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.
Twitter: JjrkCh

Wednesday, August 31, 2011

Stakeholders? Consumers and scientists demand inclusion.

A Consumer Stakeholder Coalition responds to the FDA (link here)
Please thank the following:
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Consumers Union
Government Accountability Project
National Physicians Alliance
National Research Center for Women and Families
National Women's Health Network
Our Bodies, Ourselves
The TMJ Association, Ltd.
Truth in Medicine, Inc.
Union of Concerned Scientists
Woody Matters
U.S. PIRG


Saturday, August 27, 2011

Please sign Petition to Congress and President Obama

Sign and share with your friends/family! Thank you!  (revised link)

When I speak at the FDA/CDRH Town Hall meeting in San Francisco on 9/22/11 I will be speaking for all of you.


How much more evidence does it take to prompt change?

Patient Safety America August 2011 newsletter       (link)


Become a Member Today

For only $15, you will recieve a lifetime membership to Patient Safety America. Membership benefits include:
  • An autographed copy of “A Sea of Broken Hearts"
  • A lifetime subscription to our monthly e-newsletter
  • Informational bulletins that advocate for patient safety legislation
Please send your checks to the address below.
You will recieve your book in about one week Standard Mail.
John James
14503 Windy Ridge Lane
Houston, TX, 77062

Tuesday, August 23, 2011

(Failed medical device) Patients whose future is so uncertain . . .

J&J DePuy ASR hip recall - corporate "Plan B"   Press on this link for Reuters article 8/22/11

"Insight: DePuy's handling of hip recall sparks questions"


Doctors are paid a $50 "bounty" to encourage patients to fill out a form that may
conflict with their civil rights in court proceedings.

A elderly woman walks along a corridor in a file photo. REUTERS/Michaela Rehle

NEWS FLASH! Diane Rehm NPR will discuss failed hip implants

08/24/2011 Dallas NPR station (9a Central Time) 90.1 KERA

"Growing Concerns Over Hip Replacements"

In this Thursday, Sept. 3, 2009, photo, doctors perform a full hip replacement on Linda Rankin, 60, of Selinsgrove, Pa., at Geisinger Health System in Danville, Pa.  - (AP Photo/Matt Ford)

More failed implanted hips are being reported to the FDA

This is a link to today's New York Times story . . . "Complaints Soar on Hip Implants"
Please join these patients:  contact your Representatives in DC and demand that the Charter of the FDA be updated from 1976 - which did not account for implants.  There is currently no effective "feedback loop" to the manufacturers to stop "innovations" that hurt patients and deplete our public and personal healthcare funds.


Sunday, August 21, 2011

Orthopedic Implants and Bad Ads

DePuy Orthopaedics placed a Pinnacle hip replacement ad in the current issue of the AARP magazine (Sept/Oct 2011, p.11).  "Real life tested" with a young-looking "charity cyclist" pictured.  What is not said is that 37,000 (of 100,000 implanted) DePuy ASR hips failed.  Most joint replacement recipients are 65 and older because the life expectancy of an implant is only about 15 years. Products are cleared for market by the FDA with "predicates" and lab testing and little post-market data collection no required clinical trials.    Revision surgery is dangerous and expensive.  There is no warranty on product.

Doctors are questioning the aggressive marketing of implanted joint replacements direct-to-consumer because it fuels unrealistic demands by & expectations of patients:  
Read this --
Truth in advertising ????


ePatient Dave deBronkart speaks at TED conference 4/2011

A compelling presentation to "Let Patients Help!" Please watch !

Saturday, August 20, 2011

The public is invited (with RSVP) to the microphone!

September 22, 2011 FDA/CDRH Town Hall mtg. in San Francisco

This is an opportunity for the public to attend and support consumer/taxpayer/patient rights in determining how FDA follows up on the IOM 7/29/11 report stating that the 510(k) process is flawed.

Implanted medical devices must be safe and effective:  not just "innovative".   If you cannot come, please write to :
Dr. Jeffrey Shuren
Director CDRH
Food and Drug Administration (FDA)
9200 Corporate Boulevard
Rockville MD 20859

jeff.shuren@fda.hhs.gov

The New England Journal of Medicine - Eliminate 510(k) & track devices.

Public Health Nightmare - Implant "innovation"
published August 10, 2011



"no one's interest is served by putting defective medical devices onto the market where they cause harm to patients, waste health dollars, and may kill jobs when they (device products) are withdrawn."


Thursday, August 18, 2011

The Institute of Medicine questions whether implanted devices are safe and effective.

The Institute of Medicine 7/29/11 reports that the FDA system is flawed.

HHS/FDA  (Health and Human Services & the Food and Drug Administration) asked the objective Institute of Medicine to review the process that FDA uses to clear medical devices for the U.S. market.  The review took 22 months.

Welcome to FiDA Blog!

My brother, Steven Baker and I were photographed in Washington, DC August 3-4, 2009 at the Alliance for Justice Lobby Day for the Medical Device Safety Act.

We are asking for allies to heighten the safety and effectiveness of implanted medical devices.  This blog is to share with a diverse audience the necessity of better regulation of this industry and more transparency so that patients and their doctors can select the best devices and our economy can grow based upon healthier citizens and business practices with integrity.

Steven had an elbow implant on 5/19/08 that was "revised" on 9'29/08 by removing two components.  The surgeon was also the designer of the device.  Steven remains in intense pain and with little function.  He is also in medical and legal purgatory.
This story is not an isolated one.  Poor oversight of this industry has allowed failed implanted surgical mesh, DePuy J&J hips and other "innovative" devices onto the market without accounting for how to care for those who are not fortunate to select a doctor/hospital/manufacturer that will stand behind a product that fails.

Please select to receive an email each time a new blogpost is added.  Follow my progress as I speak at  the FDA CDRH Town Hall meeting in SF 9/22/11 and participate in the Patient Walking Gallery (Regina Holliday) in SF 9/25/11-9/27/11.  I will include articles that will inform and inspire you to write to your Senators & Representatives for this cause.  Please share this blog with those who are in the medical community, public policy activists and others who will act to improve implanted medical devices.  Thank you!