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[BreaktoGrow]

I've been seeing comments with predictions varying from 6 months to 2 years. While I understand that it is not possible to provide an accurate estimate, is anyone able to provide their logic behind their estimates? I'm one of many that has been caught in this unfortunate period and am trying to determine what timeline expectations are reasonable.

Thanks

[one]

It's not very clear what the purpose of the pause is. To study if the corrosion is dangerous ? To study why the corrosion is happening even if it is not dangerous? If the concerns are real and it is dangerous to some, will they fix it through a new version? No one knows this. So it's impossible to predict a timeline.

I think it's best to just move on with Precice since there are no concerns with it (except with the UK government who will likely approve it by June).

[maximize]

1) Short end of the spectrum (back within a few months):

NuVasive claims they are just "voluntarily recalling" it because they want to do some extra safety data collection and reporting which is not truly required. They suggest there is no other big issue whatsoever and everything is fine. If that is legitimately true it will only take a few months and it should be back on the market within 3-4 months.

2) Long end of the spectrum (6 months to 1 year or more):

NuVasive is aware of corrosion claims with patients who have elevated chromium blood levels (a known potential carcinogen). One of those patients has posted on this forum with blood levels 2-3 times the normal. One person on here claims that Paley has said he is seeing more abnormal bone formation around the distraction mechanism (unsure if this is true), perhaps from inflammation due to the corrosion.

In this scenario, NuVasive would have only "voluntarily recalled" the device because they knew if they didn't the regulatory bodies would force them to, and/or they'd be exposing themselves to massive lawsuit risks down the line if they didn't.

According to this perspective the big issue is not whether or not the Stryde is truly unsafe due to these issues. The issue would be that any patient who got one, documents elevated chromium levels, and then develops any type of cancer in the next 20 years could sue NuVasive for it, and easily win in an American court for millions of damages. Every single patient with Stryde that gets elevated chromium levels could be a legal timebomb for them so they recalled it to minimize their risk and prevent the bad press of having regulatory bodies force them to do it.

Lots of companies have taken a bath off lawsuits like this before. Eg. Johnson & Johnson talcum powder ovarian cancer lawsuits:

https://www.asbestos.com/news/2021/02/24/johnsons-billions-talc-settlements/

If this is the case, it won't come back on the market until they can identify and correct the mechanical failure that was causing the corrosion and leaching, plus test to confirm it is fixed. Unless they already figured it out before the recall, I would personally guess that altering the design in a way that confidently fixes the problem and gives them enough time to run sufficient tests to be confident would probably take 6 months to 1-2 years.

My Guess:

It's an interesting subject for speculation but we're all guessing. My guess is more along the lines of #2. I think they won't release it back to market until they can control the chromium leaching issue. I would be very surprised if they can do this within 6 months. But perhaps that is possible.

My guess is they will release a Stryde 2 that corrects the problem within a year.