Denise Grady, The New York Times: May 14, 2017
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 Ms. Hollrah, now 43, who owns an insurance agency in Hermann, Mo. “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.’”
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.
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. The F.D.A. advises women only “to follow their doctor’s recommended actions for monitoring their breast implants,” a spokeswoman said in an email this month.
An F.D.A. 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 F.D.A.’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 to 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 United States 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,” Dr. 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,” Ms. Rogers said.
She learned about the importance of having the implants removed only 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, S.C., 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.
Ms. 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.
“But it’s worth my life,” she said.
Insurers generally cover implants after a mastectomy, but not for cosmetic enlargement, which costs $7,500 or more. Repeat operations for complications are also common, and usually cost more than the original surgery.
Diagnosis and Treatment
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.
Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy.
What’s inside the implant — silicone or saline — seems to make no difference: Case numbers have been similar for the two types. 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.
To make a diagnosis, doctors drain fluid from the breast and test it for a substance called CD30, which indicates lymphoma.
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.
“In the cases where we have seen bad outcomes, it was usually because they were not treated or there was a major delay in treatment, on the level of years,” Dr. Clemens said. 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, he said. But he added that in the past, before doctors understood how well surgery worked, many women were given chemotherapy that they probably did not need.
Case reports on the F.D.A. website vary from sketchy to somewhat detailed and rarely include long-term follow-up. Some describe initial diagnoses that were apparently mistaken, including infection and other types of cancer. In some cases, symptoms lasted or recurred for years before the right diagnosis was made.
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. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted.
“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. The rough surface may be irritating or abrasive. 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. Dr. Clemens said researchers were genetically sequencing 50 patients to look for mutations that might contribute to the disease.
Dr. Clemens was a paid consultant for Allergan from 2013 to 2015, but not for breast implants, and no longer consults for any company, he said.
A spokeswoman for Mentor said the company was monitoring reports about the lymphoma, and stood behind the safety of its implants.
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