Trenton Garmon Interviews Erica Kemmer About Governmental Regulations Regarding Vaginal Mesh
Trenton Garmon’s show G File Radio brings the latest civil rights news and legal docket reporting. In this episode, he met with Erica Kemmer, an Alabama-based attorney who came to discuss issues with governmental regulations that restrict and bind. This includes a discussion of when the government fails the consumer when evaluating products. In instances where faulty products are getting implanted into unknowing surgical patients, this will lead to calls of pain and discomfort that must be dealt with both medically and legally. Erica Kemmer came on the show to talk about implanted mesh, and some of the associated problems. They also discuss how Garmon & Associates can help you or a loved one if you’ve had a hernia or vaginal mesh implanted that is causing pain or discomfort.
Trenton Garmon began by welcoming Erica Kemmer to the show, and then the two had the following Q&A discussion, which has been edited for conciseness.
Erica Kemmer: Good morning, Trent. Thank you for having me.
Trenton Garmon: Can you tell us a little bit about the differences in the types of mesh which consumers can expect to be implanted with? It’s my understanding that there’s a polymer that’s used in the products, but the MSD sheet (the datasheet supplied by the manufacturers) says this is not safe for implantation into humans. But still, surgeons are implanting those types of mesh. Tell us something about your understanding of some of the recent litigation that’s been filed.
Kemmer: The FDA has to approve any product before it is sent to market. This is true of regular prescription drugs, any over-the-counter topical, anything that you use. And it’s the same way with devices that are used for medical implantation, surgeries, repairs anything like that. And the issue that we’re seeing with mesh, specifically intra-vaginal or abdominal mesh for hernia repair, vaginal repairs, bladder slings, anything like that, is that the product that was approved, and the condition of the product for which it was approved, is different from the product that is actually used in the patient.
For example, in the case that I have currently pending before the federal court that you and I are working on, the USDA and the FDA issued a letter of approval for a product with certain components or ingredients. However, the actual product that was implanted consisted of a polyester. In that case, it was polyester, in a lot of the cases we see it’s a polypropylene, which is a polyester blend. That material is actually not intended for human implantation or consumption.
Garmon: It’s almost unbelievable to think that the FDA has a particular type of component that’s not supposed to be placed into a human, and yet we have these companies basically defrauding surgeons, or pulling the wool over their eyes. They knowingly allow it to occur, and they’re making millions upon millions of dollars at the harm of the consumer.
Kemmer: That’s right, the everyday consumer often has no way to know that. Even as attorneys, we have to often dig to find these FDA approval letters because they’re not put out there for public knowledge. A consumer may have even already been under anesthesia for surgery and been unconscious, so there’s no way that there can be consent. And even for those who are conscious, how can they knowingly consent if they were not told this is something that shouldn’t be used in humans, but we want to put this in your body anyway? Why would anyone agree to this simply because it is what this manufacturer or a company tells us is going to work the best? Who with common sense is going to approve of a doctor putting something in their body that’s basically poison?
Garmon: And so from a consumer’s perspective, not only does it involve a safety question, but you’ve got the implantation of a device, too. How much knowledge do they actually have?
Kemmer: Right, are they told, and do they inform the consumer?
Garmon: And whether they do so in advance is key.
Kemmer: Right. You have to knowingly consent; that’s what the law requires. If you don’t, then that is a tort, and you do have claims for that for damages. In our case, our client wasn’t even told; she was already under anesthesia. She was unconscious so she could not have been told. She did not consent to the procedure even being done, much less that particular product being used. Nor were any of her relatives or loved ones who could have made that decision for her contacted. Even assuming that the patient is told, whether it’s a hernia surgery, or a bladder sling surgery, if they’re not provided with the proper FDA sheets, they don’t have all the information they need to make a good, informed decision.
Garmon: That’s an important statement to make because clearly the FDA is not fulfilling its duty when they notify the company that this is approved. It’s not necessarily something that’s been decided, whether or not it’s significantly similar to the product it originally resembled, or was a deviation from it. If this was presented and considered, and then ultimately rubber-stamped through, then there is additional liability.
Attorney Kemmer, you bring up an important point, that many of these patients unknowingly have the mesh implanted into them, only to later discover that they did not realize a particular component was used in that mesh. Some come to the realization because the mesh creates pain and discomfort from the most basic actions like standing up from a chair.
What is a form of a class action intent that multiple individuals with similar issues can have resolved in one court? And what do you anticipate with the case that you have filed? What are your faults, and what are some of your strategies?
Kemmer: Well, we obviously would love to talk to anybody who believes that they have had these types, or similar products implanted into them. Specifically, what we’re dealing with in our case is a hernia mesh. And it was a type that was basically like a Velcro; it had 5000 hooks in it. Those hooks are what’s placed onto the hernia inside the human body. If you can imagine Velcro, once you hook it, it goes into the soft part, or the other side, and in this case, the other side is human flesh, human tissue, human muscle. It embeds itself. And when you have 5000 hooks in your body, obviously it’s going to, first of all, be very uncomfortable and painful, and second of all, it will quite often be placed in an area that’s going to create pressure or potential damage to other areas. In our case, with our client, it was placed directly across an artery. So it creates all kinds of pain, spasms, stretching, potentially tearing. It is so embedded with that many hooks, you aren’t able to just go back in and take it out.
It’s just like with Velcro; you can’t just reach up and pull it back off. Instead you have to rip it out, as all those hooks are embedded in there.
Garmon: It sounds like there could be a situation such as with a clot, where from a medical perspective, the mesh cannot be removed at all without causing more damage. It’s a more-harm-than-good situation.
Kemmer: Yes, that’s what we’re learning. There is some of it that can potentially be removed, but they cannot remove all of it. So even if the patient wants to have any part of it removed to try to help with those problems, there’s no way to take all of it back out. It’s embedded into their body.
Garmon: What are your thoughts with regards to the general public seeking a consultation if they are told that they need a surgical procedure that may involve the implantation of mesh? Are you recommending second opinions?
Kemmer: Absolutely.
Garmon: The case that we’re working on together is still in development, filed in the federal court. What are your thoughts as far as the company goes? In many cases these are international conglomerates; it’s companies that own companies. How do we see a case like this changing the industry? And what are your faults moving forward, to not just help our particular client, but help the consumer overall? Are there better ways to achieve informed consent and how we can help do that?
Kemmer: Additional accountability from the company, the manufacturer, the distributor, and the supplier as well.
Garmon: Hold them responsible.
Kemmer: Yes. Hold these people responsible. The people who are going to these doctors, and taking the doctors to lunch, and bringing them all these goody bags, as we know they do. We need to make sure that they are accountable for ensuring that whatever they may have sent as their test product for approval is safe. With the FDA it sometimes can be two or three years, sometimes it gets fast-tracked and it’s done in six months, which is really terrifying.
Garmon: Yes, hold them responsible. So judges and juries will do that. That’s our hope, that America continues to see justice and freedom and liberty. But the judges and juries in this civil situation need to step up along with allowing the FDA to do their part. Thank you so much for joining us. 855–99-TRENT is the number to call to learn more about your rights regarding mesh implantation.
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