Depo-Provera & Meningioma Risk: What the FDA Warning Means (Doctor Explains)

Life After Amputation: The Truth About Prosthetics & Recovery | Dr. Greg Vigna & Cary Frounfelter

You’ll also learn:   -How to choose the right prosthetic for your lifestyle -The most common mistakes patients make during recovery -How insurance and medical systems impact access to care -Why personalized prosthetic fitting is critical for long-term success -The role of support systems in physical and emotional recovery   Whether you’re navigating amputation, supporting a loved one, or interested in advancements in medical technology, this episode provides both practical guidance and a new perspective on what recovery can look like.   CONTACT US FOR INFORMATION / RESOURCES PHONE: 800-269-6514 EMAIL: INFO@INJURYCARESOLUTIONSGROUP.COM   Greg Vigna, JD, MD | Vigna Law Group 8939 S. Sepulveda Blvd. Suite 102 Los Angeles, CA, 90045 817-809-9023 | vignalawgroup.com

Critical Medical Risks Explained: What Happens When Care Goes Wrong

TRANSCRIPT: B: I'm Ben C. V: I'm Doctor V. The medical legal guys... spring training edition! V: So what have we been doing Ben Martin, over the past couple of weeks? What kind of comes to mind? B: Well, we've been handling up on coloplast. V: While the case Baltimore. And we're about to amend a complaint against coloplast and again catastrophic pain syndrome. B: Pudendal neuralgia.  V: Stiffness mesh worse outcomes with safer alternative designs. B: This is a mid urethral sling. So what’s a mid urethral sling? V: While mid urethral sling is used for women after they have childbirth they developed stress urinary incontinence as they get older.  B: And it doesn't just have to do with childbirth. People, male and female can have a stress urinary incontinence, which means they leak. Okay, the case of many women, it comes forth after childbirth, age, gravity and so the mid urethral slings here to supposedly help that issue those issues. And mid urethral sling is made of polypropylene. If it's a coloplast sling and that's a plastic. And, tell us a little bit about the Arif device. V: The aris is there trans operator sling it. Basically it's a sling that supports the mid urethra. And you have a vaginal component, and arm component that goes in the leg. B: Used to lift up the urethra, which is the tube that goes from the bladder and out the body to its failure. That right? V: Yeah. Polypropylene. The days of polypropylene are kind of on their way out because. B: Polypropylene is on the ropes. V: Basically. And it's because they're safer materials that don't include the plastic weave of mesh that causes inflammation and pain and erosions. And they have other materials that don't have that as they have less inflammation, they have less erosions, and the degree of inflammation is markablly less. And that other type of mesh is called PVD. And it doesn't shrink. Polypropylene shrinks. And if you have muscles under tension, a nerve is under tension. You could have muscle and nerve pain and unfortunately, those are the women that we represent. And we believe that this device, the outcomes show that it's the worst device. And warnings do not fully capture the frequency of risk and the severity of risks. And I don't think any doctor would choose polypropylene over PDVF. B: And Dr. V, a doctor who knows who has told the truth about this product, we say, wouldn't put in the product, or at least is going to tell the patient about the product. And once the patient is told the truth about the product, then the patient has a decision to make. And patients, if told the truth, will make the decision not to have this link.  V: So the big problem with this, in terms of pain, it causes 2.8 times the amount of frequency of dyspareunia. And that's kind of goes to the heart of the safety of the device because it's placed vaginally. But it also causes some extreme pain syndromes because it inserts on the obturator internist muscle, which is very close to various nerves. And that could cause muscle spasm, dystonia, pulling on nerves, and some serious pain syndromes. In PDF, it's gaining market share. And in Europe this PDF has been tested 1 to 1 against polypropylene trans obturator slings and was superior in terms of pain and erosions. And it's a better material. And so we're suing the manufacturer for failure to warn doctors of the specific increased risk of pain and dyspareunia, the severity of risks, but also that this is a design defect because there are safer materials that need to get to the market. And the Aris sling and the Altis device, they seem to be the worst. B: All right. So there's your co-op class. We could go on for hours for days, but, that's the general update on what these cases are about.  V: So we also filed a case. It's very important in Wisconsin okay. And it involves time is brain okay. And so it's a serious injury case. B: The time is brain doesn't have anything to do with the colo plast. Doesn't have anything to do with the med rurethral sling. So let's talk about a new case we filed in Wisconsin. And other cases exist that are similar to this case. V: Time is brain is now the standard of care. When a person presents to a hospital with symptoms or signs of a stroke, and there are certain tests that need to be done within a certain time frame, and interventions must be provided or offered because the outcomes are superior. When a person comes with an eschemic stroke from a blood clot in the brain.  B: Eschemic stroke. V: Yes. B: And hemorrhagic stroke two types of strokes and doctor V just explained hemorrhagic hemorrhagic. Very nice. And there's also the eschemic brain that involves a loss of oxygen because of a lack of blood flow or a lack of oxygen. That's an ischemia, stroke and a hemorrhagic stroke. Which doc was talking about in time is brain is the type where you actually have a bleed, vessel bleed in the brain, and that's a bad thing.  V: That's a bad thing. And obviously you want to get, proper care, proper blood pressure management, earlier treatment, the better, obviously, in terms of preventing complications. But clearly with ischemic strokes, you're on the clock, okay, to get this done. And our client unfortunately presented to the hospital had symptoms and signs we allege of a stroke. And then they didn't run the diagnostic test despite a code stroke that a nurse had significant concerns that a person was having a stroke and they didn't follow through on the policies and procedures. We allege in terms of the standard of care for the next test, which is to give a CT angiogram to see if there is a clot that can be either extracted with via thrombectomy, a catheter that can grab that clot and so that the blood flow can return, and or the thrombus lytic or blood clot clusters by veins. So it's really a sad situation. And then unfortunately, this gentleman then developed to a very big grade for bed sores. B: Alright. V: It's a nightmare hospitalization and could have been saved. He had other medical problems that would have been taken care of.  B: So Time is brain. And that's what this is all about. The faster you get to the patient, faster you understand what's going on with the patient, faster you diagnose the possible problems, and then the faster you get to the problem. It's very important because the faster you get, the better opportunity there will be to save that patient's health. V: And this occurred in the hospital within 12 hours, the change in neurological status. So it's kind of a bad story. B: It is a bad story. But I want to talk about with doctor V today is just kind of some of the general aspects of time is brain and general aspects of what kind of diagnoses are made, what kind of, indicators are there, what kind of diagnostic tests are there to make a determination as to whether or not somebody coming in with symptoms that are consistent with a stroke actually may be undergoing a stroke? And why time is brain is so, important. V: You know, these are serious. When you have a large vessel blood clot, that's like a hose that goes to various other parts of the brain. Okay. So it gets this hose and you lose a lot of brain, and the prognosis is significant. And the missed the large vessel stroke is very bad. And also small vessel stroke. There is benefit from thrombolysis better outcomes. B: You had to do them. You had to do the diagnostics to see what kind of thing was going on, what kind of things are going on with the patient. That's called doc V. We talked about this before. That's called making a differential diagnosis. And you see in medical records a lot argue that means rule out this particular condition, this other condition, this other particular condition. V: You know, a better code stroke. You know a nurse is ringing the bell. An ambulance driver is ringing the bell that they have a code stroke. And everyone in that hospital knows what should be done and what is next. Okay. It's a highly predicted diagnostic plan with certain minutes and and hours and windows where it shows outcomes are different. So there should have been nurses to say, hey, what about this? Okay. I mean, you have to think critically and understand, hey, this is what normally happens. Why why why not this case. Yeah. And ring the bell again. B: That code we're talking about. So that's important because once usually once a code is call, then it's being called because this patient is suffering from something that is likely to be a stroke or something else. Very serious. Don't call code if somebody is not having a serious problem. Is that right? V: Yeah. Yeah. There's coordination of care. There's expectations. You know, that the point that they then didn't identify or that there was a problem with the code strobe for two days.

Depo-Provera & Meningioma Risk: What the FDA Warning Means (Doctor Explains)

TRANSCRIPT: B: I'm Ben C. V: I'm Doctor V. The Medical Legal Guys.. Casual Guys! V: So yeah. So we're talking about, a recent decision by the FDA that goes to warning physicians and women about the dangers of Depo-Provera. And this is a big, big aspect of the litigation. And why is this FDA warning important as it relates to this litigation?  B: So there's something called preemption, which basically is a legal concept that says if the federal government has preempted a state law, then you can't bring a case under that state law. And it's possible that preemption can result in the dissolution of coins. So that's basically the importance. But the argument was that, hey, if we had Pfizer, if we had told the federal government, the FDA that we wanted a warning, okay, then they may not have allowed us to have a warning. And they went a step further and they said, hey, we sought approval of a warning from the FDA. And the FDA said, no, okay, no warning. About a month ago, the FDA came out with a ruling, an order, and the FDA said, oh, yes, you must put a warning label on Depo-Provera about meningioma and indeed, there is one. So now, when they say it would be impossible to put a warning on because the FDA wouldn't allow it, they've allowed it. V: We're going to talk about the warning, and that the FDA has ordered Pfizer to change the label to notify physicians of the risk of meningioma. So Ben, do you want to read the sections from the warning? B: There are really two parts of the warning label the label change. Now, this is a 27 page document. We've talked about it before. And those are labels also called instructions for use or use instructions. And if you now look at what the FDA said, Pfizer must put under warnings and precautions. Meningioma discontinue Depo-Provera if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. That's pretty straightforward. If if a doctor has a patient that has a meningioma, stop Depo-Provera. And there are reasons for that in the literature. And there's a second part of it and it's section 5.3. Let me get to it here. And that is 5.4. This is in the product insert the label, the packaging that goes with every injection of Depo-Provera.  That doctor has that warning at their disposal. Meningioma cases of meningioma have been reported following repeated administration of medroxyprogesterone acetate. That's Depo-Provera, primarily with long term use. Monitor patients on Depo-Provera for signs and symptoms of meningioma. Discontinue Depo-Provera if a meningioma is diagnosed. So that's kind of going back up to the top of the warnings. What that's what part of this is about. The other part, though, is an indicator that cases of meningioma have been reported in the literature following repeated administration. And it says generally for a long term use or long term use in the pharmaceutical industry, long term use could be anything over six months. Be anything over a year. And these studies sometimes will use that short period of time, six months for a year to mean, okay, well that's a long term use, right. So so don't get the idea that they're saying generally takes five or 10 or 15 years. Long term use can be a pretty short period of time. Yeah. V: So when I look at this label, you know, I see some issues. We're way past reported. Okay. So and we're going to go through the history. B: Of recorded, if you read the British Medical Journal article that that came out last year, and if you read that study by Doctor Rowland and others, it's way more than a sort of a case study or a few reports here and there. They studied 108,000 women. And compared to women who took Depo-Provera or had the Depo-Provera injected in their bodies versus those who did not in, that's where they found close to a 600% more probability that a woman went on Depo-Provera is going to develop a meningioma than if she had not had the Depo-Provera. So that's as dark versus that a lot more than a reported case or two, which seems to be what, what the labels sort of suggesting the reports. Could it have been stronger? Yes. But is it something the company is required to warn about Depo-Provera and its association with meningioma? And the answer now is yes. V: So in my view it's kind of a weak, weak warning. So we're going to go over the literature that kind of built up to this change. So we're going back to 2006. Was the first in the 20 years ago first indication that progestin have a relative risk for causing meningioma and explain what why relative risk of two is important from a legal standpoint.  B: So let me explain what relative risk is. So relative risk is the associated risk of being on a pharmaceutical like depo provera versus the risk as compared with someone that is not on the drug or has not taken the drug. If you have a relative risk that two or higher, then there's no question about its association. Relative risk of two means you're doubling the risk that it's a 100% increase in the risk. And if you got a 100% increase in the risk, then legally that is a an important distinction as opposed to just barely an association of pharmaceutical causing something. V: So so this article back in 2006 looked at birth control, types of birth control and their associations with gliomas, which is a type of brain tumor in meningioma and this article, 2006, showed that oral birth controls no increased relative risk of meningiomas, and when they combined the studies that looked at progestin that are embedded in IUDs and progestin that go underneath the skin and injections when they group those all together, that relative risk is two for prolonged use over five years. But the kicker is the IUD progestin. That dose is a lot less than Depo-Provera. B: Yes. V: So they have progestin in like Marina that are embedded in the IUD B: You call them, yes. V: So it's a form of birth control. So back in 2006, the pharmaceutical companies knew or should have known that progestins caused meningiomas. But if you look at the types, depo- Provera has a much higher dose of progestin than the other two forms, so it would have diluted the relative risk. B: I think what you're saying, doctor V, is that since we know there is a greater than two times risk of these other progestin, because Depo-Provera is a higher dosage, you would expect there to be a greater relative risk, right and right. V: So you're diluting the risk by having the two forms of birth control that don't cause meningioma. There's no Marina. There's no evidence that that causes meningeal. And then the underneath the skin progestin. We don't have the evidence that that causes meningioma. B: At this time. V: So they grouped both together. And the relative risk was still over two. That should trigger a study. That's right. You know you need to do something. And that's right. When the generics are getting rolled out, when generics are rolled out, the pharmaceutical liability goes way, way down. And explained why Pfizer when these medications were going generic, what would that do to Pfizer's liability? B: Well, there was a U.S. Supreme Court case some number of years ago that essentially said that a case involving a generic drug is really preempted. Okay. Talked about preemption earlier. And if it is a certain type of generic, okay, an unauthorized generic, we'll call it not authorized by the manufacturer or the founder, then there's no liability on the part of the manufacturers under certain circumstances. And generic manufacture under certain circumstances is seen as having no liability, essentially because they say, well, wait, we're just we're forced to use the same formula as the original manufacturer, right? In this case, when you get down to it for liability purposes, that would have been Pfizer. V: Yeah. So I'm thinking more of it that it's becoming generic. It's becoming a lot cheaper. It's being a more wide use because the price has gone down because it's going generic and Pfizer just sat there, looked at the data and did nothing. Okay. This is 2006. B: Yeah. You're talking about almost 20 years ago. V: 20 years ago, they could have studied. So then the next thing that really happened was 2015 study that identified the specific mutation that is associated with Depo-Provera. They didn't quite identify the link, but they identified the mutation that is most associated with Depo-Provera that causes multiple meningioma that tend to be on the skull base, which are the worst type of tumor.

IVC Filter Safety Concerns: What Patients Need to Know About Medical Devices

📩 For additional information, visit:  vignalawgroup.com  FREE Consultation: 817-809-9023  Greg Vigna, JD, MD | Vigna Law Group 8939 S. Sepulveda Blvd. Suite 102 Los Angeles, CA, 90045 817-809-9023 | vignalawgroup.com  Ben C Martin | Ben Martin Law Group 3500 MAPLE AVE. SUITE 400 DALLAS, TEXAS 75219 (214) 761-6614 | bencmartin.com TRANSCRIPT: B: I'm Ben C V: I'm Doctor V The Medical Legal Guys B: Let me ask you this. So what now should happen with regard to what company should I gather that they ought to use a better product? Right. V: That's a good point. This is brutal. Okay. That we have devices on the market. Okay. But the device is not getting studied. 1 to 1 against the inferior catheters, because the manufacturers of these inferior catheters are not going to agree for a study against the better catheters. You see, what I'm saying is that you're not getting the studies. They're doing studies to show this and that. But the big question is a new technology, old technology study. This shelved the old technology, move forward, improve. From there we're stuck. We're stuck here. And it's sad. B: You know, maybe here today should be on what leads a company in what leads the public to have knowledge of and what leads the scientist to determine that something is safer than something else. That particular disease or condition is caused by a product or particular pharmaceutical, a particular medical device. These are determinations that they don't just come out of the air. People can't just guess at it and be accurate unless it's just totally about what doctor V, how do people and how to researchers go about determining what is the cause of a problem and what is a solution to a problem. V: Ben, you know, you're the co-lead of the IBC litigation and that is to go, this sounds to the Cook Pharmaceutical. I was involved in a lot of that discovery in the select IVC filter was one of the worst devices on the market, because it had a tendency to perforate. And when that device perforated the IVC, then it would fracture and that device had horrible complications. The company, Cook Pharmaceutical, they knew all the complications. And while they kept the bad device on the market without telling doctors, they devised a safer, alternative design to fix the problem of this device. That is what is supposed to happen. But you're supposed to study this device before it gets on the market so it doesn't get on the market. Right. And in this situation, cook pharmaceutical. Medical. Cook medical. Sorry. Yeah. Medical out of Indiana. What they did was they had a problem. They fix the problem which they should have. They should have taken this device off the market. You know, they should have said, hey, this device is a bad device. We're sorry. We're going to pay for our sins. Instead, they kept this device on the market. They introduced the better device. They kept this device on the shelves, didn't tell doctors, and they let doctors continue to use the inventory on the shelf. B: Knowing that it had the perforation problem that the newer problem didn't have in as great of an incident. V: Yeah. So, Ben, you know, our work, your work, you were the head lead in this IVC litigation. I was just kind of the guy who was looking at the documents. And this device, the IVC filter, would go in the vena cava of patients. And for a purpose of preventing blood clots that generally start in the legs to travel up into the lungs and cause death by way of pulmonary embolism. So this device was to prevent serious problems, including death. And the problem with this filter, it goes into the IBC and it looks like a wire kind of right. You've described it in trial. You describe. B: So we don't see the picture. It's like a badminton, a smaller version of a badminton,, about three inches tall, two and a half, three inches tall in height. And it's an upside down badminton in, in it's fed up into the vena cava. The largest vein in the body. And what it's supposed to do is catch blood clots. If they go from the lower extremities to up towards the lungs and heart, which can be dangerous, not a problems with them. And we found out that they actually don't work. V: It would go sometimes into the spine. It would go sometimes in the pancreas. It would sometimes go into the small bowel heart theorta. And it was a perforating device and it was narrow perforating machines. Pretty good word for it. Yeah. And so the work that Ben did, you know it got published in the Annuals of Internal Medicine about how this company got the device into the market by having data that's supported, it's approval by the FDA.  Right. That's how devices can get on the market because they aren't studied properly. But when they're on the market, in the market and they're safer alternatives, those safer alternatives should always be worked on and advance to the public. And we're not seeing that because of cash cows.  B: You need to tell doctors, you need to tell the patient so that they have a fully informed decision on whether or not to undergo placement, by inferior vena cava, filter and IVC filter or any of the other products. We get back to the PIC lines, we get back to the port catheters. If there's a safer alternative, use it. And if you're not going to use it, tell that patient, tell that doctor a bad product. And if you're not going to sell the the good product, tell him, tell the doctors, tell the patients, you know, this isn't the best product for you. And let's see then what happens when you tell them. V: It should come from the company. B: The company has more knowledge and the ability to have more knowledge than anybody. They're the ones that are developing the product. They're the ones who have the best knowledge, the most knowledge of the studies that go into the determination as to how to manufacture the product, how to make the product the best product, how to use the best materials and put it all together. Then they they use those studies, the experiments, the research, animal studies, the human studies, all of those things go together to get product on the market. If the product is safe, right, safe and effective and IVC filter, not only are they not safe, they're not effective. V: You know, there is some litigation that doctors have turned their, their back on. And for example, in the mid urethral sling litigation, the ultimate device that we have a case in Chicago where we are suing a implanting doctor who caused a serious injury, neurological injury. And he failed to remove the device after it caused injury because he believed in the device. Okay. So we're suing the doctor for failing to remove a device in a timely fashion on a woman who was severely injured. And, we're suing the manufacturer because the device has significant problems. And this doctor, we took his deposition a few weeks ago, and he refused to sign the confidentiality agreement, which would have allowed him to see the information that we gained through discovery, that he has never been told about the dangers of the device.  And he refused to look at the internal data from the company on why this device causes pain, and why this device causes pain and frequencies that are unusual. So, you know, doctors have some responsibility in this mess. What's your thoughts on that case? B: The fact that a doctor has the opportunity, you know, doctors usually want and doctors always need the most information, the best information, the most detailed information and some broad information. Every bit of information on a product that a doctor is putting in a patient's body is good information. It's good information. And to just think of a doctor who refuses to look at the information basis amazes me. That's what I think about at that particular case. That's what I think about that particular doctor. And that's what I think about the company, is they don't ensure that that doc gets the information and make certain that they're aware of it, because these are internal documents, right? We can't get into them because of confidentiality orders and all that stuff.But let me just tell you, internal documents will tell the story usually.  V: And in this trial that doctor is going to see some internal documents.  B: It'll be sitting there right there. And he's going to see him at trial whether he likes it or not. V: And when they become public and we'll be able to show them everywhere, and we're going to be able to show the public what the company knew and what this doctor, what this doctor did not want to see. And just shameful doctors want to know the information on safe. That's how they make an informed decision in terms of risk versus benefits. I have to believe that had he known that this is the pain generating machine that was implanted, that he implanted, that was causing serious injury, that he would have removed that device in a very timely fashion? Okay, instead of this woman having to go elsewhere. Yeah. And it's sad. B: What we do is we represent folks who have been injured by medical devices and other products, and then we follow suit and we try cases.

Are MedPorts Safe? What Patients Need to Know About Port Catheters

In this episode of Justice with Dr. V, Dr. Greg Vigna and nationally-recognized trial lawyer Ben Martin discuss the risks associated with MedPorts. They also examine how safer hydrophilic materials have been available for years, yet many devices still use designs associated with higher complication rates. If you or a loved one experienced complications from a MedPort, you may be entitled to a free case evaluation.  Contact Vigna Law Group:  📞 (817) 809-9023  🌐 https://vignalawgroup.com/ Greg Vigna, JD, MD | Vigna Law Group 8939 S. Sepulveda Blvd. Suite 102 Los Angeles, CA, 90045 817-809-9023 | vignalawgroup.com  Ben C Martin | Ben Martin Law Group 3141 Hood Street, Suite 600 | Dallas, TX 75219 Office (214) 761-6614 | bencmartin.com TRANSCRIPT: B: I'm Ben C. V: I'm Doctor V. The medical legal guys. V: Today, we're going to be talking about med ports, the complications of med ports, and the litigation that we are involved in. B: What are med ports? V: A med port is a medical device that allows easy access to the central being, a system so that medications can be given with just simply sticking the port with a needle. Picture a miniature hockey puck that is hollowed in the center of the puck. If it goes underneath the skin, you can stick a needle into that port and give medications through that port, because that port is also connected to. B: They're port catheters? V: Yeah, they're port catheters. B: Explain what a catheter is. V: A catheter is IV tubing. If you get an IV, it's a tubing that goes into a vein. The heart okay. So you have ports that go underneath the skin. You have the tubing that then goes into a bigger vein so that people can get medications very easily. The people who get these port catheters are generally very sick people. They often have cancer that they need to have chemotherapy that gets into their central vein, cannot tolerate nutrition by mouth for a they've lost a significant amount of their bowels so that they can't absorb nutrition. So they have to get IV nutrition.  B: They're not able to swallow the food and get the nutrition from the food itself. Like that, but somewhere else. V: It's much more healthy to take food by mouth. If you can't take food by mouth, get a feeding tube through the stomach. But people who who require IV nutrition, IV chemotherapy, those are very sick people. And the complications from ports are generally infection, fractures and blood clots. B: A lot of blood clots form when you're talking about this tubing. That's the catheter part of it. And then you've got the port which is the hockey puck. Right? Correct. So how does it happen that these side effects, where these effects can develop. V: Those are great questions. So if you have a tubing and these tubes are usually silicone or polyurethane, those tubing connect to the hockey pot and go into a central vein. Those tubing they cause a immunological response where the body understands that it's a foreign body. And when it causes a foreign body, it causes a foreign body reaction. And platelets then adhere to the tubing and they form blood clots. Okay. So now they're safe for materials that prevent platelets from adhering to the tubing. So it decreases the rate of blood clots. And if you get a blood clot with a device those blood clots can occlude central veins. Those blood clots can then travel through the heart into the lung. And you can have a pulmonary embolism. Having blood clots are bad deals. Obviously polyurethane and silicone tubing because of the foreign body reaction it causes kind of a fibrous where there's kind of like a scar tissue formation along that tubing. And the more scar tissue you have, there is a tendency for that scar tissue to then get colonized by bacteria. So then you get infections to the newer materials, prevent bacteria from adhering to the tubing. So we're suing on behalf of people who are chronically sick, who have complications from blood clots and infection from these lines. And if you get an infection of the line that goes into the central vein, that's a very bad problem, okay, that causes sepsis and could cause death. It could cause an ICU stay low blood pressures, brain injuries and all sorts of problems. In terms of the the hockey puck complications, these complications of the hockey puck, you can get clots within the hockey puck. The hockey puck can then sometimes flip B: And migrate. V: Migrate, flip. And if it flips, then you have a person who has big time medical problems having to have another surgery to fix that. And if you have surgery and you're immunocompromised, then the hockey puck can get infected. So there are safer materials that prevent a lot of these complications. These materials have been available for over a decade, but they're still implanting inferior materials into people who should have the safest material because they're set profits over safety. B: Two concepts that come to mind. First of all, it's the material. And I'm going to guess that, when you say profits over safety, if there's a product on the market and it's been on the market for years and the company finds out product has problems but no one to pull this product off, the market because it's a money maker, right. And then let's say inserted within that idea is that the company has also become aware that there is a safer alternative. Safer means are methods okay? Meaning safer material, better material, less dangerous material. But here's the rub it's difficult for that company to want to give up that profit because it takes time, effort, and money. A lot of money sometimes to develop this new product so they may continue to market and sell the bad product knowing that there's a better product. Make sense? V: Well, in this case, it's a little bit worse that this technology has been available for over a decade. And one of the companies bought the technology and shelled it. B: What company was that? V: That was BD Becton Dickinson. This is called super hydrophilic technology, and the concept has been around since the 1980s. And there are safer devices that are available. B: Hydro meaning water right and fillic meaning good with water, right. If you're using these catheters, if you're using these hockey pucks, if you're using these ports, you want them to be hydrophilic. They get along well with water because we are water.  V: Then bacteria and platelets, they are repelled by hydrophilic. Okay. So you're not getting the bacteria colonization of the tubing which reduces infection. And you're not having the platelets adhere to the tubing. So there is a prevention of clots.  B: When those platelets are adhering to the tubing. And when and when you've got this clotting going on that's called hydrophobic. Let's think of phobia right. If you have a phobia to something you're afraid of, you're going to have a phobia from heights. Right? You don't want to go on a tall building just like this. Hydrophobic means, hey, I don't want to go there right? So you got a hydrophobic product because blood clots can cause infection and infections can lead to blood clots. And you can it can actually ultimately damage the material because it does not get along with water. And we are water. V: So these concepts have been around. They're safer materials on the market. The the worst thing about this one thing that is really I find irritating is that some of the best literature that is coming out, the safer materials, they're coming from China, they are looking past the United States cash cows, and they are developing safer tubing for a purpose. Okay. If you have safer products, your people aren't going to get septic shock. They're not going to be in hospitals for weeks on end. And it's greater safety for the people. So, you know, why are the U.S. companies not going to the safer materials? Why are these studies coming from China? We need to be the place of innovation. We need to be the place of safety and profit over safety does not work. B: Does not work for the betterment of. V: Yeah, the patient, the public, and we should always be working towards better products, better medications, better avenues of care. And we're not doing this in terms of this medical product. Certainly it's good business for us. But we just find it despicable. Conduct from our manufacturers. B: Manufacturers are responsible for putting on a safe product, putting a safe product on the market.  V: It's the right thing to do. And for these companies to be using 1950s technology, 1960 technology, I mean, these companies need to be producing the best medical devices to prevent complication.