Mesh after removal

May 10, 2012 ~ ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the marketplace every year that do not undergo Food and Drug Administration (FDA) scrutiny.

The bottom line – medical devices are big business bringing over $100 billion-a-year to the industry, giving industry the muscle to get what it wants – products to market quickly and with the least cost.

Unlike the scrutiny drugs must undergo, when a medical device is fast-tracked onto the market without premarket review for safety, the public becomes the real-world clinical trial and we see the complications.

The fast-track process is called 510(k) and after a fee and an exchange of paperwork, the manufacturer must name a ‘predicate’ or a device already on the market that their new device resembles.  The new device is okayed for marketing by the FDA. The Institute of Medicine last spring called the 510(k) process “fatally flawed” and recommended it be abolished, but the FDA did not adopt the recommendation of the IOM.

Most low, medium and some high-risk permanently implanted medical devices are put on the market through the 510(k) process.

In January, 31 mesh manufacturers received letters from the FDA requiring three years of post-implant surveillance to monitor the complication rate. This is after the device is already implanted in women. Background story is here.

It should come as no surprise then that transvaginal mesh, used in women, makes the Big Four.

Prolene mesh

Surgical Mesh

ProPublica reports implantable surgical mesh is a reinforcement structure used to shore up organs that have prolapse through the vagina or to treat stress urinary incontinence.

Problems: First used in the 1990s to fix internal hernias, the invention of surgical mesh “kits” appear to have accelerated the rate of complications with the FDA noting in 2011 that the thousands of complications reported to the agency represented a five-fold increase in recent years and an average of 15 percent a year over the past decade. When the FDA reported that complications are not rare and that the benefits of using polypropylene mesh may not be worth the risks, lawsuits were filed by the hundreds against the four main manufacturers, Boston Scientific, Ethicon, C.R Bard and American Medical Systems.

The industry continues to report that mesh is safe and any problems are due to the training of implant surgeons.

Hip Implants

As the Baby Boomer population ages, thousand of Americans are affected by advanced arthritis and broken hips and get a total hip replacement. Traditionally the implants contain a metal head that fits into a plastic cup. In 2005, Johnson & Johnson’s DePuy Orthopaedics introduced a metal-on-metal (MOM) hip claiming it was  “substantially equivalent” to other artificial hips already being marketed. With the exception of the MOM hips that used a novel approach called “resurfacing,” metal hips went on the market after passing 510(k) scrutiny for substantial equivalence.

DePuy metal hip

Problems: According to the British Hip Society, the DePuy had a failure rate of almost half of the patients who received implants within six years. Hips are designed to last about 15 before they need to be replaced but patients had metallic particles in the blood and surrounding tissue. Joint pain from metal caused thousands of complaints and lawsuits. The DePuy was recalled in 2010 based on new information the company said it received, but not before almost 100,000 patients had the DePuy hip implanted.

Heart valves, from ProPublica

Heart Valve Rings

Heart valves or annuloplasty rings are a circular device that pinch together flaps of the heart valve to prevent blood from flowing back into the lungs or heart. Originally classified as high risk or Class III, they were supposed to go through premarket approval (PMA), a process that requires clinical studies to prove a device is safe before it makes it to the market. That all changed in 1997. After petition the government, the FDA agreed to lower the class risk to Class II or moderate-risk even though the rings were implanted putting it in a class with sutures and hearing aids.

That means if you seek a replacement heart valve, you can be sure the medical device has gone through rigorous FDA examination, not so for the rings which undergo 510(k) approval for sale. Advanced Medical Technology Association, AdvaMed, the aggressive industry trade group was behind the reclassification, reports a Chicago Tribune investigation.

Problem: Annuloplasty rings top Class II in the number of deaths. ProPublica reports manufacturer, Edwards Lifescience, didn’t even bother to go through the fast-track 510(k) clearance process, instead marketing the Myxo ring which was implanted in more than 100 people without any FDA clearance.  The FDA let the company off the hook saying it made an “honest attempt” to interpret the regulations.

Defibrillator lead, ProPublica

Defibrillator Leads

A defibrillator can be implanted in the chest of a cardiac patient to deliver life-sustaining shocks when it suspects heart failure. Leads connect the defibrillator to the heart and they are supposed to deliver the shock when needed, then shut off.  However problems arose when faulty defibrillator leads fired unexpectedly or failed to fire when needed. The industry is a $10 billion dollar one that has had more than its share of failures and lawsuits.

Problems: The St. Jude’s Riata lead was recalled last year because of a potential to short circuit in the body or deliver a high voltage, but not before about 79,999 patients received the medical device. The group reports the maker knew about the problems for a full year before the recall. That led to an additional 20 deaths. The company says the device went in for a redesign and is conducting a study of the Riata lead.

Knowing there is a problem with medical devices and the people they harm, the FDA is considering an enhances premarket, postmarket and compliance plan, but that takes additional funding, a portion of which comes from the very medical device industries the FDA monitors.

Learn More:

ProPublica
http://www.propublica.org/special/four-medical-implants-that-escaped-fda-scrutiny

CDRH 2012 strategy
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/ucm288735.htm#Strategy1_1

Chicago Tribune -heart valve ring and AdvaMed petitioned the FDA to lower class
http://articles.chicagotribune.com/2011-05-22/health/ct-met-medical-devices-20110521_1_annuloplasty-rings-faulty-heart-valve-diana-zuckerman

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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 System – Biomet, 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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