News/Media

Contact: Dr. Bob Christensen

Landline: 303-425-6482                                           FOR IMMEDIATE RELEASE

Cell: 303-549-6674

Email: tmjsurgeon@gmail.com

Web: www.drbobscrusade.com

 

RENOWNED SURGEON EXPOSES FLAWED FDA

Surgeon’s Message Echoes Loudly With Sen. Rand Paul

(Denver, CO, November 26, 2012) – In a book released in August by Tate Publishing Company, FDA, You Were  WRONG!, a Colorado surgeon describes the internal conflicts, biases and even corruption he faced in bringing a much needed and grandfathered medical device through a frustrating approval process with the U.S. Food and Drug Administration (FDA).

Sen. Rand Paul’s (R-Ky) new book, Government Bullies, Attacks Over-Regulation much like Dr. Bob’s book.  On Sep. 10, 2012, Sen. Rand Paul appeared on CBS News to promote his new book, Government Bullies, which specifically addresses many of the regulatory issues highlighted by Dr. Bob in his book: http://www.cbsnews.com/video/watch/?id=7421218n

Like a modern-day David Vs. Goliath story, Dr. Robert W. Christensen, the medical device innovator, describes his 12 year, multimillion dollar battle with the FDA to bring his much needed and successful 1960 implants for the reconstruction of the degenerated or missing temporomandibular joint (TMJ) through the approval process. The implants should have been favored, as were other orthopedic implants developed and in commercial distribution before the 1976 Medical Device Amendment, but were treated shabbily by the lead investigator, Dr. Susan Runner, at the Center for Devices and Radiological Health (CDRH) which caused much delay to these most successful and innovative devices.

Two leading scientists, who are quite familiar with the Christensen battle, have made the following statements:

Thank you for your knowledge and insight contained in your recent book, FDA, You Were WRONG!, regarding the cumbersome bureaucracy faced by the innovation and research community.”

Eugene E. Keller, DDS. MSD

Director, Oral and Maxillofacial Surgery

Mayo Clinic, Rochester, MN

Dr. Christensen has presented a horrendous report on the misapplication of its regulatory authority and worse. The public needs to heed his clarion call for corrective pressure by Congressional oversight of the FDA.”

                                          Charles Homsy,  Sc.D.

One of the original writers of the Medical Device Amendment of 1976 says this about Dr. Bob’s Crusade:

Your experience with the FDA/CDRH was unfortunate, unnecessary, and a supportable criticism of all those involved, some of whom remain well paid employees of the FDA.”

Larry Pilot, Esq.

It is Dr. Christensen’s hope to establish the fact that “Stopping Innovation Stops America” so that our future generations will have the opportunities which they will need to bring forth creative ideas for mankind.

As a footnote, Dr. Christensen  received a special recognition award for his 64 years of innovations and contributions to the surgical community at the Annual Meeting of the Colorado Society of Oral and Maxillofacial Surgeons.  The award  reads:

“Special Recognition Award for a lifetime of service to humanity and your contributions to Oral and Maxillofacial Surgery.”

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FOR IMMEDIATE RELEASE: February 12, 2012
MEDIA CONTACT:
Dr. Bob Christensen
Phone:  303-425-6482 or 303-549-6674
Email: tmjsurgeon@gmail.com

Web: http://drbobscrusade.com

FDA Taken To Task By Prominent Oral Surgeon

A Precautionary Tale by Dr. Bob Christensen Reveals Flaws — and Offers Solutions — for the FDA’s Medical Device Approval Process — A Letter Has Been Sent To All Congressional Representatives

FOR IMMEDIATE RELEASE

Denver, CO February 21 – “FDA, you were WRONG!”is an eye-opening account of how the FDA agency of the federal government, which is supposedly there to help protect the public, has actually been doing more harm than good in recent years; this is the story of Dr. Bob Christensen and his small medical device company, TMJ Implants, Inc., and how they confronted and overcame the corruption, abuses of power, conflicts of interest, and ignorance within the FDA in this tragic yet ultimately purposeful story.  While similar to the Erin Brockovich case, Dr. Christensen’s “David Vs. Goliath” experience offers lessons for any small business entrepreneur needing an FDA approval as well as holding the FDA accountable for uniform approval processes.

Dr. Christensen’s company, TMJ Implants, Inc., originally held the earliest US patent, in 1960, for the reconstruction of the degenerated or missing temporomandibular joints, and the product sold extremely well and helped thousands of patients, including hundreds at the Mayo Clinic.  After nearly forty years of success with TMJ patients, the FDA implemented the Medical Device Amendment in 1999 for TMJ devices — and curtailed Dr. Christensen’s sales;  as a pre-1976 Medical Device Amendment item,  the device should have been grandfathered under earlier law.   There had been no adverse patient reactions to the implants.

At this time, the FDA disapproved his Premarket Approval (PMA).  Dr. Christensen had been warned by Dr. Susan Runner, Director of the Dental Division of the FDA’s Center for Devices and Radiological Health (CDRH), not to attend the upcoming panel hearing as he would surely be turned down; however, Dr. Christensen boldly brought his staff of scientific experts with him and received a 9-0 approval from the initial FDA panel.  Dr. Runner, however, saw to it that a second panel was convened, a panel that disapproved Dr. Christensen’s device by a 8-0 vote.  As a result of the second panel, Dr. Christensen’s devices were removed from the market for a period of some twenty months, which cost the company millions of dollars in lost revenue and a staff reduction from thirty-eight to fifteen individuals.

Throughout the process, there was evidence of conflicts of interest and bias that Dr. Christensen and his company had to endure.  Several allegations have recently come to light that detail the connection between Dr. Runner and TMJ Concepts, a competitor of TMJ Implants.

Download “FDA, you were WRONG!”at www.Amazon.com where you can purchase the Kindle version today.   Dr. Christensen is a retired oral and maxillofacial surgeon who pioneered the design and implantation procedures for temporomandibular devices in 1960 which were used to correct the internal derangement disorder caused by this degenerative joint disease — of which 90% occurs in younger women.

CONTACT:

Dr. Bob Christensen

Phone: 303-425-6482 or 303-549-6674

http://drbobscrusade.com

Email: tmjsurgeon@gmail.com


 

FOR IMMEDIATE RELEASE:  November 17, 2011
MEDIA CONTACT:
Dr. Bob Christensen
P:  303-425-6482 or 303-549-6674
E: tmjsurgeon@gmail.com

Oral Surgeon Takes Battle With FDA to Print

Developer of first jaw joint implants claims agency delayed approval and removed medical products that once offered relief and benefit to jaw bone patients

Arvada, Colorado – November 17, 2011 – An 8-million dollar struggle against the FDA to provide implant solutions for suffering patients will resume this summer when retired oral and maxillofacial surgeon Dr. Robert “Bob” Christensen’s FDA, You Were Wrong is published, exposing the outlandish requirements that forced medically necessary jaw (TMJ) implant and replacement devices out of production.

Christensen’s small medical device company successfully supplied patients with degenerative joint disease for decades until the Medical Device Act of May 28, 1976 eventually removed a perfectly safe and necessary medical product 39 years after their innovation and first use, Christensen alleges, removing all solutions for patients suffering excruciating pain from bone-on-bone contact caused by the disintegration or displacement of a thin fibrous disc between the jaws that acts as a “separating” medium.

“The medical device classification system is not now, and never has been, based on the inherent risk posed by the devices,” asserts the nationally known maxillofacial implant expert. “This has profound consequences for the future of medical device regulation,” Christensen warns, referring to increasingly burdensome data requirements that deter device manufacturers attempting to bring new products to market in the United States.

FDA, You Were Wrong will be published by August 2012 by Oklahoma- based Tate Publishing.  To join Dr. Bob’s mailing list or for an interview to learn about his innovative medical devices, visit drbobchristensen.com or call 888-771-8658

CONTACT:

Dr. Bob Christensen

Phone: 303-425-6482 or 303-549-6674

http://drbobscrusade.com

Email: tmjsurgeon@gmail.com