U.S. Victims bravely tell their stories. This is so very wrong.
My brother and I are grateful to be with the Consumers Union Patient Safety Project. We have met with Congressional office holders and their staffs to demand better regulation of implanted medical devices. The response has been discouraging since there are 12 proposed pieces of legislation pertaining to medical devices, but none includes patient safety and public health protections. The medical device industry is lucrative and has a powerful lobby. This is an election year and politicians are raising money. That is an excuse for not doing their job: protecting American citizens from unsafe and unproven implanted medical devices. Corporations that have been granted the privilege (not entitlement) by the citizens of the United States to do business in our country must act as lawful and ethical businesses. Using influence to corrupt regulations so that failed medical devices are not identified and banned and obscuring information that would inform patients so they can select life-enhancing devices is criminal. It must stop.
Steven Baker, MedWatch # 5009052 came to Washington, DC and encountered the metal detector at the Senate Hart Office Building. He was asked to take off belt and shoes and his implanted elbow suddenly went "out of alignment" . During his presentation he was asked if we should call an ambulance. It is unreasonable to ask the victims to do anymore. It is time for the medical device industry to be honest, responsible and account for the failures as well as the successful innovations that it produces. Our economy cannot sustain this and no patient deserves this medical and legal purgatory.
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.
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