The FDA Takes Significant Steps to Enhance Breast Implant Safety — And I’m Fully Supportive

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For years, countless women have raised alarms about the safety of breast implants. Certain types have been associated with a rare form of lymphoma, while all implants carry risks such as rupture, interference with cancer screenings (yes, that’s true), and a range of other complications. Recently, the breast implant illness (BII) community has gained traction, bringing to light the struggles of many women, myself included, who suspect they suffer from this condition. BII encompasses over fifty possible symptoms that can leave women feeling extremely unwell. The trend of explanting, or removing implants, has grown so prevalent that some plastic surgeons focus solely on this procedure.

This week, the FDA surprised many by announcing a two-part directive regarding breast implant safety, which made me shed tears of joy. Like many others, I had implants placed without conducting thorough research, believing that FDA approval meant safety. I assumed that rigorous testing would have ensured their safety—how wrong I was. It wasn’t until I began experiencing severe health issues that I understood my implants were harming me. I’ve previously shared that my implants made me feel like a rapidly aging zombie, and it genuinely felt as though I was fading away.

New FDA Orders

The FDA’s first order restricts the sale and distribution of breast implants to ensure that patients receive comprehensive information about potential risks, allowing them to make informed choices. You would think this would be standard practice, but it wasn’t. No healthcare provider ever took the time to explain the possible complications associated with my implants. I was in a fog of cancer treatment when I chose to get implants during my bilateral mastectomy surgery. Although I likely signed documents outlining risks in fine print, the prevailing belief among many cancer patients is that youth should not come without breasts. Implants are often seen as a lifeline, a second chance at femininity, and an antidote to insecurities. The risks are downplayed while the advantages are emphasized—a lucrative strategy for cosmetic surgery.

I remember a friend suggesting I consider going flat after learning about potential downsides of implants. I dismissed her concerns, not wanting to add further complications to my already challenging cancer journey. Recently, I stumbled upon my old notes where I had jotted down a question about the toxicity of implants for my doctor. I can’t recall if I ever asked. All I wanted was to eradicate the cancer and quickly proceed with the implants. I understood that implants weren’t permanent and that some individuals faced complications like hardening or flipping.

The FDA’s second order filled me with hope as a survivor of BII and breast cancer. They mandated a “boxed warning” for implants and required a “patient decision checklist” to be reviewed by healthcare providers. This checklist is designed to ensure that patients comprehend the risks and benefits associated with breast implants. Patients must sign the checklist, and the healthcare provider must also sign it.

Are Certain Types of Implants Safer?

Are certain types of implants safer than others? There are saline and silicone options. As a non-medical professional, I can’t provide medical advice, but many in the BII community believe no implant is entirely safe, as both types share the same outer shell. Women have experienced illness and pain, leading them to explant both types.

The FDA also updated its recommendations for screening ruptures in silicone gel-filled implants and required a detailed list of materials used in the devices. Patients will receive a “device card,” and manufacturers must update their labeling on their websites within the next thirty days.

Jessica Miller, a two-time breast cancer survivor, leads a support group called Empowered and Explanting, which has grown to 5,600 members. Jessica received implants in 2015 but had them removed in 2020 due to complications. She highlighted the significant number of women suffering from breast implant-related health issues during her testimony at the FDA Hearing on Breast Implant Safety. Jessica stated, “It’s incredibly gratifying to see our stories and experiences acknowledged, even if it took time.”

The Struggles of the BII Community

Women in the breast implant illness community have faced years of medical gaslighting and dismissal. Throughout my journey with implants, not a single healthcare provider suggested my implants might be the source of my numerous ailments. Countless women, including myself, have been told our symptoms are psychosomatic. After all, how could implants be unsafe if they are readily available?

My implants looked flawless, and I was excited to transition from my natural breasts to my new ones post-mastectomy. I believed this choice would mitigate some psychological trauma faced by cancer survivors. Instead, I endured nearly four years of suffering, experiencing pain, food intolerances, dizziness, joint discomfort, inflammation, and numerous other symptoms. Thankfully, after explanting—removing my implants and capsules—most of my health issues disappeared. It’s been eight months since then, and I’m still detoxing from the implants.

Additionally, some women have expressed skepticism towards those of us who have experienced complications, insisting their implants are “perfectly safe.” This pressure to conform can be disheartening, especially when it undermines the voices of those advocating for change.

I am grateful for the FDA’s recent orders and for influential women like Sarah Johnson, Emily White, and Olivia Brown who have spoken out about their breast implant experiences. Support groups like Jessica’s have been life-saving for many who were unaware of the potential consequences of their choices. With these new regulations, I hope more women can make genuinely informed decisions rather than being misled, dismissed, or belittled.

A Monumental Step Forward

The FDA’s actions represent a significant victory for those of us who have lost years to medical appointments and health struggles. Explanting gave me back my life, and I hope no woman has to endure what I did.

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In summary, the FDA’s new mandates on breast implant safety are a monumental step forward for informed consent and patient safety. With the rise of the BII community and the acknowledgment of the risks associated with implants, it’s a hopeful time for women seeking clarity and support in their choices.

Keyphrase: Breast implant safety

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