LUVMyBirman
Well-known member
You may recognize this article as our member Billy from Ireland and his wife's Silzone events are highlighted. I feel this information needs to be out here. Do not intend for it to frighten anyone. Let's put our thoughts and engery with Billy and his family. Thanks.
Heart Valve Killed My Wife
Aug 21 2003
By Karen Quinn
AN Ulsterman whose wife died after being implanted with a defective heart valve has begun High Court action against the manufacturers of the device.
Myrtle McCombe, 44, was found dying on her bed by the couple's 15-year-old son just 10 weeks after having the Silzone valve fitted in 1998.
A post-mortem by Northern Ireland state pathologist Jack Crane recorded the cause of death as the Silzone coated heart valve, manufactured by St Jude Medical.
Yesterday, her grieving husband Billy took his fight for justice to London's High Court. "I don't think we will ever get over her death. It has devastated our family,'' he said.
"I had no idea what a Silzone valve was or that Myrtle had been implanted with one, until I read the post-mortem report. I feel that St Jude have a lot of questions to answer about their conduct over this product.''
Mr McCombe's solicitor, Richard Meeran, partner at Leigh, Day & Co, claimed it was going to be hard for St Jude to defend the case.
"The Consumer Protection Act imposes strict liability on manufactures and importers of products for injuries caused by defects in these products.
"Many people in this country may potentially have been seriously harmed by this product. The circumstances under which the Silzone valve was introduced into the European market by St Jude, with no or virtually no clinical testing, needs to be fully investigated.''
St Jude Medical applied a silver coating (Silzone) to a range of their conventional, tried and tested heart valves, with the stated aim of reducing the incidence of infective endocarditis.
However, in April 1988 a medical publication by Montana State University alleged that the Silzone coating attracted bacteria.
In the same year, a British surgeon reported a 25 per cent failure rate in patients implanted with Silzone valves.
It is claimed at one UK centre seven out of 51 patients implanted with the valve suffered complications such as strokes. In one Northern Ireland centre there were three deaths in a group of 15-20 patients.
In November 1999 the Medical Devices Agency issued a notice highlighting possible risks of thromboembolic complications among patients with Silzone heart valve and in January 2000 it issued a recall notice prohibiting further usage of the Silzone valve.
Later, an international study found an eight-fold increase in leakages associated with Silzone heart valves compared to conventional uncoated valves.
In 2000, St Jude Medical initiated a world-wide recall of all Silzone heart valves.
Heart Valve Killed My Wife
Aug 21 2003
By Karen Quinn
AN Ulsterman whose wife died after being implanted with a defective heart valve has begun High Court action against the manufacturers of the device.
Myrtle McCombe, 44, was found dying on her bed by the couple's 15-year-old son just 10 weeks after having the Silzone valve fitted in 1998.
A post-mortem by Northern Ireland state pathologist Jack Crane recorded the cause of death as the Silzone coated heart valve, manufactured by St Jude Medical.
Yesterday, her grieving husband Billy took his fight for justice to London's High Court. "I don't think we will ever get over her death. It has devastated our family,'' he said.
"I had no idea what a Silzone valve was or that Myrtle had been implanted with one, until I read the post-mortem report. I feel that St Jude have a lot of questions to answer about their conduct over this product.''
Mr McCombe's solicitor, Richard Meeran, partner at Leigh, Day & Co, claimed it was going to be hard for St Jude to defend the case.
"The Consumer Protection Act imposes strict liability on manufactures and importers of products for injuries caused by defects in these products.
"Many people in this country may potentially have been seriously harmed by this product. The circumstances under which the Silzone valve was introduced into the European market by St Jude, with no or virtually no clinical testing, needs to be fully investigated.''
St Jude Medical applied a silver coating (Silzone) to a range of their conventional, tried and tested heart valves, with the stated aim of reducing the incidence of infective endocarditis.
However, in April 1988 a medical publication by Montana State University alleged that the Silzone coating attracted bacteria.
In the same year, a British surgeon reported a 25 per cent failure rate in patients implanted with Silzone valves.
It is claimed at one UK centre seven out of 51 patients implanted with the valve suffered complications such as strokes. In one Northern Ireland centre there were three deaths in a group of 15-20 patients.
In November 1999 the Medical Devices Agency issued a notice highlighting possible risks of thromboembolic complications among patients with Silzone heart valve and in January 2000 it issued a recall notice prohibiting further usage of the Silzone valve.
Later, an international study found an eight-fold increase in leakages associated with Silzone heart valves compared to conventional uncoated valves.
In 2000, St Jude Medical initiated a world-wide recall of all Silzone heart valves.
