THE LYODURA STORY
A short timeline that tells the history of the product, Lyodura.
Go to Fifth Estate to read about 14 year old Dominic Roy-Régimbald,
a Canadian boy who died after recieving a Lyodura implant.
1969 Lyodura was a medical product made with material
harvested from cadaver's brains.
The German manufacturer B.Braun Melsungen AG introduces a new
product called Lyodura. It is processed dura mater. Dura mater is the tough outside membrane covering the brain. Lyodura is
dura mater obtained from cadavers, then soaked in disinfecting chemicals and treated with radiation. (read more about Lyodura)
Early 1970's Lyodura is distributed to Canadian hospitals.
It will be for nearly 20 years.
1973 Japanese health ministry authorizes import of Lyodura
1987 Gayle Bourquin died after recieving a Lyodura implant
alerting health officials in the US to the problem.
Turning point in Lyodura's history. Gayle Bourquin, a 28-year-old
Connecticut woman, sick with Creutzfeldt-Jakob Disease, comes to the attention of Yale University doctors. She is the first
reported case of CJD that is linked to Lyodura. She had been implanted - two years before her death- with lot number 2105
that had been sold to Saint-Francis Hospital by Tri Hawk International, a Montreal distributor. (read more about CJD)
March Gayle Bourquin dies of CJD.
April The U.S. Food and Drug Administration issues
a Safety Alert to US doctors and hospitals recommending the disposal of all Lyodura from packages bearing a four-digit number
beginning with a 2, as well as all unmarked Lyodura.
Health Canada official Dr. Blais had been sounding the alarm
about Lyodura for years.
May Health and Welfare Canada issues an Alert to
hospitals with departments of neurology, neuro-surgery, otolaryngology, plastic surgery gynecology and urology. They are told
not to use Lyodura believed to be related to the same batch that was used in Connecticut. Distributors were asked in March
to contact their customers and begin a recall of the product from Canadian hospitals.
B.Braun Melsungen AG is told by Health Canada that Lyodura
now needs a " Notice of Compliance ". In other words, the German company has to prove the safety of its product before it
can be sold again into Canadian hospitals.
1988 A year after the Alert, three- year-old Dominic
Roy-Régimbald is implanted in Montreal with a Lyodura graft. So is Guiseppe Armata, a Toronto-area horse trainer. (Read more
about Dominic's Story)
1992 B.Braun Melsungen AG's official Canadian distributor
-Tri Hawk International - is charged with illegally selling Lyodura in this country. The company is later fined $2151.36.
In September. Toronto horse-trainer Giuseppe Armata dies of CJD at age 39. It is believed to be the first officially reported
case of CJD linked to Lyodura in Canada
1993 Six years after the 1987 Alert, Health Canada sends
a second Alert to Canadian hospitals. " The branch is concerned about the possible continued availability of Lyodura in Canada
Patients' families in Japan sued the manufacturer and won $600,000
1996 B. Braun Melsungen AG withdraws Lyodura from the
market. Between 1969 and 1996, the German manufacturer had sold more than one million units of Lyodura worldwide. Later that
year, 13 Japanese CJD patients sue B.Braun Melsungen, its Japanese importer and the Japanese health ministry. A second group
of CJD patients files suit the following year.
1998 Sebastien Roussel, dies at 19, from Creutzfeldt-Jakob
Disease. He had received a Lyodura graft seventeen years earlier in Montreal. (read an account of his death written by his
father) NOTE: The CBC does not endorse and is not responsible for the content of external sites
1999 Dominic Roy-Regimbald-Régimbald dies at 14 from
2001 B. Braun Melsungen AG writes to Dominic Roy-Régimbald's
father saying that " a causal relationship between the implantation of Lyodura and the onset of CJD has never been established
in any single case "
Public Citizen, an American consumer organization, calls on
the FDA to ban the sale of all human cadaveric dura-mater because the tissue has caused -worldwide- at least 114 cases of
2002 B.Braun Melsungen, its Japanese distributor and
the Japanese health ministry agree to compensate the families of Japanese CJD victims, as ordered by the Japanese courts.
Each family will receive more than $600,000. By far, the largest outbreak of Lyodura-associated CJD occurred in Japan.
2002 Health Canada reports four cases of CJD linked to
At Fifth Estate there is much more information. Link Is At