Lyodura

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title: "Lyodura" type: doc version: 1 created: 2026-02-28 author: "Wikipedia contributors" status: active scope: public tags: ["medical-scandals", "drug-safety"] description: "Medical product now known as a transmitter of Creutzfeldt–Jakob disease" topic_path: "general/medical-scandals" source: "https://en.wikipedia.org/wiki/Lyodura" license: "CC BY-SA 4.0" wikipedia_page_id: 0 wikipedia_revision_id: 0

::summary Medical product now known as a transmitter of Creutzfeldt–Jakob disease ::

Lyodura was a medical product used in neurosurgery that has been shown to have a risk of transmitting Creutzfeldt–Jakob disease, a degenerative neurological disorder that is 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. As suggested by the name, Lyodura consisted of lyophilized dura mater. Lyophilization is a technical term for freeze-drying.

Until 1987, Lyodura was manufacted by mixing together harvested tissue from different donors. The dura matter was then sterilized in batches using gamma radiation and freeze-drying. The manufacturer believed that its sterilization procedure was sufficiently powerful to render any diseases in the 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 of the Lyodura product that was contaminated, almost all was tainted through this process.{{cite journal | last1 = Ae | first1 = Ryusuke | last2 = Hamaguchi | first2 = Tsuyoshi | last3 = Nakamura | first3 = Yosikazu | last4 = Yamada | first4 = Masahito | last5 = Tsukamoto | first5 = Tadashi | last6 = Mizusawa | first6 = Hidehiro | last7 = Belay | first7 = Ermias D. | last8 = Schonberger | first8 = Lawrence B. | title = Update: Dura Mater Graft–Associated Creutzfeldt-Jakob Disease — Japan, 1975–2017 | journal = Morbidity and Mortality Weekly Report | publisher = Center for Disease Control and Prevention | location = Atlanta, Georgia | date = March 9, 2018 | volume = 67 | issue = 9 | pages = 274–278 | language = English | doi = 10.15585/mmwr.mm6709a3 | doi-access = free | pmid = 29518068 | pmc = 5844283 | archive-url = https://web.archive.org/web/20090512061017/http://www.fda.gov/ora/fiars/ora_import_ia8403.html | archive-date = May 12, 2009 | url = https://www.fda.gov/ora/fiars/ora_import_ia8403.html | url-status = dead | title = FDA Import Alert #84-03 | date = June 27, 1987 | website = Office of Regulatory Affairs | publisher = Food and Drug Administration | access-date = September 5, 2024

The manufacturer did not keep records that allowed contaminated product to be traced back to a specific donor. According to an article published in 1991, "unsubstantiated reports suggested that donor screening was not rigidly adhered to."

Lyodura was removed from sale in 1996. The World Health Organization recommended in 1997 that the medical field move away from cadaver-sourced dura mater grafts due to the risk of transmitting Creutzfeldt–Jakob disease highlighted by Lyodura-related cases.{{cite web | url = http://www.who.int/emc/diseases/bse/tse_9703.html | url-status = dead | archive-url = https://web.archive.org/web/20000816220438/http://www.who.int/emc/diseases/bse/tse_9703.html | archive-date = August 16, 2000 | title = Report of a WHO Consultation on Medicinal and other Products in Relation to Human and Animal Transmissible Spongiform Encephalopathies | date = March 24–26, 1997 | website = Communicable Disease Surveillance and Response | publisher = World Health Organization | access-date = September 6, 2024 | quote = "The group strongly recommended that cadaveric dura mater grafts ... no longer be used, especially in the case of neurosurgery, unless no alternative is available"

The product's largest consumer was Japan. By 2017, 154 patients in Japan had been diagnosed with Creutzfeldt–Jakob disease after receiving dural grafts. Every patient where the brand of graft could be identified from medical records had received a Lyodura graft. Patients continued to develop symptoms up to thirty years after their surgery.

An award-winning documentary was produced on the subject. The Canadian Broadcasting Corporation's The Fifth Estate segment, "Deadly Harvest", dealt with the product's history, sale in Canada, and health effects worldwide. The product has since been banned for use in Canada.

References

References

1. (August 1999). "Use of lyodura for bone augmentation of osseous defects around dental implants". Journal of Periodontology.
2. (2004-02-16). "Lyodura use and the risk of iatrogenic Creutzfeldt–Jakob disease in Australia". The Medical Journal of Australia.
3. (1991). "Creutzfeldt-Jakob Disease from allogeneic dura: a review of risks and safety". Journal of Oral and Maxillofacial Surgery.
4. "CBC News: The fifth estate: Deadly Harvest - Fact Sheet on Lyodura".
5. "CBC News: The fifth estate: Deadly Harvest - Fact Sheet on Lyodura".
6. "CBC News: The fifth estate: Deadly Harvest".
7. [https://web.archive.org/web/20121026105416/http://www.cbc.ca/news/story/2002/04/12/brainpatch_020412.html CBC news article announcing Lyodura ban. 2002]

::callout[type=info title="Wikipedia Source"] This article was imported from Wikipedia and is available under the Creative Commons Attribution-ShareAlike 4.0 License. Content has been adapted to SurfDoc format. Original contributors can be found on the article history page. ::