On 7/29/11 the Institute of Medicine concluded a 22 month study (commissioned by HHS Health and Human Services) stating that the 510(k) process of approving implanted medical devices is flawed and should be abandoned. The medical device industry and the bureaucracy of FDA is resisting updating the regulations that are 35 years OLD. Congress must act to update federal public policy.
This is a personal story of the medical and legal purgatory awaiting the unfortunate percentage of patients in which implanted medical devices fail. Share Your Prescription Drug or Medical Device Story
Have you or a loved one experienced a problem with a prescription drug or medical device? Consumers Union "Safe Patient Project" would like to hear your story, or any other comment you may have about your experience.
https://secure.consumersunion.org/site/SPageNavigator/spp_prescription_drug_m...
What a horrifying experience. Best wishes on your continued recovery and advocacy for yourself and others.
CJLillis 2 weeks ago