Anaplastic large-cell lymphoma is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface.

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Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest.

“My whole world came crumbling down again,” said Hollrah, now 43, who owns an insurance agency in Hermann, Missouri.

Her disease — breast-implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer. If detected early, the lymphoma is often curable.

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The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling. But the added warnings are deeply embedded in a dense list of complications, and no implants have been recalled.

Until recently, many doctors had never heard of the disease, and little was known about the women who suddenly received the shocking diagnosis of cancer brought on by implants.

An FDA update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the FDA’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease.

Women who have had the lymphoma say that the attention is long overdue, that too few women have been informed of the risk and that those with symptoms often face delays and mistakes in diagnosis, and difficulties in receiving proper care. Some have become severely ill.

Implants have become increasingly popular. From 2000-2016, the number of breast augmentations in the United States rose 37 percent, and reconstructions after mastectomy rose 39 percent.

Annually, nearly 400,000 women in the U.S. get breast implants, about 300,000 for cosmetic enlargement and about 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons. Allergan and Mentor are the major manufacturers. Worldwide, an estimated 1.4 million women got implants in 2015.

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston.

“I’d like to think that since then we’ve made progress on that,” Clemens said.

Late last year, an alliance of cancer centers, the National Comprehensive Cancer Network, issued treatment guidelines. Experts agree that the essential first step is to remove the implant and the entire capsule of scar tissue around it. Otherwise, the disease is likely to recur, and the prognosis to worsen.

Not all women have been able to get the recommended treatment. Kimra Rogers, 50, a nursing assistant in Caldwell, Idaho, learned last May that she had lymphoma, from textured implants she had for more than 10 years. But instead of removing the implants and capsules immediately, her doctor prescribed six rounds of chemotherapy and 25 rounds of radiation. A year later, she still has the implants.

“Unfortunately, my doctor didn’t know the first line of defense,” Rogers said.

She learned about the importance of having the implants removed from other women in a Facebook group for those with the disease.

Her health insurer, Blue Cross Blue Shield of Montana, covered the chemotherapy and radiation but has refused to pay for removal of the implants, and told her that her appeal rights were “exhausted.” In a statement sent to The New York Times, a spokesman said, “Cosmetic breast implants are a contract exclusion, as are any services related to complications of the cosmetic breast implants, including implant removal and reconstruction.”

Physicians dispute that reasoning, saying the surgery is needed to treat cancer. Her lawyer, Graham Newman, from Columbia, South Carolina, said he was planning a lawsuit against the implant makers, and had about 20 other clients with breast-implant lymphoma from Australia, Canada, England and the United States.

Rogers has been unable to work for a year. If she has to pay to have the implants removed, it will mean taking out a $12,000 loan. Insurers generally cover implants after a mastectomy, but not for cosmetic enlargement, which costs $7,500 or more.



Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants.

Most implants in the United States are smooth. But for some, including those with teardrop shapes that would look odd if they rotated, texturing is preferable, because tissue can grow into the rough surface and help anchor the implant.

What is inside the implant — silicone or saline — seems to make no difference: Case numbers have been similar. The reason for the implants — cosmetic breast enlargement or reconstruction after a mastectomy — makes no difference, either.

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit.

The disease is usually treatable and not often fatal. Removing the implant and the entire capsule of scar tissue around it often eliminates the lymphoma. But if the cancer has spread, women need chemotherapy and sometimes radiation.

Doctors at MD Anderson have treated 38 cases and have a laboratory dedicated to studying the disease.

About 85 percent of cases can be cured with surgery alone, Clemens said. But he added that in the past, before doctors understood how well surgery worked, many women were given chemotherapy that they likely did not need.

Clemens was a paid consultant for Allergan from 2013-2015, but not for breast implants, and no longer consults for any company, he said.

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma.

Allergan implants seem to be associated with more cases than other types, possibly because they are more deeply textured and have more surface area for bacteria to stick to, he said. Allergan uses a “lost-salt” method that involves rolling an implant in salt to create texture and then washing the salt away. Other makers use a sponge to imprint texturing onto the implant surface.

Allergan is studying bacterial biofilms, and immune and inflammatory responses to breast implants, a spokesman said in an email. He said the company took the disease seriously and was working with professional societies to distribute educational materials about it.

Another possible cause is that some women have a genetic trait that somehow, in the presence of implants, predisposes them to lymphoma. A spokeswoman for Mentor said the company was monitoring reports about the lymphoma, and stood behind the safety of its implants.

Hollrah had implants inserted in 2008 and felt fine for five years. Then in 2013, in a matter of days, her right breast tripled in size, filling painfully with fluid.

Her plastic surgeon removed the implant and replaced it. He had just read about the lymphoma, so to be on the safe side, he ordered CD30 testing. The results were positive.

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

On her doctor’s recommendation, she saw Clemens, who removed the implants and surrounding tissue. Chemotherapy and radiation were planned but turned out to be unneeded, because tests found no spread of the cancer. She remains well, but returns to MD Anderson once a year for scans.

“I will be monitored for the rest of my life,” she said.

She started a nonprofit, Just Call Me Ray, to help educate women about implants, and she participates in the Facebook group for women who have had the implant-related cancer.

Other women have needed more extreme treatment. Terri McGregor, 52, from North Bay, Ontario, had implant surgery in 2009. Six years later, after a routine mammogram with normal results, she felt lumps in her breast. Thinking the mammogram had ruptured her implants, her doctor removed and replaced them.

Because the tissue around the implants looked abnormal, he had it tested for CD30.

McGregor was stunned to learn she had the implant-associated lymphoma.

“I had no symptoms,” she said.

The new implants had to be removed. Further tests led to another shock: The cancer was advanced. McGregor felt ashamed, because she had gotten the implants simply to improve her appearance.

“I brought this on myself. I brought this on my family,” she said. “I really needed to work through that shame and guilt.”

Two chemotherapy regimens failed. In March 2016, she was given three to six months to live. There was one more option: a drug called brentuximab vedotin.

“I had four rounds,” McGregor said. “The tumor on my chest literally disappeared.”

Doctors then gave her high-dose chemotherapy, a transplant of her own stem cells and, in December, 15 radiation treatments. The aggressive treatment has taken its toll. She used to shovel asphalt and hoist cement bags.

“Now I struggle to carry my laundry basket upstairs,” she said.

She hopes the treatment has cured her. Like Hollrah, she participates in the Facebook group, and thinks women need more information.

“Our motive is informed consent,” she said.

Vikki Radow, 46, of Los Angeles, said that when she had heard the FDA reported nine deaths from implant-associated lymphoma, “I said, ‘Oh, my God, my mother was one of those nine.’”

Radow’s mother, Bettye C. Yaller, first received an implant about 30 years ago after a mastectomy for breast cancer. She had the implant removed and replaced a few times, and began to have swelling and pain in 2009 or 2010, Radow said.

Doctors diagnosed an infection, removed the implant and replaced it. In 2012, at 76, her mother became short of breath and had pain and swelling in her breast, a lump in her chest, and swollen lymph nodes.

“It started the most wild goose chase I’ve ever been on,” Radow said.

Her mother was hospitalized for two months, worsening steadily, as doctors struggled to determine what was wrong. In desperation, Radow’s husband consulted a physician friend, who suggested testing for lymphoma — and the diagnosis was finally made. By then, Yaller was critically ill, on a ventilator.

She improved with chemotherapy and came home from the hospital. When she was considered strong enough for surgery, she went back to the hospital to have the implant removed. Her heart stopped on the operating table. She was resuscitated but died two weeks later.