Newly Released Book by Dr. Robert Christensen is a Must Read for Individuals or Businesses Concerned about Medical Innovation and Patient Care

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) January 21, 2012 -- FOR IMMEDIATE RELEASE

“FDA, You Were Wrong!” is the eye-opening account of how a small medical device Company who held the earliest U.S. Patents, for total and partial TMJ implants for the reconstruction of the degenerated or missing temporomandibular joints were harmed by the FDA approval bureaucracy. The devices should have been allowed through the approval process as pre-amendment, or grandfathered, devices with little need for protracted and expensive testing, but instead were taken off the market for 20 months through the original approval process in 1999. The pre-amendment hip and knee implants had been grandfathered through the approval process quite simply, but not Dr. Christensen’s devices, as they should have been.

“FDA, You Were Wrong!” by Dr. Bob Christensen is now available at the Amazon Kindle Store as a service to the public. At a time when medical assistance is needed more than ever in American history and the technology is available, the Food and Drug Administration (FDA) is hurting patients and suppressing small business innovation by making it more difficult for smaller companies’ to get through the red tape and whims of regulatory committees. Dr. Christensen’s book provides insight to how the FDA can play a part in the eventual closing of a medical device company, preventing patients from receiving a successful implant due to governmental bureaucracy.

In 1976, the Medical Device Safety Amendment was signed by President Gerald Ford with the promise to the public that medical health would be protected for the future. The book explains how, after a 40 year proven track record and success of a device to help patients with Temporomandibular Joint Disorder, section 510(k) of the 1976 Medical Device Safety Amendment forced Dr. Christensen from continuing to produce the device and assist patients.

The new rules required his company to reapply to the FDA for approval in Feb of 1999, and submit the expensive and cumbersome PMA process, which was instituted for new devices and drugs.. Dr. Christensen’s devices were removed from the market for a period of some 20 months, which cost the company many millions of dollars in lost revenues and caused a reduction in staff from 38 to 15 individuals. There was evidence of conflicts of interest and bias, if not outright corruption in the approval process which Christensen and his company had to endure.

As quoted by Tom Tancredo, member of Congress in a letter to the Inspector General at the time, “the FDA has engaged in an obvious pattern of delay and deception and even went as far as to remove TMJ Implants' Fossa-Eminence Prosthesis from the market, which had been available for almost 40 years. This has done nothing more than to cause harm to patients and has cost the company more than $6 million in lost profits. This was done at the same time the application for TMJ Concepts, a competitor of TMJ Implants, sailed through the process.

Several allegations have come to light over the last year detailing the fact that several agency (FDA) employees have worked under the direction of TMJ Concepts' associates”, which was a competing company with less than 6 years of prior implant sales experience. Eventually, due to protracted bureaucratic interference and legal costs, the company was forced into bankruptcy in 2010.

Download the full account that demonstrates how the FDA is hurting patients and medical futures at Amazon.com.

Dr. Christensen is a retired Oral and Maxillofacial Surgeon who began the implantation of a temperomandibular joint device that corrected the deformity associated with the degenerative joint disease since 1960. For more information about the author, visit Dr. Christensens website at http://www.drbobchristensen.com.

ISBN: B006M6EEPI

CONTACT:
Dr. Robert Christensen
P.O.BOX 80001-0443
303-549-6674
http://www.drbobchristensen.com

fda     Robert Christensen