boivette
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Metal-on-Metal implant concerns
- Thread starter boivette
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United Kingdom
U.K. safety agency issues medical device alert for metal-on-metal hip arthroplasties
May 3, 2010
The United Kingdom’s Medicines and Healthcare products Regulatory Agency recently issued a medical device alert requesting that U.K. orthopedic surgeons further investigate the cause of pain in patients with painful metal-on-metal hip arthroplasties and resurfacings.
In the April 22 medical device alert, the Medicines and Healthcare products Regulatory Agency (MHRA) noted that it received reports about revisions of these implants involving soft tissue reactions, which may be associated with unexplained hip pain.
In the alert, which is not a recall affecting all U.K. patients with a metal resurfacing arthroplasty, the group wrote, “Early revision of poorly performing metal-on-metal hip replacements should give a better revision outcome.”
The MHRA asked that orthopedic departments and surgeons, hospital medical directors and others perform annual follow-ups in asymptomatic patients for 5 years and more frequent follow-ups in symptomatic patients.
In appropriate patients, blood metal-ion measurements and cross-sectional imaging should be performed, the U.K. health officials noted.
BOA, British Hip Society statement:
The British Orthopaedic Association (BOA) and the British Hip Society (BHS) have issued a 5-page document to help orthopaedic surgeons interpret the alert. In the document, officials from the BOA and BHS wrote, “The key points are that excellent results are reported with metal-on-metal hip resurfacing arthroplasty and total hip replacement from many centers. It is accepted that metal-on-metal bearings have a higher incidence of painful joints. There are a small, but significant number of patients who develop pain and significant tissue damage.
“It is felt that pain with metal-on-metal bearings should be investigated as we are still uncertain which patients are likely to progress or develop serious soft tissue reactions.”
In light of this alert, “All patients should probably be contacted by letter and told of the alert. Patients can be reassured that in the absence of pain or symptoms, the serious soft tissue reactions/tissue necrosis are rare,” officials stated in the document.
May 3, 2010
The United Kingdom’s Medicines and Healthcare products Regulatory Agency recently issued a medical device alert requesting that U.K. orthopedic surgeons further investigate the cause of pain in patients with painful metal-on-metal hip arthroplasties and resurfacings.
In the April 22 medical device alert, the Medicines and Healthcare products Regulatory Agency (MHRA) noted that it received reports about revisions of these implants involving soft tissue reactions, which may be associated with unexplained hip pain.
In the alert, which is not a recall affecting all U.K. patients with a metal resurfacing arthroplasty, the group wrote, “Early revision of poorly performing metal-on-metal hip replacements should give a better revision outcome.”
The MHRA asked that orthopedic departments and surgeons, hospital medical directors and others perform annual follow-ups in asymptomatic patients for 5 years and more frequent follow-ups in symptomatic patients.
In appropriate patients, blood metal-ion measurements and cross-sectional imaging should be performed, the U.K. health officials noted.
BOA, British Hip Society statement:
The British Orthopaedic Association (BOA) and the British Hip Society (BHS) have issued a 5-page document to help orthopaedic surgeons interpret the alert. In the document, officials from the BOA and BHS wrote, “The key points are that excellent results are reported with metal-on-metal hip resurfacing arthroplasty and total hip replacement from many centers. It is accepted that metal-on-metal bearings have a higher incidence of painful joints. There are a small, but significant number of patients who develop pain and significant tissue damage.
“It is felt that pain with metal-on-metal bearings should be investigated as we are still uncertain which patients are likely to progress or develop serious soft tissue reactions.”
In light of this alert, “All patients should probably be contacted by letter and told of the alert. Patients can be reassured that in the absence of pain or symptoms, the serious soft tissue reactions/tissue necrosis are rare,” officials stated in the document.
Among 150 U.S. orthopedic surgeons polled by the Millennium Research Group, 25% planned to reduce their use of metal-on-metal hip implants in the next 12 months, according the results of a survey the Waltham, Mass.-based research firm included in its newest Physician Forum Publication: Metal-on-Metal Hip Implants: Bad Idea, or Just Bad Press?
The physician publication, which is now available, investigated a highly controversial area and sought to determine whether any of the recent articles in the New York Times and The Sunday Times, as well as scientific reports and authoritative actions, have affected clinical decision-making concerning these prostheses.
“Continued negative media and clinical focus have led some orthopedic surgeons to be wary of metal-on-metal implants,” Melissa Hussey, senior analyst at Millennium Research Group, stated in a press release. “A significant minority stated they will curtail usage of these devices in primary total hip arthroplasty in favor of alternative bearing surfaces such as ceramic-on-polyethylene. This is not a universal trend, however; most metal-on-metal current users remain devoted fans, seeing superior range of motion, low revision rates, and generally good success.”
Respondents’ statistics
Those orthopedists surveyed gave hip implant manufacturers Biomet, DePuy, a Johnson & Johnson company, Smith & Nephew, Stryker and Zimmer moderately high satisfaction ratings, with the highest ratings among those surveyed going to DePuy and Biomet, according to the release.
In statistics that the Millennium Research Group provided to ORTHOSuperSite.com, 89% of the orthopedists surveyed were either generalists or total joint arthroplasty specialists; 16% overall had never used metal-on-metal implants, but were considering using them. Among those surveyed, who were recruited by a third-party agency, 47% practiced in the Midwest or Northeast, 36% in the South and 17% in the West.
Articles published in March and April in the New York Times and The Sunday Times cited concerns with the all-metal hip implants and on April 22 the United Kingdom’s Medicines and Healthcare products Review Agency issued a medical device alert about metal-on-metal resurfacing and total hip arthroplasty prostheses.
The orthopedic surgeons surveyed perform about 8.5 total hip replacements monthly and 60 of them were metal-on-metal implant users at the time of the survey.
copied in full from OrthoSupersite.com
www.mrg.net
The physician publication, which is now available, investigated a highly controversial area and sought to determine whether any of the recent articles in the New York Times and The Sunday Times, as well as scientific reports and authoritative actions, have affected clinical decision-making concerning these prostheses.
“Continued negative media and clinical focus have led some orthopedic surgeons to be wary of metal-on-metal implants,” Melissa Hussey, senior analyst at Millennium Research Group, stated in a press release. “A significant minority stated they will curtail usage of these devices in primary total hip arthroplasty in favor of alternative bearing surfaces such as ceramic-on-polyethylene. This is not a universal trend, however; most metal-on-metal current users remain devoted fans, seeing superior range of motion, low revision rates, and generally good success.”
Respondents’ statistics
Those orthopedists surveyed gave hip implant manufacturers Biomet, DePuy, a Johnson & Johnson company, Smith & Nephew, Stryker and Zimmer moderately high satisfaction ratings, with the highest ratings among those surveyed going to DePuy and Biomet, according to the release.
In statistics that the Millennium Research Group provided to ORTHOSuperSite.com, 89% of the orthopedists surveyed were either generalists or total joint arthroplasty specialists; 16% overall had never used metal-on-metal implants, but were considering using them. Among those surveyed, who were recruited by a third-party agency, 47% practiced in the Midwest or Northeast, 36% in the South and 17% in the West.
Articles published in March and April in the New York Times and The Sunday Times cited concerns with the all-metal hip implants and on April 22 the United Kingdom’s Medicines and Healthcare products Review Agency issued a medical device alert about metal-on-metal resurfacing and total hip arthroplasty prostheses.
The orthopedic surgeons surveyed perform about 8.5 total hip replacements monthly and 60 of them were metal-on-metal implant users at the time of the survey.
copied in full from OrthoSupersite.com
www.mrg.net
Bumpa
graduate
Smith & Nephew withdraws cup
A change to one of the metal-to-metal devices:
Smith & Nephew withdraws hip component from market
June 4, 2012
A change to one of the metal-to-metal devices:
Smith & Nephew withdraws hip component from market
June 4, 2012
Smith & Nephew has initiated a voluntary market withdrawal of the optional metal liner component of its R3 Acetabular System, according to a company press release.
Since the component was introduced in 2007 and launched globally in 2009, approximately 7,700 metal-liners have been implanted. Overall, the majority of the metal-liners have been used in stemmed total hip replacement.
“We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component,” Andy Weymann, MD, chief medical officer of Smith & Nephew, said in the release. “As with all medical devices, anyone experiencing unusual symptoms should contact their surgeon.”
According to the release, the withdrawal does not affect the current practice for patient follow-up care for the component or impact other R3 System liners.
Since the component was introduced in 2007 and launched globally in 2009, approximately 7,700 metal-liners have been implanted. Overall, the majority of the metal-liners have been used in stemmed total hip replacement.
“We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component,” Andy Weymann, MD, chief medical officer of Smith & Nephew, said in the release. “As with all medical devices, anyone experiencing unusual symptoms should contact their surgeon.”
According to the release, the withdrawal does not affect the current practice for patient follow-up care for the component or impact other R3 System liners.
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