FDA: Rare Cancer Linked to Breast Implants Have Killed at Least Nine People

Dr. Brad Jacobs holds up a silicone implant gel (L) and a saline implant gel (R) inside of his office in New York City, on Nov. 21, 2006. Spencer Platt/Getty Images

The U.S. Food and Drug Administration (FDA) sent out a letter doctors to be on the lookout for a rare type of cancer associated with breast implants, adding that nine women have died from the illness.

In the letter, the FDA warned about a form of lymphoma that affects patients who have received breast implants. The note was sent out to nurses, family doctors, and other health care professionals.

So far, 660 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) have been received in the past decade, the FDA said, adding that of that figure, 457 unique cases of have now been confirmed.

Dr. Brad Jacobs holds up a silicone implant gel (L) and a saline implant gel (R) inside of his office in New York City, on Nov. 21, 2006. Spencer Platt/Getty Images

“Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL,” the FDA’s letter said.

BIA-ALCL is a type of non-Hodgkin’s lymphoma, which is not a form of breast tissue. It’s often found in scar tissue and fluid close to the implant, said the agency.

“We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy,” said the FDA. “We are also asking health care providers to report to the FDA cases of BIA-ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.”

The agency noted that implants aren’t the only cause of BIA-ALCL but stressed that women who have received the surgery have an increased risk of getting it.

Meanwhile, “Most cases reported in the literature describe individuals who have had textured implants,” said the FDA, which added that there have been reports of cancer in patients with smooth-surfaced implants.

“In most of the cases reported to the FDA, patients were diagnosed with BIA-ALCL when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (seroma), or masses surrounding the breast implant,” the officials also wrote.

The FDA recommends that patients who get breast implants should be screened three years after the surgery and every two years after that.

“The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. The life of breast implants varies by person and can’t be predicted. That means everyone with breast implants will face additional surgeries—but no one can tell them when. And while a few people may keep their original implants for 20 to 30 years, that is not the common experience,” the agency on its website.

Victim Speaks Out

Raylene Hollrah told the New York Times in 2017 that she got breast cancer years ago, but six years later, in 2013, she was diagnosed BIA-ALCL due to implants.

“My whole world came crumbling down again,” she told the Times.

“I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer. I thought, ‘I’m not going to see my kids grow up.’”

She had the implants inserted in 2008 and was fine for five years until the diagnosis.

“It’s a moment I’ll never forget,” Hollrah said of what the doctor told her. “He said, ‘You have cancer again, but it’s not breast cancer.’”