In the last outbreak, at least 87 people had signs of tuberculosis after spinal surgery.
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Not again! Bone grafts linked to another deadly, bizarre TB outbreak
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I was wondering why they didn't test for this since it seems so obvious, but it turns out they did (via third party) and the tests were negative. So it seems the wrong batch was tested, they didn't test enough to account for false negatives, or the tests were faulty/not sufficiently sensitive. In any case, yikes.
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Or they're wrong about how and where the contamination occurred, and all their testing was done prior to the point of contamination. It doesn't matter how much testing you do, if you're not testing in the right ways, you're not going to find the problem.
For example: if all your testing for water contamination occurs at the treatment facility, you're never going to find contaminants from the pipes distributing it.
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On a related note John Green has gone all-in on spreading the word about tuberculosis over the past year, to the point of shaming Johnson & Johnson into dialing back their attempt to evergreen their patent on their TB drug.
https://www.mmm-online.com/home/cha...o-task-for-plans-to-extend-patent-on-tb-drug/
https://www.mmm-online.com/home/cha...o-task-for-plans-to-extend-patent-on-tb-drug/
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This can happen. Once.
The second time is negligence, and people should go to jail.
The second time is negligence, and people should go to jail.
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ColdWetDog
Ars Legatus Legionis
'Testing' can mean a whole lot of things here. Since it was described as a 'nucleic acid test' it was probably a PCR (polymerase chain reaction - like the lab based tests for COVID) possibly on the donors blood (bad idea), possibly on a sample of the donor bone.
The problem is that TB can be isolated to a single organ (typically lung) or disseminated. It does have a propensity for bone - you can see evidence of TB infection in archaeologic specimens. If they sampled the wrong place or wrong part, then you can slip through the cracks.
I'd imagine that people are revving up now to look to see if donor guidelines need to be changed or if it was just lax behavior / lab error.
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At least in the first case they seem to have overwhelming evidence that the donor was the source of the contamination. It's not an environmental contamination that could have happened later.
Implanting things into your body that can't be sterilized is a scary business.
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"yet this isn't the first time Aziyo's bone graft products have been linked to such an outbreak. Just two years ago, a different bone graft product from the company was linked to a large outbreak in which at least 87 patients developed tuberculosis, and eight died."
The lawyers are gathering like hyenas for the kill....
The lawyers are gathering like hyenas for the kill....
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...but ate contaminated cases and got sick and died themselves?
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Two separately contaminated lots from the same company? How common is TB and many TB positive people are donating? This seems outrageously unlikely. Are they harvesting from vulnerable people in third world countries where TB is more common?
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Have to wonder if bone-harvest guidelines (FDA? Company?) require lots be single-donor or not, or are simply agnostic, and if a single test from a single donor/lot is sufficient. A lot of eggs in one basket, even for such a relatively rare situation.
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Great! One more thing I'll have to worry about as I lie on the OR table in a coma with my splintered limbs dangling.
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I love that ARS Technica is my go to source for health articles involving eye-drops that blind people and tuberculosis directly to the spine.
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Actually it seems hard to test for TB in this case:
88 recipients got tested for TB with 28 of those tested negative. So potentially 1 in 3 chance of a negative result in any one sample.
60 tested positive yet 7 were not sequenced. But seems more [/i]sampling mistajes[/i] but 2 of those 7 had negative cultures.
Would appear that samples used for tested was inadequate either more samples or material. Hopefully CDC investigates the testing lab as well.
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At this pace, Beth's going to have me so completely convinced I can't trust anything in the medical industry pipeline that I will never seek medical treatment again
(maybe that's the overall evil plan)
(humour... humour people..)
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There's a definite "I dunno" factor with TB. Long ago, in a war far away, in a country where TB was and still is rampant, part of my job was participating in sick call for the locals wherever we were at the moment. Perhaps due to the language barrier, TB-infected people would open wide and cough in our faces to show they had a coughing/breathing problem.
I was given a Schick test on arrival back in the US -- came up negative. I've never had any symptoms of TB. Who knows what I've got hanging around inside, perhaps encapsulated in bone, 56 years later? If there is anything, is it detectable? I dunno. I am a registered organ donor, so someone may have to find out eventually.
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Maybe someone working at the lab is asymptomatically coughing up TB.
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The humour theory of disease has been out of fashion for quite some time
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Who's negligent, though? The company, or the independent lab that verified the company's products were okie dokie for implant?
Without details from the first round of contamination, that's hard to say. But if it was the same lab that certified the material to be pathogen-free and made THAT mistake twice, then you're looking at a different company, and potentially at some kind of grudge/vendetta against the graft material maker.
Given the way corporation laws shield liability for the individuals in the case of negligence, it's unlikely that anyone will go to jail. I prefer to hold corporate officers personally liable for decisions they make that end up injuring/killing people, myself. But the worst that will happen here is one, or the other, or both will get shut down.
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Was wondering the same thing, unless they are about the ONLY company that does this type of thing
making the "paste" (or just the cheapest)
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A negative result in a lab is not proof of zero TB. It is statistical estimate giving high likelihood of no TB in that sample. So the lab can be absolutely correct and following sound procedures while missing TB that is present.
Welcome to the world of real life analysis!
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On behalf of myself and anyone else how might need this kind of bone graft material for something as simple as a dental procedure, perhaps you could make a note not to use your bones? And let your family know, since they are ultimately the ones who must agree to donating any of your organs.
Speaking to your family about your wishes also goes for anyone who would like to donate their organs. Signing an organ donor card or checking a box on your license doesn't do it. Your surviving family / next-of-kin ultimately must agree.
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Or perhaps just a visit to your dentist to have a tooth implanted after a crown goes bad. I had 2 units of bone graft for mine.
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I'm really impressed that you're still posting. Best of luck with the reassembly and recovery.
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Some states have moved to a "first party consent" system, by which only the deceased donor needs to have agreed, and no consent from their next of kin is required.
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Made me go through and look at all of my cortico-cancellous allograft material to make sure it wasn't from that company. Thank goodness it isn't. That stuff is like $120/cc and I'd hate to have to trash it.
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YetAnotherAnonymousAppellation
Ars Praefectus
I had a bone graft as part of a dental procedure years ago. The dentist guaranteed to me that the material was sterilized. Was she lying/misinformed or are there other products that are sterilized?
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No, we buy it pre-sterilized. The stuff I use is washed in sodium hypochlorite, rinsed in saline, ground to the desired size, dried and then irradiated to kill everything still present. There's also non-bone based grafting materials these days. My personal favorite is a bovine collagen matrix with hydroxyapatite crystals throughout it to stimulate both angiogenesis and proliferation of osteoblasts. Goes from tooth out to implant ready high quality bone in 4-6 months.
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agreed, exposing people to the truth is an admirable quality, better than whitewashing done by influencers with greedy motives to feed.
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