Aa
I thought this was interesting...
Not sure where to put this and hope its okay here. I just received this today and it needs some attention I think...
http://tinyurl.com/7hb772p
http://tinyurl.com/82d7464
Meg
http://tinyurl.com/7hb772p
http://tinyurl.com/82d7464
Meg
My husband had his hip replaced 5 yrs ago. It was never right. He has had constant pain that also affects his back. There is a recall now for his hip. DePuy by Johnson and Johnson.
We find out when he'll have surgery to remove and replace on Feb 14.
Happy Valentines Day.
Kristi
We find out when he'll have surgery to remove and replace on Feb 14.
Happy Valentines Day.
Kristi
Before my hip replacement my max walking distance was 25'-50' so I can sympathize with your husband :-)
There is something of an enigma associated with medical device (and drug) testing. The pace of change is so rapid now that by the time something has survived exhaustive, long term testing it's likely to be obsolete :-)
I'm lucky that I have access to some of the finest doctors and hospitals in the world. This means that not only does the FDA have to be satisfied with something, but my doctors do as well. So far my trust has been well placed :-)
There is something of an enigma associated with medical device (and drug) testing. The pace of change is so rapid now that by the time something has survived exhaustive, long term testing it's likely to be obsolete :-)
I'm lucky that I have access to some of the finest doctors and hospitals in the world. This means that not only does the FDA have to be satisfied with something, but my doctors do as well. So far my trust has been well placed :-)
Kyle, my husband has one of those space age material hips as well and will probably get the second one next year. He would not be walking without it. I would still like more oversight on these devices, but like to believe doctors only use products that they know will produce positive resuls.
That said, there have been a number of implants in recent years, including morphine pumps and I believe ICDs - implantable cardiac devices (pace makers) that have failed and been under a recall. That's scarey to know something has been surgically implanted in your body and it needs to be removed/replaced due to manufacturing problems.
The way our FDA approval process moves, it might be near impossible to ever get a device approved. The logistics of finding volunteers and monitoring results would be monumental. How long should a pateint be monitored before we know something is ok?
Just askking questions and thinking out loud!
Lulu
That said, there have been a number of implants in recent years, including morphine pumps and I believe ICDs - implantable cardiac devices (pace makers) that have failed and been under a recall. That's scarey to know something has been surgically implanted in your body and it needs to be removed/replaced due to manufacturing problems.
The way our FDA approval process moves, it might be near impossible to ever get a device approved. The logistics of finding volunteers and monitoring results would be monumental. How long should a pateint be monitored before we know something is ok?
Just askking questions and thinking out loud!
Lulu
I can say only this. As the proud owner of a chromium left hip, I had and have no doubts about its safety. It was recommend by a surgeon I trusted working out of one of the top orthopedic hospitals in the country. It will have its 3rd birthday on the 13 of this month and it's doin' just fine :-)
Kyle
Kyle
This is no surprise.. It is sickening, but that's the way it is unfortunately. It's not about helping people by ensuring medical equipment are safe, it's about green paper we call MONEY!!!!
Consumers Union’s full letter to Congress follows:
November 15, 2011
Dear Member of Congress,
Consumers Union’s Safe Patient Project is writing to urge you to use the opportunity provided by the upcoming reauthorization of the Medical Device User Fee Act (MDUFA) to improve the quality, safety and effectiveness of medical devices. We believe the essential goal of not harming patients can be achieved without harming true innovation.
You have been hearing that the medical device industry faces onerous regulation by FDA. But in many respects, the device industry is far less regulated than the drug industry. For example, the standards for the fuller pre-market approval of devices that require clinical trials are weaker than are used for drug approval. Drugs must show substantial evidence of safety and effectiveness where devices must merely show reasonable assurance of safety and efficacy.
Furthermore, more than 90 percent of devices are cleared through the 510(k) process, a process that does not require clinical trials but merely a showing that the new device is similar to an existing one called a predicate. The predicate device upon which a device is cleared may never have been through a clinical trial. Devices may vary quite considerably from the initial predicate, as each newer model with modifications from the initial predicate can then become the predicate for subsequent models. Once a predicate device has been removed from the market, it is not necessarily removed as a predicate, and subsequent devices approved based on that removed predicate are not automatically reviewed or removed from the market.
Recent high-profile device failures such as those that occurred with metal-on-metal hip implants and surgical mesh-devices that were approved through the 510(k) process illustrate that lax approval standards for devices are allowing faulty high risk devices to make it to market, where they have caused considerable harm to patients and cost to the health care system. When an implanted device is recalled or removed from the market, patients cannot simply stop using them. Removal of the device requires surgery, sometimes multiple surgeries, and it may take months or years to repair the damage done by the device. Some patients are permanently disabled or die due to complications from a device.
Below are Consumers Union’s recommendations for Congress to improve the safety and effectiveness of devices for consumers:
Improve the pre-market approval process by:
Raising standards of approval for devices from “reasonable assurance” of safety to “substantial evidence” of safety to bring it in line with the standard for drugs.
Ensuring that implantable and life-sustaining devices do not go through the 510(k) process - requiring them to go through the full pre-market approval process, which requires clinical trials.
Removing recalled devices from the list of predicates upon which other devices may seek to be cleared and requiring that devices approved based on a recalled device be automatically reviewed for safety.
Improve current Post-Market Surveillance of devices by:
Requiring the FDA to implement a national unique identifier system for devices so that patients and health care providers can be contacted when problems with that device are identified. Currently, there is no universal way to find out which devices went into which patients.
Ensuring that the FDA has adequate resources to fully implement existing patient protection programs for monitoring and reporting adverse events such as MedWatch, MAUDE and the Sentinel initiative. Used effectively, these programs can help the FDA identify early and ongoing problems with medical devices that are causing harm to patients.
Enabling the FDA to use its recall authority more effectively and providing the FDA with authority to call for longer term post market studies and to require device makers to meet their commitments to conduct post market studies.
Retaining current conflict of interest standards for federal advisory committees.
Five years ago, consumer organizations, including Consumers Union, advocated strongly for these standards to ensure the integrity of the advisory committee process. Decisions regarding new drugs and devices must be free from even the perception of bias. We question whether any relaxation of these standards is truly needed.
Finally, in order to ensure the quality and safety of devices, FDA has to be adequately funded from the medical device fees that are the subject of the reauthorization of MDUFA.
We look forward to working with you on ways to improve the medical device user fee program as Congress works through the process of reauthorization.
DeAnn Friedholm
Director, Health Reform
Consumers Union
Lisa McGiffert
Director, Safe Patient Project
Consumers Union
November 15, 2011
Dear Member of Congress,
Consumers Union’s Safe Patient Project is writing to urge you to use the opportunity provided by the upcoming reauthorization of the Medical Device User Fee Act (MDUFA) to improve the quality, safety and effectiveness of medical devices. We believe the essential goal of not harming patients can be achieved without harming true innovation.
You have been hearing that the medical device industry faces onerous regulation by FDA. But in many respects, the device industry is far less regulated than the drug industry. For example, the standards for the fuller pre-market approval of devices that require clinical trials are weaker than are used for drug approval. Drugs must show substantial evidence of safety and effectiveness where devices must merely show reasonable assurance of safety and efficacy.
Furthermore, more than 90 percent of devices are cleared through the 510(k) process, a process that does not require clinical trials but merely a showing that the new device is similar to an existing one called a predicate. The predicate device upon which a device is cleared may never have been through a clinical trial. Devices may vary quite considerably from the initial predicate, as each newer model with modifications from the initial predicate can then become the predicate for subsequent models. Once a predicate device has been removed from the market, it is not necessarily removed as a predicate, and subsequent devices approved based on that removed predicate are not automatically reviewed or removed from the market.
Recent high-profile device failures such as those that occurred with metal-on-metal hip implants and surgical mesh-devices that were approved through the 510(k) process illustrate that lax approval standards for devices are allowing faulty high risk devices to make it to market, where they have caused considerable harm to patients and cost to the health care system. When an implanted device is recalled or removed from the market, patients cannot simply stop using them. Removal of the device requires surgery, sometimes multiple surgeries, and it may take months or years to repair the damage done by the device. Some patients are permanently disabled or die due to complications from a device.
Below are Consumers Union’s recommendations for Congress to improve the safety and effectiveness of devices for consumers:
Improve the pre-market approval process by:
Raising standards of approval for devices from “reasonable assurance” of safety to “substantial evidence” of safety to bring it in line with the standard for drugs.
Ensuring that implantable and life-sustaining devices do not go through the 510(k) process - requiring them to go through the full pre-market approval process, which requires clinical trials.
Removing recalled devices from the list of predicates upon which other devices may seek to be cleared and requiring that devices approved based on a recalled device be automatically reviewed for safety.
Improve current Post-Market Surveillance of devices by:
Requiring the FDA to implement a national unique identifier system for devices so that patients and health care providers can be contacted when problems with that device are identified. Currently, there is no universal way to find out which devices went into which patients.
Ensuring that the FDA has adequate resources to fully implement existing patient protection programs for monitoring and reporting adverse events such as MedWatch, MAUDE and the Sentinel initiative. Used effectively, these programs can help the FDA identify early and ongoing problems with medical devices that are causing harm to patients.
Enabling the FDA to use its recall authority more effectively and providing the FDA with authority to call for longer term post market studies and to require device makers to meet their commitments to conduct post market studies.
Retaining current conflict of interest standards for federal advisory committees.
Five years ago, consumer organizations, including Consumers Union, advocated strongly for these standards to ensure the integrity of the advisory committee process. Decisions regarding new drugs and devices must be free from even the perception of bias. We question whether any relaxation of these standards is truly needed.
Finally, in order to ensure the quality and safety of devices, FDA has to be adequately funded from the medical device fees that are the subject of the reauthorization of MDUFA.
We look forward to working with you on ways to improve the medical device user fee program as Congress works through the process of reauthorization.
DeAnn Friedholm
Director, Health Reform
Consumers Union
Lisa McGiffert
Director, Safe Patient Project
Consumers Union
I checked the Consumer Reports/Health site and this information IS there. It's in a letter to Congress dated 11/15/2011. I will post the text in a separate message.
I find it curious that they are taking an advocacy position. Does this mean I should take my left hip back?
Kyle
I find it curious that they are taking an advocacy position. Does this mean I should take my left hip back?
Kyle
The first url works, the second one is a strange link. Anyway, the consumer union story is interesting. I find it hard to believe that as difficult as it is to get anything approved here in the US by the FDA, that they would want to let this happen. I will try to look into it later and see if this is a true story.
Have an Answer?
You are reading content posted in the Multiple Sclerosis Community
Top Neurology Answerers
Australia
ON
Queensland, Australia
Queen Creek, AZ
Find out how beta-blocker eye drops show promising results for acute migraine relief.
In this special Missouri Medicine report, doctors examine advances in diagnosis and treatment of this devastating and costly neurodegenerative disease.
Here are 12 simple – and fun! – ways to boost your brainpower.
Discover some of the causes of dizziness and how to treat it.
Discover the common causes of headaches and how to treat headache pain.
Two of the largest studies on Alzheimer’s have yielded new clues about the disease
