Just over eight years ago, at age 40, I was diagnosed with early-stage ER-positive, HER2-positive breast cancer. It was picked up not on a mammogram but when my wife felt a lump with the tell-tale bad signs — small, hard, immovable — and insisted I have it worked up. Not long afterward, I also learned I carried a gene mutation called CHEK2, which not only raised my risk for another breast cancer, but for uterine and ovarian cancer, as well.
HER2-positive cancers are known to be aggressive, and I was quickly put on a regimen of chemotherapy and immunotherapy, which would be followed by surgery to remove the tumor. In the intervening five months, I had some time to consider my surgical options. Because of the CHEK2 mutation and my risk for new breast cancers, bilateral mastectomy — the removal of both breasts — was the surgical option most likely to reduce my risk of either recurrence or a second breast cancer.
After that decision was made, reconstruction seemed like an obvious choice. Everyone from my oncology team to survivor friends told me I’d feel better with new, forever-perky “boobs” as a cancer consolation prize. And having struggled with body image most of my life, I did feel oddly consoled by the notion that reconstruction would allow me to control (and maybe even improve?) my post-cancer body shape.
My reconstructive surgeon helped me navigate the options. I wasn’t a good candidate for reconstruction that relied on taking some of my abdominal tissue (DIEP flap or TRAM flap) since the additional abdominal surgery would delay my return to the Pilates studio (I’m a full-time instructor) and could permanently disrupt my ability to engage the deep core muscles that are crucial to my practice and my career.
Opting for Textured Breast Implants
My reconstructive surgeon, who I’ll call Dr. P for “Perky,” recommended textured silicone implants under the muscle as the best available option. The textured surface was thought to assist the body in building a scar capsule that would adhere to the implant, reducing the likelihood of having the prosthesis slip or flip inside the scar capsule.
Reconstruction was not a small process. It involved, firstly, the placement of temporary tissue expanders placed under the pectoral muscle at the time of the mastectomy to stretch the muscle and surrounding tissues to make room for the implants. Then I visited Dr. P every two to three weeks to have the tissue expanders injected with saline to gradually increase their volume until they reached the desired size (a full “C” cup, slightly larger than my natural ones, to better match the 20-pound weight gain I had experienced from chemo and hormone therapy).
About eight months after my mastectomy, Dr. P replace my tissue expanders with the textured implants. After several more months, when the mastectomy scars were well healed, Dr. P would create nipple-like protrusions from the scar tissue, to represent nipples. Finally, once the nipple reconstruction was healed, a specialist in reconstructive tattoos tattooed areolas around the “nipples.”
I healed fairly well and moved on with survivorship — building my physical strength back slowly and steadily in the Pilates studio, doing crossword puzzles and keeping lists to combat “chemo brain,” managing the many side effects of tamoxifen, and working on returning to a life that wasn’t defined by cancer.
Textured Implants Linked to Breast Implant Illness
Then, in 2018, about two years after my last surgery, news research came out demonstrating a link between textured implants (mine) and a breast implant illness, a rare lymphoma called BIA-ALCL (breast implant–associated anaplastic large-cell lymphoma). Further investigation turned up more disturbing news. In 2011, the U.S. Food and Drug Administration (FDA) had issued a safety warning about the potential link between breast implants and ALCL. And in 2016, a year after my implants were placed, the World Health Organization designated BIA-ALCL as a distinct form of lymphoma. All known cases of BIA-ALCL have occurred in women who currently have or previously had textured (not smooth) implants.
This info made me uneasy, but I worked hard to temper my anxiety about this risk much as I manage the anxiety (present but not debilitating) about the potential return of my breast cancer. Then in 2019, Allergan issued a recall of its textured implants, because data showed that nearly 70 percent of known cases of BIA-ALCL worldwide were found in patients with Allergan implants.
Lucky me, that’s the brand I had on my chest.
Around the same time, I noticed small lumps around the edge of my right implant. One of the symptoms of BIA-ALCL is swollen lymph nodes in the vicinity of the prosthesis. My breast surgeon decided to biopsy the largest one, and it turned out to be a reactive lymph node inflamed due to the presence of silicone granulomas (microscopic bits of silicone that had migrated outside of the scar capsule). This is considered a normal immune reaction to having silicone implants, so I was referred back to Dr. P.
Dr. P assured me that the incidence of BIA-ALCL was low — somewhere between 1 in 3,000 and 1 in 30,000. He suggested that I stop reading social media posts about BIA-ALCL because it was fueling my anxiety.
He was right. But, for people like me who have already lived through one cancer diagnosis, a small risk of cancer is still a pretty big deal. And the sense of risk and uncertainty is made worse by the fact that the problem of monitoring people like me has been punted to multiple doctors, none of whom seemed especially concerned about the risk.
Why I Worry BIA-ALCL Is Underreported
It seemed to me that what was getting lost in the analysis of available (but scarce) clinical data was the personal experience of patients like me who were walking around with these recalled implants in our bodies. As a patient I couldn’t help but wonder: Is it truly rare, or is there simply insufficient data because BIA-ALCL is so hard to diagnose?
Diagnosing BIA-ALCL isn’t easy. It develops in the tissue of the capsule surrounding the breast implant, causing an over-expression of a protein called CD30. To test for it, fluid from around the implant is aspirated and tested for CD30. But sometimes there’s no fluid, or the fluid has a negative result, but the CD30 protein is in fact present in the capsule. The gold standard for diagnosis is to remove the implants and the entire capsule and to have a knowledgeable lab test 12 samples from each capsule. The current recommendation is: Wait until you have clear symptoms of BIA-ALCL — severe asymmetry, or one breast swells like a balloon — before considering implant removal.
Other potential symptoms include pain around the implant, lumps in or around the implant, swollen lymph nodes, itching or redness of skin on or near the breast, and lesions on or near the breast. But these could all also be perfectly normal reactions to having a prosthesis in the body, so they’re not sufficient to suspect BIA-ALCL. More systemic symptoms include night sweats, fever, fatigue, and unintended weight loss. But these symptoms can occur for other reasons, including as side effects from ongoing hormone suppression to reduce the chance of recurrence of breast cancer. In the United States, textured implants have been used in reconstructive surgery about 4 times as often as for cosmetic purposes. So most U.S. patients with textured implants have some combination of one or more of the symptoms above thanks to their breast cancer treatment.
There’s more to make people like me uneasy.
The Status Quo for Reporting BIA-ALCL
The FDA and the American Society of Plastic Surgeons have created a registry called PROFILE to capture data on all U.S. cases of BIA-ALCL. However, the reporting is voluntary and requires the reporting physician or institution to execute a business agreement with PROFILE and to assume the cost associated with IRB (internal review board) approval. Not all independent plastic surgeons have the staff to take these extra administrative steps. PROFILE has limited the eligible reporters to physicians to avoid duplicate reports, but it also may be missing diagnoses because there is no incentive for a physician to take the extra steps to report.
BIA-ALCL survivors are highly motivated to report these statistics to help their community of women with recalled implants better understand their risk, but they are not eligible to do so. Many of the recently diagnosed women in a Facebook group for those diagnosed or at risk for BIA-ALCL have had multiple symptoms, including those above, but their plastic surgeons and even pathologists resisted testing for BIA-ALCL because they believe it is so rare.
What’s more, for the majority of cases of BIA-ALCL, removal of the implant and surrounding capsule is sufficient to cure the disease. So patients who undergo explant because of breast implant illness (BII), a collection of symptoms believed to be associated with breast implants of all kinds, may be unknowingly removing BIA-ALCL, but their capsules would never be tested for it, and there’s no incentive for plastic surgeons to send the capsules to pathology if the explant is voluntary. Further, when explant is voluntary, the patient is responsible for all costs associated with the explant, including any pathology on it, so this pathology is not done as a rule for every explant.
And guess what? Since the initial recall in 2019, more research has been done and three world conferences have been held, and it’s now theorized that the incidence for textured implants in general is 1 in 2000 — and for Allergan in particular it’s likely closer to 1 in 350, but may be as high as 1 in 150. Since the chance of getting breast cancer at age 40 is about 1 in 250, and I managed to win that lottery, I’m not convinced that 1 in 350 or higher is anything to sneeze at. It’s a big deal to me, as it is to most of us who have the recalled implants inside us.
Right now, women like me are left with the same old advice: Leave the implants in unless your body shows a clear sign of potential cancer. Ironically, this goes against everything a breast cancer survivor has been conditioned to do. As a survivor of cancer, feeling pain or noticing asymmetry are big red flags. So are swollen lymph nodes that linger. Unintended weight loss? Red flag. Unusual rash? Ditto. As breast cancer survivors, we’re told to be on high alert for any of these things. But as patients at risk for BIA-ALCL, we’re told to ignore those symptoms unless one breast blows up like a balloon. It’s hard to reconcile.
How Reporting BIA-ALCL Should Work
I’ve made sacrifices, removed my breasts, uterus, and ovaries, managed the side effects of chemo, immunotherapy and hormone therapy, all to keep cancer away. But for BIA-ALCL, we’re being told “wait for the cancer to emerge before you do anything.” That advice is hard to swallow knowing that untreated BIA-ALCL could spread to the muscle tissue or chest wall, or metastasize via the lymphatic system. This would necessitate chemo (again). Chemo was pretty hard on me the first time around. It gave me fun side effects like severe diarrhea, fatigue, skin rashes, and sores inside my eyelids that scratched my corneas. I had shortness of breath when climbing stairs or hills, cardiotoxicity, and developed a fatty liver. All of these subsided when I finished treatment, but I’d really like to avoid having any of them again.
I have some recommendations for the medical field. First, I think breast cancer centers should create BIA-ALCL teams with a designated reconstructive surgeon, pathologist, and hematologist oncologist tasked with staying current with emerging information on BIA-ALCL. Patients with recalled or textured implants should be seen by a member of this team annually (or earlier, if new symptoms emerge) to address any concerning symptoms. I also think any explanted textured breast prosthesis (whether placed for cosmetic or reconstructive reasons) should be sent for pathology so unknown BIA-ALCL can be documented in the PROFILE registry. And all clinicians should recognize the dichotomy of the approaches to breast cancer and BIA-ALCL, and should recognize that these conflicting approaches are likely to cause confusion and anxiety among patients.
It’s important that patients not be dismissed for their fears. We are managing the low-grade background stress of trying to prevent our primary cancer — breast cancer — from recurring. Most importantly, clinicians must not dismiss the concerns of their patients with recalled implants. As patients we can understand and even accept that explant may not be the right option at this time, but we must not be dismissed as “hysterical females.”
We are not necessarily alleging fault or blame, but our anxiety — and confusion — is real and is part of our complete clinical picture.