Woman’s abdominal implant erupts from her leg; experts call for FDA reforms

Suspicious deaths, perforated sheep veins went unreported before device hit market.

See full article...

 

[Deleted member 414155]

"During the litigation, expert witnesses and lawyers discovered red flags in safety data and trial design that were not previously publicly reported or made available to patients. That included eight suspicious deaths among clinical trial participants and perforated veins among sheep used in animal experiments. But, those revelations have remained out of public view due to a court confidentiality order"

I assume this was a civil case. But once these overt attempts to cover up negative data became known, why was a criminal case not launched against this company and its executives?

Explicitly covering up deadly flaws in their products should land those responsible in prison, and their company should receive the corporate personhood equivalent of the death penalty and be taken apart by the courts and sold off to help repay the victims.

And also, their device should be pulled from the market.

 

[launcap]

Best healthcare in the world.

Finest that 'contributions' to politicians can buy.

 

[GottaSaySomething]

Dated 2011....

Courts are getting too slow. That was (shudder) 13 years ago. A kid born then would be entering highschool.

 

[Emon]

In the future it will be a requirement of GOP membership to have a brainworm implanted.

As was pointed out by someone on reddit a while ago, if you look into it, RFK has always been nuts well before the brain worms.

It's probably more accurate to say the brain worms caught RFK

"I'm not stuck in here with you, you're stuck in here with me!"

 

[Kevdog]

When I read stories like these I always feel for the patients. Clearly there is a liability issue here with Cook Medical and their very poor design of this IVC filter. I always wonder however why the government agencies themselves don't hold any liability. The device can't be sold without FDA approval and in this particular case (per the article above since I didn't reference any other source) the FDA first voted down the approval but later approved the device without any additional device modifications. The FDA does a lot of things but I think it's imperative that their agents hold these companies' feet to fire during the device approval process. Clearly the company seemed to be evasive with their sheep testing data, however isn't it the FDA's job to cut through the bullshit and just say we don't agree with your testing methodology and therefore don't approve the phase of the application? Even the FDA is this particular case is being evasive with it's answers of why they "changed" their mind during the approval process.

 

[ChicagoCurmudgeon]

No person will answer for this, ever. Cook Medical will be fined 1% of the profit made on it. Politicians will blame the other party.

I think you are missing out counting the injury and wrongful death lawsuits. The kind of information coming out is not only the stuff of losing the case but having punitive damages stacked on top of them.

 

[ChicagoCurmudgeon]

I get that double blind randomized trials with a control group are the gold standard statistically. But I'm struggling to figure out how you would do that while retrieving an devices that had been implanted. Perform surgery on half the participants, but don't actually implant the device?

In this case, I think the control group is the general public?

It depends. Where it unethical to leave people untreated the control group is treated with the industry standard of care. For example, cancer patients are not left untreated.

 

[methodmadness00]

Rampant deregulation and the defunding of many government agencies will SURELY prevent situations like these! /s

 

[Tom the Melaniephile]

Ask any nurse who starts IVs on a regular basis. Despite the vessel being just below the surface of the skin, often palpable and at times somewhat visible (eyes or ultrasound), at times, an IV just cannot be established at that particular location. Anatomy is very individual, and can be very tricky.

Haven't ever had ultrasound for vein location - have had something like this laser system used on me multiple times to image veins.

 

[NetMage]

I've scrolled (quickly) though the comments and I don't even see a mention of how Musk / Ramaswamy are advising trump to cut the FDA's regulations, budget, and staff. That will definitely improve testing and reporting on new medical devices!

I am not sure it would make it worse over all.

 

[MedicalGeek]

Haven't ever had ultrasound for vein location - have had something like this laser system used on me multiple times to image veins.

That technology is used for veins that are closer to the skin ("superficial veins"). Ultrasound can be used to place iv catheters in superficial arm veins, or larger, deep veins including the brachial vein, basilic vein or cephalic vein (standard iv line or PICC line), the jugular vein, the subclavian vein, the femoral vein ("central veins"). This list is probably not complete, it covers the uses of ultrasound for iv placement that I have familiarity with.

 

[Tom the Melaniephile]

Neat!

 

[johnbramhall]

With only a 95 percent extraction rate over 43 patients with 18% mortality rate, I'm not sure success is the right word there. Other words come to mind like criminal. It's too bad that it's taken this long for the court cases as the internal paper trail showing who was complicit in driving an unsafe product to marked and hiding the failures is probably long destroyed.

I agree that the full details of studies used to promote introduction of new devices need to be available; one problem is that many of these “experimental” design studies are never actually published in the open literature. The data are reviewed in some detail, but usually just by a small panel of clinicians. My experience is that the oversight is made in good faith, but not open to external scrutiny - until something untoward happens (20 years later). One point that seems to be missed is that these IVC filters are placed for a reason - reason being that there’s a significant risk of fatal thrombotic events without them. It’s not as though the filters are just inserted randomly! The devices are designed for a purpose, and design improves over time with experience and clinical study insights. I do agree that filters should be removed when the risk of thromboses is reduced - but PE and stroke are big life events and can be very hard to predict with certainty.

 

[darriengineer]

I know a Beth article when I see one

 

[data venia]

The device reminds of a scalp massager I bought years ago. On a more serious note, there are some legitimate concerns about the certification of medical devices. This is exacerbated by a medical culture that has a bias towards intervention. I cannot count how many patients have been told that their arteries were almost completely occluded and if they didn't have a cardiac stent they would likely have died. Both the COURAGE and ORBITA trials showed that stenting was of no benefit with stable angina. There is no doubt that in the midst of an acute MI, angioplasty and stenting is of benefit just not routinely as stable outpatient. The US medical system promotes interventions but also patients have that same expectation, wanting doctors to prescribe antibiotics for viral infections. I wonder if advertising is a major contributor to this false expectation. How far do they stretch the truth until it becomes a lie?

 

[maxoakland]

I think that's better known as "stifling innovation". At least by one party.

That's a great reason we should stop letting that party make decisions. Their policies are actively harmful and ironically they stifle innovation by making things too dangerous