Applying Principles of Evolutionary Biology to Plastic Surgery at an Organizational Level Predicts an Extinction Event.

As an organized profession, plastic surgery struggles delivering a clear message regarding scope of practice to patients given the diversity of procedures performed. Whereas granting licensure to practice medicine resides with governmental bodies, certification rests with organizations. However, certification is not required to practice plastic surgery. Since plastic surgery operationalizes techniques rather than working within a defined body organ, competition for patients is intense. Mapping territorial interactions between healthcare providers while parsing taxonomy elucidates individual, community, organizational, and governmental levels, creating various selection pressures. Applying evolutionary biology as a framework predicts the termination of plastic surgery over time as a unique specialty. An entirely new domain, Restorative Healthcare, is proposed which circumvents an extinction outcome.

Downstream Impact for Plastic Surgeons in the United States from the "No Surprises Act".

The No Surprises Act, signed into the US federal law in 2020, establishes a floor for reimbursement determined by insurance payors for out-of-network charges rendered by providers in emergency services. Physicians are not permitted to balance bill patients for the difference. An arbitration process is outlined for mediation between provider and payor if needed. Methods: Policy analysis demonstrates many plastic surgeons utilize a revenue stream including both fee-for-service cosmetic work and insurance-covered reconstructive intervention. For Maintenance of Certification from the American Board of Plastic Surgery and/or membership to the American Society of Plastic Surgeons, plastic surgeons must operate only in accredited facilities, which in turn require that similar privileges are held in a hospital. Results: Given rapidly developing economic pressures, hospitals no longer remain neutral sites for surgical privileging as they seek strategies to mitigate financial loss by directly competing for patients. A downstream consequence of the requirement for hospital privileging is that plastic surgeons are forced to manage increasing on-call responsibilities despite shrinking reimbursement. Plastic surgeons whose board certification was the first to be time-limited are now reaching the stage of practice where they may transition exclusively to out-patient services. Conclusions: Plastic surgeons in independent solo or small group practices are rendered vulnerable since they may not be able to find coverage of in-patient responsibilities at lower reimbursement rates. Rather than allowing loss of board certification in this population, rational alternatives on an organizational level are proposed for keeping the process equitable as plastic surgeons progress along the practice pathway.

Results from the MemoryGel Post-approval Study.

The approval of Mentor MemoryGel Breast Implants in November 2006 was conditional on conducting a 10-year study designed to collect long-term experience in US women with MemoryGel Breast Implants, known as the MemoryGel Post-Approval Study. METHODS: This prospective, observational 10-year follow-up study used a current cohort design that began in 2007, which included both MemoryGel Breast Implant participants and concurrent saline controls to assess rheumatologic and neurologic signs and symptoms. The protocol was amended in 2015, which limited the scope of further data collection for the study to only secondary procedure/re-operation data for MemoryGel participants. RESULTS: Primary augmentation (n = 6743), revision augmentation (n = 2071), primary reconstruction (n = 1763), and revision reconstruction (n = 557) participants were enrolled in the Re-operation Phase Safety Set. Kaplan-Meier-estimated 10-year cumulative incidence of re-operation and explantation on a participant-level were 10.5% and 4.2% (primary augmentation), 14.1% and 7.7% (revision augmentation), 20.8% and 12.8% (primary reconstruction), and 25.0% and 16.6% (revision reconstruction). CONCLUSIONS: The Re-operation Phase of the post-approval study addressed the Kaplan-Meier implant removal and re-operation rates over time, and provided the reasons for re-operation over time. Overall, no significant new hazards, increased risk, or unexpected adverse events were identified in the MemoryGel Post-Approval Study Re-operation Phase Safety Set.

Safety of CPX4 Breast Tissue Expanders in Primary Reconstruction Patients.

In the United States, 2-stage expander-to-implant-based breast reconstruction accounts for more than half of all breast reconstruction procedures. Tissue expansion technology has undergone significant advancements in the past few decades. Previous reports suggest that the most common perioperative complications associated with breast tissue expanders are infection and skin flap necrosis. However, little clinical data are available for CPX4 Breast Tissue Expanders. The aim of the study was to measure real-world outcomes related to safety and effectiveness of the tissue expansion process, in patients who underwent primary breast reconstruction following the use of CPX4 Breast Tissue Expanders. METHODS: This was a single-arm retrospective cohort design looking at patients who underwent 2-stage, expander-to-implant-based primary breast reconstruction at a single site between April 2013 and December 2016 and who had a minimum of 2 years follow-up. Descriptive statistics were used to summarize baseline characteristics and safety outcomes. RESULTS: A total of 123 patients were followed for an average of 3.73 ± 0.94 years. At least 1 complication during the time of tissue expansion, before the permanent implant, was reported in 39/123 (31.7%) patients [51/220 implants (23.2%)]. The most frequently reported complications were delayed wound healing (13.8%) and cellulitis/infection (9.7%). CONCLUSION: Analyses of real-world data from a single site provide further support for the safety and effectiveness of the CPX4 Breast Tissue Expander for women undergoing 2-stage expander-to-implant primary breast reconstruction.

Safety and Effectiveness of Silicone Gel-Filled Breast Implants in Primary Augmentation Patients.

BACKGROUND: Results from the MemoryGel Breast Implants Core Clinical Study suggest these devices are safe and effective at 10 years after implantation. Although clinical trials are essential for measuring the safety and effectiveness of a device, real-world evidence can supplement clinical trials by providing information on outcomes observed in diverse clinical settings for a more heterogeneous population, without fixed treatment patterns, and without continuous patient monitoring, such that follow-up is more representative of normal clinical practice. OBJECTIVES: The aim of this study was to measure real-world outcomes, including safety and effectiveness, in patients who underwent primary breast augmentation with smooth MemoryGel implants. METHODS: This was a case series looking at patients, age 22 years and older, who underwent primary breast augmentation at a single site between December 2006 and December 2016 and who had a minimum of 2 years of follow-up. Descriptive statistics were used to summarize baseline characteristics and outcomes. Kaplan-Meier models were used to estimate safety outcomes for capsular contracture (Baker grade III/IV), infection, and rupture. RESULTS: A total of 50/777 (6.4%) patients reported a complication, with an average time to complication of 3.9 years (range, 19 days-11.8 years) postprocedure. Kaplan-Meier estimates of the 10-year cumulative incidence of capsular contracture (Baker grade III/IV), infection, and rupture were 4.7%, 0.1%, and 1.6%, respectively. CONCLUSIONS: Analyses of a large population from a single site provide further support for the long-term safety and effectiveness of MemoryGel breast implants in a primary augmentation cohort.

MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up.

BACKGROUND: Mentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years. METHODS: This prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure. RESULTS: Primary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent. CONCLUSION: The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Device-Specific Findings of Imprinted-Texture Breast Implants: Characteristics, Risks, and Benefits.

BACKGROUND: The relative risks and benefits of various textured breast implants are the focus of considerable discussion. Studies have suggested different risk-benefit profiles for different implant surface topographies. OBJECTIVES: The study aim was to provide device-specific, quantitative information on Mentor's imprinted Siltex Textured breast implants with respect to textured surface characteristics and ISO 14607 classification, risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and risk-reduction benefits relative to smooth implants. METHODS: Surface metrology was performed. Data for smooth and Siltex implants from the prospective MemoryGel Core Study were evaluated by Kaplan-Meier analysis for the most frequently occurring postoperative complications in augmentation and reconstruction leading to subsequent reoperation. RESULTS: The overall average surface roughness for Siltex MemoryGel and MemoryShape implants was 29.5 and 36.1 µm, respectively. A statistically significantly lower rate of reoperation in patients with Siltex compared with smooth devices over 10 years was observed for both capsular contracture in subglandular primary augmentation patients (4.21% vs 19.84%) and for asymmetry in primary reconstruction patients (3.88% vs 11.1%). CONCLUSIONS: Surface analysis demonstrated that Siltex implants fall within the ISO 14607 category of "microtexture" breast implants. These devices exhibited a rare risk of BIA-ALCL (0.0012%) based on the most extensive data available. Relative to smooth implants, these Siltex devices provided risk-reduction benefits for the most common reason of reoperation in patients who underwent primary augmentation (capsular contracture) or primary reconstruction (asymmetry) in the Core Study. These findings provide valuable risk-benefit information for surgeons and their patients.

Interferon regulatory factor 6 is required for proper wound healing in vivo.

BACKGROUND: Van der Woude syndrome (VWS) is the most common form of syndromic orofacial cleft caused predominantly by mutations in Interferon Regulatory Factor 6 (IRF6). We previously reported that individuals with VWS have increased risk of wound healing complications following cleft repair compared with individuals with nonsyndromic orofacial clefts (nonsyndromic cleft lip and palate-NSCLP). In vitro, absence of IRF6 leads to impaired keratinocyte migration and embryonic wound healing. However, there is currently no data on tissue repair in adult animals and cells with reduced levels of IRF6 like in VWS. RESULTS: Excisional wounds of Irf6+/- and wild-type animals were analyzed 4 and 7 days post-wounding. Although all wounds were reepithelialized after 7 days, the epidermal and wound volume of repaired wounds was larger in Irf6+/- . These data were supported by increased keratinocyte proliferation in the neoformed epidermis and a less mature granulation tissue with increased cytokine levels. This effect was not cell autonomous, as Irf6+/- neonatal keratinocytes in vitro did not exhibit defects in scratch wound closure or proliferation. Keratinocytes from individuals with VWS also migrated similarly to keratinocytes from NSCLP individuals. CONCLUSIONS: These data support a role for IRF6 in wound healing by regulating keratinocyte proliferation, granulation tissue maturation, and cytokine levels.

Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years.

BACKGROUND: Contour Profile Gel/MemoryShape breast implants consist of a textured silicone elastomer shell filled with silicone gel. The objective of this clinical study was to assess the safety and effectiveness of Contour Profile Gel/MemoryShape breast implants in women who were undergoing primary breast augmentation, primary breast reconstruction, or revision surgery (revision-augmentation or revision-reconstruction). METHODS: This was a prospective, open-label, multicenter clinical study involving Contour Profile Gel/MemoryShape breast implants in 955 female subjects, including 572 primary augmentation, 124 revision-augmentation, 190 primary reconstruction, and 69 revision-reconstruction subjects. Safety was assessed based on the incidence, severity, and method of resolution of all complications. Endpoints were examined on both a per-subject and a per-implant basis. RESULTS: For the primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction cohorts, the Kaplan-Meier estimated 10-year cumulative incidence rates for the key complications at the subject level were as follows: Baker grade III/IV capsular contracture, 3.6 (primary augmentation), 15.5 (revision-augmentation), 14.3 (primary reconstruction), and 16.4 (revision-reconstruction) percent; infection, 0.7 (primary augmentation), 1.9 (revision-augmentation), 1.6 (primary reconstruction), and 2.9 (revision-reconstruction) percent; explantation with or without replacement, 9.2 (primary augmentation), 25.9 (revision-augmentation), 34.1 (primary reconstruction), and 49.0 (revision-reconstruction) percent; explantation with replacement with study device, 4.0 (primary augmentation), 10.8 (revision-augmentation), 16.7 (primary reconstruction), and 27.9 (revision-reconstruction) percent; and any reoperation, 22.3 (primary augmentation), 35.0 (revision-augmentation), 52.7 (primary reconstruction), and 59.7 (revision-reconstruction) percent. CONCLUSION: The results of this study demonstrate that Contour Profile Gel/MemoryShape breast implants are safe and effective for primary and revision breast augmentation and reconstruction for women at least 22 years old.

Interferon Regulatory Factor 6 Controls Proliferation of Keratinocytes From Children With Van der Woude Syndrome.

OBJECTIVE: Interferon Regulatory Factor 6 (IRF6) is critical for craniofacial development, epidermal differentiation, and tissue repair. IRF6 mutations cause Van der Woude Syndrome (VWS) and Popliteal Pterygium Syndrome. Individuals with VWS exhibit craniofacial anomalies, including cleft lip and palate and lip pits. Furthermore, they have an increased risk for wound-healing complications following surgical repair when compared with patients with nonsyndromic cleft lip and palate (NSCLP). However, nothing is known about the skin of these patients. The objective was to characterize the skin of patients with VWS. We hypothesize that IRF6 is required for proper skin homeostasis in humans. DESIGN: Discarded tissue from a hip was collected during surgical alveolar bone graft. Samples from children with VWS harboring IRF6 mutations (n = 2) were compared with samples from children with NSCLP (n = 7). Histology was assessed following hematoxylin and eosin staining. The expressions of Proliferating Cell Nuclear Antigen, IRF6, P63, and Keratin 10 were determined by immunofluorescence. Keratinocytes were isolated and their proliferation potential was assessed by colony-forming efficiency assay. RESULTS: Hip skin from children with VWS showed a thicker epidermis when compared with that from children with NSCLP. Proliferating Cell Nuclear Antigen staining revealed an increase in proliferation in syndromic tissues when compared with controls. However, P63 and Keratin 10 expression were similar between groups. Finally, keratinocytes from VWS showed increased long-term proliferation when compared with NSCLP. CONCLUSIONS: These results support, in vivo and in vitro, a previously described role for IRF6 in epidermal proliferation in humans. They further demonstrate a critical function for IRF6 in cutaneous homeostasis.

An evidence-based approach to secondary cleft lip nasal deformity.

The Maintenance of Certification module series is designed to help the clinician structure his or her study in specific areas appropriate to his or her clinical practice. This article is prepared to accompany practice-based assessment of preoperative assessment, anesthesia, surgical treatment plan, perioperative management, and outcomes. In this format, the clinician is invited to compare his or her methods of patient assessment and treatment, outcomes, and complications, with authoritative, information-based references. This information base is then used for self-assessment and benchmarking in parts II and IV of the Maintenance of Certification process of the American Board of Plastic Surgery. This article is not intended to be an exhaustive treatise on the subject. Rather, it is designed to serve as a reference point for further in-depth study by review of the reference articles presented.

Wound complications after cleft repair in children with Van der Woude syndrome.

Van der Woude syndrome (VWS; OMIM 119300) is an autosomal-dominant condition associated with clefts of the lip and/or palate and lower lip pits and is caused by mutations in interferon regulatory factor 6 (IRF6). The standard of practice for children born with cleft lip/palate is surgical repair, which requires proper wound healing. We tested the hypothesis that children with VWS are more likely to have wound complications after cleft repair than children with nonsyndromic cleft lip/palate (NSCLP). Furthermore, we hypothesized that children with VWS have more surgical procedures. A retrospective, case-controlled study was performed. Seventeen children with VWS and 68 matched controls with NSCLP were scored for the presence of wound complications after cleft repair, for the severity of complications, and for number of surgeries from age 0 to 10. Of the 17 children with VWS, 8 had wound complications. Of 68 controls, 13 had wound complications (P = 0.02). Of 8 wound complications in the VWS group, 6 were major, whereas of 13 complications in the control group, 9 were major (P = 0.04). Most wound complications were fistulae and occurred in isolated cleft palate and bilateral cleft lip. The mean number of surgeries in the VWS group was 3.0 compared with 2.8 in the control group (P = 0.67). Our studies suggest that children with VWS have an increased risk for wound complications after cleft repair compared with children with NSCLP. Furthermore, these data support a role for IRF6 in wound healing.

The disruptive physician: righteous Maverick or dangerous Pariah?

BACKGROUND: "Disruptive physician" is a term appearing more frequently in many hospital bylaws. It has significant negative implications that can lead to loss of privileges for plastic surgeons. METHODS: Exploring the various definitions of disruptive physician reveals palpable differences between those of the Joint Commission and the American Medical Association. These discrepancies expose plastic surgeons to potential harm when actively addressing quality issues in the hospital environment. RESULTS: The disruptive label can be inappropriately leveraged by hospital administrators against plastic surgeons who confront quality issues. Moreover, the term disruptive is open to subjective interpretation. Challenging the disruptive label in court reveals only that the justice system is concerned that the actual process leading to the disruptive charge is followed appropriately as outlined within the organizational bylaws; the courts are not interested in the actual quality issues and generally will not second-guess the judgment of peer review panels or hospital administrators. CONCLUSIONS: Plastic surgeons would benefit from familiarizing themselves with these issues. Hospitals should be required to use root cause analysis when dealing with quality issues raised by members of the medical staff. Furthermore, findings from root cause analysis should be privileged from legal discovery in all jurisdictions to permit honest exploration of quality issues. When a conflict does arise, consideration of mediation should be given to resolve disputes.

Ethical issues for the plastic surgeon in a tumultuous health care system: dissecting the anatomy of a decision.

BACKGROUND: Society anticipates that plastic surgeons will make ethical decisions that are solely in the best interest of their patients. However, a variety of competing factors exert an influence on all decision-making processes. METHODS: Multiple competing factors that commonly influence decision-making by plastic surgeons, on both conscious and subconscious levels, are identified. By exploring the ramifications of these factors, a more ethical outcome can be achieved. RESULTS: Some of these competing interests that can sidetrack ethical decision-making include personal finances (e.g., ownership of surgical centers, selection of procedures, pricing); outside regulations (e.g., Emergency Medical Treatment and Active Labor Act of 1986 and care of the uninsured); and professional duty (e.g., informed consent, discussion of error). CONCLUSIONS: Plastic surgeons who are aware of the competing interests that influence their decision-making processes stand a greater chance of achieving ethical outcomes. Nevertheless, with the growing volume of nonreimbursed care and expectations of perfect outcomes, achieving uniformly ethical decisions without burdensome self-sacrifice is difficult at best.

Caregiver and patient reported outcomes after repair of cleft lip and/or palate in the Philippines.

OBJECTIVES: To establish the feasibility of conducting outcomes research among patients treated during a medical mission and to identify the salient outcomes for patients and caregivers in one region of the Philippines. DESIGN AND SETTING: Prospective structured interview conducted in or near participants' homes on the island of Cebu, Philippines. PARTICIPANTS: Individuals who had surgery at least 6 months earlier within the study region were eligible. Recipients of surgery were located from surgical records and by word of mouth. MAIN OUTCOME MEASURES: (1) Proportion of individuals located. (2) Primary outcomes of oral cleft repair identified for the sample. RESULTS: Of 99 people on a surgical list, 52 (53%) were located, eight were excluded (ineligible, unavailable, or inaccessible), and 44 agreed to participate in the study. Ten participants were identified via word of mouth. Seventy-five interviews were conducted (21 caregiver-patient pairs, one adolescent, and 32 caregivers of a child <7 years). Nearly all participants (99%) would encourage others to pursue surgery. Open-ended questions were coded to identify primary outcomes: improved speech (52%), improved eating (25%), social benefits (14%), and improved appearance (6%). Caregivers (50%) and patients (68%) reported that improved speech was the most important change after surgery. CONCLUSIONS: Patients and caregivers ascribe positive changes related to cleft surgery. Outcomes research requires cooperation with local professionals who can communicate effectively. These data serve to demonstrate feasibility and as a model for future studies of treatment outcomes in follow-up to international medical missions.