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Comments from Howard

Here is the letter – Smith & Nephew Letter 5-6-2009

1. Smith & Nephew failed to include the probability that metal particles were caused from the components of the BHR rubbing against each other just from normal activity thus pseudo-tumors appeared causing loss of tissue and the pain and suffering that follows.

2. In many instances a Smith & Nephew representative was present in the OR during the procedure (unbeknown to most patients including myself) they were there to observe and answer questions: so Smith & Nephew should do less finger pointing to human error after all Smith & Nephew trained a core group of surgeons to perform the procedure ( by video ? )

3. the metal sensitivity is another finger pointing from Smith & Nephew for a reason the BHR may fail.

4. The PMA approval of the BHR had stipulations one of which Smith & Nephew was to continue investigations and reports as to the metal particle issue, where are these ????

5.This letter states the same as above comment as to studies and reports to have been provided by Smith & Nephew where are these documents ????

6.Smith & Nephew believe in the benefits of the BHR for young and active patients, there marketing promotes the BHR for older active folks. The little to no information I found in MAUDE regarding Smith & Nephews required reports used 18-21 year old patients. The data included told me nothing at all as to the above.

Had Smith and Nephew been candid as to their findings and their knowledge regarding the metal particle issue 1000’s of patients could have avoided pain, suffering etc. However market share and rate of return to Smith & Nephew’s investors would have suffered.

Respectfully

Howard Sadwin

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