FDA issues 2019 update on BIA-ALCL
The American Society of Plastic Surgeons (ASPS) would like to make members aware of a Feb. 6 statement by the Food and Drug Administration (FDA) updating the number of adverse event reports submitted to the agency related to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The statement notes that as of September 2018, the agency has received 660 total medical device reports (MDR) regarding BIA-ALCL cases in the United States – an increase of 246 new MDRs (59 percent) from the previous year’s update. Acknowledging that the nature of the MAUDE database’s reporting system is susceptible to duplicate reports, the agency’s analysis suggests there are only 457 unique cases, including nine deaths, of BIA-ALCL reported (since 2010). The FDA also notes that while the MDR system is a valuable source of information, it is a passive surveillance system with limitations, including incomplete, inaccurate, untimely, unverified or biased data in the reports. The incidence or prevalence of BIA-ALCL cannot be determined from this reporting system alone, due to potential under-reporting, duplicate reporting and lack of information about the total number of breast implants.
In addition to MDRs, the FDA also relies on reviews of medical literature and data from the ASPS/PSF Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE) – which collects suspected and confirmed diagnoses of BIA-ALCL. As of Feb. 7, 265 suspected or confirmed cases of BIA-ALCL have been reported to PROFILE, a collaboration between ASPS, The PSF and the FDA. Worldwide, ASPS is aware of 681 cases and 17 deaths.
“Given the agency’s continued efforts to communicate with stakeholders about BIA-ALCL risks, and our work to encourage patients and providers to file MDRs with the agency, these types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA,” writes Binita Ashar, MD, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiologic Health.
The FDA also issued a letter to health care providers to raise awareness of symptoms related to BIA-ALCL, such as pain, lumps, swelling or asymmetry that developed after a patient’s initial surgical sites were fully healed. The letter notes the risk of developing BIA-ALCL for a woman with textured implants is 1:3,817 to 1:30,000, which remains consistent with the previous year’s report. Though the FDA indicates it has received 39 reports associated with smooth surfaces, to date there have been no confirmed smooth surface-only cases reported to PROFILE.
FDA recommendations to health care providers
In most of the cases reported to the FDA, patients were diagnosed with BIA-ALCL when they sought medical treatment for implant-related symptoms resulting from the collection of fluid (seroma) or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the BIA-ALCL diagnosis. Therefore, the FDA is recommending that health care providers:
- Prior to implantation, provide all patients with the breast implant manufacturer’s labeling, including the patient-specific labeling, as well as other educational material prior, and make sure they are aware of the benefits and risks of the different types of implants. Most confirmed cases of BIA-ALCL have occurred in patients with textured-surface implants, although there are known cases in patients with only smooth-surface implants.
- Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant seroma. In some cases, patients presented with a mass or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the individual’s case to a multidisciplinary team for evaluation.
- Collect fresh seroma fluid and representative portions of the capsule, and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid or mass with Wright Giemsa stained smears, and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers.
- Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Consider current clinical practice guidelines, such as those from The PSF or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
- Report all confirmed cases of BIA-ALCL in individuals with breast implants to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Health-care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
- Submit case reports of BIA-ALCL to the Patient Registry and Outcomes For Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE) registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.
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.
BIA-ALCL is a rare condition that occurs most frequently in patients who have breast implants with textured surfaces. Patients should discuss with their health-care provider the benefits and risks of textured-surface versus smooth-surface implants. All cases of BIA-ALCL should be reported to the FDA and to the PROFILE registry.
The FDA will convene a panel on BIA-ALCL and breast implant safety in March. Further updates will be shared with membership in Plastic Surgery News and additional communications as more information is available.
Additional resources:
For more information on BIA-ALCL, visit plasticsurgery.org/alcl or the FDA website.
ASPS resources for physicians include:
Educational Brochure for Patients »
Collection of PRS articles on BIA-ALCL »
BIA-ALCL Frequently Asked Questions »
Sample informational letter to patients »
ASPS Recommended Insurance Coverage Criteria for Third-Party Payers »
Additional resources for patients are available at plasticsurgery.org/alcl-info.
ASPS is committed to patient safety, advancing quality of care, and practicing medicine based upon the best available scientific evidence. The Society will continue to monitor and review all new information as it becomes available to keep ASPS members and the rest of the plastic surgery community informed.
ASPS members contacted by the media are encouraged to forward inquiries to Adam Ross, ASPS Media Relations manager, at aross@plasticsurgery.org or 847-228-3361.
