Docket No. FDA-2010-N-0389
March 28, 2012
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
The MDUFMA agreement process was not inclusive of patient participation and the lack of funding for regulation of implanted medical devices places patients in medical and legal purgatory. The medical device industry is lucrative and powerful and entitled. Patients that have been implanted with failed devices are often in pain, disfigured and debilitated both mentally and financially. They are the very people who had faith in both the FDA and the medical device industry and whose voices are suppressed. Much evidence exists showing that the medical device industry orchestrated legislation that reduced patient protections while allowing marketing of devices with questionable value.
I am a tenacious patient advocate that has experienced rejection and barriers rather than access and support from the FDA and the device industry. My brother, Steven Baker (FDA adverse event MedWatch 5009052 reported on 11/18/08) had a Tornier lateral elbow prosthesis implanted at the Mayo Clinic on 5/19/2008 to reduce pain and increase function. It did neither, and on 9/29/2008 (just 4 months later) the surgeon/designer performed “revision” surgery and removed - and confiscated- two components. My brother was placed on long-term maximum dose hydrocodone (opiate). His teeth began to disintegrate as he slept at night and he learned that was a side effect of the pain medication. There was no UDI unique device identifier for the implant. The surgeon refused to report it to the FDA as an adverse event & legally only a fatality is required to be reported. There is no registry of these devices so a patient cannot make an informed decision based upon post-market data. Steven was not informed that the Minnesota Medical Board is considered one of the worst in the nation. Steven was not informed that the FDA allows implanted devices on the market with no clinical testing. Steven was not informed that 2/2008 the Supreme Court provided even more entitlement to the medical device/pharma companies with Riegel v Medtronic decision.
All the legal wrangling to give preference to these producers of implanted medical devices loses sight of the need of the patient: care! Steven has not filed a lawsuit. He has not attacked the reputation of the surgeon. He wants care for the failed implanted device. It is clear that access to care is also trumped by corporate greed and defensiveness: the Mayo Clinic sent him a letter stating that only Federally mandated emergency care will be provided. How many other harmed patients does this experience represent?
As a patient advocate, my goal is to change federal public policy to provide for safe and effective implanted medical devices. Citizens should be able to expect the U.S. government agency (FDA) and the producers of these medical devices to have the same mission. Financial investment in regulation should not be disparaged by the very businesses that experience the greatest profit margins of all U.S. market segments. It cannot expect the taxpayers and harmed patients to absorb the cost of device failures.