Lyodura
Encyclopedia
Lyodura was a medical product used in neurosurgery that has been shown to transmit Creutzfeldt-Jakob disease
, a degenerative neurological disorder that is presently incurable, from affected donor cadavers to surgical recipients. Lyodura was introduced in 1969 as a product of B. Braun Melsungen AG
, a leading hospital supply company based in Germany
.
The product was used as a quick and effective patch material for surgery on the brain
. It was a section of freeze-dried tissue which could be stored for extended periods on hospital shelves and could be made ready for use simply by soaking it in water for a few minutes.
What was not known by the consumer was the origin of the source material, the efficacy of its processing methods, and the danger of its use.
The raw material for Lyodura was the dura mater
of a human cadaver
. The tissue would usually be harvested during an autopsy
and then sold to the manufacturer. After neurological diseases were linked to use of Lyodura, an investigation determined that the manufacturer had obtained the donor tissue by black market methods. Autopsy staff would remove the tissue from cadavers, regardless of whether the deceased's family had agreed to an autopsy or not, and sell it in quantity to representatives of the manufacturer. Due to this illegal method of collection, no record of patient history accompanied the tissue to production.
Large quantities of the harvested tissue would be mass sterilized
in a heated vat. The tissue would then be freeze dried and packaged for purchase. The manufacturer believed that its sterilization procedure was sufficiently powerful to render any tissue harmless and was therefore unconcerned about cross-contamination from CJD-containing tissue to other tissue in the same sterilization vat. It is now believed that almost all Lyodura product was tainted with Creutzfeldt-Jakob disease
through this process.
An award-winning documentary was produced on the subject. CBC's The Fifth Estate
segment, Deadly Harvest, dealt with the product's history, sale in Canada, and health effects worldwide. According to the documentary, there have been more than 70 CJD-related deaths in Japan since Lyodura's distribution. The product has since been banned for use in Canada.
Creutzfeldt-Jakob disease
Creutzfeldt–Jakob disease or CJD is a degenerative neurological disorder that is incurable and invariably fatal. CJD is at times called a human form of mad cow disease, given that bovine spongiform encephalopathy is believed to be the cause of variant Creutzfeldt–Jakob disease in humans.CJD...
, a degenerative neurological disorder that is presently incurable, from affected donor cadavers to surgical recipients. Lyodura was introduced in 1969 as a product of B. Braun Melsungen AG
B. Braun Melsungen
B. Braun Melsungen AG is a German medical and pharmaceutical company, which has offices and facilities in 50 countries. Its headquarters are located in the small town of Melsungen, in central Germany...
, a leading hospital supply company based in Germany
Germany
Germany , officially the Federal Republic of Germany , is a federal parliamentary republic in Europe. The country consists of 16 states while the capital and largest city is Berlin. Germany covers an area of 357,021 km2 and has a largely temperate seasonal climate...
.
The product was used as a quick and effective patch material for surgery on the brain
Brain
The brain is the center of the nervous system in all vertebrate and most invertebrate animals—only a few primitive invertebrates such as sponges, jellyfish, sea squirts and starfishes do not have one. It is located in the head, usually close to primary sensory apparatus such as vision, hearing,...
. It was a section of freeze-dried tissue which could be stored for extended periods on hospital shelves and could be made ready for use simply by soaking it in water for a few minutes.
What was not known by the consumer was the origin of the source material, the efficacy of its processing methods, and the danger of its use.
The raw material for Lyodura was the dura mater
Dura mater
The dura mater , or dura, is the outermost of the three layers of the meninges surrounding the brain and spinal cord. It is derived from Mesoderm. The other two meningeal layers are the pia mater and the arachnoid mater. The dura surrounds the brain and the spinal cord and is responsible for...
of a human cadaver
Cadaver
A cadaver is a dead human body.Cadaver may also refer to:* Cadaver tomb, tomb featuring an effigy in the form of a decomposing body* Cadaver , a video game* cadaver A command-line WebDAV client for Unix....
. The tissue would usually be harvested during an autopsy
Autopsy
An autopsy—also known as a post-mortem examination, necropsy , autopsia cadaverum, or obduction—is a highly specialized surgical procedure that consists of a thorough examination of a corpse to determine the cause and manner of death and to evaluate any disease or injury that may be present...
and then sold to the manufacturer. After neurological diseases were linked to use of Lyodura, an investigation determined that the manufacturer had obtained the donor tissue by black market methods. Autopsy staff would remove the tissue from cadavers, regardless of whether the deceased's family had agreed to an autopsy or not, and sell it in quantity to representatives of the manufacturer. Due to this illegal method of collection, no record of patient history accompanied the tissue to production.
Large quantities of the harvested tissue would be mass sterilized
Sterilization (microbiology)
Sterilization is a term referring to any process that eliminates or kills all forms of microbial life, including transmissible agents present on a surface, contained in a fluid, in medication, or in a compound such as biological culture media...
in a heated vat. The tissue would then be freeze dried and packaged for purchase. The manufacturer believed that its sterilization procedure was sufficiently powerful to render any tissue harmless and was therefore unconcerned about cross-contamination from CJD-containing tissue to other tissue in the same sterilization vat. It is now believed that almost all Lyodura product was tainted with Creutzfeldt-Jakob disease
Creutzfeldt-Jakob disease
Creutzfeldt–Jakob disease or CJD is a degenerative neurological disorder that is incurable and invariably fatal. CJD is at times called a human form of mad cow disease, given that bovine spongiform encephalopathy is believed to be the cause of variant Creutzfeldt–Jakob disease in humans.CJD...
through this process.
An award-winning documentary was produced on the subject. CBC's The Fifth Estate
The fifth estate
the fifth estate is a Canadian television newsmagazine, which airs on the English language CBC Television network. The name is a play on the fact that the media are sometimes referred to as the Fourth Estate, and was chosen to highlight the program's determination to go beyond everyday news into...
segment, Deadly Harvest, dealt with the product's history, sale in Canada, and health effects worldwide. According to the documentary, there have been more than 70 CJD-related deaths in Japan since Lyodura's distribution. The product has since been banned for use in Canada.