May 10, 2011 — How should breast surgeons explain the risk of developing a rare cancer to women seeking breast implants? And what are the best treatment options for this cancer?
These questions are at the heart of a fierce debate about whether representatives of 2 plastic surgery organizations accurately advised their members about the risk for postimplant anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin's lymphoma.
The debate began with a February 3 webinar for members of the American Society of Aesthetic Plastic Surgery and the American Society of Plastic Surgeons (ASPS). A surgeon who heard the webinar and disagreed with the language used to describe ALCL risk in breast implant patients transcribed and sent some of the comments to Sidney Wolfe, MD, director of the health research group for the consumer rights organization Public Citizen.
Dr. Wolfe cited the surgeon's transcript in a February 17 letter to the FDA criticizing the 2 societies. In his letter, Dr. Wolfe said that in the webinar, Phil Haeck, MD, president of the ASPS, said that ALCL "has such a benign course that...we decided that we would call this a condition when we talked to the media, not a tumor, not a disease, and certainly not a malignancy."
Dr. Wolfe wrote that "the webinar also stated that 'surgery was curative' " for ALCL.
Dr. Wolfe told Medscape Medical News that he finds it "inappropriate and really reprehensible" for the organizations "to be advising their own members to pretend that this is not a cancer and that it's completely curable, even though, as we pointed out in the letter, a large number of these people had chemotherapy and/or radiation therapy."
Public Citizen has petitioned to ban silicone gel breast implants in the past, primarily based on evidence of cancer from animal studies.
Recent FDA Review of ALCL Cases
The February webinar came on the heels of a warning from the US Food and Drug Administration (FDA) in January that found an increased incidence of ALCL in women with breast implants.
About 3 in 100 million US women without breast implants develop ALCL in the breast each year. A literature review by the FDA, however, found 34 separate cases of ALCL in women who received breast implants from January 1997 to May 2010. Worldwide, about 5 to 10 million women have breast implants.
Breast implant–associated ALCL develops in the capsule of scar tissue that forms around the breast implant. The symptoms of ALCL often include swelling or pain near the implant site, according to the FDA. Symptoms can occur many years after a breast implant procedure is performed. The cancer, which can also present on the skin, in the lymph nodes, or elsewhere in the body, affects about 1 in every 500,000 US women each year, according to the National Cancer Institute. Treatment options for ALCL vary depending on the site and depth of the cancer.
As a result of its findings, the FDA recommended that providers report confirmed ALCL cases to MedWatch, the FDA's safety information and adverse event reporting program.
Dr. Wolfe also reviewed the 34 cases of breast implant ALCL. He found that half the patients with ALCL (17 patients) received chemotherapy and/or radiation treatment. Disease is documented to have recurred in 3 of these 17 patients after treatment. Five of the 34 patients showed evidence of ALCL beyond the breast area before or when ALCL appeared in the breast, Dr. Wolfe wrote in his February 17 letter.
"The findings from review of these published cases are therefore inconsistent with phrases such as a 'benign course' or a 'condition' rather than cancer, a tumor, or a malignancy," he wrote.
Dr. Wolfe believes that ALCL might be underdiagnosed because plastic surgeons who treat complications after breast implants have not always tested tissue specimens for the presence of cancer. Furthermore, Dr. Wolfe stated in his letter, there may be more cases diagnosed in the future because ALCL near a breast implant takes a median of 9 years to present.
"We don't know the long-term follow-up," Dr. Wolfe told Medscape Medical News. Because of latency periods with cancer, "a lot of women who have [implants] may well at some point develop cancer," he said.
In addition, many ALCL cases might not be published in the literature, Dr. Wolfe pointed out. "Published case reports represent just a tiny fraction of cases that have occurred."
ASPS Response and Studies
In a statement about the webinar, the ASPS said that Dr. Haeck's comments were misconstrued and taken out of context.
"Far from intending to trivialize or minimize the issue," the ASPS stated, "Dr. Haeck's extemporaneous remarks were well understood by the physicians present to mean that the type of ALCL that has been observed in possible association with breast implants does not appear to have the malignant course of classic ALCL which is a systemic disease."
Because evidence suggests that breast implant ALCL is "clinically indolent," the ASPS stated, surgically removing the implant and capsule and following up with the patient are appropriate treatments and can help women avoid "unnecessary chemotherapy and radiation treatment which may not be clinically appropriate."
In response to the Public Citizen letter, the FDA asked the ASPS and the American Society of Aesthetic Plastic Surgery to remove the February 3 webinar from their Web sites, which they did. The FDA and the ASPS are also creating a registry of women with breast implants who develop ALCL.
On April 19, the nonprofit research group RAND Corporation released a study of ALCL and breast implants, commissioned by the ASPS. The study found that ALCL after breast implants could be surgically treated in some cases.
The RAND study looked at 29 published cases of ALCL in women with breast implants. Twelve or more of the women had a history of cancer.
"While some patients received chemotherapy and/or radiation," RAND stated in a press release, "the treatment in most instances consisted of surgically removing the affected implant and surrounding tissue, which appeared to successfully control the disease."
The RAND study concluded that "the disease takes a slow course and can be controlled by surgical removal of the implant and surrounding capsule."
When the RAND study results were shared with a medical panel, the panel found that "the evidence suggests an association between breast implants and [ALCL], but cannot definitely prove that implants cause the disease nor explain how the implants might trigger ALCL," the press release stated.
The RAND organization recommends evaluating a patient for ALCL if a seroma develops near a breast implant 6 months or more postsurgery. If ALCL is diagnosed, the implant and its lining should be removed, and the patient should be evaluated for disease beyond the implant area.
Medscape Medical News © 2011 WebMD, LLC
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Cite this: Breast Implants and Lymphoma Risk: Webinar Triggers Debate - Medscape - May 10, 2011.