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For years, countless women have raised alarms regarding the safety of breast implants, with certain types linked to a rare form of lymphoma. Even if a woman doesn’t have these specific implants, any implant can rupture, obscure cancer during screenings (yes, you read that right), and lead to various other complications. Recently, there has been a surge of awareness and activism within the breast implant illness (BII) community. Though BII isn’t officially recognized as a medical diagnosis, many women, myself included, feel they suffer from it. BII encompasses over fifty potential symptoms that can leave a woman feeling extremely unwell. The trend of opting for explant surgery is on the rise, with some plastic surgeons exclusively focusing on removal.
This week, the FDA surprised many of us with a two-part announcement concerning breast implant safety. I might have shed a few tears of joy. Like numerous women, I opted for implants without conducting thorough research. After all, FDA approval implies safety, right? I assumed they underwent extensive testing and safety assessments—how wrong I was. It was only after my health deteriorated that I realized my breast implants were harming me. I’ve previously shared that my implants made me feel like a rapidly aging zombie, and at times, I truly felt I was on the brink of death.
New FDA Orders
First, the FDA “issued orders limiting the sale and distribution of breast implants to ensure that patients contemplating breast implants receive comprehensive risk information, enabling them to make fully informed decisions.” One would think this should have been standard practice—but it wasn’t.
No one ever took the time to explain to me what could potentially go wrong with my implants. I was in a haze during my cancer treatment when I decided to get implants, opting for them during the same surgery as my bilateral mastectomy. I’m sure I signed documents filled with fine print outlining all the possible risks, but there was an assumption that many cancer survivors share: some of us are simply too young not to have breasts. Implants became our saving grace, a second hope, and a close substitute for our natural breasts. Similarly, women desiring a boost in their appearance are often sold the benefits of implants, all based on insecurities. The risks are downplayed while the advantages are exaggerated. Cosmetic surgery is a highly profitable industry.
I recall a friend suggesting I consider going flat after she read about potential issues associated with implants. I dismissed her concerns. I didn’t want to hear that my implants could lead to more complications, especially on top of my already challenging cancer journey. Recently, I stumbled upon my notes from before my surgery, where I had written to ask my doctor about implant toxicity. I can’t remember if I ever followed up. Instead, I was focused on getting the cancer out and the implants in as swiftly as possible. I knew my implants weren’t permanent and that some patients dealt with complications like hardening or flipping.
Boxed Warnings and Patient Decision Checklists
The second part of the FDA’s orders filled me with hope as a BII and breast cancer survivor. Implants will now carry a “boxed warning.” The highlight of this order is a “patient decision checklist,” which must be discussed with the prospective patient by their healthcare provider. This aims to ensure that patients comprehend the risks, benefits, and other pertinent information regarding the breast implant device. Patients must initial and sign this checklist, and the doctor performing the implant procedure must also sign it.
Are some implants safer than others? There are two types: saline and silicone. While I’m not a medical professional, I can share that within the BII community, many believe that no implant is truly safe, as both saline and silicone implants share the same outer shell. Women have undergone explant surgery due to health issues with both types of implants.
Additionally, the FDA has released “updated silicone gel-filled breast implant rupture screening recommendations” and called for a “device description with a list of specific materials in the device.” Patients will also receive a “device card.” Finally, the FDA “expects manufacturers to update their device labeling on their websites within the next thirty days,” meaning they have until the end of November to comply.
Community Voices
Maya Johnson, a two-time breast cancer survivor, runs a Facebook support group called Strong, Flat, Forward, which has 5,600 members. In 2015, Maya got implants but had them removed in 2020 due to capsular contracture, a complication that occurs in about 10.6% of cases. After her explant, Maya discovered she had been experiencing numerous symptoms linked to breast implant illness.
In March 2020, Maya testified before the FDA at their hearing on breast implant safety, sharing her experiences and the need for informed consent regarding the risks associated with breast implants as medical devices. When I asked her what the recent FDA announcement meant to her, she expressed that “our powerful testimony about the negative effects of breast implants on our health had an impact on the panel.” She finds it “very gratifying,” even though the announcement came two years after her testimony. She added, “I’m grateful that future patients will be better informed and receive the true informed consent we advocated for.”
Women in the breast implant illness community have faced years of medical gaslighting and denial. Throughout my three-and-a-half-year experience with implants, not once did a healthcare provider suggest my implants were responsible for my persistent sickness and twenty-nine symptoms. Many women, like me, have been 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 encountered claims that there are only a few large studies suggesting a possible link between breast implants and autoimmune diseases, dismissing the reality of my illness.
Personal Reflections
Though my implants looked fantastic, I was thrilled to enter my mastectomy surgery with one set of breasts and emerge with another. I thought this choice would shield me from the psychological distress many cancer survivors experience. Instead, I lost nearly four years of my life battling rib and shoulder pain, sudden food intolerances, dizziness, joint and muscle pain, digestive problems, inflammation, sleep disruption, and a host of other symptoms. I’m relieved to report that after undergoing explant surgery—removing my implants and their capsules—most of my symptoms vanished. It’s been eight months since my explant, and I’m continuing to detox from the effects.
Sadly, those of us who have suffered have also been criticized by other women who argue that our implants are “perfectly safe” and cause no issues, or that complications are rare. Some have suggested we should remain silent and not disrupt another person’s happiness. I find it troubling that some women feel compelled to dismiss the struggles of others, perpetuating societal expectations that women should be content, quiet, and aesthetically pleasing at all costs.
A Step Forward
I’m thankful for the FDA’s orders, and I appreciate that prominent women on social media—like Sarah Thompson, Emily Rivera, and Laura James—are sharing their experiences with breast implant issues. Support groups, like Maya’s, have been transformative. Many women, including myself, were unaware of the potential risks when we chose to get breast implants. With these new regulations, I hope more women will be truly informed rather than misled, disregarded, or labeled as “crazy.”
The FDA’s actions are a significant victory for those of us who’ve lost years to medical appointments, expenses, and lost time with family and at work. Explant surgery restored my life. I want to ensure that no other woman suffers as I did.
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In summary, the FDA’s recent actions to enhance breast implant safety are a crucial step forward for women who have faced health issues related to implants. With new regulations for informed consent and risk disclosure, future patients will be better equipped to make educated decisions about their health. This change comes as a result of years of advocacy by women who have bravely shared their experiences. It’s a victory for those who have suffered in silence, and a promise for safer practices in the cosmetic surgery industry.