Harmed Patient asks PCORI to Fund Research on Implants

This letter was emailed to Susan E. Sheridan, Director of Patient Engagement, PCORI Patient Centered Outcomes Research Institute, www.pcori.org ssheridan@pcori.org 10/29/12

Dear Susan,

Joleen Chambers has asked me to send information to help enlighten your knowledge as to failed implants. On June 27-28^th, 2012 I traveled to Washington, DC to speak to the FDA re: metal hips.

I was proud to participate in this function, hoping some good may come from the meeting. However, the FDA heard testimonies from other victims of metal hip nightmares and they heard from renown scientist, surgeons and doctors from our country that they saw no need to use metal on metal hip devices as they have recently proven to cause more harm than good. The FDA has been gathering information on this matter for years

Yet market share and rate of returns seem to dictate what actions are or are not taken regarding these devices. The apparent ongoing corruption is sickening.

If the Church, the auto and oil industries, Penn State, now the Boy Scouts are all held accountable for their miss deeds or malfunctions how does a medical device get a free pass when it causes harm to more people than the acceptable failure rate.

I had a Smith & Nephew Birmingham hip resurfacing device implanted in 2007, after my 3^rd dislocation the device was removed in 2010 leaving me in the  hospital fighting for my life for 11 months, 12+ surgeries etc.

I was an active 61 old, played sports, great work, great grandchildren and family, friends etc all of these great things have been altered for the rest of my life. Today I am in a wheelchair, I can no longer do the things I enjoyed the most in life, playing with the kids, hunting, fishing my personal life with my wife has been destroyed. The list goes on and on.

 I have become an advocate in as much I am searching for answers as to why this happened, how it happened and what can I do to see it never happens again based on present day circumstances.

I have helped folks through the internet, letting them know they aren’t alone in this nightmare, I have actually got a few victims into see a specialist in orthopaedic hip problems when other surgeons refused to help.

If you are so inclined please read the FDA notes on the meeting held in DC on September 8, 2005 regarding the approval of the Smith & Nephew hip (BHR) The sole patient test group was controlled by one of the inventors of the bhr, these patients were cherry picked all from the abroad, no test done in the USA, this individual received 66 million pounds for his company ( the highest gross income reported by this company Midland Medical Tech was 23 million pounds—so how is it worth 66 million—then the individual received an additional 33 million pounds once the bhr was pma (pre-marketing approved) by the FDA—Conflict of interest???

The minutes of this meeting clearly state enough unkown answers and it expressed enough concerns on the bhr that it never should have been approved, yet it passed by a 3/2 vote.

Wright medical submitted a letter asking for this device’s approval to be denied as it had conflicting materials of the rules and regulations stated by the FDA, so how did it get approved –CORRUPTION.

To make matters worse because the bhr was pma approved it is now protected by the pre-emption laws. Basically they get to hurt me (others) and there is little I can do about it.

I have accumulated enough information and material on this matter to write a book, however what I want is accountability from the manufacturer for me and the 1000’s of others the device has hurt.

I think this is enough to get you started, I am available and willing to do whatever I can to see justice is served and those that need help will receive it.

You can reach me hbs924@verizon.net  or my cell is 941-928-29