My Mum and the St Jude Silzone Heart Valve

 

Those of you who know me or read this blog will have heard me mention my mum and that she passed when my boy was small. Those of you who know me well may have heard me mention that she had heart valve surgery not long before she died, or that there is a complicated backstory around her death. Over the years I have become increasing frustrated with this subject and today I’m taking the step to explain what I can. It’s long and I hope you stick with me.

2014 sees the 15th anniversary of my mother's passing. She was 55 years old and had 6 children. My youngest brother was 14 when she died. My sister first came into the care of my mum and dad at 1 year old through the foster care system. At the time of her death she was grandmother to 5 grandchilden, 3 by my sister, 1 by my brother, and my son who was diagnosed with an intellectual disability and autism only weeks before. She was also carer to countless others kids. It wasn't unusual for our garden to be filled with children playing or for my older brothers to bring home their friends for plates of egg and chips. One older teen stayed for six months after trouble at home.

Before I was born she was a hairdresser and owned her own business. I was spoiled and didn’t have to do chores around the house(although I eventually did without being asked). My brother, who did have to, told me she said there would be expectation of that as a woman when I grew up. She didn't see the need for car gears other than 2nd and 3rd. She loved the sun and had a holiday booked for Portugal when she died. She was the life of any party, and people loved being in her company. A spice rack on our kitchen wall reads "Feeding the Multitudes by Evelyn Oates" and was made by the father of two of the kids she minded. It was a nod to her many words of wisdom, her enormous dinners, the mounds of Sunday baking, the many who ate at her table including students and lecturers from All Hollows College in Drumcondra while it was still a seminary.

At her funeral, the local priest commented he had never seen a gathering of so many young people for the passing of an adult. The church holds hundreds and yet there were people out the door. Among the cards and messages were notes from people she had helped over the years, many of whom were not known to the family. What I've given you there isn't even a scrap of the person. She didn't boast of her goodness. She was just good.

She was immensely proud of her children, but didn't get to see her youngest graduate school and then college, or see me publish my first book, which was dedicated to her. She didn't get to meet her other grandchildren or my sister's first grandchild.

I remember the day I knew she was sick. She walked a lot and this one day we were walking from the city. We came to a small hill, barely more than a slope and she couldn't walk over it without resting.  I tell you all this because when reading the following, I want you to see her as a person, not a statistic.

She died the end of July, 1999. 8 days after a check up said all was fine and 5 months after heart surgery in February of the same year to replace the mitral heart valve with a St Jude Medical Silzone Heart Valve. In plain language she suffered a blood clotting of the valve. Clots can sometimes happens in a small minority of any valve replacement.

It was suggested by the consultant in a meeting with my brother and father that in this instance, it was perhaps a production fault(using a car as an example, 1 in 20,000 coming off production) or a course of antibiotics interfered with the anti-coagulant drugs.

Her doctor confirmed that she had not been on antibiotics and at the beginning of 2000, St Jude Medical indicated by email that the production fault was not to blame. At the time, St Jude Medical also indicated they encourage hospitals to report incidents involving the valve but could not be held responsible for procedures or lack thereof for hospitals and governments reporting them. An email also indicates the study that prompted the recall(below) showed no increased clotting.

Introduced in 1997, the St Jude Silzone was similar to previous models but with a silzone coating on the sewing cuff. FDA approved the silzone-coated valve in 1998 on the basis they weren't marketed as having less risk of endocarditis, simply because testing had not been conducted yet to show this. It’s alleged it was introduced to the European market in 1997 with virtually no clinical testing(60 patients and 5 sheep, one of which died and was removed from the study but found to have a large blood clot on it’s lung).

Also in 1997 the Cardiff Embolic Risk Factor Study, began including Silzone patients in the trial. Less than Two year later the doctor in charge reported to the British agency that regulates medical devices. While 1 of the 115 patients with the conventional valve suffered clots, 7 of 51 Silzone patients in the study had suffered strokes, and 5 more were suspected.

From Eric Butchart, Surgeon(CERFS): “In my opinion the large differences in thromboembolism are clinically significant and the incidence of thromboembolism after mitral valve replacement is so high that the Silzone valve would almost certainly not have received FDA approval if these figures had been submitted in pursuit of approval of a new prosthesis."

St Jude Medical received Butchart’s report in late 1998 and investigated it in conjunction with UK and US regulatory agencies. However, because the findings were found to be different to the larger AVERT trial, they were set aside.

The British government issued a warning at the end of 1999.

Meanwhile, A lady in Northern Ireland died in July, 1998, of “Thrombotic occlusion of St Jude's medical Prosthetic mitral heart valve - Silzone coated”. A blood clot. Her husband later pursued through the courts.

The Artificial Valve Endocarditis Reduction Trial (AVERT) began in 1998(estimated conclusion was to be 2014),

A DSMB meeting held April, 1999 in response to concerns that the Silzone valves showed higher thromboembolic event rates at one U.K. centre. It was considered not statistically significant enough to halt the study and was appropriate to continue patient enrolment. Another meeting in November of the same year came to the same conclusion.

The study was eventually halted because the increased risk of paravalvular leakage became apparent. A random cross section of patients from America and Europe showed of 403 patients given silzone valves, 18 suffered leakage verses 4 of the 404 patients without silzone valves.

The valve was officially withdrawn in 2000 by St Jude Medical, citing  AVERT. Approximately 36,000 of these valves were implanted.

Although initially my father was informed that my mother did not receive a silzone valve. This was confirmed by obtaining medical records with the valve serial number and contacting St Jude Medical.

This is a transcript of an article published in THE EXAMINER, Ireland in April 2000.

Husband wants to know the truth of wife's death

“The devastated widow of a woman who died after receiving a possibly defective heart valve last night appealed to Health Minister Micheal Martin to investigate the cause of her death.
St Jude Medical, a US company, recalled a batch of silzone-coated heart valves last November when a small minority of them appeared to be defective. The company warned patients who had been fitted with heart valves to have a check-up.
It has now emerged that 20 Irish patients who received this silzone-coated valve died before they could be tested.
Dubliner Evelyn Oates died last July before the warning was issued. Her husband Thomas has now received confirmation from St Jude Medical that she was fitted with a valve from the suspicious batch, but they could not confirm whether the valve she received was defective.
Mr Oates is now calling on Minister Martin to launch an investigation.
"I am not looking for compensation just to know if my wife, Evelyn, was given one of these recalled valves," he said.
National Cardiac Surgical Unit Director, Maurice Neligan, who oversaw the re-examination of patients fitted with the suspicious batch, confirmed that 213 Irish patients were fitted with the valves in the past two years.
But only 193 were alive when the US company withdrew the batch. Me Neligan stressed that none of these 20 deaths were as a result of a leaking valve - many patients died during surgery.
And the 193 patients who came back for a check-up did not have any problems that merited further surgery, Mr Neligan said.
Mr Oates lost his wife last July when she died following heart surgery.
That was the official cause of  death in the coroner's report, which also stated that this is a well recognised complication of heart valve surgery, and in no way implies a defect in the valve.
But when Mr Oates first read about the recall of the silzone valves in The Examiner, he immediately checked his wife's medical records to see which one she had received.
After months of trying to secure her medical records he got the number and type of valve she received. And St Jude's Mechanical Heart Valves Marketing Manager, Tina King, confirmed that particular serial number was in fact one of the batch of silzone valves that had been recalled.
And now Mr Oates wants Minister Martin to investigate the true cause of his wife's death, because US company, St Jude Medical is only answerable to the American Food and Drug Administration.
A spokesman for Minister Martin could not be reached when going to press.”

Needless to say, we never heard from Minister Martin, now leader of his political party. A later article from another paper stated no one in Ireland had died as a result of these silzone valves being used here.

In 2010, insurers covering St Jude Medical attempted to remove responsibility for paying out on claims, but courts found in favor of St Jude Medical.

In 2012, the Independent Newspaper reported a Dublin man is a key claimant in a US class action suit against St Jude Medical concerning a allegedly defective artificial heart valve. The article was titled EU 'guiea pigs' in heart valve compensation claim. The article goes on to say: “St Jude Medical used Europe as a testing ground for its Silzone valves and labelled the continent the "guinea pig" area, solicitors Leigh, Day and Co, representing the claimants, said yesterday.”

Also in 2012,  in Canadian court, a class action found that St Jude Medical didn't know that there were issues with this valves and so concluded St Jude Medical was not negligent. In 2013, on appeal, an agreement of monetary compensation without liability was reached.

Cases are still on-going in the US.

In conclusion, I’m not stupid. I know there is absolutely nothing that can bring my mum back. But am I bitter about it? Heck yeah. I am bitter that her death might have been prevented, that she didn’t understand the valve was new and virtually untested. That the increased risk of thrombosis wasn’t considered statically significant in the April before she died. That when she died in 1999, no one mentioned on going studies suggested any increased risk, that we found out how we did through a newspaper article. I’m bitter that my brother had to track down the information on the valve she received.

I’m bitter because almost 15 years later, my family still has no real closure. Because of that my family will never get over this. This has broken all our hearts.

Mostly, I’m bitter that her death is given no credence in any discussion of these valves because it’s not considered to be associated with the specific valve she received. All my family wanted was answers and instead hit roadblocks.