Suffering in Silence: Howard Sadwin’s Story of Metal-on-Metal Hip Failure

Mar 5th, 2012 | By | Category: News, Patient Profiles

Howard Sadwin is 65 years old and lives in Sarasota, Florida. Life has not been the same since a metal-on-metal hip implant in 2007. In fact, during his 10-month hospital stay, Howard’s doctor leaned over and whispered to him that Howard was dying. But Sadwin survived and today is fighting mad about the artificial hip and its metal components that were approved for use in this country by the Food and Drug Administration (FDA).   

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,” he tells MDND.

Howard’s Story

“I was 61 and the pain I was getting in my hip and lower back was beyond tolerance,” says Sadwin, now age 65.

An x-ray showed he needed his right hip replaced. The left hip had been replaced 16 years earlier in 1991 and so when it was time for the right hip his expectation was that it would be the same successful procedure which he chose to have done by a reputable orthopaedic surgeon at Sarasota Memorial Hospital.

Howard says today, “I don’t have any doubts to his sincerity, honesty and integrity. It wasn’t human error or doctor error.”

Howard Sadwin

So in 2007, Howard Sadwin was implanted with the metal-on-metal (MOM) Smith and Nephew, Birmingham Hip Resurfacing System (BHR), an artificial hip replacement system which was approved for sale in the U.S. the year earlier. The BHR hip is globally marketed in 23 countries for younger, active Baby Boomers who want to stay active, according to its website (here):

 “This successful, bone conserving total hip system is well documented through independent clinical and laboratory studies. Additional clinical evidence supporting our BIRMINGHAM HIP Resurfacing System is published in multiple registries. This bone conserving procedure, combined with the virtual elimination of dislocation and excellent survivorship make the BIRMINGHAM HIP Resurfacing ideal for the active informed patient.”

“Within 10 to 11 months I began limping and my back pain increased. The pain was getting worse and low grade fevers appeared along with rashes and blurry vision. I visited my orthopedic surgeon several times, the doctor who put it in, and he x-rayed the hip and saw no signs of a problem. My family doctor checked me almost weekly and recommended I see a back doctor, eye doctor, cardio doctor, dermatologist, but things got progressively worse. At one point I thought it was just me so I began taking anti-depression medication,” says Sadwin.

“At this point I had an active life. I fished, hunted, and competed my dozen Labrador retrievers in field trials. I have four grandchildren, ages 4 to 8, 3 girls and 1 boy, and they are a big part of my life. I have a loving wife of 23 years, I went 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. I would pick him up at school in my truck, and the last time we were together we went riding ATVs and he was getting into racing.”

Progressive Deterioration

Howard says by 2010 he was living with the constant pain but tried to maintain an active life. But in the beginning of January, while getting out of bed, he dislocated his hip which landed him in an ambulance to hospital.

“The hip was put back in place and I returned home after a few days in the hospital. I saw my orthopedic surgeon, more x-rays and he said everything looked okay, 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 second time, another ambulance trip, same routine.”

A second opinion from another surgeon confirmed the diagnosis – if the hip dislocated again it would have to be removed.

“The new surgeon suspected there was a buildup of fluids around the hip and ordered an MRI for me to have done the following day. Two hours later I got up from my office chair and out the hip came.

“The BHR was removed and the surgeon told my wife he had never seen such a mess. All the tissue and muscle surrounding my hip area was gone, there was nothing to support a hip. It had deteriorated.”

After being hospitalized and sent home to recuperate, Howard spiked a fever of 105° F and he says there was a liquid-like substance coming from his body. For more than nine months, Howard would remain in the hospital undergoing 12 operations performed by four different surgeons.

“The operations were not just simple clean-ups. They had to cut off part of my femur twice. They had to go through abdomen to get muscle to cover the wound that was gaping open, about the size of a fist and a half. The muscle was used to help the wound heal from the outside as it was not healing from the inside. I never saw it but my wife had to leave the room.

“One surgeon came into see how I was doing, which was 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. I was dying with so much dope and medication going in me. I was listless.  I was getting six different antibiotics a couple of times a day. After several months, the wound began to close. 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.

Howard and grandson

“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.”

Howard attributes his survival to, “God, great doctors and nurses, my loving wife, family, and friends. My Labrador retriever service dog came to the hospital regularly. My now 8-year-old grandson, the apple of my life and my beautiful granddaughters, my spirituality, and my will to survive kept me alive.”

Background – Smith and Nephew

On February 28, 2012, the BBC and British Medical Journal (BBC/BMJ) issued a joint investigation into patient complications from metal-on-metal hip implants. Researchers have known for at least a decade that metal debris was excreted in the blood of some patients and that hundreds of thousands worldwide may be at risk for the complications which can include toxic levels of cobalt and chromium ions that can seep into tissues and organs and destroy muscle and bone, leaving some patients with a long-term disability.

The BBC/BMJ (here) looked at hips made by the largest companies including J&J of New Brunswick, New Jersey; Warsaw, Indiana-based Zimmer Holdings Inc.; and Smith & Nephew Plc of London.

From S & N website

On its website, Smith & Nephew admits metal ions can be released from wear and/or corrosion once the metal hip is implanted in the body. Some individuals have developed an immune response to the particulate or metal ion/protein complexes, though the company calls the reaction “extremely rare.” And an inflammatory response known as “pseudotumors” has been reported in some patients along with fluid or soft tissue mass, largely thought the result of a higher rate of wear.

In May 2006, the FDA finally approved the BHR for sale in the U.S. after it had been rejected two years earlier. The principal investigator for Smith & Nephew who developed the device, then sold it to the company for $119 million with an additional $59 million in incentives, something a competitive company called a violation of the FDA’s own rules on conflict-of-interest.

The head of a competing company, Wright Medical Technology, of Arlington, TN challenged the FDA’s approval the second time around. In a Citizen’s Petition, dated October 29, 2005, Jeffrey G. Roberts, Senior VP Chief Technology Officer, said the approval was rife with conflicts and the BHR should never have been approved. (See the Petition here).

Because the new technology of “resurfacing” was dissimilar to anything on the market, the FDA required premarket approval (PMA) requiring clinical data to prove the artificial hip was safe and effective.

This puts the BHR in a class by itself in that most hip replacements or implants get on the market after a relatively fast-tracked FDA approval process, called 510(k), after exchanging paperwork and naming a similar device that is a “predicate” already being sold. Having a PMA approved medical device means the medical device makers enjoy immunity if their device has undergone a PMA, because the device is FDA approved.

That anti-consumer decision was made by the U.S. Supreme Court in a case known as Riegel v. Medtronic (here) and it has yet to be successfully overturned. The bottom line remains, anyone who is harmed by an FDA-approved medical device has no recourse in the courts.

Complication Rate

In the United Kingdom, MOM hip replacement patients have been tracked post operatively since May 2010 and Australia’s 2008 National Joint Replacement Registry found less than one-third of one percent of BHR implants were removed due to a metal reaction.

But in the U.S., there is no post-operative follow-up of patients. With approximately 500,000 U.S. patients with all-metal hips, there is no data on the complication rate. To correct that, the FDA in May of last year, wrote to 20 manufacturers to require post-market studies including blood samples to test for metal, and to determine the number of failures.

Andrew Burns, a spokesman for S & N, would not release figures on the number of implants or the complication rates of its product in the U.S. citing proprietary company information.

The London-based company stresses assurances of safety and in a February news release (here)
reported among 400 patients who had received the BHR, 99 percent had a successful or very positive outcome after a decade. The company sites its metallurgy and design as a reason for its success.

The BMJ report says the average failure rate at seven years is 11.8 percent for resurfacing metal hips and 13.6 percent for metal-on-metal total hip replacement, although the failure rates vary depending on the company. Compare that to the 3.3 percent to 4.9 percent failure rate of artificial hips made out of other materials.

Because the resurfacing process was new, as a condition of its May 9, 2006 FDA approval (here),  the agency required Smith & Nephew to monitor patients, take blood sample sand determine the rate of complications and removals. The company tells MDND that the findings are not publicly available.

Howard Sadwin wonders what has happened to the data.

“What did the FDA do with it? In my opinion, the FDA has not been under control since conception with strict laws, rules, and implementation of fines to these device companies when they do wrong. This is the only business on earth, the medical device world, that doesn’t seem to have to follow any rules unless it is okay with them.”

Support Team

Today Sadwin is in a wheelchair. While his plastic 16 year-old-hip has given him no problem, the S & N metal-on-metal hip was replaced on October 10, 2011 with a Regenerex® RingLoc®+ Modular Acetabular SystemBiomet, constructed with titanium.

The tissues and muscle in his hip are what he calls ‘gone’ and he walks with a shoe that is two inches higher on the right side because of the atrophy of the leg muscles. He does water therapy and lifts weights twice a week. Sadwin can walk with a walker for about 15 minutes, and can also walk with a special leg brace. Otherwise he uses the wheelchair.

He says he’s been told his quadriceps will probably not function, despite his trips to the gym.

“I work at it as hard as if I was a 30 year old guy training for sports, I don’t stop till I’m ready to leave.  Whatever it is, I have to deal with it. I have to accept the reality, I don’t dwell on it, if I did, I’d be in a mass depression. The list goes on and on and on. Who the hell knows why some people react more than others.”

Howard’s Education

Howard and grandson

“I’ve reeducated myself after talking to the second surgeon and asked ‘Did this device do this to me,’ and he said ‘Yes.’ There are scavenger ions in your body and when that device was put in, the scavenger ions created this mess, they fed off the metal-on-metal, that’s what he believes.

“My opinion is what they are telling me, I have no clue in medical jargon. It makes sense to me, all I know is I’m in a wheelchair. “

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

“Ask your surgeons about whether the hip they are putting in you will still be in in six months or six years. Ask to see the data. There is none. That data will eventually come from me, you and every other person who is going to have or had a resurfacing procedure or complete hip replacement—in other words I consider myself a test rat.”

“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 he could do whatever he wished. I understood.

“The biggest drawback when dealing with BHR clients is the lack of numbers when comparing to DePuy, ASR hips by Johnson & Johnson etc. This is a drawback in the U.S. and probably the UK. However, the fact remains there are people suffering due to this device. I am trying to reach out to these people so they seek out proper medical attention, if needed, and try to explain that they are not alone, and they need to come forward. Little by little people are coming forward.”

Sadwin reaches out as a patient advocate through the growing blog, “Earl’s View” started by Earl Stevens of New Zealand and now Australia who suffered debilitating complications after his Birmingham Spectron total hip-joint replacement. Other patients have come forward on “Earl’s View” with their tales of complications following hip replacements.

“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 that is responsible for doing this to me or to you is ever going to be changed, we must prevail. #

Learn More

Earl’s View- Forum on Hip Replacement- his story
http://earlsview.com/hip-hell/

How safe are metal-on-metal hip implants?
http://www.bmj.com/content/344/bmj.e1410

BBC- Metal hip patients need lifelong checks
http://www.bbc.co.uk/news/health-17192520

Metal-on-metal implants: FDA’s role and activities
www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm

Birmingham Hip Resurfacing System (BHR)
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078189.htm

BBC- Metal hip patients need lifelong checks
http://www.bbc.co.uk/news/health-17192520

Patient POV on metal hips/ combine with BBC and BMJ
http://www.patientpov.org/

Newcastle University, UK on Improving Metal Hip Designs
http://research.ncl.ac.uk/metalhip/

Smith & Nephew BHR
http://global.smith-nephew.com/us/14635_14636.htm

Riegel v. Medtronic decision, February 20, 2008
http://www.law.cornell.edu/supct/html/06-179.ZS.html

Citizen’s Petition by Wright Medical Technology
http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-cp00001-01-vol1.pdf

Blog, Medical Device Cases Dismissed under Riegel

http://druganddevicelaw.blogspot.com/2008/08/new-medical-device-preemption-scorecard.html


 

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6 Comments to “Suffering in Silence: Howard Sadwin’s Story of Metal-on-Metal Hip Failure”

  1. Dear Howard, I remember reading all about this and what has happened to people with these implants. SFor mne, suffering from a mesh implant and trying to live a life with pain is hard enough, What you are going through is darn right terrible. I just wanted to let you know that someone cares.

  2. Diane Fichter says:

    Dear Howard
    I am a mesh implant person also….I know how it has affected my daily living but can not fathom what you have gone through! I think it is a tragedy what you have had to go through and think your story needs to be put out there for all fellow implant or mesh patients along with potential patients. EVERYONE should know what the potential risks are PRIOR to surgery.
    Keep up the good work in bringing light to your story and know that there are people out there who care!!! We are behind you 100%….
    Take care

  3. Butch says:

    Howard,
    I too have had an early, painful failure of my Smith and Nephew metal on metal BHR hip replacement. The thing didn’t last three years, and I also now have a condition my doctor called metalosis, which are foreign ‘masses’ around my implant and are what caused the extreme pain and early failure I experienced with this new type of total hip. I was told these lesions form as a result of metal ions being released, when the metal rubbed against the metal in the Smith and nephew BHR joint (with every step). I was told these were just microscopic metal ‘shavings’, and they created these strange ‘pseudotumors’ which had to be cut out during the replacement surgery.

    So I was told I could expect twenty years from this hip, wasn’t told it was a completely new (and untested design), and three years later am having the same hip replaced again. And I have the pleasure of paying for it twice! Not only that, but all of the pain and rehabilitation gets to be repeated (and paid for) as well. These companies are using us as guinea pigs, and couldn’t care less about the human beings that are suffering because of them being used as the ‘laboratory’ for these toxic devices.

    My new (second) hip has a polyethylene liner on the pelvic side, because apparently my surgeon — who must have been hoodwinked by the device makers — no longer implants any metal on metal device. I agree this is an experience no other person should have to go through, and I would much rather have my old hip, arthritis and all, back in my body than to have had to endure this whole thing twice in 36 moths. Plus, I’m in my mid-fifties — how many more times will I need to have this done? I wonder if I’ll run out of pelvis for them to keep reaming into in order to place their artificial cups. What happens then?

    I hope you start feeling better, Howard, and I’m glad and thankful you’re speaking out. I agree that more people should be warned, and I hope all hospitals stop using these if they haven’t already. These ‘caregivers’ harmed me. I mean they simply did more harm than good in both of our cases, and I’m reading about a lot more people like us who are out there going through the same thing all over the world. But at least the word is being spread thanks to guys like you.

  4. […] of patients who have been severely injured by defective metal-on-metal hip implants.  You can read about Howard’s ordeal caused by a defective Smith & Nephew hip implant. This entry was posted in Uncategorized. […]

  5. […] TagsFDA, Food & Drug Administration, Hip Replacement, hip resurfacing, Howard, Johnson, Sarasota Memorial Hospital, UNited States Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk. […]

  6. Elizabeth Bledsoe says:

    I am sorry to report that I have the exact same story. I was told that there was nothing wrong with my hip replacement. Even though in the very short weeks after my total hip I began to have horrible pain and when I would walk (especially when going u or down stairs, you could hear my implant “squeak” like a closing screen door, it would pop in and out of place. I was sent to physical therapy but after an initial evaluation the therapist said “I am sorry but I will not touch you because I really question the “stability” of the implant.” Things just went downhill from there. I was in contact with the orthopedic surgeon that did my surgery who had me come in and all he did was do an x-ray and said “This hip is fine noting wrong with my work”. He said if you are looking for pain eds you will have to go somewhere else. I informed my surgeon that I was not looking for pain mes just wanted my quality of life returned. He refused to see me for further check-ups. His actual words were, ” you just need to exercise.” Again, I explained to him the reason I could not rehab my hip because of the instability of the implant. So i have been in pain management since that day. I have no quality of like and now find out that I have to have the surgery on the right hip and it scares me to death.
    Still suffering in severe pain with very limited mobility and really impaired quality of life. Please, please stay away from this product. …………………………………………Still suffering in Fla., Elizabeth Bledsoe

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