The FDA Takes Action on Breast Implant Safety — A Positive Step Forward

For years, countless women have raised alarms regarding the safety of breast implants. Some implants have been associated with a rare type of lymphoma. Even if someone doesn’t have the specific implants in question, any implant can rupture, obscure cancer during screenings (yes, you read that right), and lead to numerous other complications. Recently, there has been a surge in awareness and activism within the breast implant illness (BII) community. Although BII isn’t officially recognized as a medical diagnosis, many women, including myself, feel they suffer from it. This condition presents over fifty potential symptoms that can leave women feeling extremely unwell. The trend of opting for explantation has grown so significant that some plastic surgeons specialize solely in this procedure.

This week, the FDA surprised many with a two-part announcement regarding the safety of breast implants. I couldn’t help but shed tears of joy. Like many women, I got implants without doing enough research. After all, if they’re FDA-approved, they must be safe, right? I assumed they underwent thorough testing backed by comprehensive safety data—or so I believed. It wasn’t until I became ill that I discovered my breast implants were harming me. I’ve previously shared how my implants made me feel like a rapidly aging zombie, and I genuinely felt as if I was dying.

Initially, the FDA “issued orders restricting the sale and distribution of breast implants to ensure that patients are adequately informed about the risks, enabling them to make fully informed choices.” You would think this would be standard practice, but it wasn’t.

No one ever properly informed me about the potential complications associated with my implants. I was in a daze after my cancer diagnosis when I decided to get implants during the same surgery as my bilateral mastectomy. I’m sure I signed documents filled with fine print detailing various risks. However, the expectation placed on women, especially those battling cancer, is that we are too young not to have breasts. Implants are often presented as a lifeline, a second chance, and the next best thing to our natural breasts. Similarly, women seeking to enhance their appearance are sold on the benefits of implants, which are often rooted in their insecurities. The risks are downplayed, while the advantages are exaggerated, making cosmetic surgery a profitable industry.

I recall a friend once asking if I had considered going flat. She had read about some potential downsides of implants. I dismissed her concerns. I didn’t want to hear that my implants could lead to further complications, especially on top of my already challenging cancer journey. Recently, I stumbled upon my “boob notes” from before my surgery, where I had intended to ask my doctor about implant toxicity. I can’t remember if I ever did. Instead, I was focused on getting the cancer removed and the implants in as quickly as possible. I knew my implants weren’t permanent and that some patients experienced problems like hardening or flipping.

The second part of the FDA’s announcement filled me with hope as a BII and breast cancer survivor. Implants will now carry a “boxed warning.” More importantly, a “patient decision checklist” must be reviewed with prospective patients by healthcare providers. This checklist aims to ensure that patients understand the risks, benefits, and other critical information about the breast implant device. Patients must sign this checklist, and the doctor performing the procedure must also sign it.

Are some implants safer than others? There are two types of implants: saline and silicone. While I’m not a medical professional, I can say that within the BII community, the belief persists that no implant is entirely safe, as both saline and silicone implants share the same outer shell. Women have opted for explantation due to illness and pain associated with both types of implants.

The FDA also released “updated silicone gel-filled breast implant rupture screening recommendations,” along with a “device description listing specific materials in the device.” Patients will receive a “device card,” and the FDA expects manufacturers to update their device labeling on their websites by the end of November.

Christy Anderson, a two-time breast cancer survivor, runs a Facebook support group called Stronger Together, which has over 5,600 members. She received implants in 2014 but had them removed in 2019 due to capsular contracture, a complication that occurs when the body reacts excessively to the implant. After explanting, Anderson realized she had been suffering from a range of other BII symptoms.

In March 2019, Anderson testified before the FDA about breast implant safety, sharing her experiences and advocating for informed consent regarding the risks of breast implants as medical devices. When I asked her what the recent FDA announcement meant to her, she expressed satisfaction that the testimony of women like her had made an impact. She said, “I’m grateful that the women who come after us will be better informed and have the true informed consent we fought for.”

Women within the breast implant illness community have long faced medical gaslighting and denial. During my three-and-a-half years with implants, not once did a medical professional suggest that my implants could be the source of my persistent illness and twenty-nine symptoms. Many of us are told that our symptoms are merely psychological. After all, why would we be allowed to receive implants if they weren’t safe? I’ve also been informed that there are very few substantial studies indicating a link between breast implants and autoimmune diseases, leading to the conclusion that my illness wasn’t legitimate.

My implants appeared flawless. I went into my mastectomy surgery with my natural breasts and left with implants. I thought this choice would spare me from the psychological harm many cancer survivors experience. Unfortunately, I lost nearly four years of my life to rib and shoulder pain, sudden food intolerances, dizzy spells, joint pain, muscle pain, digestive problems, inflammation, sleep disturbances, and many other issues. However, after explantation—removing my implants and capsules—most of my symptoms faded. I’ve been implant-free for eight months and continue to detox from the effects.

Additionally, those of us who suffered have been dismissed by other women with implants, who insist that theirs are “perfectly safe” and cause no issues or that complications are infrequent. They often imply that we should stop complaining and remain silent—why disrupt another’s happiness? I find it particularly troubling when women resort to silencing others, perpetuating societal expectations that women must be content, quiet, and aesthetically pleasing at all costs.

I’m thankful for the FDA’s recent orders and for women with substantial social media followings—such as Emily Thompson, Sarah Blake, and Jessica Miles—who are opening up about their experiences with breast implant complications. Support groups like Anderson’s have been transformative. Many women, like me, had no idea what we were getting into when choosing breast implants. With these new regulations, I hope more women will be genuinely informed rather than misled, dismissed, or labeled as “crazy.”

The FDA’s orders represent a significant victory for those of us who have endured years of medical appointments, bills, and lost time at work and with family. Explantation has given me my life back. I want to ensure that no other woman has to go through what I did.

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Summary

The FDA’s recent actions to improve breast implant safety reflect a long-overdue recognition of the risks associated with these devices. As a breast cancer survivor, I found hope in the new regulations requiring more thorough patient education and informed consent. These changes may help prevent other women from experiencing the health issues I faced, including the debilitating effects of breast implant illness.