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
27-28th,
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 3rd
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.
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