Award Winners and Funded Projects - The Aesthetic Surgery Education and Research Foundation

Award Winners and Funded Projects

Prevalence of Adverse Childhood Experiences and Adult Health in ASAPS Members

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Mark B. Constantian, MD, FACS

Grant Award: ASERF Interim Grant

Amount Awarded: $5,000.00

Project Name: Prevalence of Adverse Childhood Experiences and Adult Health in ASAPS Members

Project Summary: We have recently documented the prevalence of 10 different types of adverse childhood experiences (ACE's) and body shame in 218 plastic surgery patients. ACE's are both common (64% in a general medical population, 80% in our patients), and ACE Score correlates directly with many adult health problems. To our knowledge, no physician group has ever been tested. That is the goal of this study.

Quantitative and Qualitative Analysis of Bacterial Load Contamination in Breast Implant Surfaces and Capsular Tissue

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Rafael Couto, MD and William P. Adams, Jr., MD

Grant Award: ASERF Interim Grant

Amount Awarded: $38,338.00

Project Name: Quantitative and Qualitative Analysis of Bacterial Load Contamination in Breast Implant Surfaces and Capsular Tissue

Project Summary:
Breast augmentation is the most common cosmetic surgery performed in the United States. The role of bacterial contamination on breast implant surfaces has been associated with device-associated infection including the capsular contracture and breast implant-associated anaplastic lymphoma (BIAALCL). Critically, it is not well understood what the relative degree of total bacterial load that exist between an implant and it’s capsular tissue. The purposes of this investigation are: 1) to quantitatively and qualitatively analyze the bacterial contamination between the breast implant and its respective capsular tissue; 2) determine whether the implant or the capsular tissue has the greatest capacity for maintaining a bacterial load of the breast pocket; 3) qualitatively and qualitatively analyze the effectiveness of povidone iodine-triple antibiotic irrigation in decreasing the bacterial load of capsular tissue. We hypothesize that the bacterial contamination on the breast implant ill be significantly higher than in the capsular tissue, and that povidone iodine antibiotic irrigation will significantly decrease the bacterial load in the capsule. Clinically, these data are essential when treating a variety of breast implant cases, particularly common patients currently seen who are asymptomatic and wanting to exchange textured implants or want to have their capsules removed for a variety of reasons.

Power-asisted Liposuction Vibration Exposure and Safety Guidelines

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Rolando Morales, MD

Grant Award: ASERF Interim Grant

Amount Awarded: $4,300

Project Name: Power-asisted Liposuction Vibration Exposure and Safety Guidelines

Project Summary:

Plastic surgeons are increasingly exposed to the hazard of hand-transmitted vibration as liposuction gains popularity, specifically for those using power-assisted liposuction (PAL) devices. With long-term use, this increases the risk of developing a group of insidious neurovascular symptoms termed hand-arm vibration syndrome (HAVS). HAVS manifests in debilitating and irreversible numbness and later painful vasospasm of the fingers (Raynaud’s phenomenon). Therefore, it is important to determine the safety limits and establish standardized guidelines for long-term exposure to PAL-associated vibration because the development of HAVS can be detrimental to a plastic surgeon’s career.

The proposed study will examine vibration emission of a commonly used PAL device under varying conditions of use in order to make relevant recommendations for plastic surgeons to minimize the risk of developing HAVS. This will be examined in the experiments of the following specific aims:

Aim 1: Determine PAL system vibration emission under various controlled conditions compared to manufacturer’s declared values.
Rationale: PAL manufacturers publish only one vibration emission value, however this measured under controlled laboratory conditions and will not be consistent under different conditions of use. These conditions include vibration of the handle without an attached cannula and with attached cannulas of different lengths/diameters.
Hypothesis: Vibration emission value will measure higher with increasing length and diameter of the cannula attached.

Aim 2: Determine PAL system vibration exposure under true conditions of use during surgery.
Rationale: Vibration at the handle will change depending on the resistance applied at the cannula tip. For example, the PAL handle vibrates less intensely when the cannula is in the air compared to when it is being driven through fibrous tissue during surgery.
Hypothesis: Vibration exposure will measure higher during actual surgical use of the PAL system than that estimated from manufacturer specifications.

Aim 3: Create PAL surgical safety guidelines to minimize the risk of vibration induced health hazards for surgeons
Rationale: It is important to inform plastic surgeons about the use of PAL and the risk of HAVS as an occupational hazard. Vibration exposure during actual surgical use of the PAL system will differ from manufacturer calculations, therefore more accurate guidelines for safe surgical use should be calculated from on-the-job surgical data collected from this study.

Hypothesis: PAL surgical safety guidelines from this study will estimate a shorter safe duration of use compared to manufacturer guidelines.

Bacterial Biofilms Associated with Breast Implant Illness

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Mithun Sinha , PhD

Grant Award: ASERF Interim Grant

Amount Awarded: $23,110

Project Name: Bacterial Biofilms Associated with Breast Implant Illness

Project Summary:

More than 330,000 women in US undergo breast implant augmentation surgeries every year. In recent years, a number of patients have self-described a constellation of symptoms that they believe are related to their breast implants. These patients have given this constellation of symptoms they believe to be directly related to their implants the name Breast Implant Illness (BII). The symptoms described are numerous but generally include symptoms typical of fibromyalgia, chronic fatigue and a host of other symptoms often associated with autoimmune illnesses. Generally, the causation of these symptoms are ascribed to the implants. An ever-increasing number of patients are seeking to have their implants removed.
These conditions have been attributed to the type and material of the implant. The FDA has conducted multiple studies and have found silicone implants to be safe. Still, the patient reported symptoms are on the rise. Recently, in March 2019, the FDA held a panel hearing specifically to address the rising concerns for reast implant associated illness. It is to be noted that bacterial biofilms have been reported around breast implants. Bacterial biofilms are resistant to the host immune system due to the presence of extra polymeric substance (EPS). The low level of inflammation by bacterial biofilms have been implicated to cause cancer (gastric cancer by Helicobacter pylori). We propose that occult peri-implant Pseudomonas biofilms present around the capsule secrete an enzyme acting on the adipose tissue to form oxylipins. Since the introduction of silicone breast implants in the nineteen sixties several issues have been raised regarding their safety. Silicone as a biomaterial is inert but time and again studies have been conducted to determine their long term effects. Bacterial biofilms associated with implants have not been well studied in context of implant associated illness. Gram negative Pseudomonas aeruginosa is a commonly identified pathogen associated with breast implant infection(1). The species is also one of the most robust biofilm formers(2). Pseudomonas aeruginosa (PA) interacts with host biomolecules and such interactions are critical toward the formation of biofilm(3). Breast parenchyma is comprised of both glandular and adipose tissue; breast adipose is rich in oleic acids. Oleic acids oxidized derivatives have been recently reported to facilitate the formation of biofilms in vitro(4). Pseudomonas expresses fatty acid di-oxygenase (DOX) enzyme. DOX catalyzes oleic acid to oxylipins, 10-HOME and 7,10-DiHOME(4)

Systemic Symptoms: Biospecimen Analysis Study

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Patricia McGuire, MD & Caroline Glicksman, MD

Grant Award: ASERF Interim Grant

Amount Awarded: $221,925.00

Project Name: Systemic Symptoms: Biospecimen Analysis Study

Project Summary:

Although it is accepted that there is an association between textured breast implants and Anaplastic Large Cell Lymphoma, there is no current definitive epidemiologic evidence to support a direct link between breast implants and any autoimmune disorders at this time. However, there are an increasing number of women who are pursuing an explantation because of what is being referred to as “breast implant illness” ("BII"), a term originating from a social media group used to describe a collection of nonspecific systemic symptoms thought to be caused by breast implants. As of 2018, there were over 80,000 women on the two main Facebook sites, Breast Implant Illness and Healing and Breast Implant Victim Advocacy. Reported symptoms include but are not limited to fatigue, chest pain, hair loss, headaches, arthralgias, allergies, easy bruising, heartburn, decreased sex drive, gastrointestinal upset, heart palpitations, hot flashes, infections, night sweats, heat/cold intolerance, migraines, anxiety, swelling, tinnitus, weight gain, chronic muscle/joint pain, rash, body odor, brain fog, sleep disturbance, depression, cognitive dysfunction, hormone imbalances, dry eyes and skin changes. In the majority of patients, objective markers, such as serologic abnormalities are absent. There is no established pathophysiologic explanation or diagnostic test for "breast implant illness"; it is not a recognized medical disease at this time.

Recently, several new studies have been designed and funded to better understand the possible role of psychological and social behavioral factors that may be concomitant in women who are reporting symptoms of "BII." This study, in contrast, has been designed to scientifically analyze biospecimens from three groups: Group 1 - women with breast implants who are presenting with "BII" and pursuing explantation; Group 2 - women with breast implants who are not presenting with "BII" and are undergoing explantation for other reasons (weight gain, or elective explantation with mastopexy); and Group 3: an age matched control group of women undergoing an elective mastopexy without previous exposure to breast implants.

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