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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Twitter: @JjrkCh

Wednesday, April 18, 2012

Patient Harm: A Political Game for Senator Franken?

Steven Baker is holding a component of the Tornier elbow replacement that the Mayo surgeon/designer removed in a 'revision' surgery just 4 months after implanting the elbow.  Tornier claims to be a global company-from Amsterdam, from France or from Edina, MN.   No matter, regulation of the medical device industry does not include pre-market clinical trial, there is no FDA Advisory Panel of stakeholders that votes, no post-market registry and no accountability for patient harm.
Senator Franken is aware of this, yet he introjects himself as the "friend" of industry rather than representing his harmed constituents.  The medical device industry can only be sustained by addressing the "bad players" it is harboring and provide care to those who have been (and will be harmed) if this practice continues.
My 4 year mission as an uncompensated patient advocate to change federal public policy prompted me to compile a timeline of articles (FiDA blog) that would guide other harmed patients to understand the causes of the broken system and hopefully prevent others from entering this "perfect storm" of entitlements to the medical device industry, lack of regulation and suppression of patient protections.  

Senator Al Franken's staff were called 4/13, 4/16 and 4/17/12 to arrange for a meeting to discuss the Star Tribune article announcing his partnership with industry and the lack of accountability of Tornier.  No call has been returned to this harmed patient.  ( FiDA Blog)  04/19/12 update:  Franken's MN staff are all "incredibly busy" and will meet with Steven Baker on first opportunity:  April 26.

Tornier consolidates to MN (LINK)


Franken "friends" MN medical device industry.

Franken says U.S. can improve medical device approval process while ensuring safety

Posted by: James Walsh Updated: April 12, 2012 - 1:53 PM

The United States does not have to choose between the vitality of its medical device industry or the health of its people, U.S. Sen. Al Franken said in an interview at the Design of Medical Devices Conference hosted by the University of Minnesota. It is possible to improve both.
By bringing regulators and manufacturers together to communicate and find common ground, he said, they can find a way to get life-saving devices to market faster while not compromising patient safety. “To some degree, there is a false choice there,” said Franken, who is a member of the Senate Health Committee.
While acknowledging that the range of issues involved are “pretty complex stuff,” Franken pointed to his efforts to bring Jeffrey Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, to Minnesota to meet with leaders of the medical device industry.
Those meetings subsequently led to an agreement between the FDA and the industry to develop a Regulatory Sciences Partnership that will be centered in Minnesota. The idea is to help two very different cultures – regulatory and manufacturing – find common ground to improve the system while enhancing safety.
“These people better start talking to each other,” Franken said of any hoped-for improvements in the American device-approval system. “I want to be a bridge there.”
Franken has introduced legislation, included in a larger medical device bill now being considered by the U.S. Senate, that has two provisions: the first would make it easier for the FDA to work with experts from around the country in the review of proposed medical devices, providing a deeper well of technical expertise. The second would remove the profit prohibition for medical devices that are developed to treat patients with rare diseases, essentially streamlining the development and approval of such devices.
“The longer things take to get to market, it makes the thing not cost-effective to do in the first place,” Franken said Thursday. “There are people who need these devices.”

Apr 13, 12
7:22 pm
Medical devices could be safer with some common sense changes, such as ending the practice of approving new devices based on their similarity to devices that have been recalled for safety concerns. This has to be among the most absurd federal policies on the books, yet Sen. Franken has not publicly supported the elimination of this major safety loophole. This policy has put devices on the market that have harmed thousands of people, including transvaginal mesh implants and several cardiovascular catheters. Franken has a chance to vote to change this policy in the next few weeks when the committee he sits on starts writing legislation on medical device issues.

Apr 16, 12
5:35 pm
Steven Baker (MedWatch Adverse Event #5009052) has met with the Senator and his staff since 2009 with patients with failed implanted medical devices. They are asking for Congress to update the charter of the FDA. When medical device rules were written in 1976 the explosion of devices was not anticipated. Poor regulation (confirmed 7/29/11 by the Institute of Medicine) combined with weak judicial protections for patients and entitlements for the industry has designed this "perfect storm" of harm. Senator Franken's efforts should not be on bridging the gap between just regulator and industry, but on convening public health leaders, aviation safety leaders, patients/advocates with regulators and the industry to prevent major global snafu's like surgical mesh and J&J ASR hips. Senator Franken and the MN device industry must aim higher and be more collaborative and responsive.

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