Two plastic surgery professional organizations have removed a members-only webinar in the wake of complaints by an advocacy group that the program downplayed the risk of anaplastic large-cell lymphoma (ALCL) in women who have breast implants.
Public Citizens Health Research Group wrote to the Food and Drug Administration on Feb. 17 to urge the agency to take action against the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS).
The Washington-based nonprofit said that the groups held the webinar in the wake of the FDA’s Jan. 26 announcement that there were a growing number of cases of ALCL in women with implants.
Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Feb. 28 letter (pdf) to Public Citizen that it had viewed the webinar and "spoke with representatives of both organizations." Dr. Shuren added that, "They informed us of their plans to remove the webinar from their Web site."
Both organizations said that they were not instructed by the FDA to take the webinar down, but that it was a voluntary decision.
In a March 2 statement, the ASAPS said that it removed the webinar "as newer information became available a week ago." That information, according to ASAPS president Felmont F. Eaves III, is "an independent, systematic review of ALCL, which will be published in an upcoming edition of Plastic and Reconstructive Surgery."
Dr. Eaves said in an interview that the Rand Corp. conducted the review and that it is his understanding that the article will be available some time in June. For the time being, the advanced copy of the article is available only to ASAPS members.
The ASPS said in a March 2 statement, "It was never our intention to downplay the risk of a very rarely occurring cancer associated with breast implants." Rather, said the Society, "We did not want to unnecessarily alarm patients when the risk of ALCL associated with breast implants is so low."
According to Public Citizen, ASPS president Phil Haeck explained in the webinar that ALCL should not be referred to as a tumor or a malignancy, but as a "condition." Dr. Haeck said, "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," according to Public Citizen. Dr. Haeck added, "And I think you are certainly justified, with what we know now, in downplaying the malignant potential of these."
Public Citizen also objected to the webinar telling members that "surgery was curative," for ALCL.
In his response to Public Citizen, the FDA’s Dr. Shuren said, "the FDA believes the optimal treatment regimen has not been established and that additional data collection is needed to fully understand the possible relationship between ALCL and breast implants, as well as the risk factors, optimal treatment plan, and prognosis."
The FDA is asking health care providers to report confirmed cases of ALCL. The agency also notes that ASPS and others are collaborating with the agency to develop a registry tracking ALCL and implants. ASAPS said in late January that it also is supporting the registry. Details are still being worked out.