Part II: Breast Implants, Big Pharma and Covid
Lessons about the FDA, experts, and due diligence
As I reported in Part I, I was diagnosed with breast cancer in April of 2014 and underwent treatment including a mastectomy, the placement of implants, and chemotherapy. By November of 2014, chemotherapy was done, and I began my recovery from its toxic effects.
Prior to my breast cancer diagnosis, I had been a lifelong athlete with running serving as my church. It was out on the open road that I would process and reflect as the miles passed beneath my feet. By the age of 45, I had competed in 4 marathons and had a personal best of 3 hours, 27 minutes for the grueling 26.2 mile distance. Following the completion of my chemotherapy, I was eager to regain my health. A week after my last treatment, I went out for a run. Looking back, I was obviously in denial about the impact that cancer had had on my life and that chemotherapy had had on my system.
I had been that patient who always showed up at the infusion center with a smile on her face, powering through the regimen that had been prescribed. My husband wondered at times if I actually identified as a cancer patient. My powers of denial can be strong.
However, I soon discovered during that short run following the completion of chemotherapy and in the months that followed just how hard it would be to recover my health. They say that it can take a year or more (but count on at least a year) to feel like yourself again.
Another side effect of a cancer diagnosis and treatment is one finds themself on high alert in the years that follow, always nervous that cancer will reappear in your life. Imagine picking up a hitchhiker and driving down the highway watching him in your rearview mirror wondering if he has a knife or gun and devious plans for your demise. That is what it is like in those first years after diagnosis and treatment, cancer once in your life never fully leaves. You do your best to be vigilant against its return, alert to any signs that your cancer is mounting a new attack. With time, a couple of years, cancer slowly stops dominating your waking thoughts. It takes time. I knew this. I understood it and I lived it.
However, by 2017, my overall health seemed to be getting worse not better. My joints were sore. I would wake in the morning with hands swollen to the point that I could not bend them. I would creep out of bed like a 80 year old, barely able to stand up. Fatigue dominated my days. Emotionally I struggled.
I had started an anti-depressant, Effexor, as an off-label use to help cope with the hot flashes and soon found myself asking my doctor to up the dose to help me deal with my emotional struggles related to my inability to recover my health. I distinctly remember one afternoon trying to rake the lawn and thinking to myself, I can’t do this for another 30 years.
My family, husband, and friends wanted me to feel better. Yet I didn’t and I didn’t know why. Those years were so disheartening and difficult for not only me, but for my family as well. They missed the way I had been before my cancer diagnosis. I missed my former self.
In 2017, I recall stepping out of the shower and noting that my implants/chest looked lumpy. It alarmed me. I called my oncologist and reported that something was not right. I wondered if the implants were leaking or had ruptured. My oncologist’s office dismissed me and told me to call my plastic surgeon. My plastic surgeon reassured me that the implants were good for 10 years and there was no need for my concern.
At some point, however, around this time I was offered an MRI, because you are entitled to one every three years with implants. I recall my plastic surgeon telling me that generally he did not think it was necessary, but I had some swollen lymph nodes under my right arm so the MRI would serve two purposes…check my implants and also look for evidence of a reoccurrence. The report from that MRI stated that my implants looked folded in certain places. Again, my plastic surgeon assured me that was not unusual and was no cause for alarm.
It was in 2018, as I continued to struggle to recover my health, that I began reading in the mainstream media about a suspected link between texturized silicone implants and a special type of lymphoma, BIA-ALCL. The special type of lymphoma was being diagnosed in women with such implants.
I raised the issue with my oncologist and was supremely disappointed when she had no idea what I was talking about. I was in disbelief that an oncologist that advises women diagnosed with breast cancer about treatment options had no awareness of these reported issues. I began to do my own research on the implants. And soon thereafter, I would also go looking for a new oncologist.
By 2019, the FDA was nicely asking Allergan to voluntarily recall its texturized silicone implants.
https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
By this time, I had a new oncologist because I had been dissatisfied with my former oncologist’s dismissal of my struggles. My new oncologist was much more thorough and sympathetic. Due to my serious ongoing symptoms, she had done what she called a “million dollar” work up and found no explanation for my symptoms. I could not disagree. There was no evidence of metastatic disease, no explanation and just worrying symptoms and no relief in sight.
Based on my own research, I asked both my new oncologist and my plastic surgeon if it could be my implants causing my problems. Not only had I read up on the connection between lymphoma and the silicone implants, but I had joined a Facebook group called Breast Implant Illness and Healing. The FB group boasted a membership of over 150,000 women worldwide. It was incredible to read the collective knowledge and wisdom of these women who were suffering and together sought answers that their medical providers and the experts seemed unable to fathom, you know because “safe and effective.” It becomes a tool at their disposal for dismissing complaints and dismissing patients….maybe it is menopause that has you so tired, your anxious about cancer returning so that anxiety is manifesting itself with physical symptoms, you worry too much, etc. Such is the power of the stamp of approval of the FDA, “safe and effective,” as the years tick by for women suffering.
Consider that many women are middle aged when they are diagnosed with breast cancer and undergo treatment. In the aftermath, I fear doctors often dismiss concerns raised as essentially being “in one’s head.”
I began talking with both my doctor and plastic surgeon about having the implants removed. I was desperate to get better. My oncologist first wanted me to go off from my adjuvant cancer medication for three months to ensure that my symptoms were not side effects of those pharmaceuticals. She like so many others did not want me to be brash and remove the implants that maintained my female shape. My oncologist is an attractive woman who always dresses with style and flair, I recall thinking she was more troubled by the prospect of my going flat than I was. I agreed to the trial period of three months with no Arimidex. Despite stopping my cancer medication, I saw no improvement.
I then saw my plastic surgeon and we talked about the FDA’s recall of silicone implants. He excused himself from the exam room for a few moments to check my chart and confirm which implants I had. When he returned he said that he had bad news. He said my implants, Allergan’s Natrelle 410, were the ones most implicated in the connection between lymphoma and the texturized silicone implants.
He, however, went on to assure me that I did not need to have them out as the FDA had stated that the number of cases of lymphoma were rare. Even then, before the COVID debacle, it was not lost on me that of course the number of cases reported to the FDA were few. After all, the mantra of “safe and effective” would have stood in the way of doctors recognizing and reporting cases. How can one identify and report what the FDA had been saying previously did not exist? Right? I took no comfort from the suggestion that the cases of lymphoma were rare. As me and my buddies in the support group would say, “yeah, ok…I’ll keep the implants as long as you are going to die for me?”
Therefore, I respectfully told my plastic surgeon that I did not beat cancer to have cancer causing implants placed in my body. I was fortunate that my insurance company would cover explant. Many women who have had implants placed for cosmetic reasons do not have the option of removal without substantial costs because their insurance company will not cover the explant. You see, the FDA while acknowledging that the implants cause cancer, does not at this time recommend removal. Cause you know…it’s rare. This is the business of big pharma with its finger on the scale of public health, no? Why ruin a billion-dollar business with a few rare cases of lymphoma?
I explained to my plastic surgeon that I wondered if my inability to recover my health following my cancer treatment was due to the implants. Based on my research, I theorized that my body, especially in light of my autoimmune history, likely did not like the implants as they were foreign objects in my body. I suspected that the systemic inflammation I was experiencing was due to my body essentially rejecting the implants. My plastic surgeon did not dismiss me. He thought I might be onto something. I had gone to the appointment with my research in hand, but thankfully I found he was receptive to my request to have the implants removed. The question remains for me, if my common sense led me to suspect the implants why the hell has big pharma or the FDA ignored the obvious?
Where my plastic surgeon and I differed was that, based on my research, I was insisting that he remove not only the implants but also the scar tissue surrounding the implants. My doctor told me that was not necessary. He said that he could simply make an incision and the implants would peel right out, like peeling an orange.
I had explained to my plastic surgeon that the lymphoma was thought to be the result of an autoimmune like response to silicone flaking off from the grooved surface and entering the bloodstream and tissue of the patient. It is considered a disease of the immune system that often starts in the scar tissue or fluid surrounding the implant.
https://my.clevelandclinic.org/health/diseases/21078-bia-alcl#What%20Is%20Breast%20Implant-Associated%20Anaplastic%20Large%20Cell%20Lymphoma%20(Bia-Alcl)?
I was supposed to have my implants removed in May of 2020. However, my plastic surgeon was former military and belonged to the reserves. He was called to New York to serve on the ship brought to NYC as part of the COVID response. My surgery was delayed until November of 2020.
Thankfully, my plastic surgeon and I were largely on the same page regarding COVID and he did not press me to be vaccinated for surgery. He explained it would be a day surgery and as such I could avoid any mandate around vaccination. As he put it, I would be in a pod and not on the mother ship!
On the morning of surgery, I took my COVID iodine bath, put on my hospital gown and waited to speak to the doctor before heading to the OR. My doctor came in and I pressed him, “Doc…you are going to take out the implants AND the scar tissue/capsule, right?” He shrugged his shoulders and said he would try. He spoke of how thin I am and how he did not want to puncture a lung, etc. I told the nurse that I wanted pictures of the implants after surgery. Here, I again have to thank the many wise women on the FB page who had gone before me and whose advice I had taken to heart relative to ensuring proper treatment and handling of one’s implants following explant.
In the recovery room, I slowly regained consciousness. I turned my head to the nurse fiddling at my side and asked, “How did it go?” Her response, “It was not pretty, Dr. X is angry.” I asked her if she got pictures. “Yes,” she said, she would get them and show me what they found.
Below is the picture of the implant from my left side:
The doctor initially, thinking the implants were intact, made an incision line similar to the one from when the implants were placed. That is, he went across the top of the breast and upon peeling back my tissue discovered a severely ruptured implant. At this point, he was committed to removing what he saw as best he could. As he put it, he had to scrape crap off my ribs and irrigate the whole area, flushing the toxic chemicals from my chest cavity. Sounds lovely, doesn’t it?
When it came to the right side, he did not commit to a large incision. Instead, he did a small incision and took a peek. He found that like the left side, my right side was also severely ruptured. He then proceeded to do an “en bloc” explant. What this means is that he would remove the implant by cutting around it and removing it still encapsulated in the scar tissue.
This method is used as a means of ensuring that both the toxic chemicals are contained and also it ensures the removal of the scar tissue where the lymphoma is often thought to originate in many instances.
Prior to surgery, my plastic surgeon had thought that he would be able to do a decent job of smoothing out my chest area and even possibly creating a mounded effect rather than the concave appearance of breast cancer survivors who do not have implants. Many women who opt to go flat have surgeons who do a wonderful job of what is called and “aesthetic flat closure.” Strangely, my surgeon found himself in a bit of a triage situation given that he had no idea that the lumpy implants I had complained of looked more like apple jelly and were not going to peel out like an orange.
I can’t really get mad at my plastic surgeon. He, unlike others, was willing to listen and at the end of the day, he learned a valuable lesson. He told me he was angry and that he would tell any women that have those implants to get them the hell out of their body. I was satisfied that I had blown the “safe and effective” narrative out of the water in at least one practice.
What I remain angry about is that women are needlessly suffering and the agency that is supposed to protect public health does not give a sufficient damn.
Here’s the thing. Silicone implants were taken off the market in 1993 due to health concerns. In 2006, silicone implants were once again authorized by the FDA for use.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1676088/
In the above article, it is interesting to note that there seems to be some confusion around customer satisfaction. Can one be satisfied with the appearance and feel of a breast implant, but not satisfied with the adverse side effects? Have the two been conveniently conflated along the way in a pitch to get the billion dollar product back on the market?
The article further states:
”In an editorial the New York Times said, “These devices are prone to rupture, contract or cause pain and inflammation in the breast as time goes on. One study found that 69% of the recipients experienced a rupture, and almost a quarter of the women who received one manufacturer's implant for cosmetic reasons had to have it removed within the first four years. The FDA recommends that women have regular MRI screenings …
“Unfortunately [the agency] has a poor track record in forcing companies to complete post-marketing studies. It will need to be vigilant in keeping the implant makers honest” (www.nytimes.com, 21 Nov 2006, “The return of silicone breast implants”).
The FDA will require the two companies that make the implants, Allergan of Irvine, California, and Mentor of Santa Barbara, California, to do postapproval studies, following 40 000 women for 10 years after receiving the implants.”
Let me see if I have this right…the breast implants are allowed onto the market based on the FDA and big pharma pinky swearing that they will monitor those receiving the implants as a means of continuing to monitor whether implants are safe.
There is now a class action lawsuit and litigation pending around these implants. Part of how this litigation came to pass was that cases of lymphoma were reported and interestingly, the companies that were supposed to be monitoring patient health had failed to comply. Imagine that.
Allergan tried to have the litigation tossed on the fact that the FDA had approved the implants for use. Like with the COVID vaccine, we are supposed to take some comfort that our regulators in DC have our back. At this point, that is a proposition that is truly laughable.
To better understand the swamp and the capture of the FDA, I highly recommend the Netflix documentary, “THE BLEEDING EDGE.” My nurse sister had told me to watch it. I put it off. But man, oh man, when I did finally watch it, I was disgusted. It is so revealing relative to how the FDA is not functioning how we would think or hope that it would. You need to watch it….today. Sooner rather than later.
Another documentary premiered in 2021 relative to the plight of women suffering from toxic implants. It is called “Explant.”
https://www.tribecafilm.com/films/explant-2021
Thankfully, the class action lawsuit continues on despite the effort of big pharma to hide behind the FDA and have the claims of literally thousands of women dismissed.
https://newyork.legalexaminer.com/legal/allergan-fails-to-escape-liability-in-textured-breast-implant-litigation/
The rest of my story is this. Within 48 hours of removal of my implants, there was a noticeable difference in my systemic inflammation. One look at pictures of my face before surgery and a bit later after surgery is telling. In the FB group, there is a practice by the women of showing pictures of their faces before explant and then after. The contrast of the images is astounding, sometimes with only a few days between the photos.
Before surgery, I was increasingly moon faced and even my weight was ballooning despite nothing changing in my diet. Following surgery, I lost 10 pounds almost immediately. I could get out of bed in the morning without the debilitating joint pain. My energy levels soon increased. In my husband’s words, “It is like night and day.” I am still not 100%. I still have unexplained swelling and go through periods of stiffness and soreness in my joints. Some say that it takes time for one’s system to detox the heavy metals and toxins in the implants. I have no way of knowing exactly how long my implants were ruptured and leaking their toxins into my system.
I am thankful that I asked questions, pushed back and did not believe those who suggested my issues were “in my head.” I literally lost years off from my life and missed out on critical time with my family due to my debilitating symptoms from the toxic implants. I am now proudly flat with a scarred and disfigured chest that is far from flat. But I am happier and healthier now than I was from 2014-2020.
Recently, I saw an article in the MIT news about research that confirms the problems with the texturized surface of implants and how it causes scarring, inflammation and other complications. I am left wondering why such research was not done BEFORE the implants were put on the market and found their way into women the world over?
https://news.mit.edu/2021/silicone-breast-implants-surfaces-health-0621#:~:text=A%20team%20led%20by%20MIT%20researchers%20has%20systematically,rare%20type%20of%20lymphoma.%20Credits%20Image%3A%20Felice%20Frankel
I have come to scoff at the FDA’s proclamations of “no evidence” of problems or ill effects of a product they approve. In my head I immediately think….”well clearly, you can’t find what you refuse to look for.” FDA approval is no consolation. It means that you may want to follow the money and lobbyists, check the connections of the regulators, see what members of Congress have investments in big pharma and conveniently look away or read from a script that is more about big business than public health. Sound familiar?
Oh, and I am perfectly happy being flat ESPECIALLY because it means I have a better shot at being healthy. I still wonder about the impact of the toxic materials that leached into my system. And once again, I find myself needing to advocate and push the “experts” around pursuing that potential complication. If you ask for a blood test regarding heavy metals in your system, the refrain is likely to be, “that’s not protocol, not sure what you are looking for.” That is just an example of how the practice of medicine has come to be driven by algorithms, formulas related to standard of care often based on shoddy research, doctors checking boxes and moving on…because you know…..$$$$ talks and it is louder than the pleas of thousands of women.
I do believe that having “Esquire” behind my name has helped me to push back on my doctors and forced their hand in terms of making sure they respect my choices. I worry again about all the women told that it is in their head or are dismissed as not knowing what they are talking about. Told to get off the internet and stop researching. These days it can be the only way to get a lead on what ails you.
Don’t be afraid to ask questions and press the doctors. It is your body after all. There is a reason it is referred to as the “practice of medicine.” Despite Fauci’s claims that he (and presumably the FDA) are “science,” based on my experience nothing could be farther from the truth. They are the bought and paid for science.
All I can say is this is one more of your superbly informative articles!
What a tragic story. -and to know that there are so many that do not know, that do not communicate with their docs so they think it is "all in their heads" or for what ever other reasons, but never the implants.
You have been to hell and back. Yes, the anxiety of recurring cancer and just the horror of the past cancer is very mentally damaging. I know that.
I am beginning to believe that big pharma is just playing around with drugs and we are the guinea piggies. This is the same game they play with doctor practices. The merchants make an appointment and bring all of their new drugs and leave samples. I recall that practice even back in the 80's when I was a nurse in an ortho practice. new drugs, new devices, kickbacks, gifts.