The Plastic Surgery Foundation
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The PSF President's Page: May 2018


Summer is an active time for The PSF. The PSF Study Section and Research Oversight Council met recently, and more than $700,000 in awards for research funding will soon be announced. These awards will fund 30 Investigator-Initiated Grants, to include nine Combined Pilot Research Grants and 10 PSF Pilot Research Grants. This illustrates the tremendous success of the combined grant program, which engages our sister societies and leverages funding to provide an additional $50,000 towards research.

Awards of up to $50,000 or more have been made towards three grants in the new translational grant program and four National Endowment (NEPS) grants. In addition, three research fellowships have been awarded – including the first recipient of the Scott Spear Innovation in Breast Reconstruction Research Fellowship to support researchers focused on breast reconstruction. We are also excited to announce an off-cycle grant supported by MTF for up to $100,000, which will be awarded by this fall and directed towards both clinical and basic research incorporating applications of allograft in plastic surgery. Collating all funding sources, up to $1 million in research funding could be made available in the current year.

The PSF also remains committed to remaining on the forefront of breast implants and their potential sequelae. Reviewing procedural statistics as of 2017, cosmetic breast implants comprised 27 percent of all cases submitted through tracer modules for Maintenance of Certification (ABPS data), making it the most common of any of the tracers submitted.

ASPS data showed cosmetic breast implants to be the most common of any cosmetic surgical procedure performed. Breast implants have increased from 11 percent of all surgical cosmetic procedures in 2000 to 27 percent of these procedures in 2017, and the importance of following outcomes of breast implants for the practicing plastic surgeon cannot be overemphasized. However, outcomes are not without controversy, and data-driven efforts to track these outcomes are key to our members both in responding to controversial topics that may be picked up by the media, as well as in providing information to their patients derived from evidence-based medicine regarding the safety of breast implants.

The PSF has developed several mechanisms to remain ahead of data derived from breast-implant outcomes. We have two ongoing registries to evaluate outcomes of breast implants, beginning with the second phase of the National Breast Implant Registry (NBIR), which will launch broadly this year, and the PROFILE Registry, which tracks cases of anaplastic large cell lymphoma (ALCL) associated with breast implants. Two committees within The PSF are critical to this data-driven approach to breast implants: The BIA-ALCL Subcommittee, chaired by Mark Clemens, MD, and the PROFILE Steering Committee, chaired by Colleen McCarthy, MD. Both members provide a brief update on the progress of their very important efforts below.

Respectfully,

Arun Gosain, MD


BIA-ALCL Subcommittee Update

BIA-ALCL is a shared concern between patients, physicians, implant manufacturers and government authorities. In partnership with these stakeholders, ASPS ensures BIA-ALCL remains a priority and focuses efforts on this uncommon malignancy threefold; by educating physicians, informing patients and prioritizing research.

Disease updates are incorporated at nearly all national meetings and by a PSEN video series. Working together with ASPS leadership, the committee has been petitioning insurance companies and implant manufacturers for coverage of BIA-ALCL diagnosis and treatment to ensure no patient is denied cancer care. The committee has been instrumental in crafting biannual FAQs to regularly update the membership on guidelines set forth by the FDA, World Health Organization and the National Comprehensive Cancer Network. These updates represent a collaborative effort with ASAPS, and are an example of the major societies in plastic surgery finding consensus and speaking with one unified voice.

Newly designed physician-facing and patient-facing websites are now live. An educational tri-fold pamphlet, example informed consent and patient notification letters, as well as a compendium of relevant articles are just some of the continuously updated resources now available from ASPS. The subcommittee also oversees the BIA-ALCL Global Network, a task force that meets quarterly to exchange information with 26 participating countries (a number that's growing). Finally, the subcommittee collaborated with researchers from Penn State to survey ASPS membership on the current understanding of BIA-ALCL to help identify educational gaps and barriers to reporting. This proactive approach to BIA-ALCL ensures that ASPS members will stay on top of the challenges of this emerging disease.

-Mark Clemens, MD, Chair


PROFILE Steering Committee Update

BIA-ALCL is one of the most clinically relevant areas of focus for plastic surgery. The PROFILE registry, established in 2012, is a surgeon's responsibility to prospectively track the outcomes of this malignancy. We work closely with the FDA to monitor BIA-ALCL, and have already generated clinically useful data to ensure patient safety. The goals of The PSF and FDA are closely aligned with this high-impact registry through monthly meetings, and results from preliminary data analysis have already been shared at national conferences with manuscript updates to closely follow. Over the past year, the committee has worked to increase national capture of cases for PROFILE and implemented a process to review all PROFILE cases to ensure the integrity of the data. The committee is also working to update the PROFILE tissue collection process, as collection of tissue specimens through a centralized national tissue repository are critical to understanding disease pathogenesis. If you encounter a case, please report to PROFILE, and consider sharing specimens for our ongoing research efforts.

-Colleen McCarthy, MD, Chair