Front Burner - Women's lives upended after cancer diagnosis linked to Biocell breast implants

Episode Date: August 19, 2019

In Canada and around the world, women who’ve been struck with a rare form of cancer are joining class action lawsuits against the manufacturer of the Biocell textured breast implant. Today, on Front Burner, CBC investigative journalist Valérie Ouellet explains how this particular breast implant flew under the radar for so long.

In the Dragon's Den, a simple pitch can lead to a life-changing connection. Watch new episodes of Dragon's Den free on CBC Gem. Brought to you in part by National Angel Capital Organization, empowering Canada's entrepreneurs through angel investment and industry connections. This is a CBC Podcast. Hello, I'm Jamie Poisson. Today we're going to dig into the story of a specific breast implant that has been linked to a rare form of cancer. Over the weekend, more than 20 women in the United Kingdom launched a class action lawsuit against the manufacturer of these implants, a company called Allergen. Hundreds of women are believed to be affected worldwide, including here in Canada. My colleague Valerie Ouellette is here. She's a data journalist with the CBC,

and she's spoken with women here who have had their lives upended. I do want to be clear, though, before we start, and I think this is important to highlight. There are several different kinds of breast implants available to women on the market, and there's no evidence the vast majority of these are linked to these same health issues. Okay, let's get to it. This is FrontBurner. Valerie, thank you so much for being here today. It's my pleasure. So I know that you've spoken with several women who have been affected by this. Can you tell me about one of them? One of the cases that impacted me the most was meeting with Terry McGregor.

I don't think I'm very unique. And I think that's what's most terrifying about my story is there's nothing special about me. I never had an allergy in my life. I never had an autoimmune issue. I have no hereditary issues that I'm aware of. Terry is 54. She lives in North Bay, Ontario. And about 10 years ago, she was leading a very busy life. She ran a paving company. She was caring for her children. And at one point, she really wanted to do something for herself to get her old pre-children body back. She wanted to just boost her self-esteem. And so she started looking into breast implants. Absolutely. It's an evasive

surgery and it's not for everyone. But I did it more as an anti-aging, you know, to delay the aging process. Not unlike dyeing my gray hair roots. I'm not ready to be gray. And what did she end up doing? So her doctor recommended textured breast implants for her because she mentioned very clearly that she did not want bigger breasts. She just wanted a little lift, right? You know, breasts to be a little bit perkier. So she could sort of feel like herself again. So she could feel like herself again. And so the recommendation was textured breast implants. I did not tell my surgeon what I wanted. I really left that up to his expertise because I assumed as far as product knowledge goes, that's not my responsibility.

Now there are two big kinds of breast implants on the market right now. There are the smooth ones and the textured ones. The smooth ones are the typical breast implants that you hear about. They're bags that are filled with gel or silicone, and you place them on top of your existing breasts to create a look of bigger or rounder breasts. Okay. And what are textured implants? And the textured ones are much different. They have a surface that's a little bit like sandpaper or like Velcro, so lots of holes and bumps. And that is made for it to stick to your chest and to create the shape of a breast when there is none. So that's typically used for post-mastectomy patients, breast cancer survivors, or trans patients who are undergoing gender confirmation surgery.

Okay. And so those are less present on the market, but they have been approved for sale in Canada since 2006 for the biocell breast textured implants. And Terry's case, at what point does she realize something ends up going wrong here? She had her surgery in 2009. And then for years and years, everything was fine. She said she was really happy with the outcome. And she underwent a routine mammogram in 2015. And after the mammogram, she started feeling different. There was something wrong with her implants. She could feel pain, she could feel swelling. About a week later, I ended up with some very hard lumps. That's not

normal. She went to a doctor and you know, her body was scanned. She underwent MRIs. And that's when her doctor told her that both her implants had ruptured. My surgeon said, it's not an emergency, but it's not good practice to keep that ruptured implant. So she went under again. Okay, and she got them removed because they had ruptured. She had them removed, but that is not the strangest thing in this story. What is the most striking is what happened when she came out of surgery. I went in for a routine re-opt and got a call about two weeks later saying that my capsule tissue had tested positive for BIA-ALCL.

Her doctor told her that they had found tumors in her breasts and that she had an advanced stage lymphoma. She had cancer. My diagnosis came back at stage four because the disease had metastasized. And the cancer had spread from the scar tissue in her breast to the entirety of her upper body. She had cancer in her chest and in her stomach. And she says that the worst part of it was that she had never noticed.

She had virtually no symptoms. So this strange twist of fate led her life to be saved in a way, because this was discovered before it was too late. Okay. Weird twist of fate is exactly the truth. And I suspect that you and I would not be having this conversation, because I would not have survived to 2019. And this cancer that the doctors found, is it breast cancer? No, it's not breast cancer. It's a lymphoma. It's a cancer of the immune system.

It's called breast implant-associated anaplastic large cell lymphoma. Okay. I've never heard of that before. And I wish the acronym was shorter, but it's also a mouthful. It's B-I-A-A-L-C-L. What it does is it grows in the scar tissue that forms around the breast, just like it worked for Terry. And then there is a chance that it is slow growing, but if it goes unnoticed for too long, there is a chance that it can spread to the rest of the body. And because the symptoms are so subtle, inflammation or pain or swelling, it can take a while for women to put two and two together.

My breasts looked a little different, but I was also six years older. I was in menopause rather than perimenopausal. I weighed 10 pounds more than when I got my implants. So did they look different? Sure, a little bit, but nothing that would ever alerted me that there was a problem. And because it is such a rare occurrence, it is also hard for doctors to really recognize and diagnose it, which can lead to cases, extreme cases like Terry, who was diagnosed with an advanced stage of it. And what do we know about what causes this? Well, this disease is very new to scientists. BIA-ALCL was only officially recognized by the World Health Organization in 2016. And as of right now, the real cause remains unknown. But most researchers will agree that the

rougher, bumpy surface of the textured implants plays a role. And they also know that most patients diagnosed with BIA-ALCL had textured implants, and the research was also able to narrow it down to one model that seems to come back again and again, the biocell textured implant made by Allergan. But at this point, there isn't enough clinical evidence to really say more about what causes the disease. As more patients are diagnosed, researchers are also getting a clearer idea of the prevalence of this. Until recently, they thought the disease was very rare. So we were talking about a prevalence of roughly one in 300,000. That means one patient with two breast implants out of every 300,000

patients will develop BIA-ALCL. And they've now revised that risk. They think it's probably somewhere in between one in 1,000 and one in 30,000. And Health Canada says that roughly one in 12,000 women with textured breast implants specifically will develop BIA-ALCL. Now, if you put yourself in a patient's shoes, that is a different kind of risk. And do we have a sense now of how many women are reporting having this kind of cancer and also have these textured breast implants? Well, in July, the FDA released its latest figures, and so far it's identified 573 unique cases of BIA-ALCL worldwide. The vast majority of them, all allergen-textured breast implants.

And it's also investigating more than 30 patient deaths that might be related to that cancer. So those are big red flags for the FDA. On Health Canada's side, they've received reports of 28 confirmed cases of BIA-ALCL, and that number might increase because researchers estimate it could take years for symptoms to develop. The next wave of emotions for me was guilt and shame that I had somehow elected a surgery and caused cancer. You know, this is a man-made cancer without a doubt. And I actually felt shame that I had given myself cancer. I'm struck here by something you mentioned earlier, that these are breast implants that would have been recommended to women who were getting mastectomies, you know, either to prevent cancer or to remove cancer. So essentially, is what you're saying here that there are women in this group who would have gone through these steps to either prevent cancer or remove cancer they already had to then find themselves either at risk or having cancer due to these implants?

who are breast cancer survivors, they've undergone mastectomies, chemotherapy, radiotherapy. They survived it all, only to now have to worry about another possible cancer risk. So for them, it's kind of a double whammy. How did Terry react to all of this? Terry did a year of radio and chemotherapy. None of it worked. And, you know, a year after she was diagnosed... My oncologist unfortunately had to deliver the news that I had a three- to six-month prognosis

and that if a curative treatment was not found, that I needed to get my affairs in order because he did not expect that I'd last more than six months. She really thought she was going to die. She settled her affairs. She married her partner in a last-minute ceremony. She rode her will. And at the very last second, at the 11th hour,

she tried an experimental treatment. She decided she had nothing to lose, and it worked. And her life was saved that way. Is she currently cancer-free? She has been cancer-free for three years now. When I hit five years, we'll have a party. Right now, I'm just happy. Every year that goes by, any cancer, right, our five-year survival rates are very important.

And she has dedicated her life's work now. She's retired, but she works full-time as a patient advocate, essentially. She uses social media to connect with women. The sense of belonging when you are told that you are odd, you are rare, this is unique, we don't know what to do with you. The sense of well-being when you find somebody else who can understand what you've been through is truly indescribable. She's been to hearings in the U.S.

She's been to Health Canada hearings here. She's constantly meeting with regulators and putting pressure so that these implants are removed from the market. I'm wondering why it's taken then so long for these implants to be removed from the market, if someone like Terry has been advocating for this for several years? Well what's interesting is that doctors and plastic surgeons, researchers have been putting out studies and trying to raise flags for years. Not long after the implants hit the market, we're talking 2006, one Canadian surgeon saw women coming back with pain and swelling. It had fluid buildup and had what looked like double capsule formation.

A capsule is scar tissue that forms around a foreign object. Instead of just a single capsule, there was one around the implant and one attached to the patient. She published a study in 2011. Wow. She said nothing really happened. And in September, last September, there's a doctor from Vancouver called Nick Carr. He published another study where he found that five or ten years after being implanted with the biocell implants, his patients were coming back and they were more likely to show pain, swelling,

and eventually need their implants to be removed. He found they had the highest performance failure rate and the shortest shelf life. They came out at an average of four years after having been implanted. And that changed things a little bit because his sample was much bigger, and that added credibility, and people started paying attention. But there's another reason why this connection went unseen for so long. It's that problems tied to medical devices are widely underreported, both in Canada and in the U.S. I know this is something you've been doing a lot of reporting on.

Yes. In recent months. Yes. And what we found is that the data from Health Canada and the FDA, when you looked at problems tied to breast implants in general, it seemed like there were no problems or very little problems. We're talking a dozen reports of some health problems, more or less. little problems, we're talking a dozen reports of some health problems more or less, until 2017 when both the FDA and Health Canada realized that they were counting things wrong. The reporting process was flawed and once they corrected that, the numbers exploded. We went from 50 reports a year to almost 400 reports a year, pain, swelling, lumps. That led Health Canada to start paying attention.

Health Canada suspended Allergan's biocell textured breast implants, citing an increased link to a rare form of cancer. 22 out of 26 confirmed cases are linked to that brand. So I know that in July, there were a lot of news headlines around this. Allergan, the company behind these textured breast implants, announced a voluntary worldwide recall of these textured breast implants. And so how did we get to that point? Well, I told you about the study by Dr. Nick Carr

that researchers started to take notice after that came out. But just a few months after that study, the implant files investigation aired. If we would build a vaginal mesh that was so dangerous and so ridiculous, would we get it through? So we bought a net of mandarins and we went to the notified bodies and we said, would you approve this?

And they didn't see any problem. Worldwide investigation into medical devices with the International Consortium of Investigative Journalists. CBC is a part of it. I was part of that investigation. And the members of that investigative group decided that in one day in November, we would all release our stories investigating problems with medical devices on the same day. So you can imagine the headlines worldwide, 70 different countries, hundreds of different stories, including many, many stories that were looking into the health risks of breast implants. And so dozens of sick women went public saying they were never warned,

including people like Terry McGregor. And then those stories aired just as Allergan's license was about to expire in Europe. European health authorities decided to take another look at the safety. They looked at the science again, and they found that implants needed to be banned. And then that created a worldwide domino effect where if you fast forward a few months, Australia, Canada, the US all had their safety reviews. And now we're up to 38 countries who have banned either a variety of textured implants or just specifically the bio cell implants. Because they looked at the science again, they heard from victims, and they now see that the risks of BIA-ALCL are much higher than we initially thought. So essentially, Allergan, the company behind the textured implants, announced that they would recall the implants after all of these countries raised alarms or banned these implants themselves.

Yes. Then Allergan decided that they would voluntary recall. And how is Allergan responding to all of this? They issued a short statement on July 24th. They said that they would no longer make or sell the biocell textured breast implants. They're asking all doctors and hospitals to stop using them, to even return unused products. And they're framing this as a precaution. So they're not speaking towards the risk or the health risk or reviewing the way they're framing this. They're just saying this recall is a precaution following the release of new figures released by the FDA.

Okay. And what about all the women that have these implants in their breasts right now? Well, that's the one thing to keep in mind is that this recall is scary, but it is limited to a specific type and model of implants. So keep that in mind. And that this does not mean that all breast implants cause or have a connection with BIA-ALCL. So we need to clarify that. Both Health Canada and the FDA do not recommend women remove the implants if they don't have symptoms. We're talking about pain or swelling or hard lumps. I'm also told that plastic surgeons are alerting patients. They're trying to get in

touch with as many patients with the specific biocell textured implants and monitor for swelling, pain, hard lumps. The reason why the FDA and Health Canada are saying you don't need to have them removed is they're considering that surgery is difficult. Surgery is difficult for your body, for your health. You can develop other problems after surgery. So they're saying right now, everyone should just monitor their symptoms, go back to their plastic surgeons, make sure they follow the situation tightly, but they don't need to have them immediately removed. How are women that you've spoken to responding to this? I would imagine that this would be creating an incredible amount of anxiety.

Well, I asked her about that because she says that she receives phone calls and messages from dozens of women a day. She's very active on social media, raising awareness about the disease and the treatment options. She says that this worldwide recall changed everything. She's hearing more from worried women. We are seeing women who have been denied testing starting to get a little bit of traction to have these tests done.

But she's also hearing more from plastic surgeons themselves who are starting to say, hey, we thought this wasn't really an issue, but now maybe I'm going to start looking back at what I did and call my patients back and maybe monitor this and give it a little bit more credibility. But Terry's also saying that, you know, she doesn't know if her health system is equipped to help these women, because this is a very specific kind of rare disease. And a lot of women, she says, are struggling with finding credible information, finding credible studies, and finding doctors that are willing to monitor them and potentially explant.

We end up being sort of this guinea pig. We were guinea pigs with implants and now we are guinea pigs with this disease. We continue to advocate. We continue to study all of the research because our job now is to help other women. I understand Terry herself has filed a lawsuit against the company Allergan. Is she essentially saying that she thinks that there was wrongdoing there?

Well, she states that the company, quote, did not fully and clearly inform her of all the dangers in the use of its products. She said that had she been warned about the cancer risks or the heightened prevalence, she probably would have made completely different decisions, either a decision to not have the implant at all or a decision to remove it much faster. And Allergan responded by saying that, yes, breast implants carry certain, quote, inherent risks, but they're saying that they're not negligent. The lawsuit is still before the courts and none of the allegations have been proven. There's a lot of other lawsuits that are ongoing worldwide. They are all mostly from patients

who are saying they were not worn properly. And what it will come down to in a court of law is really finding out if Allergan knew about the risks and when they knew about it. Okay. I'm sure there are also thousands of women who would like the answer to that question as well. Valerie, thank you so much. My pleasure. So before we go today, some news about Jack Letts, a British-Canadian man commonly known as Jihadi Jack in the media.

He's accused of travelling to Syria to fight for ISIS and has been in a Kurdish prison for about two years now. Well, on Sunday, news broke that his British citizenship was getting revoked and the Canadian government responded that they were disappointed by that decision. A statement from the Office of the Public Safety Minister called it an offloading of responsibilities on the UK's part. It's really unclear now what Canada will do. Jack Lett's father has previously appealed

to both the UK and Canadian governments to repatriate his son. What to do with all these alleged ISIS fighters currently in Kurdish custody is a big issue, one that we've tackled on this show before. You can find it in our feed and we'll also tweet out a link. That's all for today.

I'm Jamie Poisson. Thanks so much for listening to FrontBurner. For more CBC Podcasts, go to cbc.ca slash podcasts. It's 2011 and the Arab Spring is raging. A lesbian activist in Syria starts a blog. She names it Gay Girl in Damascus. Am I crazy? Maybe. As her profile grows, so does the danger.

The object of the email was, please read this while sitting down. It's like a genie came out of the bottle and you can't put it back. Gay Girl Gone. Available now.