The FDA Takes Action on Breast Implant Safety — And I Support It

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For years, numerous women have raised alarms about the safety of breast implants. Some implants have been associated with a type of lymphoma, and even if someone doesn’t have these specific devices, any implant can rupture, obscure cancer detection during screenings (yes, you read that right), and lead to a host of other complications. In recent times, awareness and activism within the breast implant illness community have surged. Although Breast Implant Illness (BII) isn’t formally recognized as a medical diagnosis, many women, myself included, feel they suffer from it. BII involves over fifty potential symptoms that can leave a woman feeling severely unwell. The trend toward explantation has grown so prominent that some plastic surgeons focus solely on this procedure.

This week, the FDA surprised everyone by announcing a two-part statement regarding breast implant safety. I may have shed tears of joy. Like many women, I opted for implants without conducting thorough research. After all, if they’re FDA-approved, they must be safe, right? Surely they underwent rigorous testing backed by comprehensive safety studies—or so I believed. It wasn’t until I fell ill that I discovered my breast implants were harming me. I’ve previously mentioned how my implants made me feel like a rapidly aging shell of myself, and I genuinely felt like I was deteriorating.

FDA’s New Orders

First, the FDA “issued orders limiting the sale and distribution of breast implants to ensure that patients contemplating breast implants receive adequate risk information, allowing them to make fully informed decisions.” You’d think this would be standard procedure—but it wasn’t.

No one ever took the time to explain the risks associated with my implants. I was in a fog from my cancer diagnosis when I decided to get implants during my bilateral mastectomy. I’m certain I signed documents with fine print detailing potential risks, but the prevailing notion among many cancer patients is that some of us are simply too young not to have breasts. Implants are seen as a lifeline, the next best thing to our natural bodies. Similarly, women seeking an aesthetic boost are often sold on the advantages of implants, which are frequently framed around their insecurities. The risks tend to be downplayed while the advantages are emphasized. Cosmetic surgery is a thriving business.

I still remember a friend asking if I had considered going flat after learning about potential downsides of implants. I brushed her off, unwilling to accept that my implants could lead to more complications, especially on top of my cancer battle. Recently, I stumbled upon my “boob notes” from before my surgery, where I noted a question about implant toxicity. I can’t recall if I ever asked. My focus was solely on removing the cancer and getting the implants in place as soon as possible. I understood that my implants weren’t meant to last a lifetime and that some patients experienced complications like hardening or flipping.

Hope for the Future

The second part of the FDA’s order gave me immense hope as a BII and breast cancer survivor. Implants will now require a “boxed warning.” Additionally, there’s a mandate for a “patient decision checklist,” which “must be reviewed with the prospective patient by the health care provider.” This aims to “ensure the patient comprehends the risks, benefits, and other information about the breast implant device.” Patients “must have the chance to initial and sign” the checklist, and the doctor performing the procedure must also sign it.

Are certain implants safer than others? The two main types of implants are saline and silicone. While I’m not a doctor, I can share that within the BII community, many believe no implant is truly safe since both types possess the same outer shell. Women have chosen to explant due to illness and pain with both varieties.

Moreover, the FDA provided “updated silicone gel-filled breast implant rupture screening recommendations.” They also require a “device description with a list of specific materials in the device.” Patients will receive a “device card,” and the FDA “expects manufacturers to update device labeling on their websites within thirty days.” This means they have until the end of November to comply.

Voices from the Community

Julia Winters, a two-time breast cancer survivor who runs the online support group called Stronger, Flat, Forward, shared her experience with me. The group has over 5,600 members. After receiving implants in 2015, she had them removed in 2020 due to capsular contracture, which is caused by an excessive fibrotic response to the implant and occurs in about 10.6% of cases. After her explantation, Julia realized she had been suffering from various breast implant illness symptoms.

In March 2021, Julia testified before the FDA regarding breast implant safety. She informed the panel about the numerous women she had encountered who were also suffering from health issues related to breast implants, emphasizing the need for informed consent regarding the risks and dangers associated with these medical devices. When I asked her what the recent FDA announcement meant to her, she expressed that “our powerful testimonies regarding the adverse effects of breast implants on our health left a mark on the panel.” She added that it was “very gratifying,” even though the announcement came two years after her testimony. Julia also expressed her gratitude that future patients would have access to better information and genuine informed consent.

The Struggle for Recognition

Women in the breast implant illness community have long faced medical gaslighting and denial. Throughout my three-and-a-half-year experience with implants, not once did a healthcare professional suggest that my implants were the source of my ongoing sickness and twenty-nine symptoms. Many women like me are told that our symptoms are imaginary. 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 linking breast implants to autoimmune diseases, so there’s supposedly no evidence that my condition was real.

My implants looked fantastic—truly stunning. I thought that by choosing them, I could mitigate some of the psychological damage that many cancer survivors endure. Unfortunately, I ended up losing nearly four years of my life to rib and shoulder pain, sudden food intolerances, dizziness, joint pain, muscle aches, digestive issues, inflammation, sleep disturbances, and more. However, I’m pleased to report that after explantation—removing my implants and their capsules—most of my symptoms vanished. I’ve been implant-free for eight months, and I’m still detoxing from their effects.

Moreover, many of us who have suffered have also been dismissed by fellow women who have implants, who insist that their devices are “perfectly safe” and cause no issues—or that complications are rare. They often suggest that we should simply stop complaining, reinforcing a societal expectation that women should be content, silent, and aesthetically pleasing at all costs.

A Step Forward

I’m grateful for the FDA’s recent orders. I also appreciate that influential women such as Anna Caldwell, Linda Hayes, and Maria Cole are speaking out about their experiences with breast implant complications. Support groups like Julia’s have been transformative. Many women, including myself, were unaware of the potential risks we were taking when we chose breast implants. With these new regulations, I hope that more women will be genuinely informed rather than misled, ignored, gaslit, or labeled as “crazy.”

The FDA orders represent a significant victory for those of us who have endured years—sometimes decades—of medical appointments, expenses, and lost time with loved ones. Explantation restored my life, and I never want to see another woman suffer as I did.

For more insights, check out our discussion on home insemination and related topics.