Statement of Dr. Michael Carome, Deputy Director, Public Citizen’s Health Research Group
The Food and Drug Administration (FDA) has taken laudable action by prompting two leading plastic surgery associations to remove misleading information regarding breast implant-related cancer from the organizations’ websites.
In a Feb. 17 letter to the FDA, Public Citizen alerted the agency that the presidents of two leading plastic surgery organizations – the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) – urged members to inaccurately downplay the significance of recent evidence about the risks of breast implant-related cancer when speaking to female patients during a recent members-only webinar posted on the ASPS and ASAPS websites. Such communications represented a deplorable attempt to trivialize the significance of the findings of increased numbers of cases of a rare form of cancer, called anaplastic large cell lymphoma (ALCL), in women with breast implants. Public Citizen called on the FDA to stop this deliberately misleading messaging campaign, the goal of which apparently was to keep women in the dark about the dangers of breast implants so they will continue to ask for them.
In a response letter written Feb. 28 and received today by Public Citizen, Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, informed Public Citizen that after the FDA reviewed the ASPS/ASAPS webinar and spoke with representatives of both organizations, ASPS and ASAPS now plan to remove the misleading webinar from their websites.
In his letter, Dr. Shuren noted that while ASPS and ASAPS are independent organizations that FDA does not regulate, FDA is committed to assuring that health care providers and patients receive accurate information about the possible association between breast implants and the development of ALCL. Removal of the webinar from the ASPS and ASAPS websites is an important first step in undoing the misleading and inaccurate “educational” campaign initiated by these organizations.
Among the misleading claims made during the ASPS/ASAPS webinar was that the type of cancer seen in breast implant patients had a “benign course” and that “surgery [to treat the cancer] was curative.” However, as Dr. Shuren stated in his letter, “the optimal treatment regimen [for breast implant-associated ALCL] has not been established and … additional data collection is needed to fully understand … [its] risk factors, optimal treatment plan, and prognosis.”
The FDA plans to collaborate with ASPS and other experts in the clinical and scientific communities to develop a registry to gather additional information to better characterize ALCL in women with breast implants.
As the FDA moves forward with these plans, it is essential that the agency closely monitors the control of the registry to ensure that the integrity of the data being collected is not corrupted by those with significant conflicts of interest.