FDA Update on Breast Implant Associated ALCL
The FDA last updated it’s website on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in March 2017. (See corresponding blog on my website for March 2017). On March 21, 2018 the FDA announced an update to its website regarding the number of cases of BIA-ALCL submitted to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. It estimated the risk for a woman with textured implants to develop BIA-ALCL at 1:3,817 to 1:30,000. My two specialty societies, The American Society of Plastic Surgery (ASPS) and The American Society for Aesthetic Plastic Surgeons (ASAPS), have been working with the FDA to compile a Registry. The following is a summary of the FDA update.
The update acknowledges the FDA’s position that it remains difficult to determine the exact number of BIA-ALCL cases in the United States, and it notes that 414 medical device reports (MDR) have been submitted to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database as of March 21, 2018. This represents an increase of more than 15 percent since the last update in March 2017. It’s important to note that these do not necessarily represent new cases – rather, they are reports added since the previous update. The FDA acknowledges that, while its MDR system is a valuable source of information, it relies on accurate reporting and, therefore, may contain incomplete, inaccurate, untimely, unverified or biased data.
In addition to citing the increase in the number of BIA-ALCL cases reported, the FDA reports that, based on current medical literature, the risk for a woman with textured implants to develop BIA-ALCL is 1:3,817 to 1:30,000. This range is consistent with recent ASPS and ASAPS updates to membership, and the FDA update calls for no changes in recommendations regarding breast implants. For patients with breast implants, the FDA states there is no need to change routine medical care and follow-up, and there is no need to test asymptomatic patients.
Although the FDA indicates it has received 30 reports associated with smooth surfaces, to date there have been no confirmed smooth surface-only cases reported to Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE). As of March 21, 2018, 195 unique confirmed U.S. cases of BIA-ALCL have been reported to the PROFILE registry, a joint collaboration between ASPS, The Plastic Surgery Foundation (PSF), ASAPS, The Aesthetic Surgery Education and Research Foundation (ASERF), and the FDA. It’s important to note that the MAUDE database may contain limited and potentially inaccurate adverse event reports, and it may not represent the true number of U.S. cases, as some entries are duplicates and not all cases are confirmed as BIA-ALCL.
The FDA update confirms previous ASPS and ASAPS communications to membership 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 the standardized diagnosis and treatment guidelines established by The PSF, The ASERF, and 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. The agency has also updated the content and format of its webpage for breast implant post-approval studies, in order to make current information about these important studies easier for patients to read and understand.