Is Rare Breast Implant Risk Cancer, or 'Condition?'
Feb. 18, 2011— -- You might call it a scrap over semantics, but the stakes go far beyond words.
As the Food and Drug Administration continues exploring the incidence of a very rare cancer among a small group of women with breast implants, a longtime critic of the devices charged in a letter to the agency that leaders of two plastic surgery groups were encouraging their members to mislead American women by recasting the malignancy as a "condition" that could easily be remedied with surgery, and asked that the regulators stop them.
Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, and Dr. Michael Carome, the group's deputy director, sent a letter to the FDA on Thursday in which they passed along information that a concerned reconstructive surgeon shared from a Feb. 3 webinar for the American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgery.
Citing a transcript the surgeon provided, they wrote that the president of ASPS, Dr. Phil Haeck of Seattle, suggested in the members-only talk that surgeons respond to patients' questions using the term "condition," so as not to "disturb them by saying this is a cancer, this is a malignancy." In fact, Wolfe said in an interview shortly after releasing the letter, anaplastic large cell lymphoma (ALCL) is a type of cancer known as non-Hodgkin's lymphoma and is typically aggressive.
In a response released later in the day, ASPS said the partial transcript Public Citizen released took Haeck's "extemporaneous" remarks "out of context." ASPS said Haeck never meant to "trivialize or minimize" the issue and noted that the two societies had commissioned an independent scientific panel and an independent review through RAND, a think-tank in Santa Monica, Calif., and Washington, D.C., which soon will publish its findings.
The FDA's review of scientific literature from 1997 through May 2010 has identified 34 cases of ALCL among the estimated 10 million women worldwide whose breasts were surgically enlarged with silicone-filled or saline-filled implants; the cases were diagnosed when women sought treatment for pain, lumps, swelling or asymmetry after fully healing from the implant surgeries. The FDA said it was aware of about 60 cases worldwide among women with implants, but there could be duplication among the published and unpublished cases.
