Lyodura

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Lyodura was in the neurosurgery used medical product of B. Braun Melsungen AG , which is the Creutzfeldt-Jakob disease ( CJD or CJD may be transmitted); the risk of infection was around 0.04% in Japan (one patient with 2268 applications) and around 0.25% in Australia (five patients with 2208–2478 applications). It came on the market in 1969; after an unsuccessful change in the manufacturing process, B. Braun stopped production in 1996.

The product was used as a simple and efficient patch in brain surgery. It consisted of a piece of freeze-dried tissue that could be stored for an extended period of time and was made ready for use by soaking in water.

The raw material for Lyodura was the meninges of human corpses. This was usually collected at autopsies and then sold to the manufacturers. After a number of neurological disorders were linked to the use of Lyodura, an investigation followed which eventually found that the donor tissue was purchased on the black market . The personnel responsible for the autopsies removed the meninges from the dead without the relatives knowing about it, in order to then sell it in large quantities to B. Braun Melsungen AG . This procurement method also meant that there were no patient files for the donor material.

Large quantities of the donor tissue were heat sterilized together, then freeze dried, and then packaged for sale. The manufacturers were convinced that this sterilization process was sufficient, which is why cross-contamination within the devices was excluded. It later became known that almost all Lyodura products contained traces of Creutzfeld-Jakob through this process.

In Canada , an award-winning documentary drew attention to the grievances. Accordingly, there have been more than 70 deaths associated with Creutzfeldt-Jakob in Japan since Lyodura was introduced. A 2004 study listed a total of 120 cases of CJD occurring after using Lyodura.

In 2002, B. Braun Melsungen reached an agreement with the Japanese health authorities to pay compensation to the victims' families in the amount of over US $ 600,000 each.

Individual evidence

  1. ^ A b F. Brooke, A. Boyd, GM Klug, CL Masters, SJ Collins: Lyodura use and the risk of iatrogenic Creutzfeldt-Jakob disease in Australia. Med. J. Aust., February 16, 2004; 180 (4): 177-81.
  2. ^ Friedemann Hottenbacher: German pharmaceutical company sued in Japan. Report in the taz from March 25, 1998.
  3. ^ Health Canada bans 'brain patch' linked to brain disease. CBC News, April 15, 2002.