Overview

The FDA is Stifling Innovation and Hurting Patients

This David and Goliath story takes place in the medical field in the land of the FDA. During the course of a ten-year battle, a small medical device company spent upwards of 8 million dollars as a much-needed medical implant product was taken off the market.

Told with objectivity and an appreciation for the beneficial ...
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FDA, you were WRONG!

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Overview

The FDA is Stifling Innovation and Hurting Patients

This David and Goliath story takes place in the medical field in the land of the FDA. During the course of a ten-year battle, a small medical device company spent upwards of 8 million dollars as a much-needed medical implant product was taken off the market.

Told with objectivity and an appreciation for the beneficial aspects of regulatory agencies, the authors graciously acknowledge the dedication of government employees and the various branches that are vital to the safety of the American public. Nonetheless, this story recounts a good doctor’s plight when guidelines for proven TMJ devices that were beneficial to many for fifty years became intrusively restrictive after the Medical Device Amendment was established in 1976.

The unusual requests of the Center for Devices and Radiologic Health, the branch of the FDA, which approves and oversees medical devices and drugs, were so outlandish for a pre-amendment device that the cost factors eventually forced the production company and Dr. Christensen into bankruptcy. These essential implants are no longer available for purchase, depriving patients of the care which they so needed.

Dr. Bob emerges a champion, not a victim, and his story will inspire you to persevere for worthwhile causes, no matter the giants you may face.
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Product Details

  • BN ID: 2940014706803
  • Publisher: TMJ Implants, Inc
  • Publication date: 6/17/2012
  • Sold by: Barnes & Noble
  • Format: eBook
  • File size: 7 MB

Meet the Author

Dr. Christensen is a retired oral and maxillofacial surgeon who developed the first successful implants for the reconstruction and replacement of the human temporomandibular joint. These devices had been implanted in patients during the period, before and after, the Medical Device Act of May 28, 1976, was established. The implants as Total and Partial temporomandibular joint implants were implanted with great success over the next 50 years since their innovation.

Dr. Christensen is known as the pioneer in this type of surgery for degenerative joint disease, traumatically or congenitally missing portions of the associated bony anatomy and for certain tumor surgeries where resection of the actual TMJ may be required.
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Customer Reviews

Average Rating 5
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Sort by: Showing all of 3 Customer Reviews
  • Anonymous

    Posted August 21, 2012

    Leafsong

    "Hello" she pads in and sits on an empty nest.

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  • Anonymous

    Posted August 20, 2012

    Frozenfoot

    He padded in and curled up in a nest. -Frozenfoot

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  • Anonymous

    Posted August 19, 2012

    Warriors den

    Warriors den

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