Do some surgical implants do more harm than good?

This article doesn't seem to say that regulators are wise and benevolent. It looked like the author was, in fact, troubled by the lack of regulation as cited here:

> The root of the problem, of course, is money. In medicine, progress is driven by innovation, and, in our society, innovation is driven by profit. “Among implant manufacturers,” Schneider writes, “market analysis drives research and consideration of device innovation.” The implantable-device industry is even more lucrative, for many companies, than the pharmaceutical industry is. At the largest companies, operating-profit margins are typically twenty-five per cent or higher. In 2014, the industry’s over-all estimated revenues totalled more than a hundred and thirty-six billion dollars.

> The financial incentives within this industry are one of the reasons that its lack of regulation is troubling.

I believe the baseline assumption is that many people are trying to make a buck, and something like coronavirus is a great opportunity to scam people. Is that wrong?

I'll bet if I purchase ten coronavirus test kits "from the internet", at least 9 out of 10 will be bogus. In the absence of regulation, that would be 13 out of 10. There's a potential for truly massive scams: 7 billion people want something in tight supply, just announce you've got a test kit for $19.95, maybe mail people some pH test strips or nothing at all, and retire to your own private island. One of the reasons government exists is to protect the populace from threats to their health such as health scams.

1. People care about keeping medical information private.

2. Having people opt into making their medical information public would skew the data.

3. Your doctor can't be arsed to update a global registry every time you go to him for a checkup. In the long run, you have a relationship with your GP, not the surgeon who put the implant in.

4. And yeah, I assume the implant industry would like to have the aegis of the high trust people place in the medical profession, without having to do the hard work of earning that trust.

The problem is that a pre-market assessment (PMA) is a huge and expensive beast, if you require every device/implant/etc. to go through that it will definitely slow things down a lot and make them more expensive...

So the pre-market notification and de-novo paths were created to keep rigor in the system without adding years and millions to development costs of everything. For the most part it works fairly reasonably to balance these concerns.

There is already a classification system (I, II, III) which captures this and can force your device through a PMA if it is deemed high enough risk.

One could argue that class II is being used to much I suppose, but that is a very different issue than pointed at by boeing.

On the other hand, they are relatively to run and interpret. For a drug trial, you can give everybody a fixed dose of a drug (X mg; Y mg/kg bodyweight) in a fixed way (pill, injection, etc). Surgery is a lot harder to standardize. Along with the patient-to-patient variability, there's also surgeon-to-surgeon variability. Different surgeons might be faster or slower, cut more (and get a better visualization of whatever they're doing) or less (reduced tissue damage). Moreover, the individual surgeons improve with practice and it sometimes takes a lot (e.g., 100-200 knee arthroscopies) to plateau, which makes it tricky to evaluate a totally new method.

This is a nice paper discussing some of the issues in more detail: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415901/

But I work in medical devices and I know for sure that there isn’t much data available of how well a procedure works. There is no centralized database that tracks outcomes. Most surgeons view a surgery as success if the surgery as such went well. They don’t do much tracking of whether the patient is doing better so there is risk they will keep doing surgeries that don’t really work. The manufacturer gets some information but also not much.

There definitely should be a countrywide or even better worldwide database of outcomes.

"""" “It is but fitting that a great medicus like you,” said Nello, adjusting the cloth, “should be shaved by the same razor that has shaved the illustrious Antonio Benevieni, the greatest master of the chirurgic art.”

“The chirurgic art!” interrupted the doctor, with an air of contemptuous disgust. “Is it your Florentine fashion to put the masters of the science of medicine on a level with men who do carpentry on broken limbs, and sew up wounds like tailors, and carve away excrescences as a butcher trims meat? Via! A manual art, such as any artificer might learn, and which has been practised by simple barbers like yourself—on a level with the noble science of Hippocrates, Galen, and Avicenna, which penetrates into the occult influences of the stars and plants and gems!—a science locked up from the vulgar!”

"""

This tragic and inexcusable outcome is doubly so because even a "successful" implantation of a spinal fusion has, essentially, zero chance of improving pain or mobility outcomes[1] and patients would be much better off pursuing a moderate, graduated course of walking-as-physical-therapy.

I'm sorry that your mother died.

[1] https://en.wikipedia.org/wiki/Spinal_fusion#Effectiveness

The problem with your post is that you have predicated it entirely on your personal experiences, while being unwilling to describe those experiences in detail. You have not told us, for example, what kind of surgery was performed, what the complications were, who "scared" you "into having surgery" (and how), or what the negative effects on your life were, specifically.

You are free to choose not to share this information -- nobody can fairly expect you to share such intimate and painful details. I realize that is very difficult. But without specifics, an account of your personal experiences does not contribute very much to the discussion.