Search Results for "medical devices"
A veteran journalist explains why it’s so tough to inform the public about medical devices — and what can be done about it
Millions of Americans are implanted with medical devices every year, yet surprisingly little is known about whether those devices help or harm them. While Walmart tracks every head of lettuce on its shelves, no one “can say how many people are dying because of implanted medical devices. It’s a black hole,” veteran journalist Jeanne Lenzer, a […]
Why ‘approved’ medical devices may not be safe: A new addition to our toolkit
Yesterday we reported that 5 patient deaths linked to gastric weight loss balloon devices actually may be “the tip of the iceberg,” due to weak FDA regulations that don’t require mandatory reporting of complications from healthcare providers. As a result, no one really knows how many patients have died or suffered serious complications after undergoing […]
Faulty medical devices stay on the market even after manufacturers know there are problems
With proposals in the 21st Century Cures Act poised to reduce patient safeguards in the approval of new medical devices, Trudy Lieberman continues her look at the gaping holes that already exist in the FDA’s oversight of the industry. For the second time in a month the news media has told the sorry tale of […]5
Media ignore impact of unsafe medical devices — unless the company CEO is a celebrity billionaire like Elizabeth Holmes
James Stewart’s recent New York Times story about Elizabeth Holmes, the rising star in the high-tech galaxy turned media celeb, raises an important press question in this time of the 21st Century Cures Act. Are the media interested in covering problematic and potentially unsafe drugs, devices, and other medical products only when celebrity is involved? […]10
Why the media must play a bigger role in policing unsafe medical devices
Contributor Trudy Lieberman has been tracking the progress of industry-friendly regulatory legislation — the 21st Century Cures Act — through Congress. Here she examines how current medical device regulations are already allowing many faulty devices on the market — and how the media will need to be more vigilant if and when current regulations are […]10/18/2012
Medical devices and shared decision-making: Daisy chains of decades of device approval without rigorous assessment
The journal Arthritis Care & Research has accepted for future publication – and posted online (for subscribers) – an unedited paper, “Preceding the Procedure: Medical Devices and Shared Decision-Making.” The paper builds on a hypothetical example of a man in his 50s with hip arthritis who is facing a decision about total hip replacement. Excerpts: […]6/15/2012
Industry editorial makes outlandish claim about impact of medical devices
Minnesota is the home of several medical device makers. So there’s been a lot of editorializing about the medical device tax in the Affordable Care Act. There has been some criticism of Minnesota politicians over whose interests they represent on the issue. Today’s Star Tribune carries a commentary from an industry spokesman – Dale Wahlstrom, […]4
Why ‘approved’ medical devices in the U.S. may not be safe or effective
“Medtronic receives FDA clearance for two heart devices” “FDA approves device to help curb cluster headaches” MRI approved for young infants in intensive care Headlines like these instill consumer confidence that medical devices are safe and effective. After all, they have the FDA’s stamp of approval, right? The reality is, the FDA seldom requires rigorous […]9/21/2009
No way to cover new medical devices
I feel a promotional campaign underway for the trials of an implantable device to control high blood pressure that is resistant to drug therapy. NBC did a breathless story on the device a few weeks ago. And now the Des Moines Register published one that is strikingly similar to the NBC piece. * No data […]
One woman’s account of spinal cord stimulator skips realities of medical device safety in U.S.
The story also did not mention that the author acknowledged being a paid “advocate” for pain patients, which could present a conflict of interest.
Here’s how one woman used an implant to get some relief from chronic back pain
Without an independent source, BuzzFeed’s story on a medical device for OCD doesn’t offer much beyond the news release
On the upside, the story does include the side effects associated with transcranial magnetic stimulation.
The FDA Says This Brain-Stimulating Device May Help People With Obsessive-Compulsive Disorder
Too Much Medicine: A small medical conference with a big impact
The Too Much Medicine (TMM) conference is small, but has a potentially huge impact. We cover plenty of medical conferences about heart disease, cancer, and dementia (to name a few) that trigger tsunamis of media coverage because they –quite obviously and understandably — affect millions of people and involve grave outcomes. But the TMM conference, wrapping […]1
Essure’s demise isn’t an end to medical device safety problems
Last Friday’s announcement that pharmaceutical giant Bayer will stop selling its controversial Essure birth control device understandably drew massive attention from both social and mainstream media. Critics of the device — like Angie Firmalino who helped launch a social media campaign with the Facebook group “Essure Problems” — were able to claim a sober victory while […]1
Court records show how a medical device ‘seeding trial’ disguised marketing as science
As a new line of hip implants was about to be launched in 2000, a stunning email went out from the manufacturer’s marketing department. It described a “clinical research strategy” to pay orthopedic surgeons $400 for each patient they enrolled in a company-sponsored trial. Ostensibly the trial was intended to measure how often liners of […]
Medical evidence for lumbar support runs counter to claims made in U.S. News & World Report story
If research reveals that wearing an inexpensive back brace stands to actually help alleviate pain and accelerate recovery compared to alternatives (e.g. drugs and surgery), it’s newsworthy. That wasn’t the case here.