PSF, ASPS partner with FDA to create comprehensive ALCL registry
(Note: This article originally appeared in the January/February 2012 issue of Plastic Surgery News.)
Recent reports of a possible link between women with breast implants and anaplastic large cell lymphoma (ALCL) have garnered a great deal of attention in the plastic surgery community. In an effort to learn more about the potential association between breast implants and this rare condition, The PSF, ASPS and the FDA have entered a partnership to conduct research and develop a comprehensive breast implant-ALCL registry called the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE).
PROFILE seeks to increase the scientific data on the condition by identifying - both retrospectively and prospectively - confirmed cases of ALCL in women with breast implants.
"PROFILE is another important initiative that The PSF has undertaken to address immediate concerns of our members and the patients we serve," says PSF President Michael Neumeister, MD. "The PSF was proactive in responding to this unforeseen medical issue, and PROFILE is a very well thought-out collaborative effort between The PSF, ASPS and the FDA."
"For ASPS, The PSF and our members, patient safety always comes first," says ASPS President Malcolm Roth, MD. "Although this entity appears to be exceedingly rare, and in most cases relatively benign, we are eager to begin the PROFILE study and look forward to collaborating with the FDA. We have identified an exceptional group to look at the data and help us
answer all of the questions regarding the association between ALCL and patients with breast implants."
The PROFILE study will be led by Andrea Pusic, MD, associate attending physician at Memorial Sloan Kettering, on behalf of ASPS/PSF, and epidemiologist Cara Krulewitch, PhD, on behalf of the FDA.
"This new registry will provide key data to help us better understand the epidemiology and etiology of breast implant-associated ALCL," says Dr. Pusic. "This is an important patient safety initiative and it is important that we all take the time to report new cases."
Dr. Krulewitch says the registry will foster a better understanding of the role of the implant itself in the etiology of primary ALCL in women with breast implants.
"The data from the registry will be available for analytical epidemiological studies and will provide health care practitioners and patients with important information," she says. "The data will also contribute to our understanding of the potential risk factors and criteria for detection and management of primary ALCL in women with breast implants."
As the PROFILE registry is being developed, plastic surgeons or other physicians that have a patient with confirmed or suspected ALCL are asked to report the case to MedWatch – and to also contact The PSF at ALCL@plasticsurgery.org.
For more information, including resources for reporting an ALCL case in MedWatch and relevant literature about ALCL in women with breast implants, please contact ALCL@plasticsurgery.org.
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