Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Updated Report 2012-2020.

BACKGROUND: In January of 2011, the U.S. Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large-cell lymphoma (ALCL). In 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large-Cell Lymphoma Etiology and Epidemiology (PROFILE) patient registry. METHOD: This is an updated report of registry findings. From August of 2012 to August of 2020, 330 unique, suspected, or confirmed cases of breast implant-associated (BIA) ALCL in the United States were reported to PROFILE, including 144 cases newly reported since the 2018 publication. RESULTS: Median time from implantation of any device to BIA-ALCL diagnosis was 11 years (range, 2 to 44 years). At the time of presentation, 91% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was seroma, seen in 79% of patients. All patients had a history of a textured device; there were no patients who had a confirmed smooth-only device history. Approximately 11% of the reported cases were diagnosed with stage 1A disease (tumor-node-metastasis staging classification). CONCLUSIONS: The PROFILE registry continues to be an essential tool in unifying the collection of granular-level data pertaining to BIA-ALCL. These data emphasize the critical importance of detailed tracking of BIA-ALCL cases, and will contribute significantly to our understanding of the relationship between breast implants and ALCL.

The General Registry of Autologous Fat Transfer: Concept, Design, and Analysis of Fat Grafting Complications.

BACKGROUND: The American Society of Plastic Surgeons and The Plastic Surgery Foundation launched GRAFT, the General Registry of Autologous Fat Transfer, in October of 2015. This web-accessible registry addresses the need for prospective and systematic data collection, to determine the rates of unfavorable outcomes (complications) of fat grafting. Understanding and avoiding the factors that lead to complications can help establish safe practices for fat grafting. METHODS: Data collected between October of 2015 and November of 2019 were summarized for age, sex, indications, processing techniques, and fat graft volume. Rates of complications for fat grafting to various anatomical areas were calculated. RESULTS: The General Registry of Autologous Fat Transfer collected data on 7052 fat grafting procedures from 247 plastic surgery practices. The mean age of the patients in the registry was 51 years (range, 1 to 89 years), 94 percent were female, and 64 percent of the procedures were for aesthetic indications. Whereas the overall complication rate was low (5.01 percent), the complication rates for fat grafting to the breast and buttocks (7.29 percent and 4.19 percent, respectively) were higher than those for face and other areas (1.94 percent and 2.86 percent, respectively). Oil cysts (2.68 percent) and infections (1.64 percent) were the most common complications of breast fat grafting, whereas seroma (1.84 percent) and palpable mass (1.33 percent) were most common for fat grafting to buttocks. Palpable mass (0.54 percent) and infections (0.54 percent) were most common for fat grafting to face. CONCLUSIONS: The General Registry of Autologous Fat Transfer provides a valuable tool for prospective tracking of fat grafting techniques and complications. Data collected in the registry show low rates of complications for all recipient areas treated with fat grafting. CLINICAL RELEVANCE STATEMENT: GRAFT collects real world data on complications of autologous fat grafting procedures. The data collected over 4 years shows low rates of complications for fat grafting. The benchmarking tools available in GRAFT can help enhance techniques and safety of fat grafting. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Understanding Breast Implant-Associated Illness: A Delphi Survey Defining Most Frequently Associated Symptoms.

BACKGROUND: Increased understanding of the constellation of symptoms referred to as breast implant illness is necessary to better address patient concerns, provide evidence-based care, and inform prospective patients about potential risks. The aim of this study was to reach consensus on the symptoms most frequently associated with breast implant illness, which will subsequently inform the development of a symptom severity scale. METHODS: A literature search of peer-reviewed and gray literature was performed to identify a comprehensive list of symptoms associated with breast implant illness. This was followed by an online, three-round, modified Delphi survey where the list of symptoms was reviewed by an international panel to determine the top 20, 10, and five symptoms associated with breast implant illness. A virtual meeting of panelists was held to reach consensus on the symptoms to be included in a symptom severity scale. RESULTS: A total of 44 symptoms were identified through the literature search. The modified Delphi survey panel consisted of patient research partners [n = 9 (34.6 percent)], plastic surgeons [n = 10 (38.5 percent)], researchers [n = 6 (23.1 percent)], and a member of the U.S. Food and Drug Administration [n = 1 (3.8 percent)]. The response rates of round 1, 2, and 3 were 85, 96, and 100 percent, respectively. Consensus was reached on the top 19 and top six symptoms to be included in long and short forms of a symptom severity scale. CONCLUSIONS: There was a high level of agreement on the symptoms to be included in a symptom severity scale. The next steps include conducting in-depth qualitative interviews with women with these symptoms and breast implants to understand the experience and impact of these symptoms and develop the preliminary scale.

Hidradenitis Suppurativa: A Comparison of Institutional Experience and the Tracking Operations and Outcomes for Plastic Surgeons Registry.

BACKGROUND: Hidradenitis suppurativa is a chronic inflammatory dermatologic condition occurring most commonly in areas with large numbers of apocrine sweat glands. Surgical excision and wound reconstruction are indicated for severe or refractory disease. This study aims to explore institutional reconstructive outcomes following hidradenitis suppurativa excision and compare these to the nationally recognized Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database to determine best-practice guidelines. METHODS: A retrospective chart review of all patients with surgically treated hidradenitis suppurativa from January of 2004 to January of 2016 was performed. Data on patient characteristics, reconstructive methods, and outcomes were collected. Outcomes for each reconstructive method were analyzed and associations between reconstruction and complications were determined. These results were compared to TOPS data. RESULTS: A total of 382 operative sites for 101 individual patients were reviewed. Overall complication rates were 80, 68.3, and 59.6 percent for simple, intermediate, and complex closure, respectively; 68.3 percent for adjacent soft-tissue rearrangement; and 100 percent for split-thickness skin grafts and perforator flaps. Statistical significance was identified between superficial wound dehiscence and adjacent tissue rearrangement compared to intermediate and complex closure (p = 0.0132). TOPS data revealed similar wound breakdown rates for primary closure methods but much lower rates with negative-pressure wound therapy, split-thickness skin grafts, and muscle flaps. CONCLUSIONS: Primary closure techniques for hidradenitis suppurativa wound reconstruction possess high complication rates, whereas improved outcomes are observed with negative-pressure wound therapy, split-thickness skin grafts, and muscle flaps. The correlation in outcomes between our experience and that reported in the TOPS database provides a level of validation to this national database.

State of the Plastic Surgery Workforce and the Impact of Graduate Medical Education Reform on Training of Plastic Surgeons.

BACKGROUND: Although recent estimates predict a large impending shortage of plastic surgeons, graduate medical education funding through the Centers for Medicare and Medicaid Services remains capped by the 1997 Balanced Budget Act. The authors' aim was to develop a plan to stimulate legislative action. METHODS: The authors reviewed responses of the American Society of Plastic Surgeons, American College of Surgeons, and American Medical Association from January of 2015 to a House Energy & Commerce Committee request for input on graduate medical education funding. In addition, all program directors in plastic surgery were surveyed through the American Council of Academic Plastic Surgeons to determine their graduate medical education funding sources. RESULTS: All three organizations agree that current graduate medical education funding is inadequate to meet workforce needs, and this has a significant impact on specialty selection and distribution for residency training. All agreed that funding should be tied to the resident rather than to the institution, but disagreed on whether funds should be divided between direct (allocated to residency training) and indirect (allocated to patient care) pools, as is currently practiced. Program directors' survey responses indicated that only 38 percent of graduate medical education funds comes from the Centers for Medicare and Medicaid Services. CONCLUSIONS: Organized medicine is at risk of losing critically needed graduate medical education funding. Specific legislation to support additional graduate medical education positions and funding (House Resolutions 1180 and 4282) has been proposed but has not been universally endorsed, in part because of a lack of collaboration in organized medicine. Collaboration among major organizations can reinvigorate these measures and implement real change in funding.

Regulatory Advocacy Update: American Society of Plastic Surgeons Comments in Response to the U.S. Food and Drug Administration Draft Guidance Documents on Human Cell and Tissue Products.

The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.

Impact of Postoperative Antibiotic Prophylaxis Duration on Surgical Site Infections in Autologous Breast Reconstruction.

BACKGROUND: Although some surgeons prescribe prolonged postoperative antibiotics after autologous breast reconstruction, evidence is lacking to support this practice. We used the Tracking Operations and Outcomes for Plastic Surgeons database to evaluate the association between postoperative antibiotic duration and the rate of surgical site infection (SSI) in autologous breast reconstruction. STUDY DESIGN: The intervention of interest for this study was postoperative duration of antibiotic prophylaxis: either discontinued 24 hours after surgery or continued beyond 24 hours. The primary outcome variable of interest for this study was the presence of SSI within 30 days of autologous breast reconstruction. Cohort characteristics and 30-day outcomes were compared using χ² and Fischer exact tests for categorical variables and Student t tests for continuous variables. Multivariate logistic regression was used to control for confounders. RESULTS: A total of 1036 patients met inclusion criteria for our study. Six hundred fifty-nine patients (63.6%) received antibiotics for 24 hours postoperatively, and 377 patients (36.4%) received antibiotics for greater than 24 hours. The rate of SSI did not differ significantly between patients given antibiotics for only 24 hours and those continued on antibiotics beyond the 24-hour postoperative time period (5.01% vs 2.92%, P = 0.109). Furthermore, antibiotic duration was not predictive of SSI in multivariate regression modeling. CONCLUSIONS: We did not find a statistically significant difference in the rate of SSI in patients who received 24 hours of postoperative antibiotics compared to those that received antibiotics for greater than 24 hours. These findings held for both purely autologous reconstruction as well as latissimus dorsi reconstruction in conjunction with an implant. Thus, our study does not support continuation of postoperative antibiotics beyond 24 hours after autologous breast reconstruction.

Is There a Safe Lipoaspirate Volume? A Risk Assessment Model of Liposuction Volume as a Function of Body Mass Index.

BACKGROUND: No concrete data exist to support a specific volume at which liposuction becomes unsafe; surgeons rely on their own estimates, professional organization advisories, or institutional or government-imposed restrictions. This study represents the first attempt to quantify the comprehensive risk associated with varying liposuction volumes and its interaction with body mass index. METHODS: Suction-assisted lipectomies were identified from the Tracking Operations and Outcomes for Plastic Surgeons database. Multivariate regression models incorporating the interaction between liposuction volume and body mass index were used to assess the influence of liposuction volume on complications and to develop a tool that returns a single adjusted odds ratio for any combination of body mass index and liposuction volume. Recursive partitioning was used to determine whether exceeding a threshold in liposuction volume per body mass index unit significantly increased complications. RESULTS: Sixty-nine of 4534 patients (1.5 percent) meeting inclusion criteria experienced a postoperative complication. Liposuction volume and body mass index were significant independent risk factors for complications. With progressively higher volumes, increasing body mass index reduced risk (OR, 0.99; 95 percent CI, 0.98 to 0.99; p = 0.007). Liposuction volumes in excess of 100 ml per unit of body mass index were an independent predictor of complications (OR, 4.58; 95 percent CI, 2.60 to 8.05; p < 0.001). CONCLUSIONS: Liposuction by board-certified plastic surgeons is safe, with a low risk of life-threatening complications. Traditional liposuction volume thresholds do not accurately convey individualized risk. The authors' risk assessment model demonstrates that volumes in excess of 100 ml per unit of body mass index confer an increased risk of complications. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Combining abdominal and cosmetic breast surgery does not increase short-term complication rates: a comparison of each individual procedure and pretreatment risk stratification tool.

BACKGROUND: Combined abdominal and breast surgery presents a convenient and relatively cost-effective approach for accomplishing both procedures. OBJECTIVES: This study is the largest to date assessing the safety of combined procedures, and it aims to develop a simple pretreatment risk stratification method for patients who desire a combined procedure. METHODS: All women undergoing abdominoplasty, panniculectomy, augmentation mammaplasty, and/or mastopexy in the TOPS database were identified. Demographics and outcomes for combined procedures were compared to individual procedures using χ(2) and Student's t-tests. Multiple logistic regression provided adjusted odds ratios for the effect of a combined procedure on 30-day complications. Among combined procedures, a logistic regression model determined point values for pretreatment risk factors including diabetes (1 point), age over 53 (1), obesity (2), and 3+ ASA status (3), creating a 7-point pretreatment risk stratification tool. RESULTS: A total of 58,756 cases met inclusion criteria. Complication rates among combined procedures (9.40%) were greater than those of aesthetic breast surgery (2.66%; P < .001) but did not significantly differ from abdominal procedures (9.75%; P = .530). Nearly 77% of combined cases were classified as low-risk (0 points total) with a 9.78% complication rates. Medium-risk patients (1 to 3 points) had a 16.63% complication rate, and high-risk (4 to 7 points) 38.46%. CONCLUSIONS: Combining abdominal and breast procedures is safe in the majority of patients and does not increase 30-day complications rates. The risk stratification tool can continue to ensure favorable outcomes for patients who may desire a combined surgery. LEVEL OF EVIDENCE: 4 Risk.

Individualized Risk of Surgical Complications: An Application of the Breast Reconstruction Risk Assessment Score.

BACKGROUND: Risk discussion is a central tenet of the dialogue between surgeon and patient. Risk calculators have recently offered a new way to integrate evidence-based practice into the discussion of individualized patient risk and expectation management. Focusing on the comprehensive Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database, we endeavored to add plastic surgical outcomes to the previously developed Breast Reconstruction Risk Assessment (BRA) score. METHODS: The TOPS database from 2008 to 2011 was queried for patients undergoing breast reconstruction. Regression models were constructed for the following complications: seroma, dehiscence, surgical site infection (SSI), explantation, flap failure, reoperation, and overall complications. RESULTS: Of 11,992 cases, 4439 met inclusion criteria. Overall complication rate was 15.9%, with rates of 3.4% for seroma, 4.0% for SSI, 6.1% for dehiscence, 3.7% for explantation, 7.0% for flap loss, and 6.4% for reoperation. Individualized risk models were developed with acceptable goodness of fit, accuracy, and internal validity. Distribution of overall complication risk was broad and asymmetric, meaning that the average risk was often a poor estimate of the risk for any given patient. These models were added to the previously developed open-access version of the risk calculator, available at http://www.BRAscore.org. CONCLUSIONS: Population-based measures of risk may not accurately reflect risk for many individual patients. In this era of increasing emphasis on evidence-based medicine, we have developed a breast reconstruction risk assessment calculator from the robust TOPS database. The BRA Score tool can aid in individualizing-and quantifying-risk to better inform surgical decision making and better manage patient expectations.

Factors impacting successfully competing for research funding: an analysis of applications submitted to the Plastic Surgery Foundation.

BACKGROUND: Federal research funding is decreasing, forcing specialty organizations to have an increasingly important position in developing and fostering research. As the research and innovation arm of the American Society of Plastic Surgeons, The Plastic Surgery Foundation has a key role in supporting promising plastic surgery research. Understanding the grant review process and factors that contribute to funding well-written grant funding applications is essential for aspiring academic surgeons. METHODS: All research grant applications submitted to The Plastic Surgery Foundation in 2012 and 2013 were evaluated. Each reviewer comment was assessed independently by two study team members and classified into key weakness categories. The chi-square test was used to compare results between funded and unfunded grants. Linear regression identified which critique elements corresponded to changes in scores, and logistic regression identified elements that predicted funding. RESULTS: The authors analyzed 1764 comments from 240 applications. Of these, 55 received funding. Funded grants had significantly fewer reviewer comments in four of five weakness categories. As expected, funded grants received better (lower) scores. Concerns in the categories of plan for execution and other elements/grantsmanship significantly affected score and odds of funding. CONCLUSIONS: Ensuring that a grant addresses all required elements is important for receiving a low reviewer score. Our study demonstrates that plan for execution and grantsmanship influence reviewer scoring more than others. Investigators must clearly address items associated with conducting their experiments and performing the analysis. Investigators must also give equal attention to elements of overall quality and completeness to optimize chances of funding.

The use of patient registries in breast surgery: a comparison of the tracking operations and outcomes for plastic surgeons and national surgical quality improvement program data sets.

BACKGROUND: The National Surgical Quality Improvement Program (NSQIP) and the Tracking Operations and Outcomes for Plastic Surgeons (TOPS) registries gather outcomes for plastic surgery procedures. The NSQIP collects hospital data using trained nurses, and the TOPS relies on self-reported data. We endeavored to compare the TOPS and NSQIP data sets with respect to cohort characteristics and outcomes to better understand the strengths and weakness of each registry as afforded by their distinct data collection methods. STUDY DESIGN: The 2008 to 2011 TOPS and NSQIP databases were queried for breast reductions and breast reconstructions. Propensity score matching identified similar cohorts from the TOPS and NSQIP databases. Shared 30-day surgical and medical complications rates were compared across matched cohorts. RESULTS: The TOPS captured a significantly greater number of wound dehiscence occurrences (4.77%-5.47% vs 0.69%-1.17%, all P<0.001), as well as more reconstructive failures after prosthetic reconstruction (2.82% vs 0.26%, P<0.001). Medical complications were greater in NSQIP (P<0.05). Other complication rates did not differ across any procedure (all P>0.05). CONCLUSIONS: The TOPS and NSQIP capture significantly different patient populations, with TOPS' self-reported data allowing for the inclusion of private practices. This self-reporting limits TOPS' ability to identify medical complications; surgical complications and readmissions, however, were not underreported. Many surgical complications are captured by TOPS at a higher rate due to its broader definitions, and others are not captured by NSQIP at all. The TOPS and NSQIP provide complementary information with different strengths and weakness that together can guide evidence-based decision making in plastic surgery.

A Multi-institutional Analysis of Insurance Status as a Predictor of Morbidity Following Breast Reconstruction.

BACKGROUND: Although recent literature suggests that patients with Medicaid and Medicare are more likely than those with private insurance to experience complications following a variety of procedures, there has been limited evaluation of insurance-based disparities in reconstructive surgery outcomes. Using a large, multi-institutional database, we sought to evaluate the potential impact of insurance status on complications following breast reconstruction. METHODS: We identified all breast reconstructive cases in the 2008 to 2011 Tracking Operations and Outcomes for Plastic Surgeons clinical registry. Propensity scores were calculated for each case, and insurance cohorts were matched with regard to demographic and clinical characteristics. Outcomes of interest included 15 medical and 13 surgical complications. RESULTS: Propensity-score matching yielded 493 matched patients for evaluation of Medicaid and 670 matched patients for evaluation of Medicare. Overall complication rates did not significantly differ between patients with Medicaid or Medicare and those with private insurance (P = 0.167 and P = 0.861, respectively). Risk-adjusted multivariate regressions corroborated this finding, demonstrating that Medicaid and Medicare insurance status does not independently predict surgical site infection, seroma, hematoma, explantation, or wound dehiscence (all P > 0.05). Medicaid insurance status significantly predicted flap failure (odds ratio = 3.315, P = 0.027). CONCLUSIONS: This study is the first to investigate the differential effects of payer status on outcomes following breast reconstruction. Our results suggest that Medicaid and Medicare insurance status does not independently predict increased overall complication rates following breast reconstruction. This finding underscores the commitment of the plastic surgery community to providing consistent care for patients, irrespective of insurance status.

Demystifying the U.S. Food and Drug Administration: understanding regulatory pathways.

BACKGROUND: The field of plastic surgery has been at the forefront of ideation and innovation. Surgeon scientists today continue to develop novel products that fulfill the needs of the medical community and patients. Part of this process requires the approval from various regulatory agencies and offices, including the U.S. Food and Drug Administration. Unfortunately, medical training does not include regulatory knowledge, and many surgeon scientists find the regulatory pathway and U.S. Food and Drug Administration perplexing, overly complicated, and insurmountable. The authors aim to clearly outline the path of the regulatory process as it pertains to the U.S. Food and Drug Administration and its various jurisdictions that may relate to the plastic surgeon. METHODS: The authors aim to demystify the classification system, 510(k), and Premarket Approval processes for devices; clarify the Investigational New Drug and New Drug Application requirements for drugs; and explain how human cells, tissues, and cellular or tissue-based products are classified and approvals obtained. RESULTS: The structure of the U.S. Food and Drug Administration, its offices, and their roles are delineated, and the complex process of obtaining approval to market devices, drugs, biologics, and combination products is explained in a manner that is broadly useful to innovators whether new or experienced. CONCLUSION: The authors provide information for innovators and inventors developing promising technologies to be more knowledgeable and motivated to embrace the process in a fashion that will potentially save time and errors in U.S. Food and Drug Administration submissions.

Demystifying the U.S. Food and Drug Administration: I. Understanding agency structure and function.

The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologics with other materials. Within the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research is specifically responsible for the evaluation and approval of biological products. This department of the U.S. Food and Drug Administration has a series of mechanisms in place to aid researchers in the process of developing new biologics. This article outlines the study phases involved in developing new biologics and how the Center for Biologics Evaluation and Research and investigators can work together to facilitate this process. It also discusses issues specific to biologics that have been encountered in the past and that investigators should consider when developing and obtaining approval for new biologics. The equivalent center within the U.S. Food and Drug Administration for approving medical devices is the Center for Devices and Radiological Health. The equivalent process of development and approval of medical devices is similarly discussed. Finally, essential contacts for investigators within the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health are provided.

Trends in autologous fat grafting to the breast: a national survey of the american society of plastic surgeons.

BACKGROUND: Autologous fat grafting has been gaining popularity in recent years, although there remains concern regarding the safety and efficacy of the practice for breast surgery. The purpose of this study was to determine national trends for fat grafting to the breast and to establish the frequency and specific techniques of the procedure to provide more supportive data. METHODS: A questionnaire was e-mailed to 2584 members of the American Society of Plastic Surgeons. Variables included prevalence and applications of fat grafting to the breast. Components of the fat graft protocol were also assessed. RESULTS: Four hundred fifty-six of the 2584 questionnaires were completed. Sixty-two percent of all respondents reported currently using fat grafting for reconstructive breast surgery and 28% of all respondents reported currently using the practice for aesthetic breast surgery. The most common reason cited by respondents for using fat grafting to the breast was as an adjunctive therapy to implant or flap surgery. CONCLUSIONS: Fat grafting to the breast is a common procedure most often used in reconstructive operations. The increasing prevalence of fat grafting to the breast indicates a need for collection of clinical data and supports the establishment of a national prospective registry to track outcomes after aesthetic and reconstructive applications.

Medical specialty society-sponsored data registries: opportunities in plastic surgery.

SUMMARY: Clinical data registries are commonly used worldwide and are implemented for a variety of purposes ranging from physician or facility clinic logs for tracking patients, to collecting outcomes data, to measuring quality improvement or safety of medical devices. In the United States, the U.S. Food and Drug Administration has used data collected through registries to facilitate the drug and device regulatory process, for ongoing surveillance during the product life cycle, and for disease appraisals. Furthermore, the Centers for Medicare and Medicaid Services, in certain instances, bases registry participation and submitting data to registries as factors for reimbursement decisions. The purpose of this article is to discuss the use of clinical data registries; the role that medical specialty societies, in particular, the American Society of Plastic Surgeons and The Plastic Surgery Foundation, can have in the development and management of registries; and the opportunities for registry use in plastic surgery. As outcomes data are becoming essential measures of quality health care delivery, participation in registry development and centralized data collection has become a critical task for plastic surgery to engage in to proactively participate in the national quality and performance measurement agenda.