Mike Papantonio: Breast implant recipients are at an increased risk of certain forms of cancer and multiple scientific bodies have come forward and they say, this is dangerous. Don't do it, get it off the market and they were very clear about it. Steve Luongo goes here to talk about it. Steve's, Steve, you've involved in all types of litigation. This is a case I handled the first round, when the first round of breast implants were out there and I tried some of the first test cases, back then we knew how dangerous this was. But what's the new danger?

Stephen Luongo: Well, right now the new danger is with the textured breast implants and what people are finding through the research and the committees that you spoke of, is that these textured breast implants are either causing cancer through the scar tissue that's being formed in the scar package or capsule is what they call it or through a bacterial infection from the surgical site. That's what they're finding.

Mike Papantonio: Yeah. What we found the first go around, Steve, was that the, you had migration of the silicone, you had deterioration of the silicone packet and it was causing auto-immune disease, scleroderma. It was causing serious, serious Raynaud's syndrome, a whole host of auto-immune disease. Plenty of women died because of it. And we were able to get it off the market and, and so all of a sudden, just like usual, everybody forgets about it, it's back on the market. Right?

Stephen Luongo: Absolutely. And, and what we're dealing with in this particular litigation is the textured breast implants compared to what's also known as the smooth surface textured breast implants. And what we're finding is that there's a specific type of cancer that's being developed by these women who have had these implants, which is anaplastic large cell lymphoma, a non-Hodgkin's type of lymphoma cancer. It's being developed when they've had the implant for about eight to ten years. So it's not something that's readily available. It's not something that comes up right away, but it's something down the road that they're being impacted with and obviously results in serious conditions.

Mike Papantonio: One thing we found in the first round of the litigation years, decade ago, a couple, decade and a half, is that the doctors would not warn patients. They, the doctors knew about it, but they wouldn't warn patients. What's happening here?

Stephen Luongo: Right. And that, that's an issue as well. Doctors should be warning patients because these conditions are known. The litigation's been going on for several years, as well as scientific committees, such as the world health organization, the FDA, they've been releasing statements to the public identifying, educating the public about these known effects. All 33 European nations have taken the Allergan textured breast implant off the market.

Mike Papantonio: It's Allergan, specifically that is the textured implant.

Stephen Luongo: Yes sir.

Mike Papantonio: And you're involved in litigation on this case. Tell me about the litigation that's taken place. Is it a class?

Stephen Luongo: So. And I apologize. Yes, sir. Right now it's a class of litigation being up in New York or New Jersey rather and the litigation is currently on hold as will, far as the judge makes a determination as far as the preemptive issue. Cases are being accepted. Cases are being filed. The new cases are being allowed until July of 2021. So if a woman is suffering from these conditions, has been seeing it.

Mike Papantonio: She needs to get busy.

Stephen Luongo: Absolutely.

Mike Papantonio: And get something filed. So the, the, one of the big problems with the breast implant, the first round with the breast implant, was not only that the doctors didn't, didn't tell that they wouldn't tell the patients, but the industry had an all out kind of program to make women feel comfortable with it. They failed to tell women that there's a process without any type of implant where they can rebuild the, the breast with natural tissue. That was never discussed. They would say, doctors can't do that. Well, you shouldn't do that. And it was a big push by the industry to say, this is the quick answer, right?

Stephen Luongo: Absolutely.

Mike Papantonio: What, what should someone do if they have implants? What should they be looking at right now?

Stephen Luongo: Well, first and foremost, we've been talking a lot about textured implants, but also smooth implants have also been at risk as well for these cancer and for the, the symptoms that we see and the symptoms that we see are swelling of the breast implant area. There's also tenderness there as well as a mass that can form and we're also talking about loss of appetite, fatigue, night sweats as well as lymphoma.

Mike Papantonio: Are they having hair loss? The first round hair loss was a big problem.

Stephen Luongo: That isn't reported as a common factor.

Mike Papantonio: Yeah.

Stephen Luongo: It may come up on a few cases.

Mike Papantonio: Yeah.

Mike Papantonio: Well, what was happening, the hair loss was caused by the auto-immune reaction. And one, one sign, people would come into my office, I could look at exactly the same symptoms, they were startling. Black under the eyes, hair falling out, diminished weight. It was, it was, and this went on Steve for, this went on for more than five years when nobody did anything about it. So good for you. Keep it up. Good luck on this project. Okay.

Stephen Luongo: Thank you.

Mike Papantonio: Women with textured breast implants are experiencing abnormally high rates of cancer, and it's now believed that these implants are to blame. Lawsuits are beginning to emerge against Allergan, the company that manufactures these implants. They've been linked to a very specific type of cancer. Attorney Virginia Buchanan joins me now to talk about this. Virginia, lay this story out for me. You're running this national litigation in where, New Jersey?

Virginia Buchanan: Right, it is. It's before Judge Martinotti in New Jersey, and I, along with three other...

Mike Papantonio: A hugely experienced Judge, by the way.

Virginia Buchanan: Yes, yes, very well respected and very efficient even through this pandemic. But I'm working along with three other attorneys because it's such a big project. It is a mass tort and a class action claim, but in July of 2019, on July 24th, the FDA issued a recall and it came on the heels of several other countries issuing recalls for these textured implants.

Mike Papantonio: Like 33 countries?

Virginia Buchanan: 38 actually, at current count.

Mike Papantonio: 38 counties, wow.

Virginia Buchanan: The others were really ahead of us on this because I think that Allergan had superficially appeared to comply with FDA requirements, but we learned last week that the FDA issued a warning letter to Allergan saying that it had not collected the data that it was required under its pre-market approval conditions to comply with. We have a 2006 PMA process and a 2013 one where studies were not to prove the safety.

Mike Papantonio: No studies to prove it, and we know coming out of the first round of breast implants all the way back to the early nineties, those implants caused a whole host of autoimmune diseases, scleroderma, Raynuad's syndrome, just a whole host of diseases. People were losing their hair. Do you remember? I tried these cases.

Virginia Buchanan: Right, right.

Mike Papantonio: There was a hair loss that they had this hard encapsulation to where the breast implant had to be removed and sometimes resulted in a full mastectomy. But this, as bad as that was, is even worse because of lymphoma.

Virginia Buchanan: It is far worse, it is. It is, Mike, and this is a signature injury that now the World Health Organization recognizes as a distinct breast implant related illness and Allergan, the defendant in this class action, this national litigation, is the manufacturer of these implants. It is the company that has failed to comply with FDA guidance to establish the safety and the ongoing safety of the implant.

Mike Papantonio: That's public right now?

Virginia Buchanan: It is.

Mike Papantonio: Everybody knows that they've failed to comply, is that correct?

Virginia Buchanan: Yes, that's absolutely true, came out just last week as a matter of fact. But the sad part about this is that the women who have these implants are often breast cancer survivors, and the way the textured implants work is that the human tissue adheres around the implants, so removing them is a very, very difficult process.

Mike Papantonio: Results in mastectomy, is that accurate?

Virginia Buchanan: Much worse than a mastectomy, it is a full [inaudible 00:02:59] removal, basically a removal of the chest, all of the tissue below it, sometimes cartilage, and reconstructing breast tissue requires flaps to be created, muscle transfers from other parts of the body, so it's huge.

Mike Papantonio: So the good news here, after this horrible story you just told, the only good news is you're in front of an experienced Judge who has seen things like this before, you've got a team put together, a national team, that's trying to coordinate A, taking discovery here, B, trying to make sure that these women get compensated for this. Look, as I look at this from the outside looking in, obviously our law firm is involved with that, but having done breast implant one and seeing the suffering that came out of this, there's no way on earth Allergan could not have drawn on that history to know that their product was a piece of junk.

Virginia Buchanan: Right, it is a bad product, no doubt about it.

Mike Papantonio: Textured product.

Virginia Buchanan: Poorly engineered, and we think improperly manufactured, that they likely did not comply with their manufacturing specifications. We're hoping to get discovery to look at all of the actual documents and representations made, but we have some information out of French inspections, and that really gives us a lot of thought that they manufactured these things outside the scope of the specifications that were approved. It looks like they threw it on the market, they grabbed a big market share, and then they just didn't do their due diligence thereafter.

Mike Papantonio: The most troubling thing to me is all they had to do is talk to the scientist that went through breast implant one. That's all they had to do, talk to the scientists to understand how bad this is on its face. They add this texture to the implant, thinking, "Well, if we add texture, you won't have that hard encapsulation that takes place sometimes." Is the texture migrating through their body?

Virginia Buchanan: That's part of the process, it becomes particle-laden and the body can't absorb and dissolve those. We do think that's a contributing factor. Lymphoma is an illness of inflammation, so they've created all of these things going on with these implants because of the texturing process that adds to the inflammation and the development of malignancy.

Mike Papantonio: Well, your history as a trial lawyer is extraordinary, you've tried some of the biggest cases in the country. If you're looking at this, is this one that you feel like you're probably going to go to trial with, you're probably going to have to take him to trial to get a resolution? What's your thoughts?

Virginia Buchanan: I think so from what we're hearing right now. The litigation is in the stages of trying to get discovery, really trying to hold Allergen accountable for what it hasn't done. We're happy to see the FDA working in a way in step with us to try to hold them accountable.

Mike Papantonio: Mm-hmm (affirmative). Which is unusual.

Virginia Buchanan: Very unusual, especially in a Republican administration it's unusual, but we're very grateful because these women are victims.

Mike Papantonio: I'm betting on you, okay?

Virginia Buchanan: Well, thank you. I'm betting on these wonderful women. They are brave, they're intelligent, they're committed to this, and they've been through so much. They are our poster children for why we do what we do.

Mike Papantonio: Thanks for joining me, okay Virginia?

Virginia Buchanan: Yes, thank you, Mike.