Tags

, , , , , , , , ,


Howard’s Story (as written by Howard):

My intentions are to tell my story, and for others to listen to my thoughts on improving a system that is in dire need of help.

In 2007 I had a metal on metal device put into my body, 6-8 months after the procedure I began limping, back pain increased, groin pain was getting worse, and low-grade fevers appeared.

I visited my orthopedic surgeon several times, he x-rayed the hip and saw no signs of a problem.

My family checked me almost weekly and recommended I see a back doctor, this examination and x-rays showed no problem.

Things got progressively worse. At one point I thought it was just me. I had an active life at 65 years, I fished, hunted, competed my labrador retrievers in field trials.

I have four grandchildren, ages 4-8, 3 girls-1 boy, and they are a big part of my life. I have a loving wife of 23 years, I go to the gym 3 times a week, had a real estate career of 31 years, I am involved with little league.

My grandson is like my son, use to spend 3-4 times a week with me. The last we were out together, I would pick him up at school in my truck, we were riding ATVs (4 wheeler) and  he was getting into racing.

Progressive Deterioration

By 2010 I walked with a cane, lived in constant pain, but I tried to maintain my degree if activities as best I could. In the beginning of January 2010 while getting out of bed I dislocated my hip, which resulted in my 1st ambulance trip to the hospital.

The hip was put back in place, I returned home after a few days in the hospital. I saw my orthopedic surgeon, more x-rays, everything look ok, just cut back my activities, and I did.

Within one week of being at home I got up from sitting in a chair at home, and the hip dislocated for the 2nd time, another ambulance trip, same routine.

Saw my surgeon, he tells me if it dislocates again the device would have to be removed. I told him I was going for another opinion, I was referred to a surgeon that specializes in hip and knee problems.

I was in his office two days later, the x-rays looked he wanted me to have an MRI taken to get a better look, as he thought there maybe a pocket of fluid of fluid in the hip area, if so the fluids pressure could be responsible for the 2nd dislocation. Also  he told me if the hip dislocated one more time the device would probably have to be removed.

Third-Time Unlucky

I left his office and went to work in my office downtown. 2 hours later I got up from my chair and the hip popped out for the third time. Ambulance picked me up, I was on a first names basis with these folks, they were excellent in their taking care of me. off to the hospital.The second surgeon, who specializes in hip problems, removed the hip.

After Surgery

After the surgery the doctor told my wife,sister and mom he had never seen such a mess, all the muscle and tissue that supported my hip was gone, deteriorated. I returned home after my stay in the hospital. I was home in bed, woke up to a pool of fluids all over the sheets and I started a fever of 105+.

This trip in the ambulance was a rush to the hospital where I spent the next 9+ months and underwent 12+ operations performed by 3 different surgeons. These surgeries were just for a cleaning out of the debris in my hip area.

In a few of these operations parts of my femur were cut off to prevent further complications. The bottom right side of my body looks like a crater, covered with enough railroad tracks to make you think you were in grand central station (scars).

Support team

God, great doctors and nurses, my loving wife, family, friends, my labrador retriever, came to the hospital regularly, my now 8-year-old grandson, the apple of my life and my beautiful grand daughters, my spirituality, and my will to survive kept me alive.

One surgeon came into see how I was doing, not so good, he leaned over close to my ear and told me I was dying , that he thought he could keep me alive, but the rest was up to me.

Going through something like this can’t totally be understood unless one has lived the experience, I don’t wish to happen to you, my grandchildren, my friends, or anyone.

I have spent endless hours on the computer reading, researching, communicating, learning about the medical device world and how it works. I have read much about the approval process of medical devices. I have a better understanding on how the hip and knee debacle was allowed to happen.

Who is held accountable?

The medical device world provides a second chance at having a better quality of life, and has saved lives. However, its time to face the reality, metal on metal was not the materials that would prove to be my best friend.I want to do whatever I can to see this never happens again.

I have a tough time swallowing when I read how the hip device used on me was approved by the FDA.

Manufacturer & FDA Approval

In 2004, Smith and Nephew, the manufacturer of the Birmingham Hip (BHR) tried to get FDA approval on this hip device. They were denied the first go around with the FDA.

Some of the denial reasons were lack of certain data, the data used to support their approval came from a controlled group of patients, controlled by McMinn, whom is partially credited with inventing the BHR, he also worked for Smith and Nephew, he had financial interest (upon approval of the BHR by the FDA, he would be paid over $50 million dollars). The FDA’s concern was the possible influence these things could have had on the data as reported by Smith&Nephew.

There were no long-term results, that were acceptable, in determining how this product would survive and what were the adverse affects the device may have on humans. (That’s us) The FDA was also concerned on potential friction of the metals and what effect they may have on the human body. There are tons of old information on this matter available to the us. What would these metal shavings do if they entered the human blood stream and body.

Solving these issues was no problem, in 2006, using the same information and the good old 510k plan, (look up on the FDA site for information on this process if you really want the hair on your neck stand up), the BHR was approved.

There were conditions made by the FDA, that Smith & Nephew would give the FDA research data as to the hip,any adversities, and information as to the metal on metal, their particles impacting the human body.

There were surgeons and doctors expressing their concerns by use of the metal on metal devices, I guess they were misplaced or maybe ignored, or maybe got a few bucks and they were lost.

 During this time frame 2007

there were 5 of the big manufacturers under investigation by the Federal Government for deceiving marketing techniques, kickbacks (that right), surgeons, doctors, hospitals, distributors, etc were being paid millions and millions of dollars, boats, cars, vacations, and these 5 big companies, including Smith & Nephew, stopped the ongoing investigation by paying a mere $311,000,000 fine.

Some of these companies have since got caught again. The FDA is another debacle.

FDA Process is Outdated

The laws governing these devices is all about Market Share and Financing, I don’t remember reading too much about the safety and well-being of US. These laws go back to late 1970’s and have been added onto and onto etc. you would get dizzy reading about them.

The analogy I use a leaking roof can be patched so many times, then you need a new one. Could be money was paid to withhold information as to the real data available; forgot to let you in on a secret, we are the lab rats. That’s how we know metal on metal can cause serious problems to one’s health and well-being.

Last, please give me your attention for a moment. Close your eye’s, as if you were a light switch, when you open them, the switch remained off, didn’t work, all the enjoyment of your life was taken away from you. My 8-year-old grandson usually would stay over 1 or 2 nights a week.

Last week, he said to me, could he go home and not spend the night, I had expected this, my heart sunk. I picked my head up, looked into those big blue eyes and asked him was this because we couldn’t do to the things we use to do, he responded yes. I said you can do whatever you wish that I understood.

This isn’t just about court, this is about getting well first and foremost.

The most important thing we can do, is work collectively, support each other when one is in need of a shoulder, and speak your piece. If the system, or the device is responsible for doing this to me or to you is ever going to be changed, we must prevail in the courts.

Respectfully

Howard Sadwin

Thanks for taking your time to read this story, I hope it has helped.