In this week’s episode, we speak with Maria Aspan, senior writer for Fortune, where we discuss the risks and sometimes fatal results stemming from breast augmentation surgery, and we explore where the responsibilities lie for protecting the millions of woman who have had this surgery and educating those women who are exploring the surgery for the first time.

Click here to read more about Maria’s eye-opening article in Fortune

TRANSCRIPT

Jeffrey Friedman: Hello and welcome to the RP Healthcast by RooneyPartners. I am your host Jeffrey Friedman. 

Jeffrey: Our guest this week is Maria Aspan. Maria is a senior writer for Fortune Magazine, and prior to coming to Fortune she is written for Inc. Magazine, Reuters, and American Banker. Maria just wrote an incredibly interesting investigative feature in Fortune Magazine’s June-July issue about the decades of problems with breast implants and there sometimes fatal health problems for women. Now to give some context and to place some scope on this issue as to why it is so serious. More than eight million American women have undergone breast related plastic surgeries since 2000, and in 2018 alone more than four hundred thousand women had breast surgery for either cosmetic or reconstructive reasons. Breast augmentation is the most popular cosmetic procedure in the United States, and that is tracked by the American Society of Plastic Surgeons. Maria will discuss her article with us and talk about the big business behind the surgical procedure. We will talk about the potential danger it poses and what options women have if they are considering breast augmentation surgery.

Jeffrey: Maria, thank you for joining us today.

Maria: Hi, Jeffrey. Thanks so much for having me.

Jeffrey: Well first let me say, you know, I read your article and it is very thorough. It is an incredibly interesting piece on the issues surrounding breast surgery. I personally I did not realize how large an industry this is. So can we start out by framing this for our listeners? It is not just the manufacturers that are making money here.

Maria: Absolutely. It is not just the manufacturers who are making money and whatever sort of image you might have in your head about the sort of person or patient who might go for breast plastic surgery, it is probably not only devoted to that sort of woman neither. This is an industry that has served some eight million women since 2000. There are in 2018, which is the latest figures that were available, there were about 400,000 women who had a breast related plastic surgery. A hundred thousand of those women were getting reconstructive surgery, which is most often done after someone has a mastectomy for cancer related reasons. In terms of financial impact, we can say from a manufacturing side of things, it is probably under a billion dollars annually, but from an overall, including doctor fees and health insurance costs we are talking a multi billion dollar industry. Breast augmentations can cost up to twelve thousand dollars according to the American Society of Plastic Surgeons and there were three hundred thousand of them alone last year which which we are talking like three point six billion dollars from that alone.

Jeffrey: It is I mean that is mind-boggling because especially because the history and the risk behind breast implants and augmentations history. Augmentation surgery, the risk has been known for decades, and it is always been deemed as controversial right? For example in 1995 Dow Corning had over twenty thousand separate lawsuits related to the implants. What happened there? What was the outcome?

Maria: Yeah, highly controversial and also highly litigated in all senses of the word. So breast implants have been on the market since the 1960’s. They have been regulated to some extent since the 1970s. And by the 1980s women were starting to complain about about pains and illness and other side effects of their implants. Dow Corning which was a joint venture of Dow Chemical and Corning, was one of the biggest makers of silicone breast implants and by 1995 had filed for chapter 11, because it was the subject of so many complaints. Of those twenty thousand lawsuits that you mentioned, ultimately there  were more than four hundred thousand women with complaints against the manufacturer. By 1998 it had agreed to set it up a thre point two billion dollar settlement fund. Meanwhile, there were three other big manufacturers of silicone implants, Bristol-Myers Squibb, Baxter Healthcare and 3M, that set up a separate multi billion dollar settlement fund. And incidentally the Dow Corning settlement fund, that only just expired last year. Women were able to file claims for it up until June 2019. But the outcome of all of this was muddy and again controversial, but even the controversy was controversial. The science was highly disputed. The FDA had in 1992 asked for a moratorium on the sale of most silicone breast implants and lessen in certain cases, especially again for for cancer patients. So most implants were becoming saline. 

Maria: There was a highly influential study or a panel rather, that in 1999 a panel of scientists that was convened by The Institute of Medicine concluded that silicone implants did not cause any major disease, even though the panel did not really do their own research. They relied on a lot of research submitted by other entities including manufacturers and surgeons who are involved in this industry. And public health advocates pointed out at the time and still point out that some of those findings were obviously conflicted. And there was also some legitimate criticism of the sort of Gold Rush of lawsuits against the manufacturers. The idea that plaintiffs attorneys saw that breast implant makers were ripe for the plucking, were a good target of personal injury lawsuits, and that raised some concerns about the legitimacy of perhaps of all of the claims. So you have all of that and there is a lot of bad feeling all around, a lot of awareness that breast implants might not be safe, but little direct conclusion and into this in 2006, the FDA grants approval again to manufacturers, Allergan and Mentor to start selling silicone breast implants again. However, it demands as a condition of these sales that the manufacturers continue to study the impact and the health effects of their implants on patients, and neither one has to the FDA’s satisfaction. We are now 14 years after those approvals were given and the FDA has sent warning letters to all of the manufacturers of silicone breast implants saying, “You have not done what we told you, you had to do in order to sell these things.”

Jeffrey: There is so much going on here. And then it is tough to unpack it all. That is why the article is so good. It is just history has a way of repeating itself. I mean in 2017 Allergan sold about four hundred million dollars worth of implants before they were taken off the market and you mentioned that the FDA still asking them for information. What happened with Allergan? Why was not more done to them about this and are there fines? So what is going on now?

Maria: It is a good question. And again, it is hard to explain briefly, but I will try not to get too into the weeds. So I think it is first of all important to point out that Allergan is still selling some breast implants. But what started to happen actually in the late 90s, but what the FDA became fully aware of and started to warn people about in 2011 is that breast implants were being linked to a new complication, a type of cancer of the immune system that is called Breast Implant-Associated Anaplastic Large Cell Lymphoma, otherwise known as BIA-ALCL. Now these implants– This cancer has been linked to textured implants. So all the manufacturers make either smooth implants or implants that are covered in this more roughly textured silicone shell. There are a couple of reasons why it might be preferred. It allows tissue to grow onto the implant more easily. There is some doctors and patients say that it looks more natural but textured implants were not super popular in the United States. They were very popular in Europe and by the end of 2018, European Regulators were seeing a big surge in cases of BIA-ALCL and starting to get worried about the sale of textured implants and this disease that it seemed like that they were linked to and then it seems like they might be responsible for. So at the end of 2018, European Regulators stopped the sales of Allergan textured implants and later banned them entirely. The FDA in March 2019 convenes a hearing to look into– Two-day hearings actually to look into BIA-ALCL. Some of the other side effects that women are increasingly reporting- have increasingly been reporting of their breast implants, but it is not until last July 2019 that the FDA says alright five hundred seventy three women worldwide have been diagnosed with this cancer, 33 women have died from it. Women with Allergan textured implants, even though all of the manufacturers with textured implants have been linked to the disease, women with Allergan textured implants are six times as likely to contract BIA-ALCL. So Allergan, we are asking you to take your textured implants off the market, which the company did. The FDA later increased that recall to a class one designation, meaning that use of these devices could cause serious injury or death. So, it was a very– It seemed from the outside perhaps if you were not paying attention to these issues, like a very sudden withdrawal, but the awareness of these issues, the awareness of this disease had been around for years by then, and the FDA was taking action several months after Europe did.

Jeffrey: All right. Well, it is just with all the controversy, with all the awareness, it is still a billion dollar industry. All right. So let us move away for right now. Let us not talk about the economics. But let us talk about the humanistic side and in particular in your story you feature many women that have been affected by issues related to their implants and in particularly the story of Paulette Par you wrote about, she was very moving and her husband the work that he was doing. Can you share a little bit about Paulette’s story with us?

Maria: Absolutely. This was a really difficult story to tell and a very sad one. And I do have to say I am so grateful to all of the women who did talk to me or their families, in Paulette’s case, her husband because this is maybe from the outside seen as kind of a niche and taboo subject, you know, this is breast implants. This is feminine sexuality and kind of shallow plastic surgery. This is lady business, and kind of gross, and kind of silly, and not that serious. And a lot of the women that I talked to said that they had to kind of get over their own feelings of shame or the external judgement of you know, “Oh you got these things for vanity and now they gave you cancer. Are you happy?” You know, “You deserve this.” is what more than one woman told me that she had been told by family members or friends after after developing BIA-ALCL. In Paulette’s case, her story really kind of follows the history of breast implants. She lived in Missouri. She was a young mother of two children in the 1980s when she got her first set of breast implants, you know, as she wanted to feel better about her body after childbirth and nursing. And they were mostly okay. They were silicone. She was worried about the health impact when all of the news about lawsuits and the FDA moratorium on silicon implants came out, but you know, they were fine until around 2000-2001 she noticed that they were leaking and so she got– Her plastic surgeon did replace them with the first set of implants made by a company that Allergan later required. These were the textured bio cell implants that were eventually recalled due to their linkages to this cancer of the immune system. Paulette had one set of these biocell textured implants until 2010. Then there was another leak and she had them replaced with another set of biocell textured implants, and she was you know, in 2018, she was she was 67. She had just retired. She had worked in the administrative offices of her local hospital for decades. She and her husband were restarting– Her husband had retired a couple of years. before, and they were looking forward to traveling some more together and just you know, enjoying the start of their retirement together. And in the fall of 2018, Paulette noticed that she had a small pimple sized growth and she went and got it checked out and eventually was told, “Oh, you have this new rare cancer that has been linked to your type of breast implants.” A few sessions of chemo and you will be fine. And unfortunately the really, the just horrible and sad story is that over the course of the next year, she had her chemo during the Spring, as the FDA was holding hearings on breast implants, as Europe had banned the textured implants from their market, and the chemo did not work and her cancer metastasized and she wound up being hospitalized and growing weaker and weaker. And 29 days after the FDA banned her implants or asked Allergan to recall them, she passed away. 

Jeffrey: Now, the implants are deemed medical devices. So, what type of testing is done? And is the oversight just on the- you know by the FDA over these manufacturers? And how much oversight is done? It seems to be a recurring theme.

Maria: It is a really good question. It is. It is a recurring question. Medical devices in general have come under all sorts of scrutiny for the sort of lack of testing and regulation that they are subject to. I have to give a shout out to the International Consortium of Independent Journalists, which did an amazing series of articles called the Implant Files, that looked into- starting in 2018 it looked into some of the failures of regulation and study of all types of medical devices. Whether we are talking pacemakers or artificial hips or ventilators, which have been in the news so much with COVID-19. So breast implants are a specific subset, but by no means the only sort of medical device that is subject to some of these questions about the regulation and testing. For breast implants specifically the FDA now does regulate them as class 3 devices, meaning that they are the highest category of risk. And so they are subject to what is known as pre-market approval processes. They have to undergo clinical testing done by the manufacturer. But again, there is still some question about the adequacy of that testing and the data submitted. For example with Mentor, which is now owned by Johnson & Johnson, and Allergan which is now owned by AbbVie, when the FDA in 2006 gave them both approval to start selling silicone implants again, they base that improval on three or four years each of study and then required the additional study that the manufacturers have not fully complied with. 

Jeffrey: So as we said history does repeat itself. Unbelievable! All right, before we go, is there anything else you would like to warn or discuss with someone that is considering the surgery

Maria: So I think one thing that is important to point out and in that maybe does not come across in all of the discussion of the negative side effects and very serious and sometimes fatal consequences is that, I did speak to many women who are grateful to have implants as an option, including it has to be said, a lot of women who have been affected by cancer. Whether they are women who are cancer victims themselves who have undergone mastectomies to treat cancer or women who are the children of people who have been affected by breast or ovarian cancer, who have undergone preventative mastectomies and remove their breasts to remove their high risk of developing cancer. Many of these women say that they are grateful for the options, that the choice to have breast implants have given them. So I would not necessarily want somebody to come away from this thinking that all breast implants are absolutely bad, but I would conclude from all of my reporting that the breast implants that are on the market just have not been adequately tested or studied and that for women to have options they deserve to have fully studied, vetted choices that have- and to be clearly informed about the risks which many women said they had not been, whether it was the fault of their doctors, or the fault of the manufacturers not adequately communicating the risk to their doctors, or in some cases even hiding or not fully reporting the adverse events in the malfunctions of their devices. It is just there is been a lack of clear information given to women who might want to consider these medical devices.

Jeffrey: That is great advice and research and research and research is key. So Maria, thank you so much for your time today. This was incredibly interesting and enlightening and informative. Thank you.

Maria: Jeffrey, thank you so much. It was my pleasure.

Jeffrey: We hope you enjoyed this week’s podcast. If you have any questions, comments, or future story suggestions, please reach out to us on social media. Thank you, and we hope you enjoyed the RP Healthcast.