Information on BIA-ALCL
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare and highly treatable type of lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. According to the most recent data available, the lifetime risk of association between breast implants and ALCL is 1 in 30,000 patients with textured implants in the United States. Some other countries have reported risks between 1 in 1000 to one in 30,000. Since the initial case report in 1996, ASPS now recognizes approximately 183 cases in the US and a total of 439 worldwide as of November 2017.
Most of the patients who have developed BIA-ALCL receive an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule. Continued follow-up after any breast implant surgery is suggested and important for patient health, but patients who notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape, including asymmetry, should contact their plastic surgeon. In most cases, women observed changes in the look or feel of the area surrounding the implant greater than one year after their initial surgical sites were fully healed, and on average eight to ten years after receiving textured implants.
Patients undergoing plastic surgery procedures, aesthetic or reconstructive, should be thoroughly informed of the potential risks and possible complications known to be associated with the procedure, and any device used in that procedure. In the very rare cases where a diagnosis of BIA-ALCL is made, surgical treatment is essential for the management of the disease. Some patients with more advanced disease may require further treatment such as chemotherapy.
FDA updates website on BIA-ALCL
The American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) would like to make members aware of a recent safety communication update to the Food and Drug Administration (FDA) website regarding breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The March 21 website update acknowledges that while it remains difficult to determine the exact number of BIA-ALCL cases, there have now been 359 medical device reports (MDR) reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database as of Feb. 1, 2017. Of these MDRs, the FDA reports that 232 included information on the breast implant device, with 203 identified as textured, 28 smooth and one identified as "another surface." The update also confirms that both silicone gel and saline implants have been reported in cases of BIA-ALCL.
It's important to note that the MAUDE database may contain limited and potentially inaccurate adverse event reports, and does not represent the true number of U.S. cases, as some entries are duplicates and not all cases are confirmed as ALCL. To date, there has been no confirmed smooth surface-only case of BIA-ALCL reported. As of November 21, 2017, 183 possible/confirmed U.S. cases of BIA-ALCL have been reported to the Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma Etiology and Epidemiology (PROFILE) database, a joint collaboration between ASPS, PSF, and the FDA.
The FDA's website update confirms previous ASPS/ASAPS communications, noting that BIA-ALCL remains a rare condition that occurs most frequently in patients who have breast implants with textured surfaces. The report also reiterates that patients should discuss with their health-care provider the benefits and risks of textured-surface versus smooth-surface implants. The FDA highlights the World Health Organization recognition of BIA-ALCL, and standardized diagnosis and treatment guidelines established by the National Comprehensive Cancer Network (NCCN).
The FDA recommends that all cases of BIA-ALCL be reported to the FDA and to the PROFILE registry.
ASPS and ASAPS are committed to patient safety, advancing quality of care, and practicing medicine based upon the best available scientific evidence. We will continue to monitor and review all new information as it becomes available to keep the plastic surgery community informed.
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