BHR, Conserve Plus, Cormet 2000, Food & Drug Administration, Health, Hip Replacement, hip resurfacing, metal, metal ions, metal-on-metal hips, metallosis, Patient, Smith & Nephew, UNited States
Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for safety, efficacy and improvement in health outcomes for patients as an alternative to total hip arthroplasty.
The 2007 CTAF assessment stated that “It is not possible to conclude from the current peer reviewed literature that the currently approved hip resurfacing systems in the United States improve health outcomes comparably with the current standard of care, total hip arthroplasty”.
In 2010, when CTAF reviewed this topic, several questions which were of concern during the 2007 assessment remained and we reiterate them here: What is the long term durability of the resurfaced hip compared with THA? What will be the short and long term results when this generation of younger patients who have undergone hip resurfacing are eventually converted to THA? Will there be unforeseen long term complications that will make this revision more problematic than anticipated? What are the long term health consequences of increased low levels of circulating metal ions produced by MoM hip resurfacing?
Now at the time of this assessment, the same questions remain unanswered. Particularly in light of the registry evidence showing an increased revision rate with HRA compared with THA and increasing concerns about elevated metal ion levels, it is incumbent upon the hip resurfacing community to prove the efficacy and safety of MoM hip resurfacing in randomized clinical trials, rather than subjecting young patients to significant potential harm over their lifetimes.
It is recommended that metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for safety, efficacy and improvement in health outcomes for patients as an alternative to total hip arthroplasty.
Download full report here: CTAF REPORT Metal on Metal Hip Resurfacing as an Alternative to Total Hip – Metal_on_Metal_Hip_Resurfacing_100611
- SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf (earlsview.com)
- Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? (earlsview.com)
- Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
- P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices (earlsview.com)
- FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… (earlsview.com)
- Attachment B – Ragab AA., validity of Self-Assessment Outcome Questionnaires: Patient-Physician Discrepancy in Outcome Interpretation, 39 Biomed. Sci. Instrum. 579-84 (2003) (earlsview.com)
- Jack’s call for help – Legal help sought – Cormet Hip -Isn’t there some way to get beyond PMA preemptive device approval? (earlsview.com)
- Hip replacement and resurfacing equally effective at improving joint function | Arthritis Research UK (earlsview.com)
- FDA Considers Metal Hip Injuries – A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)
Pingback: Hip Prostheses: New JRC report summarises current knowledge and identifies further research needs — Institute for Health and Consumer Protection – (JRC-IHCP), European Commission « Earl's View
Pingback: Hematogenous Infection of Total Hip Arthroplasty With Actinomyces Following a Noninvasive Dental Procedure | Orthopedics « Earl's View
Pingback: Enhanced recovery program in total hip arthroplasty Dwyer AJ, Tarassoli P, Thomas W, Porter P – Indian J Orthop « Earl's View
Pingback: Adverse outcomes in hip arthroplasty: l… [J Bone Joint Surg Am. 2012] – PubMed – NCBI « Earl's View
Pingback: Ion levels poor indicator for hip arthroplasty debris « Earl's View
Pingback: Instability after total hip arthroplasty « Earl's View
Pingback: Prediction of Functional Outcome at Six Months Following Total Hip Arthroplasty « Earl's View
Pingback: Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant « Earl's View
Pingback: Journal Highlight: Differential distribution of cobalt, chromium, and nickel between whole blood, plasma and urine in patients after metal-on-metal (MoM) hip arthroplasty – Ezine – spectroscopyNOW.com « Earl's View
Pingback: Cementless Metaphyseal Fitting Anatomic Total Hip Arthroplasty with a Ceramic-on-Ceramic Bearing in Patients Thirty Years of Age or Younger « Earl's View
Pingback: One- Versus Two-stage Bilateral Total Hip Arthroplasty | Orthopedics « Earl's View
Pingback: EARLY CLINICAL FAILURE OF THE BIRMINGHAM METAL-ON-METAL HIP RESURFACING IS ASSOCIATED WITH METALOSIS AND SOFT TISSUE NECROSIS « Earl's View