Free CME Course on ALCL now available on PSEN

PSEN ALCL CourseThis month, PSEN published a new free CME course by Mark Clemens, MD, covering The Essentials of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a distinct clinical entity that can present in patients receiving either reconstructive or cosmetic breast implants. This is a CME course meant to provide an overview of recent peer-reviewed manuscripts and the essential principles of the disease while trying not to provide a single practitioner viewpoint. The three-part lecture includes government authority guidelines, a review of diagnosis and etiology theories, and treatment outcomes. Pathological diagnosis, staging, and surgical treatment is detailed. Pertinent aspects of informed consent and society recommendations for reporting of confirmed cases are included.

Dr. Clemens is on the Plastic Surgery faculty of MD Anderson Cancer Center, University of Texas in Houston and has lectured internationally and written more than 50 peer-reviewed articles and 30 book chapters.  He leads a multidisciplinary research team and tissue repository focused on the study of breast implant-associated anaplastic large-cell lymphoma (BI-ALCL).  Dr. Clemens serves as an American Society of Plastic Surgeons (ASPS) society liaison to the US Food and Drug Administration, and chairs a subcommittee for ASPS overseeing national research and education efforts for BI-ALCL.

PSEN Co-Editor Raman Mahabir, MD, notes “This is such an important issue for all plastic surgeons.  There is new information all the time and Mark has really put it all together in one cohesive, comprehensive package.”

The Learning Objectives for the course state that upon completion, surgeons should be able to:

  1. Identify diagnostic tools for the identification of suspected breast implant-associated ALCL.
  2. Explain disease course and oncologic progression of breast implant ALCL.
  3. Describe current first line and second line treatment modalities and reported outcomes.
  4. Describe current FDA recommendations regarding breast-implant associated ALCL.

Patricia McGuire, MD, an ASPS member practicing in St. Louis, took the course upon release and noted, “I just took the PSEN ALCL course that you did. It was fantastic. Very clearly presented and extremely informative. All plastic surgeons should be required to take it.”

To review the ALCL course, visit the Online Courses area of PSEN.

The United States is Facing an Opioid Epidemic

A Message From…
Raman Mahabir, MDRMahabir
PSEN Co-Editor

The Centers for Disease Control and Prevention data shows that the drug overdose death rate from opioids increased by 200% between the years 2000 and 2014.

I started medical school in 2000, just as pain was becoming the fifth vital sign and pain management became a focus of care.  Sixteen years later, reimbursement is now directly tied to pain management through HCAHPS questions and CMS rules.  The question “during your hospital stay, how often was your pain well controlled?” and answers “never, sometimes, usually or always” seem straight forward.  However, CMS only counts this as binary answer, always or not, and you only get credit for always.  This can clearly lead physicians feeling an increased pressure to treat pain and prescribe opioids.  Even for those Plastic Surgeons in private practice, this can be an issue with patient satisfaction surveys and online reviews.

There may not be any easy answers, but it does not mean we shouldn’t start to look for solutions.

This Month’s Surgery Spotlight Now Available on PSEN

In our June Surgery Spotlight, Tae Chong, MD, performs an abdominal-based unilateral breast reconstruction on a patient with recurrent breast cancer. Dr. Chong describes the importance of preoperative perforator identification using Doppler imaging and outlines the key strategies for surgical dissection and selection of the best perforator to sustain the flap. An additional venous anastomosis was performed to improve venous outflow for the flap.

Past Surgery Spotlight programs remain freely available to view on PSEN. Hard copies of these programs can also be purchased from the PSEN DVD Library
Filmed and produced by the Plastic Surgery Education Network (PSEN), Surgery Spotlights feature peer-reviewed, high-definition surgical video. It offers an excellent opportunity to study each step and technique as performed by the top names in the specialty.

A Possible Ban on Powdered Gloves by the FDA

A Message From…
Raman Mahabir, MDRMahabir
PSEN Co-Editor

On March 21st, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States.  The ban would apply to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.  The FDA believes that the gloves pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.

The proposed rule is available online at www.regulations.gov for public comment for 90 days.

Please see the FDA announcement letter for further details and additional resources.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491466

FDA Warning about the Magnetic Port in Tissue Expanders Potentially Interfering with ICD/Pacemaker Devices

 

RMahabir

A Message From…
Raman Mahabir, MD
PSEN Co-Editor

On March 8, 2016, the FDA wrote a letter to health care providers warning them about potential interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICD’s) or pacemakers.  While they recognized there is a very small population at risk, they were aware of adverse events.  They made the following recommendations:

  • Avoid, whenever possible, implanting a magnetic-port breast tissue expander in a patient with a pacemaker or an ICD.
  • If a patient has an ICD or pacemaker, a non-magnetic reconstructive option should be used.
  • When a patient with an implanted magnetic breast tissue expander requires the placement of an ICD or pacemaker, careful consideration should be given to choice of cardiac device, location and timing of implantation, the possible need for more frequent cardiac device checks and whether a different breast tissue expander might be used.
  • Warn patients who have a magnetic-port breast tissue expander and an ICD or pacemaker of the possibility of magnetic interference. Tell patients who have an ICD that emits an electronic tone when the device experiences interference to seek care if they hear the tone.
  • Report any adverse events that come to your attention. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.  Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Please see this FDA letter for further details and additional resources.  http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm489327.htm