FDA's General and Plastic Surgery Devices Panel stresses breast implant safety, importance of the NBIR, and patient engagement during March 25-26 hearing
In both invited testimony and during open public comment periods, the FDA's General and Plastic Surgery Devices Panel heard from nearly 40 ASPS member surgeons on Monday and Tuesday.
The hearing was held to discuss the benefits and risks of breast implants for both augmentation and reconstruction purposes, and was prompted by recent coverage of patients being diagnosed with BIA-ALCL or reports of breast-implant illness and actions by other international regulatory authorities. In addition to plastic surgeons, the panel also heard from breast-implant patients, patient advocates and manufacturers. The FDA will use the panel deliberations to help inform their ongoing goal of ensuring the safety of breast implants.
Invited by the FDA to discuss the importance of clinical data registries in ongoing device surveillance, The PSF President Andrea Pusic, MD, MHS, shared data on BIA-ALCL already gathered from the Society's PROFILE registry, which has collected 267 case reports of BIA-ALCL to date in the United States. She also discussed the National Breast Implant Registry (NBIR), which launched this past October to serve as the centralized infrastructure for collecting information on all breast implant devices placed by surgeons in the United States. The NBIR is a pivotal piece of the FDA's strategy for monitoring the long-term and ongoing performance of all breast implants. All plastic surgeons should participate in the NBIR to ensure the right data is collected to inform regulatory decisions regarding the safety of breast implants. The NBIR is a collaboration with the FDA, breast-implant manufacturers and other stakeholders that include surgeons, patient advocates and epidemiologists.
"The NBIR will provide real-world data that can be used to track how patients respond to their implants and how the implants perform over time," Dr. Pusic told the panel. "This design also supports the possibility of embedding post-approval studies within the NBIR to collect real word evidence facilitating the safe introduction of innovative implants into the US."
Lynn Jeffers, MD, also spoke as part of the FDA's formal agenda on behalf of ASPS/The PSF, discussing both the robust current and future research and registry work in which the Society and Foundation are engaged. Dr. Jeffers discussed the Society's efforts and commitment to fully educate and engage patients and surgeons in the understanding of evolving trends influencing the benefits and risks of breast procedures. The FDA panel emphasized the need for patients, surgeons and the agency to work together to enhance communication and understanding about breast implants.
The agenda and background materials from this week's hearing can be accessed directly from the FDA website here.
ASPS provides a host of information on breast implant safety and BIA-ALCL, including facts, statistics, informed-consent language, insurance coverage information and a list of frequently asked questions for both doctors and patients is available here.
All ASPS members should begin participating in NBIR and can register here. Additionally, the FDA recommends that any suspected or confirmed cases of BIA-ALCL be reported to the PROFILE registry and the FDA's Manufacturers and User Facility Device Experience (MAUDE) database and the device manufacturer. You can submit a case to PROFILE here, and cases to the MAUDE database here.