They got the job done!
Stephanie Fede
4 years ago
The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety. The agency has already ordered 33 manufacturers of these artificial joints to conduct post-market safety studies after it received nearly 3,000 adverse event reports […]
The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.
The agency has already ordered 33 manufacturers of these artificial joints to conduct post-market safety studies after it received nearly 3,000 adverse event reports from recipients of all-metal hips who suffered a spectrum of difficulties between months and a few years of receiving it.
Metal-on-metal hip implants have been the source of controversy since shortly after they were introduced on the U.S. market as an alternative to the traditional implants that used plastic or ceramic components at the implant’s joints. Metal, manufacturers said, would last longer and was suitable for younger recipients for that very reason. They, as a class of devices, would require less replacement surgeries, lasting closer to two decades when older devices usually need to be replaced after 15 years of use.
More than half a million Americans now depend on all-metal hip implants like the DePuy Orthopaedics ASR and Pinnacle models, as well as others manufactured by Wright Medical Group and Zimmer Holdings. Thousands have experienced malfunctions and complications soon after receiving their new artificial hips, suffering injuries ranging from pain and inflammation at the site of the surgery to full breaks of the devices.
Metal-on-metal implants also have a distinction over others in that they are the only ones which disperse small metallic fragments into a recipient’s bloodstream, their surrounding tissue and organs. If this goes unnoticed, toxic levels of cobalt and chromium can accumulate and lead to metal poisoning, metallosis, that can cause organ damage and failure.
In August 2010, DePuy recalled its ASR model of metal-on-metal hip implant and there are equal questions surrounding the safety of its Pinnacle model hip when it uses a metal cup component over a ceramic piece. Thousands of people still rely on the ASR hip implant and while manufacturers are allegedly conducting the post-market studies, the FDA is convening the two-day conference this week to determine the best procedure for dealing with the thousands who likely will require a replacement surgery far sooner than they expected.
According to Reuters, the panel will seek “guidance from doctors, manufacturers, researchers, and the public on how to monitor patients who get the implants or need them replaced.” This panel will not concern itself with the testing standards used for the concurrent tests being conducted, or about the FDA’s 510(k) “fast-track” approval system that apparently erred in allowing all-metal hip implants to reach the market before these tests were conducted.
Metal-on-metal hip implants, in studies already conducted on their early failure rate, can cause complications within weeks or months of a surgery. This results in costly and painful revision surgeries, more rehabilitation visits, and the eventual need for an early replacement surgery. Many times a replacement on a faulty hip implant will result in the loss of full mobility. Some studies already completed found that metal-on-metal hip implants, like the DePuy ASR, have failed early in between 13 and 30 percent of recipients.
The Food and Drug Administration is convening a meeting this week to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.
The agency has already ordered 33 manufacturers of these artificial joints to conduct post-market safety studies after it received nearly 3,000 adverse event reports from recipients of all-metal hips who suffered a spectrum of difficulties between months and a few years of receiving it.
Metal-on-metal hip implants have been the source of controversy since shortly after they were introduced on the U.S. market as an alternative to the traditional implants that used plastic or ceramic components at the implant’s joints. Metal, manufacturers said, would last longer and was suitable for younger recipients for that very reason. They, as a class of devices, would require less replacement surgeries, lasting closer to two decades when older devices usually need to be replaced after 15 years of use.
More than half a million Americans now depend on all-metal hip implants like the DePuy Orthopaedics ASR and Pinnacle models, as well as others manufactured by Wright Medical Group and Zimmer Holdings. Thousands have experienced malfunctions and complications soon after receiving their new artificial hips, suffering injuries ranging from pain and inflammation at the site of the surgery to full breaks of the devices.
Metal-on-metal implants also have a distinction over others in that they are the only ones which disperse small metallic fragments into a recipient’s bloodstream, their surrounding tissue and organs. If this goes unnoticed, toxic levels of cobalt and chromium can accumulate and lead to metal poisoning, metallosis, that can cause organ damage and failure.
In August 2010, DePuy recalled its ASR model of metal-on-metal hip implant and there are equal questions surrounding the safety of its Pinnacle model hip when it uses a metal cup component over a ceramic piece. Thousands of people still rely on the ASR hip implant and while manufacturers are allegedly conducting the post-market studies, the FDA is convening the two-day conference this week to determine the best procedure for dealing with the thousands who likely will require a replacement surgery far sooner than they expected.
According to Reuters, the panel will seek “guidance from doctors, manufacturers, researchers, and the public on how to monitor patients who get the implants or need them replaced.” This panel will not concern itself with the testing standards used for the concurrent tests being conducted, or about the FDA’s 510(k) “fast-track” approval system that apparently erred in allowing all-metal hip implants to reach the market before these tests were conducted.
Metal-on-metal hip implants, in studies already conducted on their early failure rate, can cause complications within weeks or months of a surgery. This results in costly and painful revision surgeries, more rehabilitation visits, and the eventual need for an early replacement surgery. Many times a replacement on a faulty hip implant will result in the loss of full mobility. Some studies already completed found that metal-on-metal hip implants, like the DePuy ASR, have failed early in between 13 and 30 percent of recipients.