Jane A. Petro

Immediate Single-Stage Reconstruction of the Breast Utilizing FlexHD and Implant following Skin-Sparing Mastectomy

Introduction: Primary reconstruction of the breast is the standard of care for patients undergoing a mastectomy for breast cancer. Surgical techniques involving immediate implant reconstruction following skin-sparing mastectomy can offer improved patient self-image and enhanced aesthetic outcomes compared with other techniques. The use of an acellular dermal matrix (ADM) as a supporting material has been shown to further improve cosmetic results. Here, we describe a technique that allows for primary reconstruction of the breast mound with implant after a skin-sparing mastectomy in a single procedure using a new form of ADM known as FlexHD. Materials and Methods: A total of 50 patients (85 breast reconstructions) over a period of 20 months underwent immediate reconstruction with this method using a silicone gel mammary implant. The surgical approach and complications for each patient were documented. In some patients, biopsies were obtained 2 and 6 months after initial placement of FlexHD (at the time of expander replacement) for pathologic and histologic evaluations. Results: All reconstructions were completed in a single-stage procedure. The technique resulted in positive aesthetic outcomes and patient satisfaction with few complications and low postoperative pain. Infections were more frequently observed following bilateral mastectomy and in patients who had previous radiation therapy or were smokers. Fibroblast migration and neovascularization of the ADM were observed at 2 months with full incorporation into native tissue at 6 months. Conclusions: Our experience suggests that single-stage breast reconstruction with FlexHD is a preferred approach to the primary reconstruction of the breast after mastectomy.

2012 American Academy of Cosmetic Surgery Review of Anesthesia Safety for the Cosmetic Surgeon

Safety guidelines from many different medical specialties have been developed and are frequently used to establish a standard of care. The American Academy of Cosmetic Surgery appointed a committee to produce a review of anesthesia safety for cosmetic surgeons. This document is not intended to represent a standard of care, but reflects what the committee considers to be key elements of practice that benefit patient safety when anesthesia is being used as part of the practice of cosmetic surgery.

History of the Facelift: The First Three Decades

Innovative surgical procedures may be presented as newly discovered procedures. This may not be true, unless the author has done a thorough search of the prior literature to confirm originality. Many techniques are described, used, and abandoned, only to reappear as a fresh discovery. In reviewing the history of facelift surgery, it is apparent that almost all of the approaches to facial rejuvenation were described in the early decades of the 1900s. Thus, this chapter will provide a summary of the key discoveries during that era. Later approaches reflect refinements and different anatomical understandings and use better materials but are not necessarily as original as claimed. Anyone writing about facelifting today would be well advised to read the contributions of CC Miller, AG Bettman, Suzanne Noel, Jacques Joseph, Julien Bourguet, and the others discussed here.

Drugs and Devices Thinking About What We Do

The pharmaceutical industry, including medical device makers, is facing nearly unprecedented scrutiny from the news media this year. Valeant Pharmaceuticals, heralded in the business press as a huge financial success story, recently saw its stock prices fall nearly 90%. Valeant started out as a small research and development company, but discovered this new tool for profit, absorbing nearly 100 small companies between 2008 and 2015. The company became a behemoth by acquiring small generic producers and boosting per pill costs. Valeant reduced their research and development costs to 3% of sales and reduced the workforce by half in most of the companies they acquired. Martin Shkreli’s boyish face became the focus of public outrage. His company, Turing Pharmaceuticals, purchased a generic drug Daraprim (pyrimethamine, used to treat toxoplasmosis) and raised the price for this essential but rarely used antibiotic by 5,556%, from

Informed Consent, Proficiency, and Competence

13.50 to

Cosmetic Surgery, Aesthetic Surgery, Plastic Surgery Are They Different? And Do They Make a Difference?

750 per pill. An obscure antiparasitic drug became the focus of public outrage, bringing such price-gouging tactics to public attention and ending with federal and state investigations, criminal charges, and widespread condemnation of the practice. But Valeant and Turing are only 2 examples. Although these practices may seem far from the everyday concerns of cosmetic surgeons, I believe that we should be looking at our own industry with both curiosity and concern. Cosmetic surgery increasingly is less about surgery and more about antiaging therapies, minimally invasive procedures, and injections of fillers and toxins, that is, use of medical devices and pharmaceuticals about which we ought to know a great deal. Most of the research and development of cosmetic products is carried out by industry and via industryfunded clinical research. This creates both a perception of conflict and the reality that conflict of interest exists in this research. Few in our community argue that the National Institutes of Health should fund cosmetic research or that the US Food and Drug Administration (FDA) should have increased regulatory control. Cosmetic products are controlled under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). Such products include “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.” If a product is intended for therapeutic use in treating or preventing disease, it is either a drug or a medical device. The practice of cosmetic surgery includes using all of the above categories, products, and devices designed to improve appearance as well as dietary supplements coming under yet another category of regulation under the FDA. Research focusing on drugs for common diseases, such as diabetes or hypertension, receives scrutiny in 3 phases, culminating in large regulated clinical trials that are typically designed as double blind, prospective, and randomized programs. Thousands of patients may be enrolled in such studies. Even with the regulations applied, negative studies have tended to be unpublished, and published studies are biased in favor of the pharmaceutical or device being studied. In contrast, prospective clinical trials in cosmetic surgery include small numbers of patients. Larger studies tend to be retrospective. For example, the excellent clinical trial on the use of pulsed carbon dioxide lasers in treating photoaging skin included 73 patients in one arm looking at perioral wrinkling and 38 evaluating periorbital wrinkling. A study of complications presented 500 patients but was retrospective. Both trials demonstrate the efficacy of this treatment for wrinkles but do not report long-term outcomes. Widely used, the carbon dioxide laser has become a standard treatment, but newer lasers continue to appear on the market, with what benefit or increased efficacy? Do the newer lasers provide any better benefit? Scar care is another area where actual clinical trials are typically in small populations. For example, a randomized, blinded, placebo-controlled clinical trial (the ideal model for clinical research) of silicone gel involved 50 ethnic patients and showed less hypertrophic scarring in the treated scar than in the placebo-treated scar, at 3 months. Although the results were reported as statistically significant, no comment about patient satisfaction or longer term outcomes is presented. In other words, the study showed that silicone made a difference in the scar, at 3 months. But statistical significance in this, and many other cases, does not tell us whether the difference is meaningful to the patient, or significant beyond the 3-month limit of the study. In a comprehensive article on skin antiaging strategies, published in the journal Dermato-Endocrinology, the authors review more than 200 publications addressing the full spectrum of antiaging practices that include the following: 663916 ACSXXX10.1177/0748806816663916The American Journal of Cosmetic Surgery research-article2016

Case 95: In Pursuit of Perfection

The doctrine of informed consent has required that you provide your patients with appropriate information to make a knowledgeable decision to proceed or to forgo surgery. Yet, there is no standard definition of what should be included, not even the personal experience of the surgeon. The surgeon is expected to provide a discussion of the risks, benefits, and alternatives of the proposed treatment/procedure. Not everyone will choose to report the risk of blindness with blepharoplasty, of or fatty emboli with liposuction. But we are expected to provide a broad array of information. There is a fair degree of latitude regarding what that information should include, and there is no consensus as to whether a multipage, detailed consent form is sufficient as a tool for patient education and decision making. And this information never includes the surgeons’ experience with the procedure. A friend recently was diagnosed with breast cancer, not a rare thing in women above the age of 50, but this was a new cancer (different type) than one she had had treated 30 years ago with radiation and lumpectomy. As I began to research the literature on the subject, I noticed that none of the leading articles I read actually presented any information that met the standard for informed consent (risks, benefits, and alternatives). In electing to have a mastectomy with reconstruction, my friend could certainly choose several different options, ranging from simple to complex. The literature seemed to support some kind of vascularized flap rather than an implant alone based reconstruction. Among the many choices between a pedicle flap of the rectus or latissimus muscle, and any of a variety of free flaps, the case reports available did not offer any clarity that distinguished one approach from another other than minor differences in recovery. No article clearly outlined the surgeon/patient decision tree that led to a particular type of reconstruction. The single feature that stood out was the low complication rates among those reports of experience with a large number of cases, no matter which technique was chosen. It should not be a surprise that volume can translate into excellence. Malcolm Gladwell’s 10 000 hours has become nearly axiomatic. Most surgeons do not give a caseload report to their patients, making it difficult to know if the surgeon is inexperienced, experienced, or vastly experienced in any given procedure. Hospitals generally require a minimal numbers of specific kinds of cases/year for reaccreditation. For instance, my former hospital decided that 10 cases of whatever/year constituted sufficient experience to grant credentials for that particular operation. Research suggests that true competency requires more than 10, and usually more than 20 to achieve some kind of expertise. But such information is not necessarily public, except to show that they are, or are not, accredited within the hospital to do a particular kind of case. Cosmetic surgery is rarely hospital based, so this information is not collected or public for liposuction, breast augmentation, or antiaging procedures. Do we even know what competence is in cosmetic surgery at this time? Are there any data indicating even how we might measure this? The American Academy of Cosmetic Surgery (AACS) fellowship programs have begun requiring specific numbers of specific cases, generally in excess of 50 in each category during the fellowship year. Other aesthetic programs report far fewer cases preformed but claim to certify competence at the end of the training program. Intrigued by the seeming absence of written articles discussing risks, benefits, and alternatives for any given condition and its treatment, I decided to look at some specific examples in the cosmetic surgery literature. First, what is the information on the number of cases that are required to reduce the number of complications of any particular procedure? As a resident, we often were required to be observed for a certain number (sometimes 1 or 2, more recently 10-12) of arterial lines, central line placement, or thoracostomy tubes. Simpler procedures like starting an intravenous (IV) entailed practice on a classmate followed by being sent out into the hospital to “take care of patients,” a typical “See one, Do one, Teach one approach.” In the absence of articles related to cosmetic surgical proficiency, I looked at a number of articles from other fields that address this question of proficiency. Proficiency standards within other surgical specialties were available. In gynecology, a recent report on laparoscopic ovum procurement (oocyte retrieval) was found to require 20 observed procedures to reach the standard 8.6 oocytes per procedure. There were several within general surgery. One article tracking skill 670383 ACSXXX10.1177/0748806816670383The American Journal of Cosmetic SurgeryPetro research-article2016

Case 77: Pseudoptosis and Asymmetry

Plastic surgeons are spending a lot of time, money, and legislative effort to define themselves as the only physicians suitable to do cosmetic surgery. Words matter. Calling yourself a plastic surgeon is different from calling yourself an aesthetic surgeon, is different from calling yourself a cosmetic surgeon. Plastic surgeons apply the term solely to board-certified surgeons (plastic or facial plastic) who have completed a specific period of training and education and successfully completed the examinations offered by their board. A subset of plastic surgeons call themselves aesthetic surgeons, implying a higher artistic standard and maintain a separate professional organization. Plastic surgery, a term that derives from the Greek term plastikos (to shape or to mold), does not define an aesthetic purpose, rather a specific process. The subset of plastic surgeons who call themselves aesthetic surgeons are identifying the artistic aspects of their practice. According to the terms as found in the standard Merriam-Webster dictionary (see Table 1), calling yourself a “cosmetic surgeon” most closely aligns with what surgeons working to beautify their patients do: enhance appearance, including correcting defects, and create a visually appealing appearance. It is the diverse group of doctors who call themselves cosmetic surgeons, focusing on those procedures that enhance appearance and/or correcting defects (large nose, small breasts, etc) that have played a major role in the development of surgery that is used to enhance beauty. No specialty should or can own surgical procedures or limit access to the tools, pharmaceuticals, and devices essential to patient care. The history of liposuction in the United States is a good example of how attitudes and opinions change over time. European surgeons perfected liposuction as a safe procedure during the 1970s and 1980s. Italian gynecologists Dr Georgio Fischer and Dr Arpad Fischer began using their technique for liposuction in 1976 and published their work 2 years later, describing a method of blunt closed liposuction. The Fischers advanced the concept of liposuction as a sculpting tool in their article on riding breeches deformity 2 years later by which time other surgeons were adopting the technique. William Coleman in his history of liposuction states that “the innovative work of the Fischers’ was generally ignored by the plastic surgery community throughout the world.” He attributes this to their formation of the International Association of Cosmetic Surgeons, which somehow was seen as an insult? or threat? Coleman postulates that is was their identification of themselves as cosmetic surgeons, and their interest in cosmetic surgery alone that contributed to this antithesis. Liposuction was adopted quickly in France, promoted and modified by Drs Yves-Gerard Illouz and Pierre Fournier. Illouz, trained as a gynecologist, had identified as a purely cosmetic surgeon since 1962, and Fournier, trained as a general surgeon, also limited his practice to cosmetic surgery. Both were deeply involved in the early teaching of the technique to any interested visiting doctors. Interest in the United States came from a variety of surgeons in the fields of dermatology, gynecology, otolaryngology, and general surgery who began watching the European surgeons and introduced liposuction into the United States: Drs Lawrence Field in 1977, Lawrence Martin in 1980, and many others thereafter, including Richard Dolsky, Michael Elam, Rhoda Narins, and Fred Berkowitz. The history of the multispecialty evolution of plastic surgery and a detailed early history of the origins of cosmetic surgery as a specific field are well detailed by Richard Dolsky in his article celebrating the 25th anniversary of the American Academy of Cosmetic Surgery. Probably the most significant advance in liposuction was provided by Dr Jeffrey Klein, a dermatologist who developed the use of tumescent local anesthesia. This significantly improved both the efficacy and the safety of liposuction, making it one of the most frequently preformed surgical procedures in the world. The successful removal of fat was followed by the use of the fat to augment soft tissue defects, first reported by Illouz in 1986. The transfer of fat was adopted for a variety of cosmetic, congenital, and posttraumatic deformities. Basic scientists studying fat metabolism had recognized the presence of stem cells in human fat. Illouz’s publication of a large case series, describing his safe and successful technique for the removal of adipose tissue, opened the door for research on human adipose-derived stem cells (ASCs). Thus, the advent of liposuction provided a safe, simple resource for harvesting these cells. 636987 ACSXXX10.1177/0748806816636987The American Journal of Cosmetic SurgeryEditorial research-article2016

Case 96: Late Pocket Infection

This 36-year-old female had breast augmentation. Following this she had two children, after which she developed rippling and moving of the implants. A revision was performed, and capsule contracture was noted on the left side during surgery. She developed breakdown of both wounds and after healing was noted to have bilateral capsule contracture Baker 2/3. Now she has some complaints about the breasts. Discussion mainly consisted of whether or not to perform revision.

Case 90: Rippling and Contracture

This 33-year-old patient had breast augmentation in 2007 with round, high-profile, smooth silicone gel implants placed in partial subpectoral pockets. Eight months postoperatively, there was breast asymmetry with right breast higher than the left.