Tag Archives: medical devices

Controversy over breast implants spreads across Europe

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Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

In the wake of the discovery that a leading international manufacturer was found to be using industrial-grade silicone in its breast implants, questions have emerged about the regulatory process that allowed the implants and who is responsible for removing the substandard implants from women who spent thousands to get them.

John Lister

John Lister

John Lister, the web coordinator of AHCJ’s focus on Europe, explores the controversy surrounding the implants, including the lack of data on how many women in the United Kingdom received them, how the United Kingdom’s National Health Service has been drawn into the business of removing the implants and the regulatory system that allowed the implants in the first place. Lister reports:

But when it came to ascertaining the numbers of women who may have had PIP implants in British private clinics, it became clear there was no comprehensive or reliable data. A working estimate of 40,000 women potentially at risk eventually emerged, while the private clinics said they were not required to remove the suspect implants or replace them with safe ones. Yet the figures that were available showed that for one clinic as many as 7 percent of PIP implants had leaked, well above initial claims of a failure rate of about one percent.

The Reuters enterprise team has a special report on the breast implant scandal and a piece that shows how the regulatory system may be another scandal waiting to happen. It also looks at how, in the United States, the FDA handled an application from that company in 2000.

The history of breast implants is littered with flawed devices, a colorful cast of intertwined players and billion-dollar lawsuits. Reuters reviewed hundreds of pages of police investigation transcripts and financial documents, and interviewed former PIP employees, the company’s suppliers, customers and health experts, to piece together this latest chapter in that history.

New Wisc. rules lead to interesting disclosures

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Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

Thanks to new disclosure requirements from the University of Wisconsin’s doctor group, the Wisconsin State Journal‘s David Wahlberg was able to report that 10 UW-Madison doctors received $48,000 or more from drug and device companies.

Thomas Zdeblick, M.D., pulled in almost $1.7 million. In fact, most of them were orthopedic surgeons, a fact which shouldn’t surprise anyone who’s been following the State Journal‘s conflict-of-interest work, as well as that of the Journal Sentinel‘s John Fauber.

Before 2010, doctors only had to report that they’d received more than $20,000 from such industry associations. Now, they have to disclose specific amounts. The disclosure requirements are currently the most prominent component of the schools’ crackdown of conflicts of interest, but activists say conflict disclosure is only half the battle.

A policy adopted in 2009 by the UW Medical Foundation, the university’s doctor group, bans doctors from doing promotional speeches for companies and accepting gifts such as free meals. Surgeons, however, can use materials created by device companies to conduct government-required training sessions, Golden said.
The foundation’s policy prohibits doctors from receiving royalties for using products at UW Health, which removes any incentive to use the doctors’ products instead of others, Golden said.

An interesting side note: UW clinics post signs detailing how patients can obtain their doctor’s disclosure form, but such requests have been few and far between, Wahlberg found “14 in 2009, 18 in 2010 and seven” in 2011.

Fauber finds ‘failed back surgery syndrome’ after off-label use of Medtronic’s Infuse

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Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

John Fauber follows up his previous investigations into the myriad problems and conflicts of interest surrounding Medtronic’s Infuse product with a story on the emerging national epidemic of what pain specialists are calling “failed back surgery syndrome.” One local pain specialist Fauber contacted said that a full 10 percent to 15 percent of his patients suffered from the condition.

To bring the whole thing full circle, Fauber spends much of the body of this latest installment explaining how conflicts of interest and other questionable ethical situations, including off-label use, propelled the early and sustained success of Medtronic’s spine-fusion blockbuster and set the stage for the emerging pain epidemic.

Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.

NYT reporters tease hip replacement numbers from difficult data

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Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

Writing for The New York Times, Barry Meier and Janet Roberts analyzed a particularly tricky batch of federal reports detailing a variety of complaints with popular metal-on-metal hip replacements. They found that, since January, the FDA has received more complaints (5,000-plus) about the devices than it did, total, from 2007 to 2010.

kidsPhoto by Michael Simmons via Flickr

While processing the data, the paper’s staff did their best to parse duplicate reports, international filings and other inconsistencies, but the reporters make it clear that the numbers are still best viewed in general terms. Even so, they demonstrate that the surge in complaints and lawsuits involving metal-on-metal hips — and the resulting mass defection of doctors who once implanted them — signals a broad shift in hip replacement surgery, one of the most common such procedures in the country. It also signals another blow for device manufacturers and patients, and a related windfall for the legal profession.

The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.
…
As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

Reporters find heart devices skipped FDA’s more rigorous approval process

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Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Deborah L. Shelton and Jason Grotto of the Chicago Tribune couldn’t help but wonder: How does a medical device get implanted into patients without first getting FDA approval?

Tricuspid valve in a model heart
Tricuspid valve in a model heart. (Photo by robswatski via Flickr)

That question led to their two-day series in late May that reported for the first time that certain heart valve repair devices had been “down-classed” from class III to class II, a regulatory category that required that they undergo less scrutiny, even though the devices are permanently implanted and life-sustaining.

One of the annuloplasty rings had been stitched into the hearts of at least 700 patients in Chicago and elsewhere without going through proper channels. In fact, even though the company could have submitted both rings for clearance through a less rigorous regulatory pathway, it didn’t even do that. In these two cases, the process was skipped in its entirety.

In this article for AHCJ members, the pair explains how they reported the story, including finding documents and persuading affected patients to speak on the record.

Pushback against Medtronic’s Infuse hits boiling point

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Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

Medtronic’s ongoing woes with its blockbuster spine fusion product Infuse have been a staple of Covering Health for as long as we can remember, but things have reached a crescendo this week.

spine
Photo by attila acs via Flickr

The first blow came with the publication of John Fauber’s in-depth report (read it at the Journal Sentinel or in MedPage Today) on the conflicts of interest and regulatory weak points that kept Infuse going strong despite serious questions about medical outcomes.

The next day, The Spine Journal made the unprecedented move of dedicating an entire issue to repudiating the failures of science and medical journal publication that made Infuse what it is today. For the record, both those links point straight to journal press releases. If you’re looking for more context, you’ll find it in Fauber’s followup to The Spine Journal‘s Infuse issue. HealthNewsReview editor and publisher Gary Schwitzer also blogged his take on the releases.

Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.

Potential changes in regulation of medical devices would likely impact health care costs

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Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

As the medical device industry ramps up its campaign against further government regulation, Merrill Goozner takes stock of the regulatory and business environment in that arena and explains what is at stake. The key battleground at present is possible modifications to the 1976 law which allows devices to bypass some rigorous testing as long as they’re similar to something that has already been approved for market. The problem? That similarity doesn’t always mean they’re safe, as Goozner points out.

glucose-testing

Photo by AlishaV via Flickr

A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only 19 percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.

Despite slipping onto market through the similarity provision, many of these new products claim to be improvements over their predecessors and thus come with commensurately higher price tags. According to Goozner and his sources, this little disconnect has done quite a bit to increase the cost of health care in America.

“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”

The device industry, often cited for its red-hot growth rates in the past, now posts numbers that, while huge, still lag behind the health sector at large. That may be why the industry is stepping up political pressure to reduce its regulatory burden and to sidestep a 2.3 percent excise tax that was passed as part of recent health care reform efforts. For more on the money and politics involved, see Goozner’s full piece, which was also published in The Fiscal Times.

Related

Medical device investigation unearths conflicts, regulatory issues

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Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

The latest investigation from the Chicago Tribune’s Jason Grotto and Deborah L. Shelton focuses on a single medical device, yet still hits many of the health beat’s biggest narratives, primarily conflicts of interest and government regulation. In their centerpiece, they dig into the tale of a cardiologist who may or may not have tested a device he invented on patients without consent or regulatory approval. It’s in those gray areas that the story takes shape.

The device in question is an annuloplasty ring, which in 2001 was reclassified from class III to class II. In practical medical device terms, this means that new models don’t need clinical trials if they’re similar enough to devices that have already been approved. The reporters write that the rings earned this change of status in part because of the relatively low number of adverse events reported between 1991 and 1995 (465). Unfortunately, as their use has increased, so have the events.

Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring

Now that you have some idea of what they were up against, here’s a healthy excerpt from their “how we did it” sidebar, which is almost always Covering Health’s favorite part of a major investigative package.

The first hurdle in stories like these is understanding the medical science behind the device in question, which required us to gather up dozens of studies and reports on annuloplasty rings and the heart valve disease the device is intended to cure. We sifted through government documents and researched regulations as well as the history of the rings.

But writing about heart valve repair rings involves more than researching a disease and a device.

We also spent a lot of time with the patients in our stories because there is a level of trust that must be built up before people are willing to share personal information about their health. The same goes for Northwestern Memorial Hospital and surgeon, Dr. Patrick McCarthy.

We had to assure each of them that their viewpoint would be reflected in the stories. It’s a difficult balancing act that we tried to buttress with reams of documents, studies and interviews with independent sources.

For more on how Grotto and Shelton reported the story, watch for a “How we did it” article on the AHCJ website in the next couple of weeks.

If the issue sounds familiar, the storyline is similar to a 2005 investigation from The Wall Street Journal‘s David Armstrong, which found a partnership between the Cleveland Clinic – and some prominent staff members – and companies manufacturing devices used in clinical trials there.

Alarm fatigue hurts patient care, overwhelms nurses

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Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

In the wake of several high-profile incidents, The Boston Globe‘s Liz Kowalczyk has assembled a thorough investigation of alarm fatigue in hospitals. Alarm fatigue, for the record, is the idea that the huge arsenal of patient monitors in any given hospital floor are going off so often that nurses become slower in their responses to the alarms. For example, in one 15-bed unit at Johns Hopkins, staff found that, on average, one critical alarm went off every 90 seconds throughout the day.

With the help of ECRI, Kowalczyk has managed to attach some numbers to the issue.

The Globe enlisted the ECRI Institute, a nonprofit health care research and consulting organization based in Pennsylvania, to help it analyze the Food and Drug Administration’s database of adverse events involving medical devices. The institute listed monitor alarms as the number-one health technology hazard for 2009. Its review found 216 deaths nationwide from 2005 to the middle of 2010 in which problems with monitor alarms occurred.

But ECRI, based on its work with hospitals, believes that the health care industry underreports these cases and that the number of deaths is far higher. It found 13 more cases in its own database, which it compiles from incident investigations on behalf of hospital clients and from its own voluntary reporting system.

Kowalczyk also looks at potential solutions to the problem and how some institutions are trying to make changes to eliminate alarm fatigue, including cutting back on unnecessary monitors and having monitor warnings appear on nurses’ pagers or cell phones.

To back up the numbers, Kowalcyzk got some telling quotes from frustrated nurses.

“Yes, this is real, and, yes, it’s getting worse,’’ said Carol Conley, chief nursing officer for Southcoast Health System, which includes Tobey Hospital. “We want to keep our patients safe and take advantage of all the technology. The unintended consequence is that we have a very over-stimulated environment.’’

“Everyone who walks in the door gets a monitor,’’ said Lisa Sawtelle, a nurse at Boston Medical Center. “We have 17 [types of] alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes . . . background.’’

Kowalcyzk’s investigation points out that, while alarms do tend to go off when there’s a real problem, it appears that they do so at the expense of also going off when there isn’t.

Monitors can be so sensitive that alarms go off when patients sit up, turn over, or cough. Some studies have found more than 85 percent of alarms are false, meaning that the patient is not in any danger. Over time this can make nurses less and less likely to respond urgently to the sound.

For more specifics on device design issues, see the final subheading, titled “Looking for solutions.”

For a one year, the Joint Commission made routine alarm testing and training part of their accreditation requirements, but dropped the stipulation in 2004 when it felt the problem had been solved.

Other parts of the series:

AHCJ asks FDA to re-evaluate embargo policy

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Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

The Association of Health Care Journalists has sent a letter to FDA officials asking them to re-examine a policy that prohibits reporters from sharing embargoed materials with sources before the embargo lifts for the purpose of obtaining outside comment and context. As AHCJ notes, this highly unusual policy severely limits the ability of reporters to give readers the full story of a federal agency.

From the letter:

The restriction imposed on the medical-device announcement rewrote a longstanding compact between reporters and various public and scientific organizations. It also hampered or delayed reporters’ ability to fully inform the public about what the FDA is doing with taxpayers’ money. The early reports on the medical device approval process were brief and uninformative as a result.

Read the complete letter.

We will be sure to update readers if AHCJ receives a response from the FDA.