The Food and Drug Administration (FDA) Notice: The Patient Preference Initiative: Incorporating Patient Preference Information Into the Medical Device Regulatory Processes: Public Workshop; Request for Comments
Docket # FDA-2013-N-0865
As the family member of a harmed patient (FDA MedWatch #5009052) and a 5 year patient advocate (FiDA Failed implant Device Alliance)(FDA Patient Representative Workshop 9/2010) on the Federal level, I submit my comments. FDA must be tasked to consider the far-reaching preventable harms of a failed implanted medical device. A harmed patient is on an infinite protocol loop. Medical boards are unreliable resources to stop aggressive and dangerous doctors who harm patients. Often the actions of these quasi/governmental panels obfuscate and protect the physicians and their entitlements even at the expense of patient harm. The Joint Commission oversees hospitals, but is not a resource for individual harmed patients. Hospital Trustees are not legally required to receive communication from or meet with harmed patients. Hospital Patient Affairs offices are staffed with Customer Service agents that are directed by corporate lawyers. If a harmed patient attempts to hire a lawyer, the lawyer is dissuaded by legislation that reduces judgments. Even a judgment for the plaintiff (years later) leaves the harmed patient with only pennies on the dollar when lawyer fees are collected. The harm from a failed implanted device immediately relegates the citizen to second-class. The medical community has entitlements that preclude harmed patients from accessing true justice. Often there is no medical Plan B for an implant failure. The patient is in for a lifetime of pain and suffering, as is the family. Along with this is medical poverty and loss of income. This has occurred to thousands of U.S. citizens (and globally) who have failed metal-on-metal hips and vaginal surgical mesh. Financial accountability shifts from private entities that produced the harm to the public realm where taxes support social welfare programs. Currently, joint replacement is the #1 category of treatment expense for CMS. Much of this harm is preventable at the legislative and regulatory level but harmed patients must be heard and valued for the information they offer, not feared and marginalized. Implanted medical devices require far greater scrutiny than the 510(k) process. Thank you for this opportunity to comment.
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