As women, it’s so important for us to stay in-the-know about current trends and products that are advertised to us. We are natural consumers, so it’s easy to fall under the influence of big names; whether it’s in reference to clothing, skincare, or even cosmetic procedures. After all, one of the best ways to get information is feedback from other women, and our girl gang is likely the first choice when looking for advice.
We have each other’s backs. And if there’s one thing this community offers, it’s definitely that.
Who are the ladies of Breast Implant Illness? A growing troop of women fighting for safety and informed consent in regards to breast implants. Breast implant surgery is a procedure that for long has been thought of as a generally simple, harmless cosmetic procedure that has little to no side effects. That is until the term ‘breast implant illness’ (BII) emerged over 25 years ago.
Although the BII community is rapidly growing and information regarding the topic is becoming more readily available, it is still not something the general public is entirely familiar with. If you were to ask one of the thousands of women who claim to be affected by BII how their life has been altered as a result of their decision to undergo breast implant surgery, I’m almost certain their explanation would spark your interest in knowing more.
What is Breast Implant Illness?
The American Society for Aesthetic Plastic Surgery describes BII as the following:
“Breast Implant Illness (BII) is a term used by women who have breast implants and who self- identify and describe a variety of symptoms including (but not limited to) fatigue, chest pain, hair loss, headaches, chills, photosensitivity, chronic pain, rash, body odor, anxiety, brain fog, sleep disturbance, depression, neurologic issues and hormonal issues that they feel are directly connected to their saline or silicone, textured or smooth breast implants.”
To be clear, BII is not actually recognized by physicians as a medical diagnosis, and many women attribute this to the FDA’s lack of regulations and manufacturer’s failure to conduct large long term studies. However, there are thousands of unrelated women with similar symptoms following implants that know one thing: they were not sick before their implants.
Countless women have revealed the sickness they have endured only to find they are not alone. These women may have “self-identified” as victims of BII, but that isn’t as a result of a lack of effort to be diagnosed. Rather, it is because of their doctor’s clear inability to further diagnose their myriad of unexplainable symptoms.
Is there any research that supports the existence of BII?
Wherever you stand on the subject, one thing is for certain. There is not enough medical research or evidence on the safety of breast implants, period. As mentioned, BII is not currently recognized as a medical diagnosis. However, there is growing evidence that serves as a warning for possible effects of implants.
In October 2019, the FDA released a draft guidance recommending a “boxed warning” (the strongest form of labeling required by FDA for warning) on labeling materials for breast implants. Some examples of the boxed warning recommendations that can be found on the draft are “the chance of developing complications increases over time” and “breast implants have been associated with the risk of developing BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma) and may be associated with systemic symptoms.”
The draft provides recommendations for the form and consent for labeling information including: boxed warning, patient decision checklist, material/device descriptions including types and quantities of chemicals and heavy metals found in or released by breast implants, rupture screening recommendations, and patient device card.
Prior to this in 1992, the FDA pulled silicone implants from the general use market after evaluating existing research (or lack thereof) on the safety and efficacy and concluding that the manufacturers had not done enough adequate research to show that the devices were reasonably safe.
The FDA then approved two silicone gel breast implants in 2005, even though scientists concluded that neither company provided sufficient data regarding safety; and scientific advisors outside of the agency recommended against the approval.
The concern with rupture
An obvious problem is that silicone gel implants break. Supporting that problem is the fact that a rupture isn’t always noticeable; in-fact most silicone gel implant ruptures are without symptoms.
When silicone implants break, silicone gel is released into the body. Silicone gel has been known to migrate to lymph nodes, and some scientists have theorized that the presence of silicone in the lymph system could result in the development of autoimmune disease.
Additionally, a study published in the Journal of Rheumatology resulted in findings revealing that women who had silicone implant ruptures and leaks into the surrounding tissues were more likely to be diagnosed with fibromyalgia.
Ignoring the FDA’s guidance, manufacturers have yet to provide more than 3 years of rupture data. That is simply not enough.
In July of 2019, pharmaceutical company and implant distributor Allergan issued a worldwide recall of Biocell textured breast implants and tissue expanders that have been linked to BIA-ALCL. Here is what the U.S. Food and Drug Administration had to say about it:
“The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.”
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.
“In a table updated today on the agency’s BIA-ALCL webpage, the FDA provides the new total of 573 unique cases globally of BIA-ALCL and 33 patient deaths, which reflect a significant increase in known cases of BIA-ALCL since the agency’s last update earlier this year —an increase of 116 new unique cases and 24 deaths. Specifically, of the 573 unique cases of BIA-ALCL, 481 are attributed to Allergan implants.”
Common symptoms among women affected by BII
Some of the most common symptoms of BII include fatigue, memory loss, and brain fog. The FDA states “these symptoms and what causes them are poorly understood. In some cases, removal of breast implants without replacement is reported to reverse symptoms.”
Muscle and joint pain, fever, dry eyes and mouth are additional reported symptoms of BII. And as mentioned, “Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a T-cell lymphoma that can develop following implants.”
In addition to the ones listed above, the following are symptoms consistently reported by over 100,000 women:
Premature aging, hair loss, weight problems, inflammation, vertigo, nausea, gastritis, leaky gut, pancreatitis, migraines, slow muscle recovery, swollen lymph nodes, liver and kidney dysfunction, toxic shock syndrome, anxiety, depression, hypo/hyper thyroid symptoms, hormone imbalance, low libido, and much more.
Reported improvements post explant
As knowledge of BII is rising, more and more women are choosing to remove their implants. This study published in the Netherlands Journal of Medicine found that most or all of the symptoms went away in 69% of women who had their implants removed. You can find supporting information on how to explant here.
What to do if you think you might be affected by BII
If you are looking for more information and/or support, this website is a great place to start. You can find a culmination of stories and medical information from over 100,000 women who have and are experiencing the very real symptoms of BII.
Interview with a woman affected by BII and post explant experience
I interviewed Nancy Gonzales Gallegos, a 45 year old woman who has been severely affected by BII and has seen improvements since explant. Nancy has been involved in advocacy work including becoming apart of many BII groups, speaking at FDA hearings, and being featured on the show ‘The Doctors’ on an episode covering BII with supermodel Angie Everhart and Eden Sassoon.
Her continuous efforts to spread knowledge through her social media accounts can be found on Instagram @NancyJGallegos and @LetsTalkBreast, and a live video recording of her explant by Dr. Hirsh can be found on her YouTube Channel @NancyGallegos.
Bailey: When did you get your implants and what kind were they?
Nancy: 1998. Textured saline implants.
Bailey: What cautions, if any, were you given by your surgeon?
Nancy: Only that they may need to be replaced in 10 years. But if you have no rupture, then you should be fine and can keep them longer.
Bailey: In your own words, what is BII?
Nancy: Sudden illness caused by the silicone shell of breast implants, ranging from auto-immunte disease to depression.
Bailey: How were you introduced to BII?
Nancy: I was introduced to it about 2 years ago by a friend who was preparing to remove her implants. She referred me to the Facebook page “Breast Implant Illness and Healing by Nicole.” There I discovered a world of information about something that could be affecting my life as it did many others.
Bailey: At what point did you realize you could relate to the women in these BII groups and had very similar, unexplainable symptoms?
Nancy: Immediately. The first day that I jumped on that page, I read about so many other women that were suffering from unexplainable health issues the same as I. It was unbelievable.
Bailey: Name some of the symptoms that started to emerge for you over the years.
Nancy: Brain fog, weight gain, depression, hair loss, blurred vision, hypothyroid, high blood pressure, anxiety, melasma, tingling sensation in my hands, joint pain, severe fatigue, memory loss, and much, much more.
Bailey: When did you start noticing symptoms?
Nancy: I started getting sick around 2012. I thought it was just because of my age (then 37 y/o) and possibly genetics. I may have even been sick before that and just didn’t put anything together because I had no idea. But I started paying closer attention in 2017.
Bailey: Which of these symptoms have also been reported by other women who are affected by BII?
Nancy: Many of all the symptoms I’ve described are relatable in other women. Most women develop autoimmune issues of some sort. Lots of undiagnosed medical issues as doctors are unaware of what BII is. I also wasn’t able to get pregnant with my husband even with the help of fertility medication, and I previously had 2 natural pregnancies with no problem prior to implants. Many other women have had fertility issues and explant and been able to get pregnant just fine. But now in my older age that’s out of the cards.
Bailey: What did your doctors tell you when you explained your symptoms?
Nancy: Basically every doctor I went to treated me with medication upon medication because there was no explainable diagnosis. After being undiagnosed, I was taking at least 1o medications a day.
Once I introduced the idea of BII, the first two doctors had no idea and really felt that my suggestion of BII was a bit of a reach. Finally, my third doctor, Dr. Heu listened to me and felt the importance of my illness and how it was affecting my daily life. She did her own research after speaking with me and running many tests. Even though she didn’t know anything about BII, she still believed me and did any other testing that I requested and just tried to help ease me from any pain or symptoms that were affecting my life.
Bailey: Were they ever able to help, provide an explanation?
Nancy: Not really. Nobody cared enough other than Dr. Heu to lead me to the path of explant. I did tests with my endocrinologist. There were times that I would cry because I had such bad brain fog that I couldn’t even drive. And doctors just didn’t know how to fix me. My endocrinologist did multiple tests and even did a treadmill test to check my metabolism due to my weight gain and all he could say was that my metabolism works three times slower than the average person. But after any and every test that I did, there was almost always no resolution. Always just another pill. I was like a trial and error case.
Bailey: Can you list some of the medications you have been on at a given time?
Nancy: Synthroid for thyroid, Lisinopril for high blood pressure, Sertraline for depression, vitamin D supplements for severe deficiency, iron supplements for anemia, Omeprazole for heartburn. For migraines alone a combination of Aimovig injections, Tizanidine, Sumatriptan, Eletriptan, Zonisamide (an epilepsy medication). Definitely more over there years that I can’t remember.
Bailey: When did you explant?
Nancy: June 14th, 2019.
Bailey: What changes/improvements have you seen in your body since explanting?
Nancy: No brain fog, no anxiety, no joint pain, easing of migraines, no more exhaustion, less shortness of breath. And I’m still in the process of allowing my body to detox.
Bailey: Tell me about your advocacy work.
Nancy: I began speaking out about a year after becoming apart of Nicole’s group. My reason for doing so is because I couldn’t not speak up to other women who are considering this choice. At least if I let my voice be heard, I could possibly save some women from this awful illness. I decided to join a group of women from all over different states to speak at a large hearing held in March of 2019 regarding the safety and concerns of breast implants. I flew to Washington D.C. on my own free will to meet ladies I had never met before with 1 common goal, which was to get the FDA to hear us and provide proper informed consent to women who have interest in getting breast implants. We also requested a black box warning label to be issued for every set of implants to be put on the market. Ultimately, our request was to ban implants entirely, but most of us know that will probably never happen.
Bailey: What is the FDA’s response to BII?
Nancy: Since our meeting in Washington, they must have listened and heard our voices as they issued a statement about proper informed consent being given. Also, months later, the ban of textured saline implants in the U.S. That’s what I had. Reason being is the textured saline implants leads to the manmade cancer known as breast implant associated anaplastic large cell lymphoma (BIA-ALCL). One of the women who spoke with us at the FDA hearing has actually been diagnosed with stage 4 BIA-ALCL.
Bailey: What would you say to someone who is considering breast implants?
Nancy: I would advise them to do as much research as possible. I would advise them to become apart of Nicole’s group to see the tragic problems many women have gone through because of implants, and then make an informed choice.
As you can probably conclude, Nancy’s life and the lives of so many other women have been largely affected by implants. Still, there is lacking adequate research that looks at the long-term effects of having these foreign objects in the body over an extended period of time. According to the American Society of Plastic Surgeons, breast augmentation was the most popular cosmetic surgical procedure performed last year.
That said, it is worth your time to thoroughly research the topic if you or someone you love is considering implants, or if you have implants and think you may be affected by BII.
Bailey is a soon-to-be new mom who goes against the grain. With a degree in communication studies, she has built a skincare company alongside her partner, which represents her lifestyle: natural, holistic, and non-toxic. Re-learning everything she knew her entire life, she began to grow her knowledge for all things natural. As an advocate for truth and women’s empowerment, her passion for writing and sharing her knowledge began to mature. Here at Intimina, she shares her experiences with pregnancy, sexual wellness, and women’s health from the perspective of a non-Western view.