially surgeons, can be slow to change, says Brian Van Tine, a physician who heads the Sarcoma Program at Barnes-Jewish Hospital in St. Louis. Part of the resistance was likely financial. If, say, half of the women who have hysterectomies have abdominal surgery rather than laparoscopy and must spend an extra day or two in the hospital, that's a lot of extra costs for insurance companies to cover. "Morcellation saves money," Van Tine says, "and these surgeries are a huge moneymaker."

As a result of the couple's efforts, new information emerged about just how uncommon leiomyosarcoma really was. Reed says that Muto, who refused to comment for this story, told her the cancer affects 1 in 10,000 women, but that statistic was based on the population at large. Among women with symptomatic fibroids, the number may be closer to 1 in 415, Noorchashm discovered—incredibly, from a paper listing Muto himself as a coauthor. In fact, Reed was the second woman within a year whose cancer was upstaged by morcellation at Brigham and Women's Hospital alone. The first woman has since died. Since Reed's surgery, at least five other women around the country whose cancers were upstaged by morcellation have come forth. And there are certainly others out there.

Though Reed's odds of living to see her youngest son graduate from high school are slim, she chooses not to focus on the numbers. 

As the winter progressed, Reed committed herself to doctors' visits and weighing treatment options—and remaining an upbeat, present mom to her children. Noorchashm stayed up nights writing strongly worded letters, posting comments on every website remotely relevant to the cause, and having strategic conversations with anyone who would talk to him. The only resulting change he saw was in his own reputation. He'd gone from star surgeon to social leper, shut out of the operating room at his own hospital (though he can't prove it was because of the campaign) and avoided by colleagues and former friends. "They closed ranks on me," he says now, with sadness in his voice. "I broke the white code of silence; I hung out our dirty laundry."

But he pushed on. He contacted hospital executives, the FDA, legislators. In return, his bosses at Brigham emailed faculty and staff warning them not to talk to Noorchashm and to speak to the hospital's chief medical officer if contacted by Noorchashm. Gerald Joseph, vice president of the American Congress of Obstetricians and Gynecologists, wrote to a colleague about Noorchashm: "Nothing is going to create any peace in this man."

And then, in February, something shifted. Kaiser (the dean at Temple) passed Noorchashm's materials to the head of gynecology, who responded by making the institution the first to ban open morcellation, requiring surgeons to use an isolation bag or not morcellate at all. Within weeks, another hospital got on board: Rochester General Health System declared that its surgeons wouldn't morcellate without a bag. Noorchashm wasn't satisfied—the bags could break, he said. He carried on with his campaign.

At the end of March, 5 months after the surgery that spread Reed's cancer, Brigham and Women's—Noorchashm's own employer—did the thing no one expected. The same administrators who had shaken their heads at this angry, disenfranchised surgeon finally acknowledged his case. They banned fibroid morcellation without a bag. Then, in mid-April, the FDA came out with a new analysis: A shocking 1 in 350 women seeking the removal of symptomatic fibroids has a hidden cancer, it said. The FDA issued an advisory strongly discouraging the use of morcellation, crediting Noorchashm with bringing the issue to its attention. More institutions, including the University of Pennsylvania Health System and Cleveland Clinic, changed policies. And Johnson & Johnson, the biggest morcellator maker in the United States, suspended production and sale of the tool. Noorchashm's life was shattered, but he had achieved much of his goal. "We have the privilege of being able to give meaning to what's happened to us," he says. "That gives us strength."

But he and Reed aren't finished. The FDA will hold a hearing in July, and Noorchashm expects it to be contentious. "That's when the likes of Gerald Joseph"—the man who said that Noorchashm would never find peace—"will come in with their suits and their lawyers and make arguments about the 'benefit of the majority,' " he says. "But medicine is not a popularity contest. You have to practice in a way that every single person matters."

Reed knows her chances of living to see her youngest son graduate from high school are slim. She copes, in part, by resisting the urge to focus on probabilities. The first time she Googled leiomyosarcoma—the day the surgeon called her—was also the last. "If your chance of living is 30% versus 70%—I don't even know what to do with that," she says. "You don't live 30%. You live or die. And either way, today I could be hit by a car."

She certainly wasn't the type to wait around for her cancer to spread. She opted instead for a radical procedure, performed by only a few surgeons in the country. The Sugarbaker operation, named for its inventor, Paul Sugarbaker, is a brutal 9-hour surgery that removes all visible evidence of sarcoma, as well as the patient's appendix, gallbladder, omentum (the fatty covering of the intestines), and peritoneum. Once the organs are gone, surgeons pour heated chemotherapy into the abdominal cavity and let it sit for 90 minutes. Sugarbaker told Reed that if the surgery went well, she'd have an 80% chance of having no recurrence in her belly in 10 years. In other words, she'd be back to baseline, back to where she would have been if the cancer had not been upstaged. "That was the best number I'd heard," she says, her eyes a little teary for the first time. So in November, she and Noorchashm flew to Washington, DC, for the surgery. Before getting on the plane, she nursed her youngest son, then 14 months old, for the last time and handed him to her mother.

Reed's recovery was more grueling than she'd anticipated. She couldn't eat for 10 days and lost 20 pounds. The incision, which runs from her sternum to her pubic bone, was so taut she couldn't stand up straight for weeks; even now she sometimes hunches to minimize the pain. Once that healed, she started on a course of chemotherapy, which just finished. And now comes the hardest part. "I'm afraid to be done with chemo," she says one afternoon, her youngest son curled on her lap under a blanket. "At least I was poisoning the cancer. Now what happens? Now I wait?"

Her son sits up suddenly and grabs a plastic hippo, making it clomp across the kitchen table. Reed holds the boy loosely, one arm across his legs, and when he slides off her lap to chase a squirrel from one window to another, she lets him go without hesitation. She's started making plans for the near future, for the time when they can get back to some semblance of normal life. She's maintained a research lab over the past 10 years, and she and Noorchashm are talking about working together to study, and ultimately defeat, leiomyosarcoma. "We have the know-how, and we certainly have the drive," she says.

At 2 am the house is quiet. Reed and the children sleep upstairs, but Noorchashm is still awake downstairs. He sits alone in a small pool of light, staring at a bronze statue on the mantel: St. George on his horse, his magical spear poised to slay the dragon. In the story, George kills the dragon to save not just the princess but also the rest of the town's children, who were being fed to the dragon one by one to appease it.

It's a metaphor, Noorchashm thinks. No, it's more than a metaphor; it's the new story of their lives, a fight to the death with the powerful creature that has changed their world forever. The horse is the media and doctors he's rallying to the cause; the shield represents the status of being a cardiac surgeon at Harvard. In some versions of the myth, the princess lives but George winds up dead; in others they get a happily-ever-after ending.

Noorchashm is a realist; he knows that odds are he will lose his wife sooner rather than later. He may also lose his career, but he's not worried about that just now. He's focused on the moment, the here and now. This fight he and his wife are immersed in, a fight not of their choosing.

He taps his long surgeon's fingers against the metal, sets the statue down on the desk, pulls the laptop closer, and opens a new email. He is not just George but the spear itself, aimed at the dark and bitter heart of the monster.