Kimberly Suiters, ABC7 WJLA: February 6, 2017
“You have cancer — again.”
“What? Breast cancer?”
“No … a new one.”
So went the conversation between a stunned 40-year-old Raylene Hollrah and the plastic surgeon who performed her reconstructive surgery after she survived breast cancer seven years earlier.
Her new cancer diagnosis? Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL for short. Of all the potential side effects of breast implants, she did not recall her surgeon ever mentioning a small but increased risk of cancer.
“I did everything to keep cancer away,” Hollrah told 7 On Your Side. “Yet, I put a device in my body that caused cancer.”
The US Food and Drug Administration is not prepared to say that the textured breast implants Hollrah chose cause lymphoma, a cancer of the immune system.
But in 2011 and again in 2016, the FDA cautioned of a “possible association” between ALCL and implants.
“This has created a certain amount of anxiety and concern among the medical community,” said Dr. Mark Clemens of MD Anderson Cancer Center, one of the leading experts on ALCL in the world.
Clemens met Hollrah after her diagnosis, explanted her implants and asked her questions about what she was told and when. His research, and others of patients and surgeons, reveals that patients never think to ask about ALCL and only one-quarter of surgeons always discuss the risk with patients in the initial consultation.
“We would like surgeons to always discuss the small, rare, but potential risk of this serious disease,” said Clemens, who serves on the board of the American Society of Plastic Surgeons (ASPS) as the liaison to the FDA. ASPS urges its board-certified members to always talk to patients about the risks as part of the informed consent process.
When 7 On Your Side filed a Freedom of Information Request (FOIA) about ALCL cases reported to the FDA, we received more than 800 documents representing 441 cases, more than one-third unconfirmed, and at least 12 deaths. Even since the 2011 advisory from the FDA about ALCL and implants, when manufacturers responded to reported adverse events, they often listed many risks but didn’t include ALCL.
“They should. Absolutely,” said Madris Tomes, CEO of Device Events, and a former FDA analyst who managed the build of a new adverse event reporting system. Tomes looks for patterns of problems with medical devices, but spotty reporting makes pinning down exact numbers for ALCL tricky.
Whether silicone or saline, Song explained why patients choose textured implants. They have a more natural, teardrop look, thinner at the top, thicker at the bottom. Texturing is intended to keep them from rotating. Researchers are evaluating whether that texturing, or a bacteria, or genetics make a patient more vulnerable to developing lymphoma.
THE ANALYST: “We don’t know how common it is.”
7 On Your Side spoke with a leader in the field of women’s health, Diana Zuckerman, PhD, President of the National Center for Health Research. Zuckerman was our chief source for information about the risk of suicide after implants. Regarding BIA-ALCL, she wrote:
“It is not true that textured implants are the only ones associated with BIA-ALCL. This summary of a recent medical journal article clearly says that “most women with ALCL have at least one textured implant” but that doesn’t mean they all do.
Read the entire article here.
The above article was published in February 2017. In August 2014, the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of leading cancer centers, provided guidelines for the diagnosis of “breast implant associated ALCL (BIA-ALCL), based on clear evidence that breast implants can cause ALCL. In 2017, the World Health Organization (WHO) and the Food and Drug Administration (FDA) both issued statements confirming that breast implants can cause ALCL. To read about the FDA’s 2017 report on breast implants and ALCL, click here (insert hyperlink to http://www.breastimplantinfo.