FDA issues BIA-ALCL update, qualifies BREAST-Q
The FDA issued an update to its breast implant safety webpages on Aug. 20 regarding adverse events reported to the Agency related to breast implants, including Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and data on medical device reports (MDR) the FDA has received on "Breast Implant Illness." The BIA-ALCL update cites a total of 733 unique cases of BIA-ALCL and 36 patient deaths globally, representing an increase of 160 new cases (64 from the United States) and three deaths since the July 2019 update.
Of the 733 total unique cases of BIA-ALCL reported to the FDA, 496 cases were reported to have textured implants, and 209 cases did not specify the implant surface. The FDA notes that 28 cases have presented with a smooth implant at the time of BIA-ALCL diagnosis. Of those cases, eight have a history of at least one textured implant, nine have a history of prior implants with unknown texture, one has a history of one smooth implant and no known textured implant, and 10 have unknown prior history of implants. The FDA also explains that many MDR reports do not contain information, or contain incomplete information, on the prior implant history of the patient so this information may change over time. As of Jan. 5, 2020, there were no reports of cases associated with tissue expanders.
BIA-ALCL occurs almost exclusively 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 ASPS/PSF PROFILE registry.
The update calls for no changes in recommended routine follow-up care for patients with breast implants.
The FDA also announced that the BREAST-Q – a patient-reported, quality-of-life outcomes measure for breast surgery funded by The PSF and developed by ASPS member Andrea Pusic, MD, MHS – has been approved as a qualified Medical Device Development Tool, which means it may be used in clinical outcomes assessment and regulatory decision-making for breast implant devices.
"Our qualification of the BREAST-Q Reconstruction Module as a validated tool to assess outcomes of breast reconstruction surgery in terms of quality of life and satisfaction helps accomplish this," stated Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health.
The FDA also updated its data on MDRs received concerning systemic signs and symptoms referred to by some patients as Breast Implant Illness (BII). The FDA received 2,497 medical device reports containing symptoms consistent with BII from November 2018 to October 2019, while the agency's data from the prior 10-year period showed 1,080 reports of such symptoms.
The FDA noted it does not have definitive evidence indicating breast implants cause these symptoms; however, the current evidence supports that some patients experience systemic symptoms that may resolve when their breast implants are removed.
ASPS actively pursues data with scientific rigor in collaboration with the FDA and patient groups. ASPS members are encouraged to participate in the National Breast Implant Registry and can register online at ThePSF.org/NBIR. Additionally, the FDA recommends that all suspected or confirmed cases of BIA-ALCL in the United States be reported to the PROFILE registry at ThePSF.org/PROFILE; to the FDA's Manufacturers and User Facility Device Experience (MAUDE) database; and to the device manufacturer.
In addition to MDRs, the FDA also relies on reviews of medical literature and data from PROFILE, which collects suspected and confirmed diagnoses of BIA-ALCL.
Health care professionals and consumers are encouraged to report any adverse events related to breast implants to the FDA's Adverse Event Reporting Program.
ASPS provides a wealth of up-to-date resources on BIA-ALCL for physicians and the public at PlasticSurgery.org/ALCL. These resources include:
- BIA-ALCL Frequently Asked Questions »
- Collection of PRS articles on BIA-ALCL »
- Informed Consent Language »
- Breast Implant Surgeon to Surgeon Expert Network »
- Sample Informational Letter to Patients »
- ASPS Recommended Insurance Coverage Criteria for Third-Party Payers »
- Educational Brochure for Patients »
Additional information for patients is 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 firstname.lastname@example.org or (847) 228-3361.