The FDA Has Finally Cracked Down On Breast Implant Safety — And I'm Here For It

by Rachel Garlinghouse
New Africa/Shutterstock

For years, thousands of women have voiced their concerns about the safety of breast implants. Certain implants have been linked to a form of lymphoma. Even if a person doesn’t have these particular implants, any implant can rupture, hide cancer in cancer screenings (yes, you read that correctly), and cause a slew of other issues. In recent years, there’s been increasing awareness and activism in the breast implant illness community. Though BII isn’t an official medical diagnosis, many women believe they have the illness, myself included. BII is an illness where there are fifty-plus possible constellations of symptoms that make a woman very sick. It’s become increasingly popular to explant, so much so that some plastic surgeons only explant.

This week, the FDA shocked us all when they released a two-part statement about the safety of breast implants. I may have cried happy tears. Like many women, I got implants without much research or thought. After all, if they’re FDA-approved, they must be safe, right? Surely they went through rigorous testing backed by extensive safety research—or so I thought. It wasn’t until I got sick—and sicker—that I realized my breast implants were poisoning me. I’ve shared before that my implants turned me into a rapidly-aging zombie, and I truly felt like I was dying.

First, the FDA “issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions.” You’d think this would have been a given—but it wasn’t.

No one ever sat me down and gave me a firm talking to about what could go wrong with my implants. I was in a cancer haze when I decided to get implants–in the same surgery as my bilateral mastectomy. Of course, I’m sure I signed some papers with eight-point font, detailing all the possible risks. But the expectation I got, and that many cancer fighters get, is that some of us are simply too young not to have breasts. Implants are our saving grace, our second hope, and the next-best thing to our natural breasts. Likewise, women looking for a pick-me-up in their appearance can be sold the perks of implants, all of which are built upon the woman’s insecurities. The risks are minimized and the benefits are amplified. Cosmetic surgery is a lucrative business.

I do remember a friend asking me if I’d considered going flat. She’d read about some of the potential downsides of implants. I blew her off. I didn’t want to hear that the implants could cause me even more issues, especially on top of my already difficult cancer battle. The other day, I found a picture of my “boob notes” from before my surgery, and on it, I’d written to ask my doctor about implant toxicity. I can’t recall if I ever asked. Instead, I just wanted the cancer out and the implants in as quickly as possible. I knew my implants weren’t lifetime devices and that a few patients have issues with the implant hardening or flipping.

The second part of the FDA order is what brought me so much hope as a BII and breast cancer survivor. Implants must include a “boxed warning.” Here’s the kicker. They are requiring a “patient decision checklist” which “must be reviewed with the prospective patient by the health care provider.” This is to “help ensure the patient understand the risks, benefits and other information about the breast implant device.” The patient “must be given the opportunity to initial and sign” the checklist, and the doctor placing the implants must also sign.

Are certain implants safer than others? There are two types of implants: saline and silicone. I’m not a doctor, so I can’t give medical advice. I can say that within the BII community, the belief is that there’s no such thing as a safe implant, since both saline and silicone implants have the same outer shell. Women have explanted—had their implants removed—due to illness and pain with both types of implants.

The FDA also issued “updated silicone gel-filled breast implant rupture screening recommendations.” Also, a “device description with a list of specific materials in the device.” The patient must receive a “device card.” Finally, the FDA “expects manufacturers to post the updated device labeling to their websites with the next thirty days.” This means, they have to the end of November to comply.

Christy Avila is a two-time breast cancer survivor who runs the Facebook support group called Fierce, Flat, Forward. The group boasts of 5,600 members. In 2014, Avila got implants. In 2019, she had them removed due to capsular contracture. This possible implant complication “is caused by an excessive fibrotic reaction to a foreign body (the implant) and has an overall incidence of 10.6%.” ‘I’m not mathmatical wiz, but 10% is a significant percentage! After explanting, Avila realized she had been suffering from “a host of other breast implant illness symptoms.”

In March of 2019, Avila testified before the FDA at their Hearing On Breast Implant Safety. She shared with me that she “informed the panel of the hundreds of women I discovered who were also suffering from breast implants, and I spoke to the need for informed consent for patients on the dangers and risks of breast implants as medical devices.”

I asked her what yesterday’s FDA declaration meant to her. She responded that “our powerful testimony of our detrimental experiences with breast implants to our health and well-being had an impact on the panel.” She added that’s “very satisfying and rewarding,” even though this announcement came two years after her testimony. Also, “I am grateful that the women who come behind us will be better informed, and have the true informed consent we advocated for.”

Women in the breast implant illness community have spent years facing medical gaslighting and flat-out denying. Not one time, over the dozens of medical appointments I attended during my three-and-a-half-year stint with implants, did a medical professional suggest my implants were the cause of my constant sickness and twenty-nine symptoms. Women like me are often told that our symptoms are all in our heads. After all, why would we be allowed to get implants if they aren’t safe? I’ve also been told there’s very few (and large) studies that prove there may be a relationship between breast implants and autoimmune disease, for example. Therefore, there’s no evidence that my illness was real.

My implants looked amazing—perfection. I was happy to go into my mastectomy surgery with one set of boobs (my natural ones) and come out with boobs. I thought once I made this choice, I would at least avoid some of the psychological harm that many cancer survivors face. Instead, I lost almost four years of my life, suffering from rib and shoulder pain, sudden food intolerances, dizzy spells, joint pain, muscle pain, digestive issues, inflammation, sleep disturbances, and many other symptoms. I’m happy to report that after explanting—that’s having my implants and capsules removed—most of my symptoms disappeared. I’ve been without implants for eight months, and I continue to detox from them.

Likewise, those of us who have been sick have also been gaslit by fellow women who have implants and clapback at us that our implants are “perfectly safe” and cause no problems—or that complications from implants are rare. Maybe we should just stop complaining, and certainly, we need to be quieter. Why disrupt another person’s happiness? I admit, I’m more disturbed by fellow women trying to calm the “hysterical” women—projecting a societal conditioning that women should be content, quiet, and look aesthetically pleasing at all costs.

I’m grateful that the FDA issued these orders. I’m also thankful that women with large social media followings—women like Clare Crawley, Michelle Visage, Mel Robbins, Chrissy Teigen–are speaking up about their journey with breast implant issues. Support group’s like Avila’s have been life-changing. Many women, like me, had no idea what we were getting ourselves into when we elected to get breast implants. Hopefully with these new orders, more and more women will become truly informed, rather than lured, dismissed, gaslit, and deemed “crazy.”

The FDA orders are a major win for those of us who have lost years (some even decades) of medical appointments, bills, and loss of time at work and with our families. Explanting gave me my life back. I don’t want to ever see another woman suffer like I did.