You’ll learn: 

What the new IFU and clinical data reveal about the Altis Mini Sling from Coloplast. 

Common complications: mesh exposure, pelvic pain, urinary retention, pudendal neuralgia, obturator neuralgia and more 

If you or a loved one has experienced complications after an Altis or other mesh sling implant, we are here for you. Our team can help you understand your medical records, rights, and options.

 📞 Contact Greg Vigna, M.D., J.D.

 ➡️ Visit: www.vignalawgroup.com

 ➡️ Email: [email protected] 

➡️ Call: (817) 809-9023 for a FREE case review 
 

TRANSCRIPT:

B: I'm Ben C.

V: I'm Doctor V, the medical legal guys! 

B: Casual version today. 

V: Today we're going to be talking about instructions for use and in particular room be talking about instructions for use of the Altis Mini sling produced by coloplast 

B: Called a package insert.

V: What is a package insert?

B: When you go to the doctor and you have a surgery performed on you and a medical device is placed inside your body or on your body with it, according to FDA regulations. An IFU or a product, insert a basically a pamphlet, right is put in the box or in the container of whatever device is being put in, right by law that has to occur. And then the doctors who implant these devices, they have to look they have to read the IFU instructions for use. Instructions for use contain things like the actual instructions on how to put the product in, what to avoid. Then it has precautions. It might have warnings right? In each of these things have different value, so to speak.

In different categories of things that they actually use. Right. So so one for instructions, one for how to put it in, one for how to board, one for warnings. One for caution. But the bottom line it's it's to tell the doctor about the important things regarding the product. So when the doctor is having his conversation or her conversation with the patient, then that doctor must inform the patient of the important things.

The important risk of placement for product and the benefits. Right? So, every placement of device involves risk versus benefit, okay. And the discussion that the doctor has with the patient is called a risk benefit discussion. But it's all about what are the risks and the benefit. Right. So if the importance of the instructions for use that if a physician doesn't know what the risks are of a device and the placement of a device, then the physician can't tell. The patient can’t inform the patient and cannot have that informed consent discussion we talked about a minute ago. So it's really important. Maybe one of the most important things, maybe more important than the device itself, are the instructions for use. Right. So because if you don't have a warning listed for a complication and that complication occurs and that complications is related to the placement or the use of the device or the device itself, that's a real problem because the patient must have proper informed consent.

And then form consent comes first from the manufacturer. The chain so to speak is manufacturer informs the doctor and the doctor informs the patient. I'll also say this that nowadays you need used to not be like this, but nowadays the patient gets information directly from the manufacturer, not just from the doctor. What the doctor gets from the manufacturer. The patient gets information off the television set as they used to call them, or streaming devices. The patient will hear all of these things that the manufacturer needs to tell it before it can put a commercial on television, right. So that's when you hear all of these risks at about 100 miles an hour.

V: The thing is, though, with instructions for use, is, is that they must tell the doctor what is material in terms of risks. That could be frequency in that could be severity. So in this list Ben this device the all this mini slang can cause peudnendial neuralgia which is a separate diagnosis. The government recognizes that it's a disabling diagnosis or treatment protocols injections, local therapy, different types of medications, stimulators, implantable devices for this diagnosis and that diagnosis is not listed on this document. This is the instructions for use from Colo Plast. And it doesn't include obturator neuralgia, which has similar disabling pain, stabbing and burning. So it doesn't mention two conditions to medical diagnosis that are the most severe. But they mention everything else.

B: What you're saying is, and we've talked about it before, on this podcast, but, there are two conditions, that are extraordinarily, bad that can result from the implantation of an altis device, right, the pudendial nerve is in the distribution of a saddle, if I'm not mistaken. Right, Greg? Absolutely right. And an opterator nerve is in the region, but not particularly in the same location. It innervates the inner leg thigh and hip And these two conditions are the one we hear of about most. And the one that probably occurs most is pudental neuralgia. And what happens with pudential neuralgia? 

V: Women have catastrophic pain that they can't have sexual relations. They have limited sitting. Any kind of touching there is is they normal touch becomes burning. So it's a severe injury and it requires nerve blocks to women's life expectancy when they're going to die. And and it requires muscle injections sometimes stimulators. So it's a diagnosis and it really is kind of a buzzword. When people see for pudendial neuralgia or obturator neuralgia, it could trigger a doctor who might not know what that is when they read the instructions for use. But a doctor might not know about this. They should read about it. And that's why it should be listed in the IFU 

B: That's a good point. Actually hadn't thought about that aspect of it, but that's a reason why the instructions for use have to have a warning about the specific condition, especially if it's a severe and debilitating condition. Pudendal neuralgia itself, the name is it speaks to severe injury, serious serious bodily harm. Right. And so what needs to be outlined in this instruction is pudendal neuralgia. Because we all know now that the altis causes pudendal neuralgia. 

V: So obviously we we believe that doctors should have this information of pudendal an obturator neuralgia a losing intimate relations where it's not even possible needs to be on this IFU and people with who are diagnosed with prudential neuralgia and doctors who see patients come in with the diagnosis of pudendal neuralgia, most of those women aren't having any type of reasonable intimate relations. These women have to go to physical therapy to even attempt sexual intercourse pudendal neuralgia and pudendal neuralgia. That needs to be and by an IFU Everyone knows that obturator neuralgia needs to be in the IFU , everyone knows that. So another disappointing aspect of of coloplast IFU that we think any reasonable manufacturer would have in their instructions for use is is that they did a 522 study after this just within the past. 

B: Tell us what a 522 study is Dr. V

V: A 522 study is one that FDA orders them to provide safety and efficacy because they feel like the device from a literature standpoint and a safety standpoint, has not been proven.

B: The truth of the matter is, in the 510 K process, where, where you got another product that is supposedly similar, substantially similar to the one they want to put on the market, as long as the substantially similar device, the first one has gone through the process of the analysis and, and all of the testing and all of the studies and stuff that get it to the point where the FDA says it's a safe and effective drug or device. All you have to show is that this device is substantially similar in its safety and effectiveness. As the prior device, and that's the same type device. Now, what's interesting is now, wait, the regulations are a manufacturer of a new device. It as long as any previous device, whether it's the device that was tested for safety or not, is on the market.

And you can point to that previous existing device as being substantially similar to the new one when we're up on the market, long as substantially similar, you can put the new one on the market, and even if the prior device has not been tested for safety.

V: Never guess what the all this device, their predicate or their device that they relied on was the just and there just isn't on the market at this point

B: Okay, that's that's a perfect example. Doctor V of a problem with the system and the problem with the system that a manufacturer of it wants to exploit. Right. Of course, I want to talk about these two trials, device related and a procedure related. So the device if any part of the device, anything about the device is the cause of the complication and only the cause of the complication. That is a device related application. And then you have a procedure related complication. I would say it like this didn't matter what kind of mesh you put in or what product or what brand you put in, it could even be a different product. If the surgery itself, the procedure itself, caused the problem, then that's a procedure related device.

V: Again, the the responsibility of a company is to inform the doctor of material risk. And material risk is how this device is different than the other devices on the market. And and coloplast does something pretty sly. And there are instructions for you said that they aren't telling doctors that this device causes unusual leg pain, which they're one of their own studies show the 522 study that this device causes two and a half times the risk of dyspareunia, compared to other devices that are on the market. 

The 522 study is is is critical. Okay. The government told coloplast that they need to provide this data, okay. And they identified this pain and that pain. They said in that article, we don't know what they told FDA was from positioning, which doesn't make sense because both groups have the same position.

This device causes pain. Okay. It causes leg pain. It causes this Bruni a two and a half times more. It causes dspeurunia, pudendal and obturator neuralgia. You will never see pudendal and obturator neuralgia in the IFU, you'll be waving this around in the trial in the courtroom. It's not there. You're going to be showing them that coloplast reports all this pain procedure related or or device related. They just combine them and they list all of them so that no doctor can tell, wow, this thing and this thing is a device related complication, that they include them all and in a picture. But then in small print, we say device related events include voiding dysfunction, urinary retention. Those are normal.

Those are device related complication. See what they call procedure related everything that includes pain. This company is saying it's procedural related. They don't include it as device in this document they wrote in the study. One line saying that this was due to positioning. It's the same procedure this group, their legs are up there, they're under anesthesia. They're getting basically the same procedure. They added this lying there ben and our discovery we have subpoenas out and our discovery is who was responsible for that lying I want to know who made that opinion and who put that in that article because it's ludicrous. They're the same procedure, the positioning of the patients is the same. 14 women on this group. Zero. And the other group. IFU is saying this is all procedural related. The position is the same, right? 

You know, this document is is killing me because it doesn't say prudential on obturator neuralgia. It doesn't talk about procedural, the product related problems with this device that causes pain. And it's been proven in this, subsequent randomized controlled study that women should not be getting this device. And it is a terrible device.