Valve Recall - TRI Technologies - Brazil

[RobThatsMe]

Hello Everyone,

I thought this worthy of posting, especially with so many now visiting the site world-wide.

Rob

Heart valve recall ordered after patient's death

Apr 15 (Reuters Health Spain) - Spain's Ministry of Health and Consumption has ordered the withdrawal from the market of artificial heart valves made by a Brazilian company after Italian health officials reported that the device was tied to a patient's death, ministry sources confirmed to Reuters Health Spain.

The valves are made by Brazil-based TRI Technologies.

Last Thursday, Italian health authorities alerted European Community countries of the death of a patient in whom a TRI valve had been implanted, the Spanish ministry told Reuters Health Spain.

One day later, the General Directorate of Pharmacy and Health Products advised the regions of the event and ordered the product's withdrawal.

The notice warns that "the autopsy report of the deceased patient in Italy points to a defect in the mechanical aortic valve that was implanted in the patient 11 days earlier," although the problem is not specified, official sources indicated to Reuters Health Spain.

According to ministry sources, to date the valve has been implanted in 13 Spaniards in three medical centers. Representatives at these centers informed Reuters Health Spain that the 13 heart patients were enrolled in a clinical trial begun in 2001 by the manufacturing company. The trial has been halted.

The 13 implanted patients are being monitored by cardiologists, who will decide "if it is warranted to subject the patients to a new operation to replace the prosthesis," the Ministry said.

The valve in question has not been approved by the US Food and Drug Administration.



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HeartCenterOnline Commentary:
For additional information about artificial heart valves and other issues related to valvular heart disease, visit HeartCenterOnline's Heart Valve Center.

 

[LUVMyBirman]

Thanks Rob. Never heard of that valve. Must be a 'European' thing?

It seems they try out the newer technologies before they get to the states. I just hope when new product is used the recipient is well aware of the controversial nature before trying something that does not have a 'proven' track record. Seriously, isn't there a way these valves can be tested in a non human subject before? It's downright upsetting

 

[hensylee]

I saw this one, too, Rob - think it was Medscape? We really need to be reminded of the care when choosing any procedure and always keep in mind that two loved ones of our family members were lost because of this sort of negligence. Upcomers, take note and be educated. God bless

 

[Jack]

Italian hospital caught up using defective heart valves

Italian hospital caught up using defective heart valves

Some surgeons are facing prison and suspension from clinical practice over accusations that they took bribes of between 10% and 20% of the purchase price for the valves, which came with the standard CE Mark and ISO 9001 certification.

Check it at:

http://www.heartcenteronline.com/myheartdr/home/research-detail_print.cfm?reutersid=3208

Jack.

 

[Billy]

Thanks Jack............

Thanks Jack............

Thanks Jack for this recent information on yet another recalled valve.

My wife died four years ago aged 44, ten weeks after implantation of the infamous St. Jude 'silzone' coated mitral valve. It also had the European 'CE' mark which I now realise stands for 'confusion everywhere.'

It also was not approved by the FDA when it was sent to Europe for testing. In fact it was in use in Europe for well over a year before the FDA gave their approval.

I wondered how a valve could be manufactured in one country and sent to another for use before it was approved 'at home.' Now I know. Having read the transcripts of the early stages of the litigation process in Minnesota, St Jude Medical Company actually refers to Europe as 'the guinea-pig continent.'

With 'friends' like them, who needs enemies?

It is all so clear now......they send these prototype valves to Europe for testing as we don't have punitive damages in Europe. I really don't know how they get the 'CE' mark awarded - well, anyway it's not worth the paper it's written on. They ignore, or deny any shortcomings in the valve's performance and unless a ****-load of folks fall down dead, they carry on regardless and hope that it will all come out OK in the end.

My wife's surgery was in April 1998 She died in July of the same year and St Jude ignored the notification of her death. They didn't even ask to have the explanted valve returned for analysis. They carried on implanting the 'silzone' valve into over 10,500 patients till January 2000 when they were shamed into recalling it.........and all because they could charge an extra $300 for each of their deadly devices.

Now I wonder what percentage they paid the European Surgeons, or did they just do a bullshit marketing exercise.

I intend to find out............and I will.