The Impact of Political Advocacy on the Plastic Surgeon: A Data-Driven Analysis.

BACKGROUND: Despite successful legislative efforts by the American Society of Plastic Surgeons (ASPS), the Plastic Surgery Political Action Committee remains underused. Participation in advocacy and financial contributions of ASPS members fall below those of similar surgical subspecialties. This study aims to perform a data-driven investigation into the impact of Plastic Surgery Political Action Committee efforts on the practicing plastic surgeon. METHODS: A retrospective review of the ASPS procedural database from 1992 to 2018 and Plastic Surgery Political Action Committee contributions from 2012 to 2018 was performed. Postmastectomy breast and congenital anomaly reconstructions were analyzed. To determine significant variations in trends, change-point analyses were conducted. Changes in surgical volume were correlated to implementation of federal legislative efforts. RESULTS: Three significant trends of increased breast reconstruction volume were detected with associations to three specific legislative changes: 1992 to 1998, which correlates with the Women's Health and Cancer Rights Act; 2006 to 2009, which correlates with the U.S. Food and Drug Administration's approval of silicone breast implant use; and 2013 to 2015, which correlates with the Breast Cancer Patient Education Act. During the study period, breast reconstruction procedures increased substantially compared with all reconstructive procedures (146.6 percent versus 3.6 percent). There were no significant trends detected for birth defect reconstructions. Although contributions were relatively stagnant, resident member contributions increased after 2015, correlating with formation of the Political Action Committee's Resident's Club. CONCLUSIONS: This study demonstrates a correlation in timing between Plastic Surgery Political Action Committee legislative accomplishments and the resulting case volume increase in some areas of plastic surgery. The data highlight the importance of political advocacy and how political action committee activities can directly impact patient access to care and the practice of plastic surgery.

Iatrogenic subcutaneous emphysema in aesthetic breast augmentation Medicolegal aspects.

The aim of the present study was to investigate clinical results and medico-legal aspects related to the surgical procedure of mini breast augmentation. In the present case, a 28-year-old young woman with bilateral mammary hypoplasia underwent surgery, under local anesthesia, with the placement of 150 cc breast implants in the sub-glandular plane. We report a case of dramatic isolated subcutaneous emphysema without pneumothorax and pneumomediastinum to be related in terms of a causal link to the surgical procedure which the patient underwent. The plastic surgeon proceeded to replace a breast implant that presumably, represented the vehicle of transmission of the suspected pathogen responsible for the infection, to become a causal role for the infectious manifestation. This case report is an emblematic example of the need for a careful and correct surgical procedure, in order to avoid serious consequences as in the case in question, burdened by the occurrence of unsafe conditions for the patient. Compliance with the guidelines and the technical datasheet of breast implants is essential in order to avoid the concrete hypothesis of professional liability. KEY WORDS: Aesthetic breast augmentation, Breast implant, Iatrogenic subcutaneous emphysema.

Management of Symptomatic Patients with Textured Implants.

SUMMARY: Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.

Implant Testing and the "Strain Energy" Concept.

Benchtop performance test methodologies differ between manufacturers as regulatory agencies often leave the interpretation of testing standards up to manufacturer discretion, resulting in an inability to directly compare implants across manufacturers. Furthermore, traditional benchtop test methodologies focus on mechanical performance standards to address objective endpoints such as shell strength. However, other more difficult to define clinical performance requirements such as softness and natural feel are often difficult to measure via these methods. This review aims to discuss the evolution of breast implant testing standards, discuss the discrepancies in benchtop characterizations of implants, and highlight one manufacturer's novel approach to utilizing benchtop methodologies to quantify previously subjective endpoints such as firmness and natural feel and define their clinical relevance.

Consequences of the U.S. Food and Drug Administration-Directed Moratorium on Silicone Gel Breast Implants: 1992 to 2006.

The U.S. Food and Drug Administration silicone gel breast implant moratorium occurred 25 years ago. The immediate and long-term consequences of the moratorium are reviewed and assessed.

Two-Stage Prosthetic Breast Reconstruction: A Comparison Between Prepectoral and Partial Subpectoral Techniques.

BACKGROUND: Prosthetic breast reconstruction with prepectoral placement may confer clinical advantages compared with subpectoral placement. The purpose of this study was to assess and compare clinical outcomes following 2-stage reconstruction following prepectoral and partial subpectoral placement of tissue expanders and implants. METHODS: A retrospective review of 39 (prepectoral) and 50 (partial subpectoral) patients was completed. Acellular dermal matrix was used in all patients. Mean age was 50.4 and 49.2 years, respectively. Body mass index (BMI) > 30 was noted in 15.4% of prepectoral and 18% of partial subpectoral patients. Radiation therapy was delivered to 38.5% of prepectoral patients and to 22% of partial subpectoral patients. Mean follow-up was 8.7 and 13 months for the prepectoral cohort and partial subpectoral cohorts. RESULTS: The percentage of patients having at least 1 adverse event was 20.5% in the prepectoral and 22% in the partial subpectoral cohorts. The incidence of surgical-site infection and seroma was 8.1% and 4.8%, respectively, for the prepectoral cohort and 4.8% and 2.4%, respectively, for the partial subpectoral cohorts. Device explantation was 6.5% for the prepectoral and 7.2% for the partial subpectoral patients. Explantation did not occur in patients who had radiation or who had a BMI > 30. Four patients (6 breasts-7.2%) required conversion from partial subpectoral to prepectoral because of animation deformity. CONCLUSIONS: Prepectoral reconstruction is a viable alternative to partial subpectoral reconstruction. Proper patient selection is an important variable. Prepectoral reconstruction can be safely performed in patients with a BMI < 40 and in patients having postmastectomy radiation therapy.

Liability for providing a prognosis in surgical practice.

The common law's development of the doctrine of informed consent has progressively imposed broader obligations on surgeons to provide patients with information about the surgical and alternative treatment choices available. Prognosis is critical because the patient cannot provide informed consent without information about the likely evolution of the physiological or pathological processes involved in the surgery under consideration. But does the duty of care that a surgeon owes a patient require a precise prognosis to be given in every case? A recent decision of the Court of Appeal considers that question.

Informed consent in Italy-traditional versus the law: a gordian knot.

BACKGROUND: Italian law no. 86 of 5 June 2012, which establishes a set of rules on the matter of breast implants, came into effect in July 2012. The law is at the center of a widespread and animated cultural debate that in recent years has been taking place in Italy. DISCUSSION: The fundamental prohibition imposed by the law concerns the age limit. Breast implants for exclusively aesthetic purposes are allowed only if the legal age (18 years) has been reached. This prohibition does not apply in cases of severe congenital malformations certified by a physician operating within the National Health Service or by a public health care institution. The legal imposition of an age limit raises a number of perplexities: one at a bioethical level and one that is strictly juridical. In fact, it is impossible to deal with this issue unless the wider debate concerning the self-determination and autonomy of underage patients in biomedical matters is considered. It appears, then, that the issue is again exclusively related to the peculiarity of cosmetic surgery, which when aimed at correcting "only" the pathologic experiences of self-image, does not acquire the dignity of therapy. If, however, the improvement of self-image serves to achieve a better psycho-emotional balance and favors the development of social relations undermined by evident physical defects, age restrictions can be disregarded. The authors believe the real risk is that the law imposed by the Italian state is based on assumptions and preformed value judgments. Furthermore, in the understanding of needs, legislation often is biased toward objective biophysical problems without attaching due importance to subjective psychological and social problems. While acknowledging the seriousness of the issue, the authors do not agree with the legislature's rigidity. However, plastic surgeons must form a plan for addressing the concerns about breast implants and evaluating whether they are appropriate for adolescents, taking into account the unique psychological and developmental considerations of adolescent cosmetic surgery patients. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A look inside the courtroom: an analysis of 292 cosmetic breast surgery medical malpractice cases.

BACKGROUND: Malpractice claims affect the cost and quality of health care. OBJECTIVE: The authors examine litigation in cosmetic breast surgery and identify factors influencing malpractice litigation outcomes. METHODS: The Westlaw database was searched for jury verdict and settlement reports related to medical malpractice and cosmetic breast surgeries. Cases included for analysis were examined for year, geographic location, patient demographics, procedure performed, alleged injury, causes of action, verdict, and indemnity payments. RESULTS: Of 292 cases, the most common injury sustained was disfigurement (53.1%). Negligent misrepresentation had a 98% greater chance of resolution in favor of the plaintiff (relative risk [RR], 1.98; 95% confidence interval [CI], 1.41-2.79), and fraud had a 92% greater chance of disposition in favor of the plaintiff (RR, 1.92; 95% CI, 1.32-2.80). The most common causes of action cited were negligence (88.7%) and lack of informed consent (43.8%). One hundred sixty-nine (58.3%) cases resulted in favor of the defendant and 121 (41.7%) cases were disposed in favor of the plaintiff; 97 (33.4%) cases resulted in damages awarded and 24 (8.3%) cases resulted in settlement. No significant difference was found between the medians of indemnity payments awarded to plaintiffs ($245 000) and settlements ($300 000). CONCLUSIONS: Based on this study, negligent or intentional misrepresentation strongly favors plaintiffs in either awarded damages or settlements in cases of cosmetic breast surgery litigation. This study emphasizes that transparency and adequate communication are at the crux of the physician-patient relationship and are tools by which plastic surgeons may reduce the frequency of litigations, thereby containing health care costs at a minimum.

'If it ain't broke, don't fix it?': scandals, 'risk', and cosmetic surgery regulation in the UK and France.

The recent PIP scandal that affected patients worldwide, and received extensive media coverage, led to concerns being felt by patients about the 'risks' of cosmetic surgery. Theories about regulation and risk refer to societies such as those in the West becoming more risk averse. Regulation, in turn, has come to be seen as an instrument to solve a problem for a community seen to be or which perceives itself to be at risk. The political and electoral risk acknowledged by government if it ignores that concern, or at least media coverage of it, can lead to regulation, or the tightening up of regulation, as a response. This article looks at current proposals for legislation in the UK following the PIP silicone implant scandal as an example of the risk-regulation premise. Are cosmetic surgery patients in the UK now going to see stricter regulation of the cosmetic surgery industry? The article argues that the UK and France have both reacted to healthcare scandals and the ensuing societal conception of risk by drawing up more thorough legislation on cosmetic surgery than previously existed. France enacted the Kouchner law in 2002 and the UK government published the Keogh Report in April 2013. A comparison is made of these to establish whether the UK can learn from the French legislation when it comes to drafting actual regulation in the future, perhaps in 2014. Finally, some arguments are made about whether risk aversion may make better law.

Escolha da técnica de mastoplastia de aumento: uma ferramenta na prevenção de litígio médico / Choosing the augmentation mammaplasty technique: a method for preventing medical disputes

INTRODUÇÃO: A cirurgia plástica é uma das especialidades médicas expostas ao risco de reivindicações abusivas. A maioria das queixas em cirurgia plástica não decorre de falhas técnicas, mas de inadequados critérios de seleção de pacientes, falha na indicação cirúrgica e falta de comunicação adequada entre o paciente e o cirurgião. O treinamento, a utilização cuidadosa de técnicas, a adoção de precauções, o cumprimento de normas de segurança e o formulário de consentimento informado são princípios fundamentais na prática da medicina defensiva. Ademais, ter nos registros dos pacientes informações objetivas sobre a cirurgia realizada avaliza o trabalho do cirurgião plástico, tornando os procedimentos profícuos e técnicos. O objetivo deste estudo é descrever uma ferramenta de prevenção de litígios médicos na mastoplastia de aumento baseada em dados de escala em graus I a IV. MÉTODO: Foram avaliadas 40 pacientes com indicação de mastoplastia de aumento. Todas as pacientes foram submetidas a mensurações anatômicas, documentação fotográfica e registro de doenças hereditárias e congênitas encontradas nas pacientes candidatas a aumento mamário. Além disso, todas as pacientes receberam explicação da indicação e do procedimento cirúrgico a ser realizado. As pacientes concordaram com a indicação cirúrgica e assinaram o termo de consentimento. RESULTADOS: O tempo de seguimento das pacientes foi de 6 meses. Todas as pacientes apresentaram alto grau de satisfação com o resultado obtido após o procedimento e não houve caso de queixa ou litígio. CONCLUSÕES: Os autores propõem o uso regular de tabelas e classificações para escolha prévia dos implantes, com o objetivo de tornar a indicação cirúrgica objetiva, facilitar o entendimento da paciente e prevenir o litígio.

BACKGROUND: Plastic surgery is a medical specialty that is particularly at risk of unwarranted claims. Most complaints regarding plastic surgery are not a consequence of technical failures but rather of inadequate criteria of patient selection, failure in surgical indication, and lack of effective communication between the patient and the surgeon. Training, careful use of techniques, adopting precautions, compliance with safety regulations, and the informed consent document are fundamental principles of defensive medical practice. Moreover, documenting objective information about the surgery in the medical records validates the work of the plastic surgeon and ensures that procedures are productive and technical. The aim of this study was to develop a tool for preventing medical litigations in augmentation mammaplasty based on data expressed on the scale from I to IV. METHODS: Forty patients with an indication for augmentation mammaplasty were evaluated. All the patients were subjected to anatomical measurements, which were photographically documented, and the hereditary and congenital diseases of the patients presenting for breast augmentation were recorded. In addition, all the patients were informed about the indication and surgical procedure to be performed. They agreed with the surgical indication and provided informed consent. RESULTS: The follow-up period was 6 months. All the patients expressed a high degree of satisfaction with the results obtained after the procedure, and no cases of complaints or disputes were encountered. CONCLUSIONS: The authors propose the regular use of tables and classifications for the selection of implants, with the aim of establishing surgical indication as an objective parameter, facilitating patients' understanding of the procedure, and preventing litigation.

Breast implants: the good, the bad and the ugly. Can nanotechnology improve implants?

This advanced review will discuss the history of implants used in breast reconstruction and augmentation, the most frequently performed plastic surgery today. Currently, only silicone rubber-based silica nanocomposite implants are available in the United States. The most prevalent issues involving breast implants include capsular contracture, gel bleed, implant rupture, and infection. In the past, studies have also been reported which linked breast implants to increased incidence of systemic diseases such as autoimmune disease, various forms of cancer, and psychological disease. The goal of this review is to survey the literature from the perspective of material science. It is also largely unnoticed that nanotechnology is involved: the silicone rubber shell is reinforced with nanosilica so implants appear to be homogeneous and crystal clear. We are hoping that this review will contribute to a better understanding of the controversial issues and motivate material scientists and medical doctors to work together to develop alternatives based on new nanotechnology for the women who opt for a device made of synthetic materials.

[French lawsuits after breast implantation]. / Mises en cause sur prothèses mammaires, le point de vue du défendeur. Etude de sinistralité sur six ans (1999-2004).

Standpoint of surgeon about the french legislation on breast implant surgery in 2005. All possible proceedings in France are listed: Ordinal court (Deontology and professional risks), Civil court (Sharing of the costs and after-effects), Penal court (Personal punishement) and recently National Office on therapeutic hazards. Sinistrality observed in one insurance practice, in France, is described (1999-2004). Preparation of surgeon's defence is described, particulary for the expertal debate, indispensable preliminar before lawsuit in France.

[Breast implants in France. New regulations, and qualitative and quantitative study of breast implants sold between 1995 and 2004]. / Le marché des prothèses mammaires en France. Evolution de la réglementation; analyse du nombre et des modèles d'implants vendus entre 1995 et 2004.

UNLABELLED: Breast implant surgery is now regulated by health laws, which stopped concerns and debates about the safety of the implants in the 90'. After a 6 years ban, silicone gel-filled implants have been allowed by the Afssaps (a national health agency) in 2001, for use in France. The comeback of the silicone gel implants has been a breakthrough in the breast implant market. GOALS OF THE STUDY: Our goal was to assess breast implant use in France, from 1995 til 2004, a time of deep turmoil for breast implant surgery due to new regulations. METHODS: All manufacturers have been requested to participate in the study and send their confidential data regarding the number and type of implants sold yearly, from 1995 to 2004. RESULTS: Breast implant sales rose by 53% in 2001, and increase by +383% from 1995 to 2004. The total number of breast implants sold in 2004 reached about 61 800. Following the lift on their ban, silicon gel-filled implants became immediately first-choice implants (they represented 72% in 2001 and more than 97% of all implants sold in 2004); saline filled implants are now rarely used. Textured envelopes are more often used (they represented 73 to 97% between 1995 and 2004), and smooth envelopes represented about 15%. CONCLUSION: Health agencies in France and Europe would benefit from a better knowledge of the use and follow-up of breast implants. These are plastic surgeon' or scientific society' responsibilities. A national breast implant registry may be a useful tool to gather information, to improve long-term follow-up and to provide better care to women concerned themselves with breast implant surgery.