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 procedures and must do it per their regulations. Of course you are always free to write the FDA directly.

Another alternative is to have me operate on you now using a different tibial component to the BP prosthesis. This is the part that goes in your leg and has two small prongs rather than one large one.

THIS SPECIAL LEG PART OF THE BP ANKLE IMPLANT CAN ONLY BE USED BY ME, AS IT IS A SPECIAL DESIGN MADE FOR ME BY THE MANUFACTURER OF THE BP IMPLANT. IT CANNOT BE USED BY ANY OTHER SURGEON IN THE UNITED STATES. I designed it because in about 10% of patients, some years after ankle replacement the patients grow bone over the implant, which limits motion. This extra bone must be excised if too much grows around the implant and limits motion. This special design is also used in Europe by a surgeon in Amsterdam with good results thus far, and has been in use for 2 years. I have implanted 11 patients with it over the past 2 years with no complications thus far.

THE OTHER 2 PARTS OF THE BP ANKLE, THE TALUS, (the part in the foot) AND THE PLASTIC SPACER ARE THE SAME AS THE BP ANKLE. ONLY THE TIBIAL (LEG) PART IS THE DIFFERENT: 2 SMALL PRONGS IN THE TIBIA AS OPPOSED TO THE 1 LARGE ONE PICTURED ON MY WEB SITE. This special implant is manufactured by the same company who makes the Beuchel-Pappas implant. Its design had to be approved by them, of course, for use with the other two parts of the BP prosthesis.

If you choose my tibial component you may be implanted as soon as you wish or as soon as my hospital can schedule you.

I am sorry to have to tell you of this development. At least you have choices you can now make, all of which are far better than ankle fusion.

If you have questions, please call me.

Yours truly,

Dr. Mark H. Feldman
Podiatric Surgeon