Several weeks after reports that unusual cases of lymphoma have been detected in 34 U.S. women with breast implants, two plastic surgeon organizations urged their members to inaccurately "trivialize" or "play down the risks" to their patients, charges the Public Citizen Health Research Group.
The group's director, Sidney Wolfe, MD, urged the U.S. Food and Drug Administration Thursday to "require them to stop such activities," because they are "misleading, dangerous and unethical."
In his letter to the FDA, Wolfe said that during a Feb. 3 webinar sponsored by the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery, the groups advised doctors to respond to reports about anaplastic large cell lymphoma, or ALCL, in patients who have had breast implants, saying that the diagnosis is a "condition," not a cancer or a malignancy.
ASPS president Phil Haeck, was alleged to have "essentially urged members to inaccurately downplay the significance of recent evidence about the risks of breast implant-related cancer when speaking to female patients," Wolfe wrote in his letter.
Wolfe wrote that in the webinar, Haeck made the following statement:
“[Y]es it’s classically a malignant tumor, but it has such a benign course that when we were discussing ways to talk to the media 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.
"Um, because, and I would recommend that you use the same terms with your patients rather than disturb them by saying this is a cancer, this is a malignancy. The best word is this is a condition. If you develop this condition here’s how we are going to treat it, the way we are going to diagnose this condition is this, and that’s very reassuring when you are using that word and not using the word cancer or malignancy. And I think you are certainly justified, with what we know now, in downplaying the malignant potential of these.”
Wolfe's letter added that the webinar's instructors also stated that "surgery was curative."
In his letter to the FDA, Wolfe wrote, "Advising against the use of the words 'cancer,' or 'tumor,' stating that 'surgery is curative' when speaking to women are all strongly contradicted by evidence from the published cases."
Asked for a response, the American Society of Plastic Surgeons’ said the FDA's disclosure about such cases "is a matter of significant concern," and said that Wolfe took Haeck's comments "out of context and misconstrued.
"Far from intending to trivialize or minimize the issue, 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.
"To be clear, our position is and has always been that ALCL associated with breast implants is a serious, but an extremely rare condition. The specific nature of this condition is unclear and it is important that more research be conducted; however, it is clear that the condition is not breast cancer, and this was confirmed by the FDA in its announcement."
"The scientific evidence to date suggests that ALCL associated with breast implants is a clinically indolent disease that behaves similarly to cutaneous ALCL and will therefore only require surgical removal of the implant and capsule and appropriate clinical follow up."
The webinar had intended to help doctors convey to patients that there is a wide spectrum of lymphomas, but this type, seen on the skin, has a different presentation than the systemic type, and "acts more benignly," says Felmont Eaves, president of the American Society for Aesthetic Plastic Surgery, which co-sponsored the webinar.
"People need to understand this is not breast cancer, and that it is incredibly rare, and at this point, appears to be highly treatable," Eaves says.
Asked if in retrospect, Haeck used a poor choice of words, Eaves replies, "Yes. We could have made it more clear."
An FDA spokeswoman acknowledged having received Wolfe's letter, and said her agency "has been very clear in our communications of the possible association between breast implants and the development of ALCL, which is a very rare type of cancer.
"It's important that health care professionals and women who have breast implants or are considering breast implants are aware of FDA's recommendations on this issue. FDA continues to work with patient groups, breast implant manufacturers and professional societies to ensure that women are adequately informed about this association so that they can make educated medical decisions," she said.
The FDA's recommendation cautions that this type of cancer has been found in 60 women worldwide, and represents "a very small fraction of the 5-10 million women who have received breast implants worldwide."