25:
165:
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
199:
In 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.
173:
in large 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
195:
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. Dural grafts are now made from bovine
187:
issued a safety alert advising medical professionals to dispose of all
Lyodura that they could not confirm was from a different batch than the contaminated one, then an import alert stating that Lyodura was believed to carry Creutzfeldt-Jakob disease and shipments of it should be stopped by US
200:
In 2004, five
Australian patients had been diagnosed with Creutzfeldt-Jacob disease after receiving Lyodura grafts. Due to the long latent period of Creutzfeldt-Jacob disease, epidemiologists remain uncertain how many people will be affected by the disease.
178:
through this process. In 1987, after the first deaths linked to
Lyodura, the manufacturer began processing tissue from each individual donor separately to prevent cross-contamination and rinsing it with
143:. 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.
161:
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
363:
Ae, Ryusuke; Hamaguchi, Tsuyoshi; Nakamura, Yosikazu; Yamada, Masahito; Tsukamoto, Tadashi; Mizusawa, Hidehiro; Belay, Ermias D.; Schonberger, Lawrence B. (March 9, 2018).
460:
The group strongly recommended that cadaveric dura mater grafts ... no longer be used, especially in the case of neurosurgery, unless no alternative is available
209:
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.
128:, a degenerative neurological disorder that is incurable, from affected donor cadavers to surgical recipients. Lyodura was introduced in 1969 as a product of
475:
283:
146:
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.
490:
440:"Report of a WHO Consultation on Medicinal and other Products in Relation to Human and Animal Transmissible Spongiform Encephalopathies"
409:
439:
89:
108:
61:
189:
485:
68:
46:
175:
125:
184:
170:
75:
282:
Brooke, Fiona J.; Boyd, Alison; Klug, Genevieve M.; Masters, Colin L.; Collins, Steven J. (2004-02-16).
505:
57:
42:
203:
An award-winning documentary was produced on the subject. The
Canadian Broadcasting Corporation's
35:
174:
sterilization vat. It is now believed that almost all affected
Lyodura product was tainted with
205:
510:
8:
480:
364:
322:
417:
387:
299:
129:
342:
338:
303:
255:
247:
82:
447:
382:
372:
334:
295:
239:
180:
365:"Update: Dura Mater Graft–Associated Creutzfeldt-Jakob Disease — Japan, 1975–2017"
183:, a proven means of deactivating prions, afterwards. That same year, the American
228:"Use of lyodura for bone augmentation of osseous defects around dental implants"
139:
The product was used as a quick and effective patch material for surgery on the
284:"Lyodura use and the risk of iatrogenic Creutzfeldt–Jakob disease in Australia"
323:"Creutzfeldt-Jakob Disease from allogeneic dura: a review of risks and safety"
243:
499:
251:
227:
377:
307:
259:
162:
124:
was a medical product used in neurosurgery that has been shown to transmit
476:
The
Medical Journal of Australia - detailed article about Lyodura-CJD link
346:
196:
tissue, various synthetic materials, or part of the patient's own body.
150:
16:
Medical product now known as a transmitter of Creutzfeldt-Jakob disease
24:
158:
154:
133:
226:
Peleg, M.; Chaushu, G.; Blinder, D.; Taicher, S. (August 1999).
371:. Atlanta, Georgia: Center for Disease Control and Prevention.
446:. World Health Organization. March 24–26, 1997. Archived from
416:. Food and Drug Administration. June 27, 1987. Archived from
140:
225:
362:
188:
customs agents as an "adulterated drug". The Australian
281:
49:. Unsourced material may be challenged and removed.
157:. The tissue would usually be harvested during an
497:
444:Communicable Disease Surveillance and Response
491:CBC news article announcing Lyodura ban. 2002
132:, a leading hospital supply company based in
481:CDC - Case histories of Lyodura-CJD patients
320:
192:also revoked its approval for use in 1987.
321:Marx, Robert E.; Carlson, Eric R. (1991).
386:
376:
327:Journal of Oral and Maxillofacial Surgery
109:Learn how and when to remove this message
402:
358:
356:
498:
486:CBC's The Fifth Estate awards website
369:Morbidity and Mortality Weekly Report
277:
275:
273:
271:
269:
149:The raw material for Lyodura was the
353:
47:adding citations to reliable sources
18:
13:
314:
300:10.5694/j.1326-5377.2004.tb05863.x
266:
14:
522:
469:
288:The Medical Journal of Australia
190:Therapeutic Goods Administration
23:
34:needs additional citations for
432:
219:
1:
212:
414:Office of Regulatory Affairs
339:10.1016/0278-2391(91)90218-B
185:Food and Drug Administration
7:
10:
527:
410:"FDA Import Alert #84-03"
244:10.1902/jop.1999.70.8.853
232:Journal of Periodontology
176:Creutzfeldt–Jakob disease
169:The harvested tissue was
126:Creutzfeldt–Jakob disease
378:10.15585/mmwr.mm6709a3
130:B. Braun Melsungen AG
43:improve this article
450:on August 16, 2000
119:
118:
111:
93:
518:
506:Medical scandals
463:
462:
457:
455:
436:
430:
429:
427:
425:
406:
400:
399:
397:
395:
390:
380:
360:
351:
350:
318:
312:
311:
294:(180): 177–181.
279:
264:
263:
223:
206:The Fifth Estate
181:sodium hydroxide
114:
107:
103:
100:
94:
92:
51:
27:
19:
526:
525:
521:
520:
519:
517:
516:
515:
496:
495:
472:
467:
466:
453:
451:
438:
437:
433:
423:
421:
420:on May 12, 2009
408:
407:
403:
393:
391:
361:
354:
319:
315:
280:
267:
224:
220:
215:
115:
104:
98:
95:
52:
50:
40:
28:
17:
12:
11:
5:
524:
514:
513:
508:
494:
493:
488:
483:
478:
471:
470:External links
468:
465:
464:
431:
401:
352:
333:(3): 272–274.
313:
265:
238:(8): 853–860.
217:
216:
214:
211:
117:
116:
31:
29:
22:
15:
9:
6:
4:
3:
2:
523:
512:
509:
507:
504:
503:
501:
492:
489:
487:
484:
482:
479:
477:
474:
473:
461:
449:
445:
441:
435:
419:
415:
411:
405:
389:
384:
379:
374:
370:
366:
359:
357:
348:
344:
340:
336:
332:
328:
324:
317:
309:
305:
301:
297:
293:
289:
285:
278:
276:
274:
272:
270:
261:
257:
253:
249:
245:
241:
237:
233:
229:
222:
218:
210:
208:
207:
201:
197:
193:
191:
186:
182:
177:
172:
167:
164:
160:
156:
152:
147:
144:
142:
137:
135:
131:
127:
123:
113:
110:
102:
91:
88:
84:
81:
77:
74:
70:
67:
63:
60: –
59:
55:
54:Find sources:
48:
44:
38:
37:
32:This article
30:
26:
21:
20:
459:
454:September 6,
452:. Retrieved
448:the original
443:
434:
424:September 5,
422:. Retrieved
418:the original
413:
404:
394:September 5,
392:. Retrieved
368:
330:
326:
316:
291:
287:
235:
231:
221:
204:
202:
198:
194:
168:
166:production.
163:black market
148:
145:
138:
121:
120:
105:
96:
86:
79:
72:
65:
53:
41:Please help
36:verification
33:
511:Drug safety
153:of a human
500:Categories
213:References
171:sterilized
151:dura mater
69:newspapers
252:0022-3492
58:"Lyodura"
308:14960140
260:10476892
99:May 2024
388:5844283
347:1995817
159:autopsy
155:cadaver
134:Germany
122:Lyodura
83:scholar
385:
345:
306:
258:
250:
85:
78:
71:
64:
56:
141:brain
90:JSTOR
76:books
456:2024
426:2024
396:2024
343:PMID
304:PMID
256:PMID
248:ISSN
62:news
383:PMC
373:doi
335:doi
296:doi
240:doi
45:by
502::
458:.
442:.
412:.
381:.
367:.
355:^
341:.
331:49
329:.
325:.
302:.
290:.
286:.
268:^
254:.
246:.
236:70
234:.
230:.
136:.
428:.
398:.
375::
349:.
337::
310:.
298::
292:4
262:.
242::
112:)
106:(
101:)
97:(
87:·
80:·
73:·
66:·
39:.
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.
