On or about Sept. 15, 2001, the FDA stopped the BP investigational implant procedure in the United States and began collecting the data from the ten surgeons performing it over the past 3 years. In total I implanted 72 patients, ages 15-83, from 14 states, Canada, Costa Rica, and Ecuador. Therefore until further notice from the FDA, no surgeon in America can implant the BP ankle. This of course, severely impacts patients in pain waiting for their new ankle.  There is no timetable for the FDA to act. As such, neither I nor the manufacturer of the implant, are able to tell you when resumption of the BP ankle implantation will begin. 

The FDA:

         a. May rule the ankle may not be implanted in America. This is unlikely because of the 85+% of good to excellent results from the procedures done in the past 3 years under the investigational basis since Sept. 1998 by 10 surgeons.

          b. Rule that the investigational protocol for the ankle continue as it has since Sept. 1998 for another number of years the FDA decides is appropriate.

          c. Make the ankle available to surgeons in general all over the United States, in effect making it implantable by any surgeon in America, trained to do it.

  BEFORE YOU ASK, I HAVE NO KNOWLEDGE OF WHAT THE FDA WILL DO, WHEN, OR WHY. YOU MAY CALL THE FDA IN WASHINGTON, THE ORTHOPEDIC DEVICES SECTION CHIEF, AND ASK THEM ABOUT THE BEUCHEL (pronounced BEEKEL) PAPPAS ANKLE IMPLANT PROGRAM.

 If you are in severe pain and cannot wait for the FDA to act, there are 2 alternatives.

          1. The FDA has a procedure called COMPASSIONATE USE. It in effect says a patient is in such pain that they cannot wait for the FDA decision. By law, when applied for the FDA must quickly say “yes or no” to a request. It usually takes 30-60 days. If you would like to apply for the COMPASSIONATE USE procedure, you must:

        A. Write a letter to me stating you are in such pain that you cannot wait for the FDA to act, and describe your circumstances

          B. GET A LETTER FROM YOUR ORTHOPEDIC OR PODIATRIC SURGEON DIRECTED TO THE FDA STATING THAT YOU HAVE BEEN EXAMINED AND IN HIS/HER OPINION YOU NEED THE SURGERY NOW BECAUSE OF PAIN AND OR DEFORMITY AND THAT WAITING IS NOT IN YOUR BEST INTEREST.

          C. I must also write a letter stating you should have the procedure now as opposed to waiting. 

All of these letters must be sent to the manufacturer by ME who in turn sends them to the FDA. THIS PROCEDURE IS DICTATED BY THE FDA THAT IS WHY IT MUST BE DONE THIS WAY RATHER THAN WRITING THE FDA DIRECTLY. You are correct, it seems to make little sense to do it this way, but we are all tied to FDA.
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