Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Sunday, August 21, 2011
Orthopedic Implants and Bad Ads
DePuy Orthopaedics placed a Pinnacle hip replacement ad in the current issue of the AARP magazine (Sept/Oct 2011, p.11). "Real life tested" with a young-looking "charity cyclist" pictured. What is not said is that 37,000 (of 100,000 implanted) DePuy ASR hips failed. Most joint replacement recipients are 65 and older because the life expectancy of an implant is only about 15 years. Products are cleared for market by the FDA with "predicates" and lab testing and little post-market data collection no required clinical trials. Revision surgery is dangerous and expensive. There is no warranty on product.
Doctors are questioning the aggressive marketing of implanted joint replacements direct-to-consumer because it fuels unrealistic demands by & expectations of patients:
Read this -- Truth in advertising ????