2010 DePuy Hip Implant Recall

2010 DePuy Hip Implant Recall: What Happened and Why? In early 2005, DePuy applied for a 510(k) Application for Clearance for its ASR Acetabular System, a metal-on-metal hip implant. After a number of complaints, its own recall of the ASR product in Australia, and a negative report written in the National Joint Registry, DePuy issued a full recall of its ASR hip product in the US in August of 2010. 93,000 Number of DePuy ASR patients 21%-49% 200,000+ Failure Rate of DePuy ASR Systems Annual number of hip replacements in the US The British Orthopaedic Association and the British Hip Society have released data on the ASR showing the rate óf second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years. 1 in8 1 in 8 DePuy ASR Patients need a second hip replacement surgery due to faulty DePuy ASR Products 887 complaints about the DePuy ASR products were filed with the FDA between 2006 and 2010 DePuy Profits in Billions $5.6 Number of Complaints Filed $5.0 $4.6 424 $4.2 ASR patients started complaining in March 2006, only 1 year after the ASRAcetabular System was introduced. The 239 numberof complaints continued to rise for the next 4 years along with 87 DePuy profits, which reached $5.6 billion in 12 2010. 2006 2007 2008 2009 2010 How Did This Happen? The FDA handles the approval of new medical devices substantially differently than it handles the approval of new prescription drugs. First, medical devíces are classified into one of three categories based on the potential risk that they present to consumers. This classification determines which type of premarketing application is required for FDA clearance of a device. Class 1 Devices include devices with the lowest risk, and are subject to the least amount of regulation. These devices must meet "General Control" requirements, such as proper labeling and packaging, suitability for intended use, registration of the manufacturing location, and listing of the device with the FDA. Class 2 Devices include devices with moderate risk, and are subject to a fair amount of regulation. These devices must meet "General Control" requirements, as well as "Special Control" requirements, such as special labeling, mandatory performance standards, and postmarket surveilance. Class 3 Devices include devices with the highest risk, and are subject to the most regulation. These devices must meet "General Control" requirements, and are subject to premarket approval by the FDA. This approval process involves scientifically reviewing each device to ensure safety and effectiveness. All class 3 medical devices must go through the process of premarket approval before they can be marketed to consumers. This process is similar to the that for prescription drugs in that it requires scientific evidence that the device is safe for consumer use. However If a device can demonstrate that it is substantially equivalent to a device that is already on the market and it doesn't raise any new safety or efficacy questions, then it is eligible for a process known as premarket notification 510(k). 510(k)'s process does not involve clinical testing to prove safety and efficacy, as these devices are considered to be at least as safe and effective as the device that they are claiming equivalence to. Furthermore, the 510(k) process is cheaper and faster than the process of premarket approval. APPROVED 510(k) APPROVED What They Said. of new devices that have entered the market in class 98% 2 or class 3 since 1976 have been approved through the 510(k) process, including DePuy's ASR Systems. of the devices that were recalled between 2005 and 71% 2009 were approved through the 510(k) process. What can I do? Efforts are already being madę to revamp the 510(k) process in order to make it more stringent and reduce thẻ number of faulty products that are approved. The FDA has committed to an action plan with the intént of increasing predicatbility, consistency, and transparency for its'device review programs, including the 510(k) process. What you can help with is spreading the word about the American Joint Replacement Registry. A similar national joint replacement registry already exists in other developed coủntries such as Sweden, England, and Australia, bút hasn't existed in the United States until the American Academy of Orthopaedic Surgeons incorporated the American Joint Replacement Registry (AJRR)'in 2009. Raising awareness about the AJRR is important to the success of the organization as it strives to continue expanding and collecting joint replacement data from hospitals across the country. This data will assist mạnufacturers such as DePuy in removing implants which are prone to early failure from the market before they become as big of an'issue as the ASR products were. Hip Implant Recovery Sources: http://www.fda.gow/cdrfvanualfy2002/ode/index.html, http://www.nytimes.com/2010/08/27/business/27hip.htm/?_r=1, http://www.depuy.com/usmedia, http//www.accessdata.fda gov/scripts/cdrhvcfdocs/cfres/res.cfm, http://www.fda.govimedicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/defaut. htm, http://www.medscape.com/viewarticie/474285_4, Ramsey SD, Luce BR, Deyo R, Franklin G. The imited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998:4 Spec No:SP188-99., http://www.fda.gowMedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, http://www.investor.jnj.com/investor-relations.cfm, http://orthodoc.aaos.org/ajrigrp_about.cfm, http://sec.gowArchives/edgar/data/200406/o00095012307002542y29901exv13.htm#402 DePuy ASR Recall ---- ---- I---I 2010 DePuy Hip Implant Recall: What Happened and Why? In early 2005, DePuy applied for a 510(k) Application for Clearance for its ASR Acetabular System, a metal-on-metal hip implant. After a number of complaints, its own recall of the ASR product in Australia, and a negative report written in the National Joint Registry, DePuy issued a full recall of its ASR hip product in the US in August of 2010. 93,000 Number of DePuy ASR patients 21%-49% 200,000+ Failure Rate of DePuy ASR Systems Annual number of hip replacements in the US The British Orthopaedic Association and the British Hip Society have released data on the ASR showing the rate óf second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years. 1 in8 1 in 8 DePuy ASR Patients need a second hip replacement surgery due to faulty DePuy ASR Products 887 complaints about the DePuy ASR products were filed with the FDA between 2006 and 2010 DePuy Profits in Billions $5.6 Number of Complaints Filed $5.0 $4.6 424 $4.2 ASR patients started complaining in March 2006, only 1 year after the ASRAcetabular System was introduced. The 239 numberof complaints continued to rise for the next 4 years along with 87 DePuy profits, which reached $5.6 billion in 12 2010. 2006 2007 2008 2009 2010 How Did This Happen? The FDA handles the approval of new medical devices substantially differently than it handles the approval of new prescription drugs. First, medical devíces are classified into one of three categories based on the potential risk that they present to consumers. This classification determines which type of premarketing application is required for FDA clearance of a device. Class 1 Devices include devices with the lowest risk, and are subject to the least amount of regulation. These devices must meet "General Control" requirements, such as proper labeling and packaging, suitability for intended use, registration of the manufacturing location, and listing of the device with the FDA. Class 2 Devices include devices with moderate risk, and are subject to a fair amount of regulation. These devices must meet "General Control" requirements, as well as "Special Control" requirements, such as special labeling, mandatory performance standards, and postmarket surveilance. Class 3 Devices include devices with the highest risk, and are subject to the most regulation. These devices must meet "General Control" requirements, and are subject to premarket approval by the FDA. This approval process involves scientifically reviewing each device to ensure safety and effectiveness. All class 3 medical devices must go through the process of premarket approval before they can be marketed to consumers. This process is similar to the that for prescription drugs in that it requires scientific evidence that the device is safe for consumer use. However If a device can demonstrate that it is substantially equivalent to a device that is already on the market and it doesn't raise any new safety or efficacy questions, then it is eligible for a process known as premarket notification 510(k). 510(k)'s process does not involve clinical testing to prove safety and efficacy, as these devices are considered to be at least as safe and effective as the device that they are claiming equivalence to. Furthermore, the 510(k) process is cheaper and faster than the process of premarket approval. APPROVED 510(k) APPROVED What They Said. of new devices that have entered the market in class 98% 2 or class 3 since 1976 have been approved through the 510(k) process, including DePuy's ASR Systems. of the devices that were recalled between 2005 and 71% 2009 were approved through the 510(k) process. What can I do? Efforts are already being madę to revamp the 510(k) process in order to make it more stringent and reduce thẻ number of faulty products that are approved. The FDA has committed to an action plan with the intént of increasing predicatbility, consistency, and transparency for its'device review programs, including the 510(k) process. What you can help with is spreading the word about the American Joint Replacement Registry. A similar national joint replacement registry already exists in other developed coủntries such as Sweden, England, and Australia, bút hasn't existed in the United States until the American Academy of Orthopaedic Surgeons incorporated the American Joint Replacement Registry (AJRR)'in 2009. Raising awareness about the AJRR is important to the success of the organization as it strives to continue expanding and collecting joint replacement data from hospitals across the country. This data will assist mạnufacturers such as DePuy in removing implants which are prone to early failure from the market before they become as big of an'issue as the ASR products were. Hip Implant Recovery Sources: http://www.fda.gow/cdrfvanualfy2002/ode/index.html, http://www.nytimes.com/2010/08/27/business/27hip.htm/?_r=1, http://www.depuy.com/usmedia, http//www.accessdata.fda gov/scripts/cdrhvcfdocs/cfres/res.cfm, http://www.fda.govimedicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/defaut. htm, http://www.medscape.com/viewarticie/474285_4, Ramsey SD, Luce BR, Deyo R, Franklin G. The imited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998:4 Spec No:SP188-99., http://www.fda.gowMedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, http://www.investor.jnj.com/investor-relations.cfm, http://orthodoc.aaos.org/ajrigrp_about.cfm, http://sec.gowArchives/edgar/data/200406/o00095012307002542y29901exv13.htm#402 DePuy ASR Recall ---- ---- I---I 2010 DePuy Hip Implant Recall: What Happened and Why? In early 2005, DePuy applied for a 510(k) Application for Clearance for its ASR Acetabular System, a metal-on-metal hip implant. After a number of complaints, its own recall of the ASR product in Australia, and a negative report written in the National Joint Registry, DePuy issued a full recall of its ASR hip product in the US in August of 2010. 93,000 Number of DePuy ASR patients 21%-49% 200,000+ Failure Rate of DePuy ASR Systems Annual number of hip replacements in the US The British Orthopaedic Association and the British Hip Society have released data on the ASR showing the rate óf second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years. 1 in8 1 in 8 DePuy ASR Patients need a second hip replacement surgery due to faulty DePuy ASR Products 887 complaints about the DePuy ASR products were filed with the FDA between 2006 and 2010 DePuy Profits in Billions $5.6 Number of Complaints Filed $5.0 $4.6 424 $4.2 ASR patients started complaining in March 2006, only 1 year after the ASRAcetabular System was introduced. The 239 numberof complaints continued to rise for the next 4 years along with 87 DePuy profits, which reached $5.6 billion in 12 2010. 2006 2007 2008 2009 2010 How Did This Happen? The FDA handles the approval of new medical devices substantially differently than it handles the approval of new prescription drugs. First, medical devíces are classified into one of three categories based on the potential risk that they present to consumers. This classification determines which type of premarketing application is required for FDA clearance of a device. Class 1 Devices include devices with the lowest risk, and are subject to the least amount of regulation. These devices must meet "General Control" requirements, such as proper labeling and packaging, suitability for intended use, registration of the manufacturing location, and listing of the device with the FDA. Class 2 Devices include devices with moderate risk, and are subject to a fair amount of regulation. These devices must meet "General Control" requirements, as well as "Special Control" requirements, such as special labeling, mandatory performance standards, and postmarket surveilance. Class 3 Devices include devices with the highest risk, and are subject to the most regulation. These devices must meet "General Control" requirements, and are subject to premarket approval by the FDA. This approval process involves scientifically reviewing each device to ensure safety and effectiveness. All class 3 medical devices must go through the process of premarket approval before they can be marketed to consumers. This process is similar to the that for prescription drugs in that it requires scientific evidence that the device is safe for consumer use. However If a device can demonstrate that it is substantially equivalent to a device that is already on the market and it doesn't raise any new safety or efficacy questions, then it is eligible for a process known as premarket notification 510(k). 510(k)'s process does not involve clinical testing to prove safety and efficacy, as these devices are considered to be at least as safe and effective as the device that they are claiming equivalence to. Furthermore, the 510(k) process is cheaper and faster than the process of premarket approval. APPROVED 510(k) APPROVED What They Said. of new devices that have entered the market in class 98% 2 or class 3 since 1976 have been approved through the 510(k) process, including DePuy's ASR Systems. of the devices that were recalled between 2005 and 71% 2009 were approved through the 510(k) process. What can I do? Efforts are already being madę to revamp the 510(k) process in order to make it more stringent and reduce thẻ number of faulty products that are approved. The FDA has committed to an action plan with the intént of increasing predicatbility, consistency, and transparency for its'device review programs, including the 510(k) process. What you can help with is spreading the word about the American Joint Replacement Registry. A similar national joint replacement registry already exists in other developed coủntries such as Sweden, England, and Australia, bút hasn't existed in the United States until the American Academy of Orthopaedic Surgeons incorporated the American Joint Replacement Registry (AJRR)'in 2009. Raising awareness about the AJRR is important to the success of the organization as it strives to continue expanding and collecting joint replacement data from hospitals across the country. This data will assist mạnufacturers such as DePuy in removing implants which are prone to early failure from the market before they become as big of an'issue as the ASR products were. Hip Implant Recovery Sources: http://www.fda.gow/cdrfvanualfy2002/ode/index.html, http://www.nytimes.com/2010/08/27/business/27hip.htm/?_r=1, http://www.depuy.com/usmedia, http//www.accessdata.fda gov/scripts/cdrhvcfdocs/cfres/res.cfm, http://www.fda.govimedicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/defaut. htm, http://www.medscape.com/viewarticie/474285_4, Ramsey SD, Luce BR, Deyo R, Franklin G. The imited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998:4 Spec No:SP188-99., http://www.fda.gowMedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, http://www.investor.jnj.com/investor-relations.cfm, http://orthodoc.aaos.org/ajrigrp_about.cfm, http://sec.gowArchives/edgar/data/200406/o00095012307002542y29901exv13.htm#402 DePuy ASR Recall ---- ---- I---I 2010 DePuy Hip Implant Recall: What Happened and Why? In early 2005, DePuy applied for a 510(k) Application for Clearance for its ASR Acetabular System, a metal-on-metal hip implant. After a number of complaints, its own recall of the ASR product in Australia, and a negative report written in the National Joint Registry, DePuy issued a full recall of its ASR hip product in the US in August of 2010. 93,000 Number of DePuy ASR patients 21%-49% 200,000+ Failure Rate of DePuy ASR Systems Annual number of hip replacements in the US The British Orthopaedic Association and the British Hip Society have released data on the ASR showing the rate óf second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years. 1 in8 1 in 8 DePuy ASR Patients need a second hip replacement surgery due to faulty DePuy ASR Products 887 complaints about the DePuy ASR products were filed with the FDA between 2006 and 2010 DePuy Profits in Billions $5.6 Number of Complaints Filed $5.0 $4.6 424 $4.2 ASR patients started complaining in March 2006, only 1 year after the ASRAcetabular System was introduced. The 239 numberof complaints continued to rise for the next 4 years along with 87 DePuy profits, which reached $5.6 billion in 12 2010. 2006 2007 2008 2009 2010 How Did This Happen? The FDA handles the approval of new medical devices substantially differently than it handles the approval of new prescription drugs. First, medical devíces are classified into one of three categories based on the potential risk that they present to consumers. This classification determines which type of premarketing application is required for FDA clearance of a device. Class 1 Devices include devices with the lowest risk, and are subject to the least amount of regulation. These devices must meet "General Control" requirements, such as proper labeling and packaging, suitability for intended use, registration of the manufacturing location, and listing of the device with the FDA. Class 2 Devices include devices with moderate risk, and are subject to a fair amount of regulation. These devices must meet "General Control" requirements, as well as "Special Control" requirements, such as special labeling, mandatory performance standards, and postmarket surveilance. Class 3 Devices include devices with the highest risk, and are subject to the most regulation. These devices must meet "General Control" requirements, and are subject to premarket approval by the FDA. This approval process involves scientifically reviewing each device to ensure safety and effectiveness. All class 3 medical devices must go through the process of premarket approval before they can be marketed to consumers. This process is similar to the that for prescription drugs in that it requires scientific evidence that the device is safe for consumer use. However If a device can demonstrate that it is substantially equivalent to a device that is already on the market and it doesn't raise any new safety or efficacy questions, then it is eligible for a process known as premarket notification 510(k). 510(k)'s process does not involve clinical testing to prove safety and efficacy, as these devices are considered to be at least as safe and effective as the device that they are claiming equivalence to. Furthermore, the 510(k) process is cheaper and faster than the process of premarket approval. APPROVED 510(k) APPROVED What They Said. of new devices that have entered the market in class 98% 2 or class 3 since 1976 have been approved through the 510(k) process, including DePuy's ASR Systems. of the devices that were recalled between 2005 and 71% 2009 were approved through the 510(k) process. What can I do? Efforts are already being madę to revamp the 510(k) process in order to make it more stringent and reduce thẻ number of faulty products that are approved. The FDA has committed to an action plan with the intént of increasing predicatbility, consistency, and transparency for its'device review programs, including the 510(k) process. What you can help with is spreading the word about the American Joint Replacement Registry. A similar national joint replacement registry already exists in other developed coủntries such as Sweden, England, and Australia, bút hasn't existed in the United States until the American Academy of Orthopaedic Surgeons incorporated the American Joint Replacement Registry (AJRR)'in 2009. Raising awareness about the AJRR is important to the success of the organization as it strives to continue expanding and collecting joint replacement data from hospitals across the country. This data will assist mạnufacturers such as DePuy in removing implants which are prone to early failure from the market before they become as big of an'issue as the ASR products were. Hip Implant Recovery Sources: http://www.fda.gow/cdrfvanualfy2002/ode/index.html, http://www.nytimes.com/2010/08/27/business/27hip.htm/?_r=1, http://www.depuy.com/usmedia, http//www.accessdata.fda gov/scripts/cdrhvcfdocs/cfres/res.cfm, http://www.fda.govimedicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/defaut. htm, http://www.medscape.com/viewarticie/474285_4, Ramsey SD, Luce BR, Deyo R, Franklin G. The imited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998:4 Spec No:SP188-99., http://www.fda.gowMedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, http://www.investor.jnj.com/investor-relations.cfm, http://orthodoc.aaos.org/ajrigrp_about.cfm, http://sec.gowArchives/edgar/data/200406/o00095012307002542y29901exv13.htm#402 DePuy ASR Recall ---- ---- I---I 2010 DePuy Hip Implant Recall: What Happened and Why? In early 2005, DePuy applied for a 510(k) Application for Clearance for its ASR Acetabular System, a metal-on-metal hip implant. After a number of complaints, its own recall of the ASR product in Australia, and a negative report written in the National Joint Registry, DePuy issued a full recall of its ASR hip product in the US in August of 2010. 93,000 Number of DePuy ASR patients 21%-49% 200,000+ Failure Rate of DePuy ASR Systems Annual number of hip replacements in the US The British Orthopaedic Association and the British Hip Society have released data on the ASR showing the rate óf second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years. 1 in8 1 in 8 DePuy ASR Patients need a second hip replacement surgery due to faulty DePuy ASR Products 887 complaints about the DePuy ASR products were filed with the FDA between 2006 and 2010 DePuy Profits in Billions $5.6 Number of Complaints Filed $5.0 $4.6 424 $4.2 ASR patients started complaining in March 2006, only 1 year after the ASRAcetabular System was introduced. The 239 numberof complaints continued to rise for the next 4 years along with 87 DePuy profits, which reached $5.6 billion in 12 2010. 2006 2007 2008 2009 2010 How Did This Happen? The FDA handles the approval of new medical devices substantially differently than it handles the approval of new prescription drugs. First, medical devíces are classified into one of three categories based on the potential risk that they present to consumers. This classification determines which type of premarketing application is required for FDA clearance of a device. Class 1 Devices include devices with the lowest risk, and are subject to the least amount of regulation. These devices must meet "General Control" requirements, such as proper labeling and packaging, suitability for intended use, registration of the manufacturing location, and listing of the device with the FDA. Class 2 Devices include devices with moderate risk, and are subject to a fair amount of regulation. These devices must meet "General Control" requirements, as well as "Special Control" requirements, such as special labeling, mandatory performance standards, and postmarket surveilance. Class 3 Devices include devices with the highest risk, and are subject to the most regulation. These devices must meet "General Control" requirements, and are subject to premarket approval by the FDA. This approval process involves scientifically reviewing each device to ensure safety and effectiveness. All class 3 medical devices must go through the process of premarket approval before they can be marketed to consumers. This process is similar to the that for prescription drugs in that it requires scientific evidence that the device is safe for consumer use. However If a device can demonstrate that it is substantially equivalent to a device that is already on the market and it doesn't raise any new safety or efficacy questions, then it is eligible for a process known as premarket notification 510(k). 510(k)'s process does not involve clinical testing to prove safety and efficacy, as these devices are considered to be at least as safe and effective as the device that they are claiming equivalence to. Furthermore, the 510(k) process is cheaper and faster than the process of premarket approval. APPROVED 510(k) APPROVED What They Said. of new devices that have entered the market in class 98% 2 or class 3 since 1976 have been approved through the 510(k) process, including DePuy's ASR Systems. of the devices that were recalled between 2005 and 71% 2009 were approved through the 510(k) process. What can I do? Efforts are already being madę to revamp the 510(k) process in order to make it more stringent and reduce thẻ number of faulty products that are approved. The FDA has committed to an action plan with the intént of increasing predicatbility, consistency, and transparency for its'device review programs, including the 510(k) process. What you can help with is spreading the word about the American Joint Replacement Registry. A similar national joint replacement registry already exists in other developed coủntries such as Sweden, England, and Australia, bút hasn't existed in the United States until the American Academy of Orthopaedic Surgeons incorporated the American Joint Replacement Registry (AJRR)'in 2009. Raising awareness about the AJRR is important to the success of the organization as it strives to continue expanding and collecting joint replacement data from hospitals across the country. This data will assist mạnufacturers such as DePuy in removing implants which are prone to early failure from the market before they become as big of an'issue as the ASR products were. Hip Implant Recovery Sources: http://www.fda.gow/cdrfvanualfy2002/ode/index.html, http://www.nytimes.com/2010/08/27/business/27hip.htm/?_r=1, http://www.depuy.com/usmedia, http//www.accessdata.fda gov/scripts/cdrhvcfdocs/cfres/res.cfm, http://www.fda.govimedicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/defaut. htm, http://www.medscape.com/viewarticie/474285_4, Ramsey SD, Luce BR, Deyo R, Franklin G. The imited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998:4 Spec No:SP188-99., http://www.fda.gowMedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, http://www.investor.jnj.com/investor-relations.cfm, http://orthodoc.aaos.org/ajrigrp_about.cfm, http://sec.gowArchives/edgar/data/200406/o00095012307002542y29901exv13.htm#402 DePuy ASR Recall ---- ---- I---I 2010 DePuy Hip Implant Recall: What Happened and Why? In early 2005, DePuy applied for a 510(k) Application for Clearance for its ASR Acetabular System, a metal-on-metal hip implant. After a number of complaints, its own recall of the ASR product in Australia, and a negative report written in the National Joint Registry, DePuy issued a full recall of its ASR hip product in the US in August of 2010. 93,000 Number of DePuy ASR patients 21%-49% 200,000+ Failure Rate of DePuy ASR Systems Annual number of hip replacements in the US The British Orthopaedic Association and the British Hip Society have released data on the ASR showing the rate óf second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years. 1 in8 1 in 8 DePuy ASR Patients need a second hip replacement surgery due to faulty DePuy ASR Products 887 complaints about the DePuy ASR products were filed with the FDA between 2006 and 2010 DePuy Profits in Billions $5.6 Number of Complaints Filed $5.0 $4.6 424 $4.2 ASR patients started complaining in March 2006, only 1 year after the ASRAcetabular System was introduced. The 239 numberof complaints continued to rise for the next 4 years along with 87 DePuy profits, which reached $5.6 billion in 12 2010. 2006 2007 2008 2009 2010 How Did This Happen? The FDA handles the approval of new medical devices substantially differently than it handles the approval of new prescription drugs. First, medical devíces are classified into one of three categories based on the potential risk that they present to consumers. This classification determines which type of premarketing application is required for FDA clearance of a device. Class 1 Devices include devices with the lowest risk, and are subject to the least amount of regulation. These devices must meet "General Control" requirements, such as proper labeling and packaging, suitability for intended use, registration of the manufacturing location, and listing of the device with the FDA. Class 2 Devices include devices with moderate risk, and are subject to a fair amount of regulation. These devices must meet "General Control" requirements, as well as "Special Control" requirements, such as special labeling, mandatory performance standards, and postmarket surveilance. Class 3 Devices include devices with the highest risk, and are subject to the most regulation. These devices must meet "General Control" requirements, and are subject to premarket approval by the FDA. This approval process involves scientifically reviewing each device to ensure safety and effectiveness. All class 3 medical devices must go through the process of premarket approval before they can be marketed to consumers. This process is similar to the that for prescription drugs in that it requires scientific evidence that the device is safe for consumer use. However If a device can demonstrate that it is substantially equivalent to a device that is already on the market and it doesn't raise any new safety or efficacy questions, then it is eligible for a process known as premarket notification 510(k). 510(k)'s process does not involve clinical testing to prove safety and efficacy, as these devices are considered to be at least as safe and effective as the device that they are claiming equivalence to. Furthermore, the 510(k) process is cheaper and faster than the process of premarket approval. APPROVED 510(k) APPROVED What They Said. of new devices that have entered the market in class 98% 2 or class 3 since 1976 have been approved through the 510(k) process, including DePuy's ASR Systems. of the devices that were recalled between 2005 and 71% 2009 were approved through the 510(k) process. What can I do? Efforts are already being madę to revamp the 510(k) process in order to make it more stringent and reduce thẻ number of faulty products that are approved. The FDA has committed to an action plan with the intént of increasing predicatbility, consistency, and transparency for its'device review programs, including the 510(k) process. What you can help with is spreading the word about the American Joint Replacement Registry. A similar national joint replacement registry already exists in other developed coủntries such as Sweden, England, and Australia, bút hasn't existed in the United States until the American Academy of Orthopaedic Surgeons incorporated the American Joint Replacement Registry (AJRR)'in 2009. Raising awareness about the AJRR is important to the success of the organization as it strives to continue expanding and collecting joint replacement data from hospitals across the country. This data will assist mạnufacturers such as DePuy in removing implants which are prone to early failure from the market before they become as big of an'issue as the ASR products were. Hip Implant Recovery Sources: http://www.fda.gow/cdrfvanualfy2002/ode/index.html, http://www.nytimes.com/2010/08/27/business/27hip.htm/?_r=1, http://www.depuy.com/usmedia, http//www.accessdata.fda gov/scripts/cdrhvcfdocs/cfres/res.cfm, http://www.fda.govimedicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/defaut. htm, http://www.medscape.com/viewarticie/474285_4, Ramsey SD, Luce BR, Deyo R, Franklin G. The imited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998:4 Spec No:SP188-99., http://www.fda.gowMedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, http://www.investor.jnj.com/investor-relations.cfm, http://orthodoc.aaos.org/ajrigrp_about.cfm, http://sec.gowArchives/edgar/data/200406/o00095012307002542y29901exv13.htm#402 DePuy ASR Recall ---- ---- I---I 2010 DePuy Hip Implant Recall: What Happened and Why? In early 2005, DePuy applied for a 510(k) Application for Clearance for its ASR Acetabular System, a metal-on-metal hip implant. After a number of complaints, its own recall of the ASR product in Australia, and a negative report written in the National Joint Registry, DePuy issued a full recall of its ASR hip product in the US in August of 2010. 93,000 Number of DePuy ASR patients 21%-49% 200,000+ Failure Rate of DePuy ASR Systems Annual number of hip replacements in the US The British Orthopaedic Association and the British Hip Society have released data on the ASR showing the rate óf second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years. 1 in8 1 in 8 DePuy ASR Patients need a second hip replacement surgery due to faulty DePuy ASR Products 887 complaints about the DePuy ASR products were filed with the FDA between 2006 and 2010 DePuy Profits in Billions $5.6 Number of Complaints Filed $5.0 $4.6 424 $4.2 ASR patients started complaining in March 2006, only 1 year after the ASRAcetabular System was introduced. The 239 numberof complaints continued to rise for the next 4 years along with 87 DePuy profits, which reached $5.6 billion in 12 2010. 2006 2007 2008 2009 2010 How Did This Happen? The FDA handles the approval of new medical devices substantially differently than it handles the approval of new prescription drugs. First, medical devíces are classified into one of three categories based on the potential risk that they present to consumers. This classification determines which type of premarketing application is required for FDA clearance of a device. Class 1 Devices include devices with the lowest risk, and are subject to the least amount of regulation. These devices must meet "General Control" requirements, such as proper labeling and packaging, suitability for intended use, registration of the manufacturing location, and listing of the device with the FDA. Class 2 Devices include devices with moderate risk, and are subject to a fair amount of regulation. These devices must meet "General Control" requirements, as well as "Special Control" requirements, such as special labeling, mandatory performance standards, and postmarket surveilance. Class 3 Devices include devices with the highest risk, and are subject to the most regulation. These devices must meet "General Control" requirements, and are subject to premarket approval by the FDA. This approval process involves scientifically reviewing each device to ensure safety and effectiveness. All class 3 medical devices must go through the process of premarket approval before they can be marketed to consumers. This process is similar to the that for prescription drugs in that it requires scientific evidence that the device is safe for consumer use. However If a device can demonstrate that it is substantially equivalent to a device that is already on the market and it doesn't raise any new safety or efficacy questions, then it is eligible for a process known as premarket notification 510(k). 510(k)'s process does not involve clinical testing to prove safety and efficacy, as these devices are considered to be at least as safe and effective as the device that they are claiming equivalence to. Furthermore, the 510(k) process is cheaper and faster than the process of premarket approval. APPROVED 510(k) APPROVED What They Said. of new devices that have entered the market in class 98% 2 or class 3 since 1976 have been approved through the 510(k) process, including DePuy's ASR Systems. of the devices that were recalled between 2005 and 71% 2009 were approved through the 510(k) process. What can I do? Efforts are already being madę to revamp the 510(k) process in order to make it more stringent and reduce thẻ number of faulty products that are approved. The FDA has committed to an action plan with the intént of increasing predicatbility, consistency, and transparency for its'device review programs, including the 510(k) process. What you can help with is spreading the word about the American Joint Replacement Registry. A similar national joint replacement registry already exists in other developed coủntries such as Sweden, England, and Australia, bút hasn't existed in the United States until the American Academy of Orthopaedic Surgeons incorporated the American Joint Replacement Registry (AJRR)'in 2009. Raising awareness about the AJRR is important to the success of the organization as it strives to continue expanding and collecting joint replacement data from hospitals across the country. This data will assist mạnufacturers such as DePuy in removing implants which are prone to early failure from the market before they become as big of an'issue as the ASR products were. Hip Implant Recovery Sources: http://www.fda.gow/cdrfvanualfy2002/ode/index.html, http://www.nytimes.com/2010/08/27/business/27hip.htm/?_r=1, http://www.depuy.com/usmedia, http//www.accessdata.fda gov/scripts/cdrhvcfdocs/cfres/res.cfm, http://www.fda.govimedicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/defaut. htm, http://www.medscape.com/viewarticie/474285_4, Ramsey SD, Luce BR, Deyo R, Franklin G. The imited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998:4 Spec No:SP188-99., http://www.fda.gowMedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, http://www.investor.jnj.com/investor-relations.cfm, http://orthodoc.aaos.org/ajrigrp_about.cfm, http://sec.gowArchives/edgar/data/200406/o00095012307002542y29901exv13.htm#402 DePuy ASR Recall ---- ---- I---I