Med Device Innovation: Profit without accountability

http://www.startribune.com/business/155855295.html

Rep. Erik Paulsen called the tax a “tax on innovation.”

Jerry Holt, Star Tribune

Taking aim at med device tax

•                Article by: JIM SPENCER and KEVIN DIAZ  (FiDA blog bold)

•                Star Tribune staff writers

•                May 30, 2012 - 9:11 PM

WASHINGTON - Republican House members are not waiting for the long-sought decision of the U.S. Supreme Court next month on the constitutionality of President Obama's signature health care law.

Spearheaded by Minnesota Republican Erik Paulsen, the GOP-led House is expected to vote next week to repeal an estimated $28 billion tax on medical device makers. While the tax is intended to help pay for the expansion of health care in the U.S., its repeal would provide relief to an industry with a major hub in the Twin Cities, home of pacemaker giant Medtronic.

Paulsen's bill, scheduled to pass out of the House Ways and Means Committee on Thursday, represents the third time this year that the House's GOP majority has moved to dismantle the health care law in whole or in part, fulfilling a central promise of the 2010 Tea Party movement that dubbed it "ObamaCare."

Paulsen's device tax repeal bill has 239 co-sponsors, including a dozen Democrats, which virtually ensures its passage once it comes to the House floor, possibly as soon as early next week. At a business roundtable in Minnetonka on Wednesday, Paulsen called the medical devices tax a "tax on innovation" that would "hit companies in Minnesota pretty hard" unless it were repealed.

Minnesota is home to some 400 medical device makers who employ 35,000 people, making the state one of the leading regional economies in the U.S. to feel the pinch once the planned 2.3 percent levy on revenue kicks in next January.

Chances for a repeal are far less likely in the Senate, where Democrats are reluctant to blow a $28 billion hole in a massive health care overhaul that needs every dollar Washington can muster to expand coverage to about 30 million people.

Potentially caught in the crossfire could be Sens. Amy Klobuchar and Al Franken, Minnesota Democrats. Both have staked out positions against the medical devices tax, but it is unclear whether they could support a repeal effort that did not include a another means of filling the funding gap.

"I still think we need to eliminate the tax," Franken said, "but any plan to do so must be offset in a responsible and fiscally sound way."

Klobuchar pushed to reduce the tax from the $40 billion that was originally proposed in the 2010 health care law. Appearing at the Minnetonka roundtable with Paulsen, she said she would "continue to support repealing it, reducing it, whatever we can do."

She has not said whether she would require the offset that other Democrats want, waiting to see what might be proposed. The GOP plan headed for the House floor next week provides no offset.

Industry presses

With no agreement on how to backfill the lost revenue that would be generated by the tax, next week's action in the House could turn out to be largely symbolic, much like previous votes to dismantle the Affordable Care Act's cost-control board or to repeal the law altogether.

But political analysts say the election-year House votes will count heavily on lawmakers' records, regardless what the Senate or the Supreme Court do in the coming weeks. The medical technology industry also has become heavily involved.

"We expect the House to pass the measure [repealing the tax] with a significant number of Democrats voting to do so," said Steve Ubl, CEO and president of AdvaMed, the country's leading medical device advocacy group. AdvaMed has poured time and hundreds of thousands of dollars into lobbying to get rid of the device tax, which it calls a job killer.

In the 2012 election cycle, Paulsen received $64,000 in campaign contributions from medical suppliers -- more than any other member of the House, according to records compiled by the Center for Responsive Politics.

Those records also show that Klobuchar, who is running for reelection this year, ranks third in the Senate, with $63,650 in campaign contributions from medical suppliers.

Paulsen quipped that "we're counting on Senator Klobuchar to twist the arm of [Senate Majority Leader] Harry Reid to schedule it on the Senate floor." But that appears unlikely.

"The Senate couldn't put [the House bill] on the floor today and pass it," admitted Shaye Mandle, government relations vice president for the LifeScience Alley, which represents the med-tech industry in Minnesota. "There's a lot of politics, given the presidential election."

'Congress' responsibility'

Even if the Supreme Court strikes down the individual mandate, which forces individuals to buy health insurance or pay a penalty, experts believe the entire Affordable Care Act will be difficult to dismantle because many parts already have been put into place.

Using the individual mandate to increase the number of healthy people buying insurance was the reform's most critical source of revenue. If the Supreme Court throws that out, other revenue sources, such as the device tax, magnify exponentially in importance.

Some in the medical device industry don't see that as their problem.

"I don't think it's our responsibility to go through the whole federal budget and find $20 billion," Mandle said. "It's [Congress'] responsibility."

AdvaMed's Ubl believes there are other ways to recoup the tax money that would be lost, should the device tax be repealed. But his organization is not advocating for any offset and in fact hopes the Senate will not attach one to the repeal bill.

The issue is complicated and controversial enough that Ubl thinks it will not be taken up as stand-alone legislation, but perhaps included in an end-of-the-year, overall tax package.

"We've heard from Senate Democrats who are concerned if it gets pushed to a vote [right now]," Ubl explained.

Meanwhile, the IRS is moving ahead with rule-making to collect the tax. The medical device industry is playing a role in that process to protect its interests in the event that the House and Senate deadlock over the device tax repeal.

"On the one hand, we want to get rid of the tax," Ubl said. "But we have to prepare for its implementation."

Jim Spencer and Kevin Diaz are correspondents in the Star Tribune Washington Bureau.

© 2011 Star Tribune

Consumer Groups criticize FDA law

http://minnesota.publicradio.org/display/web/2012/05/28/medical-device-fda-review-bill/

Consumer groups unhappy with bill easing medical device FDA review process

by Martin Moylan, Minnesota Public Radio   (FiDA blog bold)

May 29, 2012

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ST. PAUL, Minn. — Congress is considering some legislation of great interest to Minnesota's medical device industry, which employs some 35,000 people in the state.

Device companies say the legislation will speed up the lengthy process of federal approval required to bring the new life-saving devices to market.

But some consumer groups argue that Congress is missing an opportunity to strengthen a review process for the Food and Drug Administration that they say is too lenient.

The legislation passed the Senate last week and may go to a vote this week in the House.

Sen. Amy Klobuchar, D-Minn., wrote many of the bill's provisions. Both she and fellow Minnesota DFL Sen. Al Franken voted in favor of its passage.

"One of the things we've done here is to give the FDA resources so that they can get that review process going faster by having adequate staff," she said. "Safety regulators and the industry agreed that they would be able to do a much better job if they had the resources they need."

Device companies complain reviews have been taking longer and longer.

"There were literally five-, six-year delays and that's just not what should be happening," Klobuchar said. "And the FDA knew they had issues in terms of delays. They admitted it."

The legislation more than doubles the fees medical device and drug companies pay the Food and Drug Administration for safety reviews. These med-tecj companies will pay the agency about $600 million over five years, to fund an increase in review staffing.

Shaye Mandle, vice president for government relations at LifeScience Alley, a trade group for Minnesota's medical technology firms, says a better-staffed FDA could carve months or even years off the review process for new pacemakers, stents, insulin pumps and other devices.

"This package gives us some more, not guarantees, but more specific goals around the FDA making decisions up or down on our products in a more efficient manner," Mandle said, adding that those decisions have a broad economic impact.

"The quicker our companies can get their products into the hands of patients and physicians, the quicker our businesses can continue to grow and flourish, which is good for Minnesota's economy," Mandle said.

The three biggest medical devices companies operating in Minnesota --Medtronic, St. Jude Medical and Boston Scientific --declined to comment for this story.

But Steve Ubl, CEO of AdvaMed, which represents over 1,300 medical device companies, says slow FDA reviews have discouraged investors from putting money into small med-tech companies with promising products. And he says companies frustrated by slow reviews in the U.S. have chosen to launch and commercialize new products in Europe and other markets, where he said reviews are faster.

"That means that American patients wait for those break-through technologies and patients also die waiting for technology today. And that shouldn't be the case," Ubl said.

Some patient and consumer advocacy groups think it's great the FDA will get more money to perform reviews but lament Congress is missing an opportunity to make the process more thorough, starting with requiring more clinical trails of devices before they go to market.

Dr. Michael Carome, deputy director of the health research group at Public Citizen, said most medium- and high-risk devices, including many devices that are permanently implanted, come to market through a process that doesn't require any testing in a clinical trial.

"The manufacturer just simply needs to show their newly proposed device is substantially equivalent or similar to a device already on the market," he said.

Another patient advocacy group argues a more stringent reviews would reduce the number of devices pulled from the market after it's determined there's a reasonable chance they could cause serious health problems or death.

Medtronic, St. Jude and Boston Scientific have all had such serious --so-called class 1-- recalls for their products. But FDA says that in recent years, fewer than one in 2,500 devices has been subject to a class 1 recall.

Diana Zuckerman, president of the National Research Center for Women & Families in Washington, D.C., said that ratio could be even smaller with more thorough pre-market reviews.

"We had hoped that the House and Senate would agree medical devices that are implanted and that our lives depend on would always have to be tested in clinical trials and inspected prior to be being sold," she said. "But medical device companies opposed this and it did not see the light of day."

LifeScience Alley's Shaye Mandle says the review process is plenty thorough and there's no evidence of rampant use of unsafe devices.

"This is technology that's clearly on the leading edge of human knowledge," he said. "It is impossible to eliminate all risk from this. If what you want is a system that has no risk, then we can stop submitting and approving products altogether."

Most senators clearly agreed with the industry's perspective. The Senate approved the FDA funding bill 96 to 1.

Apologies must include Patient Harm/Transparency

 LINK

Investigating Untold Health Stories

By William Heisel  Reporting on Health

At its heart, the debate comes down to this: Should a doctor be able to say sorry to a patient who has been harmed and then avoid the repercussions of the error?

Doug Wojcieszak, the founder of the Sorry Works! program, makes a strong case for changing state and federal laws to encourage apologies and discourage protracted malpractice lawsuits.

A group of patient safety advocates led by Lisa McGiffert from Consumers Union's Safe Patient Project and Robert Oshel, the designer of the National Practitioner Data Bank's Public Use File, argue that the Sorry Works! plan would allow doctors to hide dangerous histories of medical errors and negligent behavior. They have presented a compelling counterargument.

On both sides of the discussion, there are basic assumptions that could be the basis for short-term or long-term projects. Here is the first – and perhaps biggest – question that could yield a fascinating answer. I'll look at more in my next post.

How many patients are harmed every year by medical errors? The patient advocates say:

Authoritative estimates of the number of malpractice deaths in the U.S. range from 100,000 to over 200,000 per year – the rough equivalent of a commercial airliner crashing every day. And the number of malpractice deaths is dwarfed by the number of people who are merely injured but not killed. Three respected studies in the past two years found that at least one in four hospital patients are harmed – that is almost nine million Americans each year.

As you might imagine, no federal government agency tracks deaths or injuries due to malpractice or medical error. (I make the distinction because the former has a legal weight and implies negligence.) The numbers above are estimates, and the range is wide.

That's one of the reasons so many reporters continue to cite the 1999 Institute of Medicine report "To Err Is Human," which said that "at least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented, according to estimates from two major studies." Even if we take the lowest estimate and adjust roughly for population growth since 1999, that's a massive percentage of the annual number of deaths in the U.S. Consumers Union provided an update to the IOM report in 2009 with "To Err is Human –  To Delay is Deadly."

McGiffert wrote to me citing three studies, all done independently, that she says offer better estimates for the number of patients harmed by the health care system. Each report looked at all harm - not just serious harm and not just what sometimes is termed "preventable harm."

•               The Office of Inspector General of the Department of Health and Human Services, also using IHI's global trigger tool, found that 27% of Medicare hospital patients had been harmed by medical error.

•               Researchers using the Institute for Healthcare Improvement's "global trigger tool" found that 1 in 3 hospital patients had been harmed.

•               And a New England Journal of Medicine study in just one state, North Carolina, which has been looked to as a model in prevention of medical errors, found that 1 in 4 patients had been harmed.

McGiffert wrote:

No one is refuting these studies - they are solid. Also, I have a beef with only talking about deaths when so many millions more are harmed.  We KNOW the IOM is wrong because the deaths from hospital acquired infections ALONE are close to 100,000. So, I think it is time to stop repeating those tired and worn out estimates.

I agree. So let's try to add to the evidence base and find out the true number of patients both killed and harmed. 

Consumers Union: Senate Medical Device Bill Weak

May 24, 2012

Senate Passes FDA Safety And Innovation Act

Bill Makes Some Improvements to Medical Device Oversight
But Important Patient Safety Protections Still Missing

WASHINGTON, D.C. – The Senate approved the Food and Drug Administration Safety and Innovation Act today. While the legislation includes some improvements over current law, it leaves significant flaws with the FDA’s current medical device oversight system in place, according to Consumers Union, the policy and advocacy arm of Consumer Reports.

“Tens of thousands of patients have been seriously harmed by dangerous and defective medical devices in recent years because our current system fails to ensure they are safe and effective,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “The Senate bill makes some improvements in the law but fails to address some longstanding flaws in our medical device oversight system that endanger patient safety. Congress is missing the opportunity to fix a broken system that lets too many unsafe medical devices on the market and limits the FDA’s ability to protect patients when problems arise.”

Among the key patient safety provisions missing from the Senate bill:

Prohibition on clearing new devices based on recalled devices: The Senate bill does not include a provision preventing medical devices with known safety problems from being used as the basis for clearing new devices. Under the FDA’s 510(k) process, the agency has to approve a new device if it is substantially equivalent to one already being sold, even when the new device is based on one that has been recalled by manufacturers due to safety problems or has a recalled device in its lineage. Currently, the FDA does not even have the authority to require manufacturers seeking clearance for new devices to demonstrate that they have addressed the flaws of the recalled device.

Consumers Union has urged Congress to prohibit recalled devices from being used as predicates for new devices. An April Consumer Reports poll found that 71 percent of Americans believe that a new medical device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

A national registry for tracking medical implant problems and notifying patients: The FDA does not have all of the tools and resources it needs to adequately track and evaluate how patients with implants and other high-risk devices are faring. While the Senate bill includes some improvements in this area, it does not address the need for creating a national registry of patients with devices, which would help the FDA more quickly identify problem devices and notify patients when their device has safety problems or has been recalled.

Stronger authority for the FDA to require post market studies: The Senate bill does not give the FDA the authority to rescind clearance of a device when a manufacturer fails to comply with an order to conduct a 522 post-market safety study (that is ordered because of harm to patients) or when a post-market study reveals safety and effectiveness problems.

Retaining Existing Conflict of Interest Standards: The Senate bill weakens current standards for preventing conflicts of interest on FDA panels that review medical devices and prescription drugs. The bill eliminates existing limits on the number of waivers the FDA may grant to experts with financial ties to the medical device industry. These limits were championed by consumer advocates and adopted by Congress just five years ago. The Consumer Reports poll found that 66 percent of Americans had a high level of concern about the safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.

The improvements in the Senate bill include:

• A provision that would allow the FDA to more easily up-classify problematic devices so that subsequent, similar devices will receive more scrutiny before they get to patients.
• A timeframe for finalizing proposed regulations on unique device identifiers and for implementing these rules. Once these rules are in place, FDA will be better able to track problematic devices and make sure patients are warned about safety problems.
• Adds medical devices to the Sentinel Initiative, created five years ago as a mechanism to enhance post market oversight of drugs. This will assist in post market oversight.
• Codifies the requirement that approval for high-risk devices is contingent on completing required post market studies. This should make it easier to impose civil monetary penalties on bad actors, leveling the playing field for companies that comply.
• Creates a timeline on 522 post-market studies for devices that had been cleared in the fast track process, aiding the FDA in reacting more quickly when device safety issues have been identified. However, the bill allows manufacturers to delay beginning these studies for fifteen months after the FDA orders them. While these studies are being conducted, doctors can still implant these questionable devices in patients.
• Requires the FDA to do more outreach to involve more non-conflicted experts and groups – including scientific societies the Institute of Medicine, and the American Academy of Medical Colleges – in its recruitment efforts for medical device advisory committees.

Contact: Michael McCauley, mmccauley@consumer.org, 415-902-9537 (cell) or 415-431-6747 or David Butler,dbutler@consumer.org or Kara Kelber, kkelber@consumer.org at 202-462-6262

Permanent link: http://safepatientproject.org/press_release/senate-passes-fda-safety-and-innovation-act 

Health Leaders Media encourages patient harm dialogue

New Facebook Page Gathers Stories of Medical Harm

Cheryl Clark, for HealthLeaders Media , May 24, 2012  (FiDA Blog Bold)

As if Facebook didn't grab enough headlines on Wall Street this week, the social media forum is also making healthcare news that should prompt any leader to pay close attention.

ProPublica, the two-time Pulitzer Prize–winning newsroom that collaborates with other media outlets for investigative journalism, a few days ago launched its Facebook "Patient Harm Community."

People can sign up and post a healthcare horror story in graphic detail. Journalists are joining to find patients in their communities who have details to share. There's a special "Files" page entitled "What to do if you've been harmed," which instructs patients on where and how to lodge complaints about doctors, nurses, and hospitals. Even some healthcare providers are weighing in.

ProPublica's Marshall Allen, who uncovered systemic poor quality in Nevada hospitals for a 2010 series in the Las Vegas Sun called Do No Harm, and himself a Pulitzer finalist, explains what prompted the Facebook venture.

For starters, he says, the one million people—a staggering number—who suffer injuries, infections, and errors in healthcare facilities across the country each year had very few places to turn for advice, until now.

"Over the years, I've talked to scores of patients who have been harmed while undergoing medical care, and the one thing that always struck me is the fact they feel so alone," he says.

"When they suffer this type of harm, they complain to doctors and hospital officials and regulators, but they often don't feel that they're being listened to. 

"I wanted to find a way to give these folks an opportunity to talk to one another, offer advice, encouragement, and comfort, and get questions answered. A lot of them are at different stages of the process of working through the things that happened to them."

Healthcare professionals especially should pay attention to what's said on this site, he says, because it might illuminate what a patient with a bad episode of care really goes through. They should join in the conversation.

"I think for hospital leaders this would be a great place for them to put an ear to the ground, to hear what patients are really saying, and factor that in when they make decisions," Allen says. "We created this for doctors, nurses, hospitals, and healthcare officials just as much as it was created for patients."

"Doctors, nurses, and hospital officials also are very interested in reducing the number of patients who suffer infections, injuries, and errors while undergoing medical care," he adds.

Leah Binder, CEO of the Leapfrog Group, which plans to publish patient safety scores for 2,600 hospitals on its website in a few weeks, says ProPublica's patient safety community "is a great idea ... so people who suffer this kind of harm don't think they're the only ones."

"All too often I will hear from someone, 'I had the most unusual experience; I got an infection in a hospital' or 'someone gave the wrong medication.' But that's not unusual; that's usual," Binder says. "Most people who have been in a hospital have suffered some kind of harm and it's time to put a stop to that. People deserve to know that some hospitals are safer than others."

She notes that the Office of Inspector General at the U.S. Department of Health and Human Services counted up the number of deaths to Medicare beneficiaries caused by medical mistakes for one month. The extrapolated one-year total was 180,000. That makes for a lot of bereaved and frustrated family members.

By my count, membership in the fledgling Patient Harm Community is growing by about 100 a day as word gets out.

In recent days, for example, postings included these issues:

• A nurse in Phoenix claimed she was fired by her hospital, and now faces nursing board charges, for informing a patient about risks of upcoming surgery and the benefits of hospice.
• An infection prevention nurse in California, formerly a hospital inspector with the state Department of Public Health, told of undergoing a spinal disc procedure with a flawed protein material she was never informed about by her surgeon, resulting in multiple subsequent surgeries.
• A warning from an employee at the federal Agency for Healthcare Research and Quality for patients to not take antibiotics and proton pump inhibitors (like Prilosec or Prevacid) at the same time because of links to clostridium difficile infections.

Allen says ProPublica's social media experts looked around the country to find a similar online forum but without success.

This isn't like Yelp or Angie's List, where unhappy patients can anonymously pile on about a rude receptionist. "These are peoples' real identities, as far as we can tell, so if they say something to the group, their name is behind it. There's a little bit more accountability," Allen says.

It occurs to me that hospitals and doctors might be nervous about the page, fearing a free-for-all of complaints from emotional patients and family members who exaggerate claims or confuse the natural course of illness and disease with preventable misdiagnoses, infections, and medication mishaps. I see both sides, and appreciate the very human ways that can happen when people are in distress.

So I asked the American Hospital Association to take a look, noting that ProPublica wants providers to join the conversation.

Nancy Foster, AHA vice president of quality and patient safety, gives a tepid response: 

"When patients have concerns about their care, we encourage them to talk with staff at the hospital. Patients and their family members will find that their care givers are deeply concerned about making care right for them and that care givers also want to improve the care experience for future patients.
"Further, it is often helpful for patients to share their stories in forums like this one. However, as providers, we are both legally and ethically bound to honor our patients' privacy and not discuss their care in open public forums."

The American Medical Association did not respond to a request for comment.

Robert Wachter, MD, a patient safety expert at the University of California in San Francisco and chief of the Division of Hospital Medicine at UCSF Medical Center, thinks the site could be useful for healthcare officials. "One learns about medical mistakes through a variety of lenses, and this is another one," he says. "I suspect there'll be some interesting, useful information, a fair amount of ranting, and lots of people with painful stories they simply want to share with others. It'll be interesting to see how it plays out and whether it gets any traction."

ProPublica's team members monitor discussions and comment, posting relevant news or reference articles. As the site gets going, Allen says, "We want to do keynote question-and-answer sections with healthcare leaders and patient advocates, and whatever the topics are that audiences are most interested in, we'll try to provide useful resources."

I wondered how Allen's team will handle comments specific to named hospital facilities or physicians. "Let's say someone posts 'St. Augustine Hospital in Kansas City, MO killed my father when it gave him an overdose of morphine?'" I asked.

He replies that ProPublica will try to seek comment, "and to the extent we become aware of something we know is not true, we will take it down."

Allen acknowledges that the Facebook effort "is kind of an experiment, to be honest. We don't know how it's going to go or what direction it's going to take. We're trying not to control it too much, but let the members participate and engage one another and direct the direction that things take."

I know people at ProPublica personally, and the excellent reputation it has garnered in the last four years. If anyone can do this in a responsible way, surely this organization can, and highlight at a human level the harm that negligence and nonchalance can cause.

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Cheryl Clark is a senior editor and California correspondent for HealthLeaders Media Online. She can be reached at cclark@healthleadersmedia.com. Follow Cheryl Clark on Twitter.

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Copyright © HealthleadersMedia, 2012

Patient Harm: Untested Medical Device

LINK                     video link
Published: May 18, 2012 Updated: May 21, 2012 8:23 a.m.

FDA rule clears medical devices without human testing

 By TONY SAAVEDRA and COURTNEY PERKES / THE ORANGE COUNTY REGISTER
(FiDA Blog bold/italics added.)


Laurie Kelly blinked awake from surgery at Hoag Hospital in Newport Beach, grateful for the cutting-edge technology that gave her the chance to beat breast cancer in a single day.

That June 2010 morning, Hoag doctors removed a tumor from her left breast. Then they positioned their brand-new Xoft Axxent device to deliver a high dose – 20 gray – of electron radiation to her surrounding flesh, eliminating the need for six weeks of treatment. Kelly's healthy tissue was protected by the Axxent FlexiShield Mini, a malleable metal pad made of silicone-wrapped tungsten.

Laurie Kelly of Irvine, diagnosed with breast cancer, went in for a new kind of intra-operative radiation treatment at Hoag Hospital in Newport Beach in June 2010. However, tungsten from the shield used to protect her healthy tissue shed into her body, and Kelly decided to get a double mastectomy. The manufacturer recalled the Axxent Flexishield in February 2011 after the breasts of 10 women were contaminated with fragments of tungsten. The number has since risen to 29.

Six months later, with her ordeal apparently behind her, Kelly, 58, went in for a routine mammogram and MRI. Her stomach dropped when the film showed white specks about the size of salt grains inside her breast.

"My nightmare started all over again," she said. "I thought, 'Oh God, they found another spot.'"

But this time, cancer wasn't the invader. Instead, tungsten particles from the shield had been driven into her breast during the procedure. Some of the metal subsequently migrated to her urine, medical records show.

"Even though the day I had my surgery the cancer was removed, something potentially worse was put inside of me. It was the most frightening thing I ever heard," said Kelly, an Irvine psychologist.

Xoft voluntarily recalled the Axxent FlexiShield in February 2011, after two of the first hospitals to use the device – Hoag and Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. – reported to the Food and Drug Administration that a metallic, powdery substance was found inside the breasts of 10 women treated with the device. One report described the metal as "apparently ... debris left from the tungsten shield." Since the recall, the number of patients reporting a metallic or powdery substance in their breasts has risen to 29.

The alarming outcomes brought new fuel to a longstanding debate over an FDA rule, known as 510 (k), that allows manufacturers to fast-track new medical devices to market without human testing.

The 1976 law was intended to provide quick approval of low- and moderate-risk medical devices. But after extensive lobbying by medical manufacturers, Congress changed the regulations to make it even easier to get clearance. Today, about 90 percent of the devices on the market are cleared for use through the 510 (k) process, FDA officials say.

Regulators, independent reviewers, doctors and consumer advocates agree that the 510 (k) process is seriously flawed. The process clears new inventions if they are "substantially equivalent" to devices already on the market. But there is a lot of leeway in that rule. The tungsten FlexiShield, for instance, was approved based on another product made from a different metal. In other cases, new inventions have been cleared even though they were similar to devices that proved faulty after their release.

"Patients and doctors would be shocked to learn how this is done," said Diana Zuckerman, president of the National Research Center for Women and Families. "The 510 (k) program is the weakest and most nonsensical program in the FDA."

Dr. Melvin Silverstein, medical director of Hoag Breast Care Center and Kelly's surgeon, declined requests to be interviewed for this article, citing lawsuits against Hoag by Kelly and 12 other patients.

But Dr. Jack Cox, chief quality officer at Hoag, told The Orange County Register in a statement: "The physicians involved with the clinical trial took immediate action upon discovering the situation and notified all of their patients involved in the clinical research trial. In addition, as soon as the physicians and Hoag clinical trials staff became aware that there were concerns about the device, they immediately notified the FDA. ... The highest quality patient care and safety are absolute top priorities at Hoag."

Hoag also noted, in court filings, that they had warned patients in a written disclosure that the treatment they would receive was new and its safety was unproven.

Xoft, the shield manufacturer, and its parent company iCAD, declined requests for an interview.

In a response to the injury lawsuits filed in Orange County Superior Court, Xoft and iCAD have denied any negligence or liability. Among the possible defenses to the lawsuit they listed were that the injuries were the plaintiffs' own fault or the fault of the hospital.

In a letter to hospitals last year, Xoft's director of regulatory affairs wrote, "We have determined that the toxicity of these very pure tungsten particles is low as few health effects have been reported in humans."

Medical device manufacturers defend the 510 (k) process, saying less than 1 percent of the estimated 3,000 to 4,000 devices cleared each year are recalled because of concerns about death or serious injury.

"It's got a good safety record," said David Nexon, senior executive vice president of the Advanced Medical Technology Association, an industry lobbying group also known as AdvaMed. "You can't always identify problems before the marketplace."

Peter Barton Hutt, a former FDA counsel who helped craft the 510 (k) statute, also defended the process in an interview with the Register.

"There's no proof that it is a broken system. I've yet to hear anybody suggest a better approach," said Hutt, a Washington, D.C., lawyer. "Any system run by human beings is going to occasionally misfire."

But when a 510 (k) device fails, the toll on patients and families can be devastating. Some examples:

•Certain hip implants in which the ball and socket are made of metal are shedding chromium and cobalt, in some cases damaging the tissue around the device, according to FDA reports. Hundreds of thousands of these devices have been implanted internationally from manufacturers such as DePuy, Zimmer and Biomet. The FDA has received more than 16,000 adverse reports and has ordered additional, post-market monitoring by the manufacturers. DePuy, a division of Johnson & Johnson, recalled its ASR device in August 2010, after implantation in 93,000 people worldwide. About 9,000 adverse reports and 6,000 lawsuits have been filed against the DePuy device alone. The hip devices were supposed to last 15 years, but in some cases are failing after two or three. "DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System," the company says on its website. Zimmer and Biomet have not recalled their devices.

•Vaginal mesh used to treat incontinence and repair a condition called prolapsed uterus has been blamed for nearly 4,000 reports of serious injury or complications, including infections and damage to internal organs, FDA documents show. The mesh has been found in some cases to be too rigid for the constant movement of a woman's pelvic area, and the production materials are not always harmonious with the bacteria found in the human vagina. Three deaths were reported to the FDA between 2008 and 2010. There are dozens of manufacturers of vaginal mesh, but the four biggest defendants in more than 600 lawsuits are Johnson & Johnson, Boston Scientific, C.R. Bard and American Medical Systems. The manufacturers insist that surgical mesh remains a valuable option for treating prolapsed uterus and incontinence. "These products offer a safe and effective alternative to non-mesh treatment options," Boston Scientific said in a statement.

•An infusion device for insulin pumps built by Roche generated 500 adverse reports to the FDA because the delivery tube kept bending and kinking, causing under-delivery of insulin. Some patients became hyperglycemic, some developing sores, severe vomiting and other complications of diabetes from using the Accu-Chek FlexLink Plus infusion set. The company recalled the device in March 2011, less than a year after it was cleared for sale. The device was cleared based on its similarity to another Accu-Chek product. Roche has advised customers to stop using the FlexLink product and consult their doctor.

•Bivona tracheostomy tubes made for children by Smiths Medical of Gary, Ind., were found to be breaking and dislodging, causing the need for emergency tube changes. The product was recalled by the manufacturer on Feb. 23. The FDA said users had trouble detaching accessories from the tube and used excessive force, causing the breathing tube to dislodge. The results could be fatal if another tube could not be immediately found. Smiths Medical noted that if the accessory is correctly connected to the affected tube, there should be no problem disconnecting.

•Some devices classified as low-risk don't even get 510 (k) scrutiny, such as the Octopus Nuvo Tissue Stabilizer by Medtronic Perfusion Systems, a device used to stabilize the heart for bypass procedures. The Octopus Nuvo fell apart in two surgeries in 2010, with pieces tumbling into the patients' chest cavities. The pieces were retrieved by surgeons, and the patients were not reported injured. However, the device was voluntarily recalled in September 2010. The FDA said there was a severe danger of broken pieces causing fatal damage to the chest cavity and heart. Medtronic stressed that no other item in the Octopus family of products is affected.

Like many other devices that had received fast-track clearance and then injured patients, the Axxent FlexiShield was recalled by manufacturer Xoft, now owned by New Hampshire imaging giant iCAD, after hospitals sent adverse event reports to the FDA.

In a letter to hospitals dated Feb. 3, 2011, Steve Lin, Xoft's director of regulatory affairs wrote, "When Intraoperative Radiation Therapy patients return for follow-up as part of their usual patient care, it is very likely that mammography and/or breast MRI exams will show evidence of small tungsten particles that were shed from the FlexiShield Mini during the IORT procedure."

The letter added, "We have determined that the toxicity of these very pure tungsten particles is low as few health effects have been reported in humans."

Thirteen women have since filed suit in Orange County Superior Court against Xoft, iCAD and Hoag, claiming personal injury, medical negligence and product liability.

Last year, Kelly made the painful decision to have a surgeon remove both of her breasts in an effort to rid her body of the tungsten. Even so, the metal continues to show up in high levels in her urine, records show, and she's experienced a variety of health maladies.

"At least with the cancer, we knew we could go in and cut it out," Kelly said. "With the tungsten, we're shooting in the dark. We're all lab rats."

Kelly said she feels let down by the FDA, the device maker, the hospital and her surgeon.

"I always thought the FDA was there to protect people," Kelly said. "Science requires investigation. You test things out. ... Instead, through their lack of oversight, they put people at tremendous risk."

When Congress passed the Food, Drug and Cosmetics Act in 1938, little attention was given to medical devices, which consisted mostly of things like tongue depressors and stethoscopes. Devices went mostly unregulated until 1976, when Congress approved the "Medical Device Amendments" in reaction to thousands of deaths and injuries – 8,000 from the IUD birth-control device alone.

Lawmakers concluded that devices should not be subject to the same level of time-consuming scrutiny as drugs. Scientists could change one aspect of a device and still have the same device. If they changed one molecule of a drug, they had a new drug. So Congress adopted a program in which devices existing in 1976 would be grandfathered in and new devices would be judged according to their risks.

High-risk devices would receive the most scrutiny, called "pre-market approval," which include human trials. Low- and moderate-risk devices would be reviewed through the 510 (k) program, according to whether they were "substantially equivalent" to devices already on the market. Industry officials say that if a device is deemed substantially equivalent, then it is "no less safe" than an existing device.

Congress expected that eventually most devices would be new and subject to the highest level of scrutiny or "pre-market approval" and that 510 (k) would ultimately be phased out, said Dr. David Challoner, a retired medical professor and chairman of a recent Institute of Medicine study critical of 510 (k).

"Of course, that is not what happened. We have the vestigial appendage for what was a transitional market process," Challoner said in an interview. "What happened is that industry, with the help of Congress, has kept this more convenient clearance process in place."

In 1997, the review process was further modified by Congress to adopt the "least burdensome" principle. That calls for reviews to be done in a way that involves the smallest investment of time, effort and resources on the part of the manufacturer and the FDA. Industry groups argued that the principle increased efficiency, which would lead to greater safety and effectiveness.

Sharon Segal, vice president of technology at AdvaMed, the industry booster group, said "least burdensome" means working smarter, not harder.

"There's no lowering of the standard of safety and effectiveness," Segal said. "The premise is to make the process more efficient."

But some critics say the "least burdensome" principle was an effort to clip the FDA's wings.

"The 'least burdensome' wording has always resulted in shoddy reviews with a lack of safeguards," said Zuckerman, the consumer advocate. "If you go too far with least burdensome, you end up with people dying."

Over the years, investigators at the Government Accountability Office have criticized the FDA for allowing some high-risk devices to be cleared through the less rigorous 510 (k) process. A loophole had allowed some Class III, or high-risk devices, that were in use prior to 1976, and their successors, to be cleared through 510 (k). The GAO concluded in a 2009 report that too many devices were going through the fast-track process when they required more intense testing.

"Although Congress envisioned that class III devices would be approved through the more stringent (pre-market approval) process, and the Safe Medical Devices Act required that FDA establish a schedule for doing so, this process remains incomplete," the GAO said in January 2009.

The program has become so convoluted that an 18-month study by the Institute of Medicine, an independent, nonprofit organization that seeks to provide unbiased scientific advice, concluded last summer that 510 (k) should be scrapped and rebuilt because it does not ensure safety and effectiveness.

"The 510 (k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence," the study concluded. "In practice, the assessment of substantial equivalence generally does not require evidence of safety and effectiveness."

The report also chided the FDA for being lenient with violators and for having inadequate databases of previously cleared devices. "Because data systems are inadequate, the FDA does not have the ability to trace 510 (k) decisions," the report said.

Challoner, who chaired the study, said, "The current program is so defective that it cannot be perfected."

The FDA has no plans to scrap the program but has initiated measures intended to make it more rigorous in some spots and more streamlined in others. For instance, the FDA is updating its appeals process for devices that don't receive clearance and is clarifying the amount of information needed for each submission.

Zuckerman doesn't think the FDA is going far enough. She and other consumer groups say the 510 (k) program should require clinical testing for all implanted or life-saving devices.

"I'm just amazed an implant, like a hip or a knee, is allowed to be sold without being tested in a human being," she said. "Patients shouldn't pay for unproven devices that are not even being studied."

Jeffrey Shapiro, an industry lawyer in Washington, D.C., disagrees.

"If you want to review the safety and effectiveness of every device starting from scratch, you're not going to have any medical devices," Shapiro said. "The device industry would grind to a halt."

While the actual 510 (k) reviews are completed in about 90 days, the time it takes between submission and clearance has grown to as much as 161 days, according to the latest GAO study in February. A pre-market approval can take as long as 627 days, the GAO says.

David Gollaher, president of California Healthcare Institute, an industry think tank, testified in September before a congressional subcommittee on health that FDA reviewers have become overly sensitive to possible risks because of criticism from consumer groups and are overlooking the potential benefits.

"Increasingly companies have encountered an attitude of risk aversion at the FDA that is expressed in demands for more and more data and larger clinical studies," Gollaher told the subcommittee. "As a result, drug and device development costs have skyrocketed."

Matthew Jenusaitis, president of OCTANe, a high-tech development group in Aliso Viejo, said the need for safety should be balanced against the cost of losing jobs.

"Any device that fails is a bad thing, but at the same time, these devices have the ability to save lives and stimulate the economy. We're at a risk in the United States of losing this industry," Jenusaitis said.

Congress has responded with 10 new bills that legislators say will make the pre-market process more efficient. All the bills were introduced Oct. 14 by members of the House Energy and Commerce Committee after robust lobbying by the industry. Consumer advocates say the new legislation would just weaken regulation.

"The industry keeps saying we're going to stifle innovation, but it's not innovative if it's not safe and does not work," said Lisa McGiffert, manager of the Safe Patient Project for Consumers Union, a national consumer advocacy group that has been raising alarm about 510 (k).

Zuckerman added: "I want jobs in my community as much as anyone, but I don't want jobs for people making devices that are going to break inside my mother's body."

Rep. Rosa DeLauro, D-Conn., says lawmakers should be working to keep dangerous products from slipping through.

"The 510 (k) device approval process must be reformed – as it stands today, the process is critically flawed. I have long called for the FDA to review this process and reform it to better protect patients," DeLauro said in an email.

A bill introduced this year by Rep. Edward Markey, D-Mass., would allow the FDA to turn down products that are based on previously cleared devices with known safety defects. The new versions would no longer be eligible for clearance simply because they are "substantially equivalent" to the defective versions.

"If an automobile is recalled for a major safety problem, we wouldn't allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies," Markey said.

Meanwhile, more complaints have come from within the FDA itself, from reviewers who say they are overworked, underpaid and saddled with incomplete submissions from manufacturers. There is high turnover, with almost half of the review staff having four years or less experience. Front-line supervisors have three years or less, according to the FDA.

The FDA is negotiating with the industry and Congress to raise the fees that help fund the program. Currently, large companies pay $4,000 per submission, while smaller companies pay $2,000. Consumer groups say the large companies should be paying more than 10 times what they pay now. The industry has tentatively agreed to double the fees.

CASE STUDY OF A DEVICE

Like other medical devices cleared by 510 (k), Xoft's Axxent radiation system has a lengthy family tree.

The system, as well as others on the market, uses a portable machine wheeled inside the operating room to deliver radiation to a cancer site in a single dose. The process is known as Intraoperative Radiation Therapy, or IORT.

With the Xoft device, electron radiation is delivered after the tumor is removed but before the incision is closed. A syringe-like applicator, with an inflatable balloon at the end, is used to guide the radiation to the treatment area. A miniature X-ray tube inside the applicator, operating at 50 kilovolts, generates the radiation. A shield is used to protect healthy tissue and organs from receiving harmful radiation.

The treatment can be delivered in less than 20 minutes, rather than the standard six weeks of post-operative radiation treatment.

FDA records describe the history that led to clearance of the radiation system and shield.

In April 2005, Xoft submitted its application for the Axxent Electronic Brachytherapy System for the radiation of breast cancer, based on the earlier clearance of three different devices. The company described the system as "very similar" to devices that were cleared between 1995 and 2004. One of those devices, the Photoelectron Corporation Photon Radiosurgery System, was cleared in 1999 based on three previous radiation systems. The FDA cleared the Xoft system in December 2005.

In February 2009, Xoft submitted an application for the FlexiShield, described as a flexible pad made of tungsten and silicone. It called its shield "substantially equivalent" to Arplay Medical Lead Blocks, which were cleared in 2001. That device is made of lead with mounts of screws or rubber. Arplay's device had been cleared based on yet another device – Aktina Photo Beam Blocking System, cleared in 1998. The Aktina application was based on the 1994 clearance of the Medtec 360 Degree Rotating1/2Beam Block.

The FDA cleared the Xoft shield in June 2009. Documents do not reflect any concern by FDA reviewers that the FlexiShield was made of a different metal than its predecessors – tungsten instead of lead.

It's unclear exactly why Hoag chose the new Xoft system for its foray into IORT.

Dr. Alice Police, a Costa Mesa surgical oncologist, said she participated in meetings at Hoag to discuss purchase of a radiation system. She advocated for a system made by Carl Zeiss Meditec, based on a 10-year trial in nine countries that followed more than 2,000 women after treatment.

Police said negotiations were under way with Zeiss when suddenly the plan changed without explanation.

"The next thing I knew, they had canceled their negotiations with Zeiss and chosen the Xoft (system)," Police said. "I was dismayed to hear they had gotten a system with no data."

Police was so upset she decided to lease the Zeiss system, for $8,000 a month, for use in her surgery center, rather than use the Xoft system at Hoag.

After recalling the FlexiShield, iCAD applied in May 2011 for clearance for a replacement shield, this one made of stainless steel. That application was based on the 1999 clearance of a shield made by Photoelectron Corp. This time, FDA documents show, iCad tested the shield for shedding and found none occurred during "worst case clinical usage."

The FDA cleared the Axxent Radiation Shield – Rigid for use in July 2011.

ICAD is continuing with its Xoft IORT radiation treatment, using the new shield, launching a 10-year study enrolling 1,000 patients at 50 study sites throughout the United States and Europe.

LIVING WITH TUNGSTEN

Kelly learned she had an aggressive form of cancer in May 2010 after discovering a lump in her breast. She was referred to Silverstein, medical director of Hoag Breast Care Center. When she saw him, he told her she was a good candidate for IORT.

"He was just totally excited about this new technology," Kelly recalled. "He was like a super fan."

He told her he'd used the technology at USC, where he worked before joining Hoag.

Kelly liked the idea of missing less time from work and the appeal of a shorter recovery. She researched IORT and USC and saw that the 10-year international clinical trial using a system by Zeiss was nearly complete.

"It never occurred to me to ask, 'Is this the same machine?' I was so frantic to get the surgery," she said.

Kelly was the first Hoag patient to undergo the lumpectomy and radiation in June 2010, not realizing that the device was in fact made by a rival company.

"I felt very lucky that I lived in a community that had such cutting-edge technology and I got to be part of it," Kelly said.

Six months later, she returned to Hoag for a follow-up mammogram. She was told she needed an MRI for more detailed images. Tiny particles were "snowing" all over the film of her left breast tissue, where the shield had been placed.

Kelly underwent a biopsy, but the particles, spread over 9 centimeters of her breast, couldn't be identified by the local lab.

Hoag sent the sample to the renowned Mayo Clinic in Minnesota, which determined that it was tungsten. One of the tissue samples contained 207 micrograms per gram of tungsten, lab records show. The second contained 67,264 micrograms per gram.

The metal subsequently migrated through her body and showed up in her urine. A lab report from May 2011 indicates the tungsten level measured in her urine at 26 micrograms per gram of creatinine, a waste product that is analyzed for foreign substances. A July 2011 urine test shows a tungsten level of 19 micrograms per gram.

Although Xoft has maintained that the tungsten particles will not harm the women, not everyone agrees.

Doctor's Data, the Illinois-based lab that examined Kelly's urine, calls any level above 0.4 micrograms/gram "potentially toxic." Long-term industrial exposure to tungsten has been associated with "hard metal lung disease" and lung cancer, the lab reported.

Kelly found a Canadian scientist, Koren Mann of McGill University in Montreal, who researches tungsten. Their conversation did not ease her fears.

"I don't think it is inert at higher levels," Mann said in an interview, adding that more studies need to be done. "If you look at higher doses, there may be toxic effects, changes to the immune system. It may damage the DNA. There isn't a lot of information."

With tungsten in her flesh, Kelly feared it would be impossible for doctors to detect a recurrence of cancer because of the obstruction on the screening films. Although the tungsten appeared in only her left breast, she worried the foreign substance in her body could cause more cancer. For those reasons, she opted to undergo a double mastectomy in April 2011.

"I decided I don't want to deal with any of this again," she said. "It was too painful."

Kelly said no one from Hoag ever apologized. She said she felt she had no choice but to go to a lawyer in search of answers and protection for herself and other women. She filed the suit using a pseudonym.

"In the beginning, if Hoag had just stood up and said this is a terrible, terrible thing that's happened; we will endeavor to do anything to help you, I never would have considered suing them," she said.

According to a Feb. 25, 2011, letter from iCAD to Silverstein, the manufacturer offered to pay for costs of biopsies, blood and urine testing, MRIs and other treatment for patients who had tungsten in their bodies. But Kelly and her attorney, Jeffrey A. Milman, say iCAD has ignored their requests to pay her medical bills.

Kelly says she has experienced a variety of health problems that she believes are tied to tungsten. Tungsten is expelled through urine and for a while urination was extremely painful for her, though doctors found no signs of a bladder infection.

She's also worried that the faulty shield means her heart was exposed to a high dose of radiation. She feels persistent fatigue.

"I just don't have my energy back," she said. "I don't do hiking. I don't do a lot of things. I used to love to cook. Now I go to work, and I'm too tired to cook when I get home."

In January, Kelly underwent an 11-hour reconstructive surgery. Afterward, she developed a staph infection and had to be hospitalized again for a week and take intravenous antibiotics for a month. When her body is strong enough, she will have a final reconstructive surgery.

"I'll never be without a lot of scars. It's not like before when it was a cancer scar," Kelly said, "and that's a badge."

Contact the writer: tsaavedra@ocregister.com

Contact the writer: cperkes@ocregister.com