Advocating for Herself Amid Treatment for a Rare Cancer

Many patients defer to their oncologists for advice on managing cancer. Roxane Vermeland, however, was committed to making her own treatment decisions every step of the way.

Vermeland developed breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of cancer not yet well understood, after undergoing mastectomy and reconstruction due to breast cancer. Because all her doctors had limited experience treating BIA-ALCL, she felt it was crucial to study clinical diagnosis and treatment guidelines and discuss them with her care team.

In part due to her persistence, Vermeland is now cancer free, and she encourages others with the disease to also advocate for themselves.

BIA-ALCL has been linked to textured breast implants filled with either saline or silicone — in particular, Allergan’s Natrelle Biocell brand — and as of Nov. 5, 2020, has been diagnosed in 1,136 patients, 36 of whom have died, according to the Food and Drug Administration (FDA). In response to a July 2019 FDA request, Allergan, which has since been purchased by AbbVie, issued a worldwide recall of those products.

On Sept. 28, 2020, the FDA urged the makers of breast implants to supplement their labeling to include a boxed warning and a patient decision checklist focusing on health problems that can arise from the implants, in particular, two major health issues: BIA-ALCL and breast implant illness, an autoimmune condition that can result in brain fog, fatigue, rash, and muscle or joint pain.

Vermeland considers that a victory for patients but remains committed to creating more awareness around the issue. “We do believe that many more women will be diagnosed properly by generating much-needed attention around this cancer,” she says.

Coping with Implant Issues

In November 2012, Vermeland was shocked to learn she had breast cancer in both her breasts, with infiltrating ductal and ductal carcinoma in situ T1c in one and T1b in the other. Vermeland underwent surgery at Rush Copley Medical Center in Aurora, Illinois, on Dec. 14, 2012, and had expanders put in at the advice of her plastic surgeon so reconstructive surgery could be performed later; she was not, however, informed of the risks of getting another cancer.

On Jan. 14, 2013, Vermeland began five months of harsh chemotherapy that included Cytoxan (cyclophosphamide), Adriamycin (doxorubicin), Taxotere (docetaxel) and Neupogen (filgrastim). “I cried every time I went because I knew how sick it was going to make me,” Vermeland says, adding that her side effects were ongoing and included hand-foot syndrome (swelling, redness and pain on the soles of the feet and/or palms of the hands), breast cellulitis (infection of the skin and tissue from bacteria), body aches, neuropathy (weakness, numbness, tingling or pain in the hands or feet) and weight loss.

In October 2013, almost a year after her diagnosis, Vermeland had smooth saline implants made by Mentor placed by her plastic surgeon, but problems cropped up right away. “They just wouldn’t stay in place,” she says.

“I went into surgery probably two more times for him to straighten them and do some fat grafting, but they always looked terrible.”

In April 2014, her plastic surgeon offered to replace them with Allergan’s Natrelle 410 textured implants that he recommended highly, assuring Vermeland and her husband that the product would not put her at risk of developing a new cancer.

Searching for Answers

In July 2015, the area around Vermeland’s implant filled with fluid. Her plastic surgeon tried to improve their appearance with fat grafting, but he never tested the fluid to determine if it could be associated with cancer. It wasn’t until July 2018, when her left breast swelled to triple the size of her right that Vermeland did some research online and learned about BIA-ALCL.

Although her plastic surgeon said that her breasts looked fine, Vermeland requested an MRI and that he test the fluid spotted during the imaging for CD30, a protein that can signal the presence of BIA-ALCL. The fluid was drained by a radiologist, who was instructed to put in a drain — but did not have orders to test the fluid. While on the operating table, Vermeland needed to advocate for herself again by requesting he call her plastic surgeon for orders, which he did. The fluid was tested by flow cytometry and immuno-chemistry in labs at Rush Copley Medical Center in Aurora, Illinois, and at Mayo Clinic in Rochester, Minnesota.

Vermeland went into septic shock a week after her drain was removed due to an infection from her left breast implant. Her plastic surgeon was called immediately to remove her left implant. Her husband asked her plastic surgeon to remove not just the implant but also the surrounding capsule made of scar tissue that forms around implants during healing. He told the doctor that this would allow Vermeland to avoid a second surgery later and prevent the spread of cancer that could occur if the capsule was disturbed but not removed.

Despite the suggestions, the surgeon only removed the left implant and multiple samples of the capsule, which were tested for CD30. This left Vermeland in fear for her life.

To make matters worse, she had trouble getting any physician to disclose her test results. “Both (the surgeon and my oncologist) knew nothing about that cancer type,” she says.

Facing Stage 4

After receiving a diagnosis of BIA-ALCL on Aug. 11, 2018, Vermeland underwent a positron emission tomography (PET) scan on Aug. 23, 2018, at Mayo Clinic that identified effected mammary lymph nodes, which were false positive due to surgery a few weeks prior. This led to their removal on Aug. 24, 2018, along with the other implant with the capsule, the remaining capsule from left implant and part of Vermeland’s ribs to get to the mammary nodes. She was given a negative result for CD30.

Her next PET scan three months later showed more mammary nodes lighting up, which biopsy results proved positive. After multiple second opinions, Vermeland chose removal of the nodes through cryoablation at Mayo Clinic to potentially bypass chemotherapy. Unfortunately, more nodes were affected, requiring more biopsies and several other PET scans at The University of Texas MD Anderson Cancer Center in Houston, all of which were either negative or inconclusive.

In July 2019, after a PET scan and a few more biopsies, she was told she was in remission. However, Vermeland was convinced otherwise because she could still feel an enlarged node along with persistent chest wall pressure.

“It was the worst thing,” she says. “I was supposed to be happy, and it was so sad for me because I felt the results just were not correct. My family was telling me to move on, thinking I (was) being too pessimistic. I was confused what to do.”

At her next PET scan in November 2019, doctors saw positive nodes throughout her body, including her lungs. Vermeland had advanced to stage 4 disease.

Hematologists at Mayo Clinic wanted to treat her with a multichemotherapy regimen known as CHOP (cyclo- phosphamide, vincristine, prednisone, Adriamycin) plus Adcetris (brentuximab vedotin), but Vermeland was against it. At the First World Consensus Conference on BIA-ALCL that she attended in October 2019, Vermeland had learned that Adcetris, an antibody-drug conjugate that targets CD30-positive cells, can be used alone to treat the disease.

Past treatment guidelines recommended giving CHOP (or that regimen with Adcetris replacing vincristine) as the preferred treatment for BIA-ALCL that had spread.

After lengthy discussions and a second opinion from MD Anderson Cancer Center, she completed treatment with Adcetris at an affiliate of Northwestern Medicine in Geneva, Illinois.

“I had a lot of side effects including neuropathy, and I was in the (emergency room) a bunch of times,” she recalls. “But after I got my second PET scan during treatment on June 8, 2020, it showed I was in remission. It was unbelievable. My oncologists at all clinics were in awe. I was the miracle child.”

Advising Others

Vermeland has these suggestions for other patients undergoing mastectomy: Find a plastic surgeon who is well informed about all kinds of implants, is familiar with the symptoms of both BIA-ALCL and breast implant illness, is willing to test for CD30 and knows how to remove both implants and capsules.

For patients who suspect they have BIA-ALCL, Vermeland warns that most health insurers won’t pay for testing or implant removal unless the patient has survived breast cancer.

According to Allergan, it is not recommended that asymptomatic women remove their Biocell implants, and the FDA recommends against this as well. Those who do choose explant will receive a free pair of smooth implants from the company, although it will not pay for surgery.

Women with Allergan implants and a confirmed case of BIA-ALCL receive $7,500 from the company, but they must sign a document releasing the company from liability, Vermeland says. The company did not respond to a request for comment on the issue.

Some women are suing Allergan, claiming that Biocell implants contain unsafe particles and contaminants, according to an article on aboutlawsuits.com. The women allege that they may have avoided BIA-ALCL if Allergan had been more forthcoming about the dangers of the implants, the article states.

Vermeland also points out that breast implant illness is not covered by insurance because it’s not recognized as a medical condition, although patient advocates want the FDA to change that. She notes that Diana Zuckerman, president of the National Center for Health Research, can help patients get insurance to pay for this by identifying the best codes to use when filing claims.

Still, Vermeland says, “We need funding to help these women. They are doing GoFundMe pages to get their breast implants removed.”

Creating Change

Giving patients the care they deserve requires action, Vermeland says. She suggests that efforts should start with studies of patients who have BIA-ALCL, the therapies they’ve received and their health outcomes so treatment guidelines can be continually updated.

In addition to the guidance it recently issued, the FDA created a registry of patients with BIA-ALCL in 2012 called PROFILE (thepsf.org/PROFILE). Still, “it’s just not enough,” Vermeland says. She wants the FDA to force Allergan to pay for the removal of its textured implants in any patients who want the procedure.

In addition, Vermeland and three other women started a Facebook group, the BIA-ALCL Global Patient-Clinician Site, aimed at patients, doctors and advocates. “We hope to contribute to the diagnosis and treatment of women with the disease and to the prevention of more cases in the future,” she says. “As we say very frequently these days: ‘Not our daughters.’”