The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
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For months the medical device industry has been lobbying Congress to keep lax safety oversight over medical implants, including heart valves, replacement joints and surgical mesh. To make sure elected officials hear from Americans who’ve been harmed by outdated safety laws, Consumers Union’s Safe Patient Project brought 10 activists from seven states to Washington D.C. to share their medical device experiences and demand improvements.
And it had a huge impact! Activists had more than 20 meetings over two and a half days with key decision-makers. And many Congressional staff told us it was the first time they heard from ‘real people’ about this issue.
Our D.C. event was preceded by more than 160,000 messages from constituents to Congress – generated by Consumers Union – in support of key safety reforms. And it all comes at a crucial time – the medical device oversight law is reviewed every five years by Congress and we have only until September to get lawmakers to adopt important safety improvements.
One critical improvement is to make sure implantable or life-saving devices are safety tested before going on the market, rather than allowing manufacturers to merely show that their new device is similar to one already on the market. Over 90 percent of devices are cleared without safety testing.
Many of those who traveled to Washington D.C. were harmed by devices that were never safety tested prior to being sold. Among them — Jim Shull, of Brown Mills, N.J., who told congressional staffers that his implanted hernia mesh hardened and destroyed tissue in his groin that required painful surgeries to remove. Shull says he continues to live in constant pain and must use a cane to walk. Unfortunately, his experience is far too common.
As a result of our efforts, Shull and Consumers Union were invited to testify before the House Energy and Commerce Committee on device safety, telling members that the fast and furious pace of approving medical devices should not trump safety and effectiveness. (You can watch their testimony here.)
With continued support of consumer activists, Consumers Union will work to make medical devices as safe and effective as possible. We will counter the industry claims that FDA safety standards impede innovation. After all, a medical device is innovative only if it works and doesn’t harm people.
A Senate draft of the legislation is expected soon, and we will count on consumers to join us in raising their voices so Congress will put the interests of patients first. The best way to do this is to be sure they hear from people harmed by untested medical devices. If you or someone you know has an experience to share, please take a moment to tell us about it.
(LINK TO: Sunday 2/27/12 article in StarTribune) Steven Baker-FDA MedWatch adverse event #5009052- also participated in the February 6-9 Consumers Union trip to DC to lobby. Intense meetings with legislators revealed how critical it is that all constituents demand that implanted medical devices be properly regulated for safety and effectiveness. 160,000 letters got us noticed. Now we must change the direction set by the powerful medical device industry lobby. We need everyone that reads this article to quickly contact their two US Senators and US House Representative. The message is simple: require clinical testing of implanted medical devices prior to marketing these devices and provide transparent and robust post-market registry/follow-up. Safe and effective medical devices will provide patient safety and will be a job-creator for the medical device industry. The current “system” is unsustainable because failed devices are not identified and they remain on the market. Trust is broken. Patients with failed devices are in medical and legal purgatory.
Balls on a priest…….and corrupt government official who invariably yield to corporate bribers and fail to protect us from unsafe food, imports and MEDICAL DEVICES. A lifelong lefty, I’m beginning to agree with Norquist.
I serve on the IRB at a city hospital. We meet monthly and I have not seen over five or six studies on medical devices in the past several years.
those politicians who do not vote for this bill will face their constituents reactions.
They will be told, I promise you that!
Imagine if you will, that you have to have an IV stent put in your body for one reason or another, or a pacemaker for your heart – and it fails because it didn’t pass muster, it just plain failed. That’s not what we pay big bucks for research and development. We want safe devices, we want them to pass tests, not just guesstimate they’ll work, and if they don’t work … its just “Oooops!” That does not work with today’s standards.
It appears that Congress has been hijacked by big business and their special interest representatives to the extent that our elected Senators and Representatives are afraid to stand up for ordinary consumers who can be hurt or die from medications and or medical appliances that may not have received enough testing and/or scrutiny to ensure they will not hurt patients. Doctors are courted in their offices or at conventions by these pharmescutical “salesmen” to give “samples” of their products to patients, which can sometimes assist patients who cannot afford the medication, but can also hurt a patient if the product has not passed the tightest quality standards. If EXCEDRIN can be recalled because of mishandling in manufacturing plants, imagine what could happen with prescription drugs! Why are doctors begging for scarce drugs to treat children’s cancer symptoms? It appears the F.D.A. needs a wake up call from American consumers, why aren’t they hearing an outcry? Why aren’t we taking our Congress to task for not protecting us?
The flip side of this coin is that every medical device I’ve participated in developing in nearly the past decade has gone for ex-US regulatory approval, not FDA approval, because it has already become nearly impossible to bring devices to market in the US. The result is that US patients will also be denied many life saving breakthroughs.
There is no such thing as a 100% safe drug or device. The FDA’s job is to balance potential risk agains potential benefit. In other words, for a chemotherapeutic agent for terminal cancer, a much worse adverse event profile is acceptable than, say, for an acne cream.
Right now we are seeing results of FDA’s previous lack of teeth in enforcing ongoing post marketing safety evaluation and registries. You won’t see the improved result of their current increased authority to impose such post marketing safety surveillance for a number of years.
I don’t think that anyone is suggesting that drugs or devices should be guaranteed 100% safe. However, some level of testing should be done to show that these devices are effective and designed to work as indicated. The usual threat by lobbyists is that “patients will be denied life saving breakthroughs if XYZ device or drug is not approved”. If the FDA approvals are not forthcoming and the device or drug is truly as effective as the developer believes then some other type of public data sharing should happen. Hopefully the developer is providing a product not only to make money but to provide a better quality of life for patients.
I owned a company which made high precision milling tools used to machine and sculpt medical implants (knees, hips, etc.). These implants are CNC (computer numerically controlled) machined to tolerances of a tenth of the thickness of a human hair. But they are are machined to a design. If the design turns out to not work properly once “installed”, it can’t be as easily removed as a faulty plumbing fixture. This is why devices must be tested and traced. Witness the faulty family of metal-on-metal implants from Johnson & Johnson making the news in the US and Europe recently.
It is all about the GREED and it MUST STOP.
“Surgical Innovations should not become widely practiced until there are reliable scientific knowledge to support their use” Clilnical Opinion from the American Journal of Obtetrics and Gynecology, January, 2010″
Again, it’s the lobbyists who have the (bought and paid for) ears and votes of “our” congressmen! Corporations would rather “invest” in buying a congressman than in doing the right thing. It really does come down to; which is the more economical? Until we get enough honest politicians (oxymoron) to outlaw or install transparency to D.C. they will continue putting the welfare of the few over the rest of us.
I have a stent implanted close to my heart five years ago, after $14,000.00 on tests (some were repeated) that were inconclusive.
When I asked my family doctor, why I should have the procedure without proof of an artery clogged, he answered me that I was lucky to have the implant, just in case I have a heart attack.
After five years, I had to go back to the cardiologist and told me that probably the same artery was clogged ( where the stent was implanted)and that I have to have a bipass to correct it.
What kind of medical establishment do we have?…………?