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.

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.

For the complete story, click here.  

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 »

Keith M. Blechman, MD, Plastic and Reconstructive Surgery. Reposted with permission from The Doctors Company.  Keith Blechman, MD is a member of the NYSSPS Executive Council and serves as the Treasurer.

Just before New York temporarily banned elective procedures, I looked across the operating table and said, “Leave the sutures long, because the patient is probably going to have to take these sutures out.”

I knew early on that COVID-19 was coming. Through personal connections, I was hearing about events in China, and as the outbreak hit Seattle, I started to prepare. After some rocky early days, leaping the hurdles set by the pandemic has created positive outcomes for my practice, as I have made changes to become more efficient through integrated telemedicine.

So far, my key takeaways for creating a lean, adaptable practice have been:

• Be prepared. I’ve experienced first-hand how practices with remote-work systems already in place have been better off.
• Find efficiencies: Making changes now in light of the pandemic can save your practice time and resources later.
• Choose vendors wisely: This crisis has shown which companies can be counted on to help, and those that fall short. Is it time to reconsider your business partnerships?
• Embrace change: It’s happening (whether you like it or not).

Read the full story

Recently, New York Governor Cuomo had an op-ed in the New York Times that touted the results of labs operating in New York State whereby 85% of the lab tests took a median of 2 days to complete.

However, anecdotes from physicians are identifying instances where it is taking far longer. 

As MSSNY continues to dialogue with the New York State Department of Health and Governor’s office regarding addressing testing delays, we invited you to take just a few minutes to complete this survey

The American Society of Plastic Surgeons and the New York State Society recognizes the challenges faced by our member physicians as well as trainees and support staff in the daily care of patients.

Enclosed are available resources to help you with coping with the challenges.  The Society plans to promote Wellness on the first Wednesday of each month to members. 

New York Specific Resource
1. NYSDOH - Managing Stress and Anxiety 
2. NYSDOH - Supporting Well-being in COVID and Beyond - Webinar 
3. MSSNY - Peer to Peer Program

Coping with COVID-19

1. Enhance Your Practice Podcast: Season 3 - Work/Life Balance
2. Hackman Academy: Homeschool Classes and Workshops
3. How to Prevent Loneliness in a Time of Social Distancing
4. Guided Meditation to De-Stress During the COVID-19 Pandemic

Self-Assessments

1. Physician Wellness Inventory
2. Maslach Burnout Inventory
3. Oldenburg Burnout Inventory
4. Physician Work-Life Study's Single Item
5. The Copenhagen Burnout Inventory
6. Stanford Professional Fulfillment Index
7. Patient Health Questionnaire-9 (PHQ-9)
8. Depression Survey Article in Academic Psychiatry

Mobile Apps

1. Headspace
2. Meditation Studio
3. 10% Happier
4. #Mindful

Robert Morton, CPHRM, CPPS, Assistant Vice President, Department of Patient Safety and Risk Management

True informed consent is a process of managing a patient’s expectations; it is not just a signature on a document. Achieving an accurate diagnosis requires the patient to provide accurate information to the physician. The physician must then provide sufficient information to the patient so that he or she can make a reasonable and informed decision regarding a comprehensive plan for medical or surgical treatment. This physician responsibility cannot be delegated.

Informed consent cannot eliminate malpractice claims, but an established rapport between the patient and the physician based on robust exchanges of information can prevent patient disappointment from ripening into a claim.

Avoid medical jargon. Define and explain medical words and concepts using simple pictures and analogies.

Identify any uncertainty and risk involved with a specific treatment plan, including the probability factors, if possible. Discuss reasonable assumptions the patient may make about the treatment plan.

Encourage questions. Questions provide a better understanding of the patient’s comprehension of the information and facilitate the dialogue between the patient and the physician.

Documentation is another key component of the informed consent process that cannot be entirely delegated to a nurse or another member of the healthcare team. If the doctor-patient discussion proceeds successfully and the patient requests treatment, the doctor is required in some jurisdictions to write a note in the patient’s record.

The consent form must be signed and dated by the patient

Consent forms should also include statements to be signed by the patient and the physician. The patient attests that he or she understands the information in the treatment agreement. The physician attests that he or she has answered all questions fully and believes that the patient/legal representative fully understands the information. These statements help defend against any claim that the patient did not understand the information.

The informed consent process for same-day surgery patients may occur in the physician’s office before scheduling the procedure. That will allow the patient time to think about the information, ask questions, and make an informed decision.

Hospitalized patients must be informed as far in advance of the procedure as practicable. If the patient is incompetent or otherwise cannot consent, the physician is legally bound to obtain informed consent from the incompetent patient’s authorized representative, except in an emergency.

Every physician should develop his or her own style and system for the informed consent process, making it easier to avoid omissions.

Do not speed through the process. Give the patient and the family time to absorb and comprehend the information.

Assess the patient’s level of understanding just before documenting the process. This will increase the likelihood that you will be able to manage the patient’s expectations effectively.

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

On June 9, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) released "Preparing for the Next Pandemic," a white paper with recommendations to address future pandemics based on lessons learned from the current crisis and historical pandemic planning under previous administrations.

Upon its release, Chairman Alexander encouraged public feedback on the paper, which explores (1) tests, treatments, and vaccines; (2) disease surveillance; (3) stockpiles, distribution, and surges; (4) public health capabilities; and (5) federal agency coordination. In its response, ASPS had two major objectives. The first was to stress those areas most central to continued operation of plastic surgery practices during an outbreak: the availability of personal protective equipment (PPE) and testing. While these are both well-known needs, ASPS took a novel approach in discussing domestic PPE production capacity based on what it has learned in talking with members of Congress and the White House over the last several months. Specifically, ASPS discussed how the United States has a profound deficit in our ability to make sewn goods, like masks, and that we need a flexible manufacturing base that allows us to redeploy domestic production capacity from a primary use in normal times (e.g., golf cart windshields) to a secondary, PPE-focused use during disease outbreaks (e.g., face shields).

The second objective of the ASPS recommendations was to introduce a new concept to help ease the burden on stressed and overwhelmed hospitals during infectious disease surges. The concept, which is under exploration in the ASPS Legislative Advocacy Committee, would create and perpetuate programs that make it easier for hospitals and health systems to temporarily contract with private specialty practices to take specific types of severe acute trauma cases when a hospital has exhausted its ICU capacity. ASPS received reports from members in various hard-hit areas who tried to work with local hospitals to make the plastic surgeons' accredited private practice ASCs available to take emergency cases, and the common barrier they faced was a lack of one or more facility accreditation types that would allow them to see specific types of patients under their states' laws.

States have varying requirements for their surgical facilities, with some requiring a state-based license, some requiring Medicare licensing, others requiring certification from one of the major private accreditation bodies, and yet others requiring a combination of certifications. ASPS's recommendation is for a federal program that allows, in extraordinary times, for any legitimate accreditation to satisfy reimbursement requirements for all patient-types. The hope is that some plastic surgeons will be able to keep their facilities and surgical skill in use, even during lockdowns, and the spread of the virus can be mitigated by keeping trauma victims out of disease-saturated facilities.

Read the complete ASPS letter. 

Restarting elective procedures or surgeries during the COVID-19 pandemic will require additional assessments to optimize your patients’ health for the best possible outcome. In today’s crisis, doctors must follow the standard of care when known, and customize and innovate when it is not. Physicians must assess not only the patients’ medical needs for surgery but also their potential for becoming infected with the COVID-19 virus during the peri-operative period.

Review this program to assemble resources to prepare for elective surgery, formulate a consent discussion including COVID-19 risk mitigation steps, and thoroughly document discussions.

The recorded presentation can be accessed here 

Strategic planning to reopen your medical/surgical office in the COVID-19 era is needed to provide safe patient care and mitigate the risk of virus spread. Many federal, state, local and professional society guidelines are available and recommended to be reviewed as practices prepare to reopen to provide healthcare to their patients.

This presentation, provided by The Doctors Company and Garfunkel Wild, P.C., will review four areas of administrative considerations, environment of care, patient management and elective surgical considerations to prepare your practice and staff to meet the changing standard of care for your patients.

The recorded presentation can be accessed here. 

While most resources are directed at screening for COVID-19 and treating affected patients, there is another important aspect of the pandemic: the impact on your patients’ mental health. Fear and uncertainty are driving the dramatic increase in stress, anxiety, and depression. While your patient’s immediate physical well-being is the primary concern, you also must consider the potential legal liability that can come from failing to adequately screen patients for suicide risk and taking the proper steps when needed.

> Read complete article

Under the Paycheck Protection Program (PPP) created by the CARES Act, loans may be forgiven if borrowers use the proceeds to maintain their payrolls and pay other specified expenses.

The Treasury Department and Small Business Administration recently released the application form and instructions for loan forgiveness. The forgiveness forms, instructions, and worksheets can be downloaded here.

PPP borrowers must apply for loan forgiveness with the lender that processed the loan.