One of Diana Cavallo's implants, made by Allergan, was recalled earlier this year.

By Maggie O'Neill
September 04, 2019
Klaus Vedfelt/Getty Images

Diana Cavallo is no stranger to breast cancer. She lost her mother to the disease, and Cavallo herself was diagnosed with breast cancer when she was 44—and then again when she was 49.

Cavallo, 58, was first diagnosed with ductal carcinoma—a breast cancer that begins in milk duct cells—in 2005. At that time, her recommended course of treatment was a lumpectomy, or the removal of the cancerous lump in her right breast. After that, she underwent seven weeks of radiation and went into remission.

But “almost five years to the date, for some reason, I had a bad feeling the cancer was back,” Cavallo tells Health. It was—“in almost the exact same spot,” she says. In 2010, she was diagnosed with breast cancer again—this time with ductal carcinoma, like before, and lobular carcinoma, a cancer that affects the lobules that produce milk and empty out in the milk ducts.

For her second bout of breast cancer, Cavallo was treated with a double mastectomy, or the removal of both breasts. She decided that she’d get breast implants at the same time, so, in one operation in December 2010, Cavallo's breast tissue was removed and her silicone implants were inserted. Six years later, in 2016, Cavallo had the silicone implant in her right breast removed and replaced with a textured implant. She made the switch because textured implants were said to be better at adhering to the skin, which the silicone implant in her right breast wasn't doing well.

Three years later, Cavallo learned that her textured implant had been linked to cancer in other women

Cavallo first found out about the association between some textured breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in May after seeing multiple news stories on the link. The association became even more worrying when the FDA requested the recall of textured breast implants made by Allergan in July, which Allergan agreed to. Cavallo's specific type of textured implant—a Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implant—was on the .

Thirty-three patient deaths have been linked to BIA-ALCL since 2010, along with 573 reported cases of BIA-ALCL worldwide, . But, to be clear, BIA-ALCL is not breast cancer. Instead, it's a type of non-Hodgkin’s lymphoma, or a cancer of the immune system, per the FDA. For most patients with BIA-ALCL, lymphoma cells are found in one of two places: In fluid that surrounds the breast implant or within the fibrous scar capsule, according to the FDA—those two specific regions are separate from the breast tissue, where breast cancers are typically found.

FDA

The main symptoms of BIA-ALCL are persistent swelling or pain around the breasts. “These symptoms may occur well after the surgical incision has healed, often years after implant placement,” . For most people with BIA-ALCL, the cancer is treated successfully with the removal of the textured implant and surrounding scar tissue. However, the FDA points out, some patients require chemotherapy and radiation.

The odds of developing BIA-ALCL in the first place, though, are slim, Andrew Salzberg, MD, a plastic and reconstructive surgeon at Mount Sinai Health System in New York City, who performed Cavallo's surgery, tells Health. “This is definitely a rare occurrence. [There are] only about 600 reported cases in the world, [with] about 75,000 textured implants in patients right now.”

The FDA also outlined the low risk in a statement released in July but still explained their reasoning for recalling the specific breast implants: "Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” Amy Abernethy, MD, PhD, Principal Deputy Commissioner for the FDA said in the press release.

Something to note: While the administration requested the recall the affected Allergen textured implants and urged their removal from shelves and future procedures, the FDA doesn't advise women to have the recalled Allergan textured implants removed unless they experience symptoms of BIA-ALCL. "If you have no symptoms, we are not recommending the removal of the implants...due to concern related to the risk of developing BIA-ALCL," an says.

That could be for a number of reasons, says Dr. Salzberg. One is to reduce the risk of harm on the body. “We don’t want to open up everyone to the cost and risk of having surgery,” Dr. Salzberg says, which can lead to infection, bleeding, and issues with anesthesia. Surgery could be riskier than leaving the implants in, he adds. 

Another issue: Experts don’t yet know that having the implants removed will necessarily reduce one's risk of suffering from BIA-ALCL, says Dr. Salzberg. 

RELATED: The 5 Breast Cancer Stages, Explained

Despite the rarity of BIA-ALCL and the risk associated with removing implants, Cavallo is not alone in her worries of developing cancer again—which is why she took action.

“Many, many patients who have read the news become alarmed,” Dr. Salzberg says. He explains how Mount Sinai patients who have the implants were notified: “We called [and said,] ‘You’ve been identified as having this device. Do you know what your risks are?’ People freaked out about the issue, obviously.”

Those most concerned include women who had the implants inserted after undergoing a mastectomy due to breast cancer. Cavallo is one of these patients—and it's why she recently chose to have her Allergan implant removed, despite not experiencing symptoms of BIA-ALCL. “I have two children. If I don’t get [it] out, and I get the cancer, I’d be kicking myself, Cavallo told Health before her operation on August 29. "Nobody wants to get cut, [but] I’m fighting to stay alive."

RELATED: The FDA Announced a Breast Implant Recall. Here's Everything You Need To Know

Her comments echoed those that Dr. Salzberg has been receiving from patients with the recalled implants ever since the recall was announced. “Patients [say], ‘I know I’m the one who’s going to get it. My luck,’” Dr. Salzberg says. “She feels as though if it’s going to happen to anyone, it’s going to happen to her.” (It should be clarified, however, that a woman's history of breast cancer does not increase her risk of developing BIA-ALCL, says Dr. Salzberg.)

Cavallo said it’s frustrating when the media and doctors emphasize how rare BIA-ALCL is. “It’s close to home when you’ve already had your boobs cut off.”

In the end, getting her breast implant taken out gave Cavallo peace of mind—and she's confident in her decision.

The recovery time for Cavallo’s surgery could be as long as eight weeks. But that’s nothing compared to the relief of having her implant removed. “The recuperating [is] not a day at the park, but I would be waiting for the other shoe to drop.” 

Overall, Cavallo says that women need to be aware of the risks associated with Allergan implants, which is why she's telling her story. She explains that she lives her life in a way, she believes, that minimizes her cancer risk. “I don’t smoke. I don’t drink. [I’m] vegetarian. I don’t want to have something in my body that’s causing [cancer],” she says. So, for her, removing her implant was the only sensible option. Cavallo had another implant inserted in place of the recalled Allergan textured implant she had removed.

Dr. Salzberg agrees that the decision to remove these textured implants without any symptoms of BIA-ALCL is a personal decision to be made by the women affected. He says he tells his patients who have the implants to "go home and think about it, and make your best decision. If you can’t live with [your implants], let me know. [The removal procedure is] certainly not having open-heart surgery.”

For Cavallo, her personal decision was made regardless of the FDA’s advice—and it's something that she wants all women to exercise. “Knowledge is power, [and] it’s a personal choice. Women have a choice.” The decision to remove her implant was the right choice for her. "I'm so relieved that the implant is out of my body," she said, the day after her surgery. "I'm so happy with my decision."

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