One of the victims of the stolen body parts scandal, who received an implant of potentially contaminated bone during surgery on the NHS in September 2005, has welcomed new regulations which come into force today (5 July 2007) to regulate the safety and quality of human tissue used in surgical procedures.
The Human Tissue (Quality and Safety for Human Application) Regulations 2007 extend the requirement under the Human Tissue Act 2004 that certain activities involving the use of human tissue should only be carried out by licensed parties to the import and export of human tissues and cells.
Delwyn Herridge (40) from Ebbw Vale, Blaenau Gwent, received a bone implant during surgery to treat a fractured vertebra in his back at the University Hospital of Wales in September 2005. . He has since learned that the implant consisted of bone product supplied by an American company which had been harvested in an unauthorised manner and which may have been contaminated or otherwise defective.
The quality of the bone Mr Herridge received could not be properly verified as documents in relation to its origin had allegedly been forged by the gangs. Once the potential problem with the implant was discovered he had to undergo tests to establish whether he had contracted diseases such as syphilis, HIV and Hepatitis from the potentially contaminated bone. Although these tests were clear, he is still concerned about the long term implications for his health.
After 5 July 2007 it will be an offence to procure, test, process, distribute, import or export tissue and cells intended for human application without being licensed by the Human Tissue Authority. The new Regulations also aim to ensure that donations of human tissue can be traced, are subject to stringent selection criteria to ensure their quality and that any adverse reactions or events in relation to the use of such tissue are recorded in a central register and communicated to relevant parties.
Mr Herridge said I support wholeheartedly any attempt to ensure that human tissue intended to be implanted in humans is of the highest quality. Unfortunately the bone that I received was not subject to such regulation and as a result I am left with the possibility that I might contract disease as a result of the implant, or that the implant might fail requiring me to undergo further surgery. Anything that could potentially prevent other people from having to suffer this kind of worry and possible future complications is very welcome.
Clive Garner, Partner at national law firm Irwin Mitchell, is representing Mr Herridge and other clients with claims arising from potentially defective or contaminated tissue implants. He said We welcome the new regulations in this area which should reduce the risk of similar problems in the future. Of course this tightening of procedures has come too late for my clients and it is highly regrettable that these safeguards were not in place long before now.
We are working with Colleagues in the US with a view to commencing legal proceedings there to recover compensation for the enormous worry and stress caused to the recipients of these implants and more importantly to ensure that they are fairly compensated for any injury or other complications that they may suffer in the longer term..