The Philip DeFranco Show - MS 5.7 What Doctors and the FDA Aren’t Telling You About The Dangers of Breast Implants…

Starting point is 00:00:00 Hello, hello, welcome to your morning show. My name is Philip DeFranco, and today we're gonna be taking a look at safety concerns, lack of information, and more regarding breast implants. Many of you might not know, but the first breast implant surgery was performed in Houston in 1962.

Starting point is 00:00:12 And in fact, although the FDA had the authority to regulate breast implants by 1976, they remained largely unregulated until the 1990s. And since then, breast augmentations have catapulted. According to the American Society of Plastic Surgeons, as of 2018, they're the most performed cosmetic surgical procedure in the United States. But what we've seen in recent months

Starting point is 00:00:29 is that the FDA has started to reexamine the risks associated with implants. This despite longstanding denials by some doctors and implant manufacturers about any risks. And more specifically, on March 25th and 26th of this year, the FDA held a two-day safety hearing about the hidden dangers of breast implants. This after reports of thousands of women

Starting point is 00:00:45 citing concerns that their breast implants were causing joint pain and fatigue. These reports also cited links to autoimmune diseases, something known as breast implant illness, and in some cases, breast implant-associated lymphoma. But one of the big issues here is that the FDA didn't just randomly decide to have these safety discussions.

Starting point is 00:00:59 It took over three years for advocates of breast implant illness awareness to bring the FDA to the table. Three years of demanding meetings, drafting petitions, gathering signatures, and filing lawsuits. During all of this, over the years, hundreds of thousands of women have come together to build a global online community where they can share their experiences with breast implants. Now if I could ask all the women who have been harmed by breast implants, or those who know someone harmed, to stand. Not all will speak at this meeting, but they come in solidarity today to say enough is enough." And thanks to these efforts, more and more women have been able to identify their symptoms early on,

Starting point is 00:01:30 and more importantly, do something about it. And this is why in recent years, we've actually seen a spike in the number of explant surgeries taking place. And for those who aren't familiar with that process, it's exactly what it sounds like. It's the medical procedure and process of removing the breast implant. And our research found that some surgeons have even gone as far as stepping away from performing breast augmentations altogether and are solely focused on explanting now. And so with all that said, to try and make sense of this situation, we had Maria Sosyan from the Rogue Rocket team jump into it. One of the major reasons why we're talking about this issue today is because concerns over breast implant safety

Starting point is 00:02:01 have been gaining serious momentum over the last six months. The Food and Drug Administration has issued a warning about a rare and deadly cancer linked to breast implants. The safety of breast implants has been in the news since certain implants were linked to a rare form of cancer. More than 10 million women worldwide have received breast implants over the last decade. But it may come as a surprise to you that in 1992, silicone breast implants were largely banned in the U.S. because of safety concerns around what happens to the body when an implant ruptures or leaks. There was evidence that showed that ruptured or leaking breast implants

Starting point is 00:02:35 could lead to cancer and various autoimmune diseases. In 1991, a program called Face to Face with Connie Chung aired on public TV, revealing the dangers associated with silicone implants. A year later, in 1992, the FDA called for a moratorium on new implants because they were unsure about their safety. That same year, a class action lawsuit was filed against the Dow Corning Corporation, a major manufacturer of silicone breast implants.

Starting point is 00:03:01 By the end of 1993, there were more than 12,000 individual lawsuits filed against Dow, with patients claiming not only localized injuries, but that diseases such as lupus or rheumatoid arthritis were caused by their implants. The class action trial revealed that Dow had knowingly deceived women by hiding information about the health risks of silicone used in breast implants. Additionally, among the two million pages of documents released by Dow Corning in the case

Starting point is 00:03:27 was a 1975 company study showing that exposure to the silicone in implants harmed the immune system of mice. Not only was Dow forced to quit the breast implant business, but they also filed for bankruptcy and settled for a $3.2 billion settlement for damages. The Dow implants contained silicone gel in a silicone casing. According to many reports, the outer shell was defective and the silicone contents were leaking into women's bodies right from the moment of implantation.

Starting point is 00:03:53 And the chemicals in the implants were toxic to the human body. We spoke to Nicole Deruta, founder of the Facebook group Healing Breast Implant Illness, a collective of over 70,000 women who have had negative experiences with implants. Before the Dow class action lawsuit, women were suing surgeons for placing silicone breast implants that were obviously, you know, leaking, you know, just in the shell, just in the casing before they put the silicone breast implants in women. You know, a lot of times they were taking them out of the casing, the packaging that they arrived in, and they would have to clean them off before they put them in women. Because with the Dow implants, they were so leaky that

Starting point is 00:04:36 they leaked right from the time they were manufactured. We know that silicone was invented by Dow Chemical, right? And Dow invented silicone as a pesticide. That's what they did. That's what Dow did. It made pesticides and chemical weapons of war. It made Agent Orange. You know, we know from the Dow trial notes when it invented silicone back in the 50s, late 50s, it actually tested it as a pesticide. The FDA made the decision to restore silicone implants

Starting point is 00:05:08 to the market in 2006. This happened after serious lobbying on behalf of two major implant manufacturers, Allergan and Mentor, who managed to convince the FDA that ruptures, leaks, and any associated illnesses reported by women with breast implants were no longer a concern. But many of the safety concerns

Starting point is 00:05:25 that caused breast implants to be banned in the first place never went away. Neither did the symptoms nor the number of women coming forward with complaints about their implants. That being said, there's now new evidence to show that a breast implant doesn't need to leak or break to cause problems. Which brings us to November,

Starting point is 00:05:41 when the International Consortium of Investigative Journalists revealed a monumental global investigation that exposed the harm caused by medical devices that haven't been tested adequately, breast implants among them. In their report, ICIJ revealed that for years, the FDA allowed breast implant manufacturers to bury reports of ruptures and other injuries by reporting them as routine events that did not require public disclosure. Sasha Chovkin is a reporter for ICIJ and the author who broke the story. If you looked at FDA records for the years after breast implants were allowed back on the market in 2006, it seemed like very few injuries were occurring. That's because the FDA was actually allowing manufacturers to report serious problems, things like ruptures of breast implants

Starting point is 00:06:34 that required surgery to get fixed, through something called alternative summary reporting, and that would allow them to condense hundreds or even thousands of incidents into a single report that would then only show up in the FDA database as one incident. ICIJ's findings revealed that the FDA had allowed some 8000 reports regarding breast implants to be hidden from the public. Fast forward to March 25th and on the eve of the safety hearing that Phil mentioned earlier, the FDA revealed it has long known

Starting point is 00:07:08 about the injuries and complications and had failed to disclose not 8,000 incident reports involving breast implants, but more than 350,000 since 2009. But before we fall too deep into the FDA and recent findings, let's cover some of the technical components that you need to know to understand this story. Like what does a breast augmentation entail?

Starting point is 00:07:28 Well, it's a surgical procedure that aims to increase the size, shape, or fullness of the breast. This is done by placing breast implants under the chest muscles or breast tissue. The implants are essentially silicone shells filled with either saline, which is pretty much salt water, or silicone gel. Just so you have a general idea, of the augmentations performed in the U.S. in 2018, 88% were silicone and only 12% were saline. Some choose to enlarge their breasts for cosmetic reasons. Others get implants for post-mastectomy reconstruction. And while the reasons why women may choose to have an augmentation vary, one thing is for certain. Breast implants are not intended for lifetime use. According to the FDA, the longer a woman has implants, the more likely

Starting point is 00:08:10 it is that she'll need to have surgery to remove or replace them. Many women are told breast implants may last a lifetime. They tell us that newer, more cohesive implants won't rupture because you can cut them in half and nothing will happen. While some people may keep their original implants for 20 to 30 years, that's not the common experience. For years, surgeons have argued that silicone is safe inside the body and not harmful to a woman's health. There are a lot of complicating factors as well. For example, there are other types of implants,

Starting point is 00:08:39 like shunts, even pacemakers that include some amount of silicone, and so what that means is that anyone who has a breast implant is exposed to a lot of silicone more than any other kind of medical device and a large surface area of silicone so it seems like breast implants do have a higher degree of silicone exposure than other medical devices. I think that more research will be necessary in order to determine whether or not silicone itself is responsible for these problems or whether it's some other type of problem caused by the introduction of a foreign body into the bodies of patients. The reality is when it comes to breast implants, the nature of the ingredients that make up the silicone outer shell or the gel inside is not public knowledge.

Starting point is 00:09:55 Here's all that's listed on the FDA's website when it comes to the contents of an implant. Saline filled breast implants contain a silicone outer shell filled with a sterile saltwater solution. Some are pre-filled and others are filled during the implant operation. Saline-filled implants come in different sizes and have either smooth or textured shells. Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. We reached out to the FDA for a statement about their pre-market approval process. On May 2nd, following our conversation with the FDA, they released a statement announcing new efforts to protect women's health and to help ensure the safety of breast implants.

Starting point is 00:10:33 Moving forward, the FDA will work to improve the information available to women and healthcare professionals about the risks of breast implants by being more transparent. Additionally, the FDA has ended all summary reporting of breast implants by being more transparent. Additionally, the FDA has ended all summary reporting of breast implants. All breast implant manufacturers will now be required to file individual medical device reports, inclusive of all adverse event reports, which will become publicly available in the coming weeks. Currently, the FDA database contains information about each medical device. Under each approved device, there's an approval order. Labeling information is limited, however. Only under some devices can you find a summary of safety and

Starting point is 00:11:08 effectiveness that includes a list of device materials supplied by the manufacturer. Although a database is available, it's difficult to find, let alone navigate. Here's an Allergan brochure for Natrel and Spiro cohesive implants, commonly referred to as gummy implants. It says their implants are filled with either cohesive silicone gel or highly cohesive silicone gel. That's it.

Starting point is 00:11:28 The only information that seems to be readily available about these implants is how they maintain their shape, how soft or bouncy they feel, and their overall squishiness. Interestingly enough, two textured implant types, microcell and biocell, used in products such as Allergan's Natrel, were pulled from European markets in December 2018 because of their association with anaplastic large cell lymphoma. This occurred after that ICIJ investigation.

Starting point is 00:11:51 Allergan said it disagrees with the reasoning of European officials but is fully cooperating. Biocell implants have since been banned in Canada as well but are still widely used in the U.S. We reached out to Allergan for a statement. Here's what they had to say. Allergan diligently reports all safety information we receive to FDA and other health authorities. Allergan supports informed consent for patients, and the company has included appropriate information in the surgeon directions for use and patient information leaflets to aid in an effective consultation and patient-physician discussion around the risks and benefits. As with all Allergan products, we are committed to strict adherence to all regulatory requirements,

Starting point is 00:12:29 to the most rigorous scientific evidence, and to the highest industry standards for our products. When Nicole's health began declining a few years after receiving her cohesive silicone gel implants, she wasn't sure what was going on. And because her symptoms didn't seem like they were directly related to her breast implants, she had no idea that they were the culprits. library card. Adventurous U owns the road with super all wheel control. Regular side alone time. Adventurous side journeys together with third row seating. The new Outlander. Bring out your adventurous side.

Starting point is 00:13:15 Mitsubishi Motors. Drive your ambition. From early morning workouts that need a boost to late night drives that need vibes. A good playlist can help you make the most out of your everyday. And when it comes to everyday spending, you can count on the PC Insider's World Elite MasterCard to help you earn the most PC Optimum points everywhere you shop. With the best playlists, you never miss a good song.

Starting point is 00:13:37 With this card, you never miss out on getting the most points on everyday purchases. The PC Insider's World Elite MasterCard. The card for living unlimited. Conditions apply to all benefits. Visit pcfinancial.ca for details. For instance, I noticed right away that my thyroid started to not work properly. The same as for my adrenals. I noticed that suddenly I started to get infections of all kinds like UTI, yeast infections, you know, periodontal infections, any kind of like broad kind of infections and that they were difficult to clear as were viruses like the flus and colds.

Starting point is 00:14:12 I was perfectly healthy before breast implants, but you know, two years into getting breast implants, I started to have all sorts of health problems. Nicole got her cohesive silicone gel implants in Canada in 2005. By 2012, she was bedridden and forced to leave her career. After explanting in early 2013, Nicole decided to create her own website to educate women about breast implant illness.

Starting point is 00:14:37 Breast implant illness, also known as BII, is a collection of systemic symptoms thought to be related to breast implants. Based on recent findings, it is the most commonly experienced illness. Symptoms of BII include memory loss, brain fog, joint pain, extreme fatigue, rashes, connective tissue disorders, hypothyroidism, chest pain, body odor, and depression. For years, she wanted to know the ingredients in her breast implants, but neither the manufacturer

Starting point is 00:15:05 nor her surgeon would disclose that information. After extensive research, she published this list of alleged ingredients on her website. Here's a list from the FDA's database. When it comes to weighing the risks associated with implants, not only do the contents inside the implant matter, but also the implant's casing, and here's why.

Starting point is 00:15:22 In 2011, the FDA issued a safety communication regarding the link between breast implants and something called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, a rare cancer of the immune system that grows in the scar tissue surrounding the implant. Experts say the chances of getting this type of cancer are extremely low, but it's something the FDA wants patients

Starting point is 00:15:44 to be aware of and doctors to be on the lookout for. According to the FDA's latest report, in the U.S. alone, there have been 457 reports of BIA-ALCL. Of these, nine patient deaths were identified. 334 of these reports included information on the implant's surface.

Starting point is 00:16:02 We know that 310 involved textured implants and 24 involved smooth implants. As for what the implants were filled with, 274 reports mentioned silicone gel filled implants and 183 reports had saline filled implants. Patients are generally diagnosed eight to ten years after getting their implants, but symptoms can begin as soon as three years after.

Starting point is 00:16:23 Were any of you told about this before you got your implants? None at all. I removed my chest to get rid of cancer, and I reconstructed it and put cancer back in. I would have never done it. Ever. To this day, most BIA ALCL cases have involved textured implants, with only some being linked to smooth ones.

Starting point is 00:16:45 But considering how recent these findings are, the FDA's warning is for all breast implants, regardless of appearance or texture. A recent lawsuit against Allergan claims that the manufacturer has known of the cancer risks associated with their breast implants since the 1990s, and despite knowing these side effects, they continue to sell textured implants associated with the development of BIA-ALCL. Another common complication is capsular contracture, where the scar tissue that forms around the implant becomes hard or tight, causing the breasts to become very stiff and misshapen, and leading to severe pain.

Starting point is 00:17:20 In addition to pain from their implants, women have reported developing diseases such as fibromyalgia, Hashimoto's thyroiditis, and mixed connective tissue diseases. The common belief and misconception is that only women with textured silicone gel breast implants are at risk of developing illness. But the two-day breast implant safety hearing included testimonies from women who became severely ill from both textured and smooth silicone implants, and even saline implants. Unlike silicone implants, saline implants have a port. The port can be a potential hazard for mold. Researchers have shown that bacteria or mold can grow inside the saline implants, and that mold can be released into the body if the implant breaks or leaks. We have documented so many implants with all types of mold floating in their body,

Starting point is 00:18:06 or sorry, floating inside the implant and also growing in the capsule, the capsule and the chest of them, right? The women with moldy saline implants are some of the sickest women we know. And once that mold is in their body, because their immune system is depressed because of the implants, their immune system is depressed and dysfunctional, they become very susceptible to mold. And literally, the interior of their body is infected with mold. In March, the FDA announced it had issued letters of warning to two breast implant manufacturers for failing to assess the safety of their implants efficiently. The warnings were sent to Mentor Worldwide LLC in Irvine, California, and Cientra Inc. in Santa Barbara, California.

Starting point is 00:18:51 FDA Commissioner Scott Gottlieb said, We're issuing these warning letters based on the manufacturer's low recruitment, poor data, and low follow-up rates in their required post-approval studies. But these companies face no consequences as of yet for failing to follow regulations. Considering these recent warnings, many women are making the decision to have their implants removed. And like we said earlier, an implant doesn't need to leak or have a rupture to cause harm to the human body. Many women who do remove their implants because of breast implant illness, fatigue, joint

Starting point is 00:19:23 pain or other ailments find out that their implants were still fully intact. After I was awake for a while, he came to me and he brought my implants. And I expected to see them ruptured, but they weren't ruptured. They were completely intact, but they were tacky, like silicone on them. It felt like tacky like tape. The shell was tacky and it was like, you know, oily with silicone. And they smelt of terrible chemicals. YouTube personality Carissa Pukas released a video last summer

Starting point is 00:19:51 talking about her own struggle with breast implant illness. All of these things started popping up and I'm talking like multiple periods a month, heart palpitations. I was having things like sternum pain, costochondritis, having things like adrenal fatigue and brain fog. I can't explain what it's like to seek medical professional help and for them to tell you that you're fine and for you to deep down know that I'm not fine and I'm dealing with things every single day. It took time before Carissa found out that her implants were making her sick and severely

Starting point is 00:20:23 impacting her quality of life. After making the decision to have them removed, she traveled to California to visit Dr. Jay Choon, a plastic surgeon who specializes in explant surgery. The main reason why I decided to focus solely on performing explantation surgery is that as I was starting to do more, I was also starting to get more consistent follow-up on a daily basis. And what I was starting to see is a significant improvement. I would say somewhere around 80-85% of my patients were feeling better. They were, you know, back to their old selves. They're once again functioning members of society, whereas prior to the surgery, they really weren't doing anything anymore. Their symptoms were so debilitating that they ceased to function

Starting point is 00:21:18 at their previous levels as mothers, as wives, as workers in our society. According to Dr. Chun, there's a lack of transparency in the industry. Many plastic surgeons do not disclose warnings like they should. Many women have also claimed that they were never supplied with the manufacturer's brochures or even told about the FDA's warnings during their consultation. Our partners at the Canadian Broadcasting Corporation did a hidden camera investigation where they sent women to plastic surgery clinics

Starting point is 00:21:52 saying that they were interested in getting a breast implant and they repeatedly found that doctors were playing up the benefits and playing down the risks without providing thorough information to them. We also did a survey later in the process specifically asking about whether women were adequately informed of the health risks connected with breast implants. And what we found was the vast majority of women, out of more than 300 responses, my memory is only two women, said that they were fully informed of risks including things like BIA, ALCL,

Starting point is 00:22:34 and breast implant illness. About half of women said they got some kind of warning about local problems like rupture or a leak. And 40 percent of women who took that survey said that they didn't get any warning at all, that there could be health problems connected to their breast implants. It's important to note that not all women with implants will experience symptoms. While many may be at risk, some women have had breast implants for over 10 years and have not experienced negative side effects. If you're someone who's interested in getting breast implants, make sure to do your due diligence and look into the specific implants you'd like to get. Ask your plastic surgeon about any possible risks and be sure to

Starting point is 00:23:20 request the manufacturer's brochure. If you're somebody that has implants and you haven't had any symptoms, I hope that you never get them. I really truly do. But. If you're somebody that has implants and you haven't had any symptoms, I hope that you never get them. I really, truly do. But I want you to know that if you start having things happen that just don't really make sense, and if your body isn't seemingly working as well as it should or could,

Starting point is 00:23:36 or if you just can't really explain what is going on, don't waste your time. Look into breast implant illness. It is a thing, regardless of the medical community Acknowledging it at this point women who have breast implants should continue with routine physical exams and mammograms Generally speaking. It's a good idea to visit your plastic surgeon for a checkup from time to time Especially if you're getting close to hitting your 10-year breast implant anniversary now regarding any story that we ever cover But especially with this story in particular,

Starting point is 00:24:06 we really can't stress enough the importance of doing your own independent research and asking questions when, where, and if you have them. If you have breast implants and you are experiencing migraines, brain fog, joint pain, extreme fatigue, frequent fevers, rashes, memory loss, be sure to visit your doctor and ask about the possibility of breast implant illness.

Starting point is 00:24:23 Also, if you are considering surgery, our research recommends that you go to a board-certified plastic surgeon, find out which type of implant is being used, which manufacturer is sourcing the implant, and if there are any potential risks related to the type of implant you choose. Currently, eight breast implants have been approved by the FDA through their pre-market approval. They're all listed in the FDA's executive summary from the safety hearing, which we've listed in the links down below. Which on that note, the FDA's own safety notices warn that as many as one in five women who receive breast implants, they'll actually get them removed within a decade due to complications. I do believe

Starting point is 00:24:51 that as a public health question, in terms of what seems to be affecting more people, the breast implant illness deserves attention. We're still talking about a minority, a significant minority of overall patients who get breast implants. But because it's such a popular procedure, more than 10 million women have gotten breast implants in the last decade. We're talking about then, you know, a population of hundreds of thousands or even over a million over time that could be exposed to this kind of threat. So I believe that breast implant illness does deserve attention from regulators and deserves more research from both regulators and academics and plastic surgeons in order to understand what's going on and what the factors driving it are.

Starting point is 00:25:50 Based on Sasha's and ICIG's overall findings, roughly 10% of breast implant patients will experience symptoms related to BII. That's nearly 3% higher than the amount of people who smoke cigarettes and develop lung cancer. But I know this is a big story. It has a lot to take in. It brings us to the part of the video

Starting point is 00:26:04 where we pass the question off to you. One, what are your thoughts on this in general? Were you aware of the issues discussed in this video before you watched it? Have you or someone you know experienced any of the symptoms related to breast implant illness? Also, I feel like this is the one time it's not creepy to say I'm even more interested to know your thoughts if you currently have breast implants or you had them removed or maybe you're thinking about getting them. But really, no matter where you stand, I'd love to hear from you in those comments down below. Also, while you're at it, if you like these extra deep dive videos, you want to support the channel, just take a second and hit that like button. Also, if you're new here, you want more of this

Starting point is 00:26:33 in your future, be sure to hit that subscribe button. Also, if you don't want 100% filled in, you can go to roguerocket.com, check out the news articles there, or you can click or tap right there to watch one of the last two videos that maybe you missed. But with that said, of course, as always, thanks for watching. I love your face, and I'll see you right here back on this channel for a brand new Philip DeFranco show later today.

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The Philip DeFranco Show - MS 5.7 What Doctors and the FDA Aren’t Telling You About The Dangers of Breast Implants…

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