Breast prosthesis implantation is currently the gold

Transcription

1 Breast Surgery Special Topic Patient Information Before Aesthetic Lipomodeling (Lipoaugmentation): A French Plastic Surgeon s Perspective INTERNATIONAL CONTRIBUTION Emmanuel Delay, MD, PhD; Raphael Sinna, MD; Thomas Delaporte, MD; Gérard Flageul, MD; Christian Tourasse, MD; and Gilles Tousson, MD Fat grafting to the breasts has long been controversial among aesthetic surgeons. We have developed a new, safe, effective, and reliable lipomodeling method to be used in breast augmentation. This method grew out of our clinical and radiologic experience acquired since 1998 with fat injections to the breast. The aim of the present report is to provide facts and data concerning lipomodeling and to document our procedures for ensuring that clear, consistent, up-to-date information is given to the patients who are undergoing aesthetic lipomodeling. The key element in our preparation is our commitment to avoid missing the diagnosis or altering the presentation of a preexisting or newly arising breast cancer. We must also ensure that the patient understands the need to comply with follow-up recommendations, such as a specific radiologic examination before and one year after the procedure, as well as a biopsy evaluation of any lesion that is considered suspicious during the physical examination. The patient must sign a confirmation that she has received the appropriate information and that she understands the notice provided by the surgeon at her first visit. This notice must deliver clear, complete, objective, evidence-based information, must be written clearly and understandably, and must not contain any unrelated or confusing information. (Aesthet Surg J;29: ) Editor s note: In 2008, Société Française de Chirurgie Plastique Reconstructrice et Esthétique (SOFCPRE) put into effect a recommendation regarding lipomodeling of the breast. According to the author, while it was not a moratorium, they did not recommend fat grafting in the native breast other than in specialized teams (trained plastic surgeons on the technique, efficient radiologists, et cetera) conducting prospective studies on the subject. As the studies of Dr. Delay and his colleagues conform to these recommendations, it did not change his practice of lipomodeling. Every patient undergoes screening for malignancy, through x-ray, ultrasound, or MRI, and injections are begun only after clearance by a radiologist. Patients are then followed up closely for any signs of concern on imaging scans. The author recommends that the guidelines of the SOFCPRE be followed and any injections be performed in a secured environment. Drs. Delay, Sinna, Delaporte and Tousson are from the Department of Plastic and Reconstructive Surgery, University of Lyon, Lyon, France. Dr. Flageul is a plastic surgeon in private practice in Paris, France. Dr. Tourasse is a radiologist in private practice in Amiens, France. Breast prosthesis implantation is currently the gold standard for breast augmentation. 1,2 Until recently, no other technique had been recognized as being both safe and reliable by the community of plastic surgeons. Some groups have proposed other options derived from the techniques used for breast reconstruction. 3,4 Others have suggested the use of autogenous augmentation mammaplasty with microsurgical tissue transfer. 5 Given that the requirements of aesthetic breast augmentation include minimal scarring, moderate surgical trauma, and the absence of morbidity at the donor site, these techniques do not seem appropriate for routine use in plastic surgery. The literature also includes reports on the injection of various products into the breast. However, because the administration of these exogenous substances may induce allergic or immune reactions and complications, 6 their use cannot be recommended at this time. We have shown that lipomodeling is a safe and effective means of aesthetic breast reconstruction. 7 We use it on a daily basis in patients with cancer 2,7,8 or for the correction of sequelae of breast conservative treatments, 2,9 tuberous breast deformity, and chest and breast deformations associated with Poland syndrome. 7 The major criticism of our technique was the possibility that it might induce a 386 Volume 29 Number 5 September/October 2009 Aesthetic Surgery Journal

2 modification of radiologic images that could hinder the detection of cancer. We have tested the radiologic impact of fat transfer on various breast imaging modalities, including mammography, ultrasound, and magnetic resonance imaging (MRI). We found no lipomodeling-induced impairment of the breast radiologic image, provided that the lipomodeling procedure is performed at a high technical standard and under strict radiologic control. 9,10 This positive radiologic evaluation has encouraged us to extend the lipomodeling technique to plastic surgery of the breast. As is legally and ethically appropriate and required by French law the patient must be thoroughly informed about the purpose and possible side effects of any surgical procedure, and full informed consent must be obtained. In this paper, we summarize the history of fat injection to the breast and provide a detailed explanation of our means of providing the most complete and accurate information possible to the patient. We also discuss obtaining full informed consent. Special attention is paid to the risks and complications attendant on this procedure and to the issue of cancer as it relates to fat injection. The Appendix (available online at is a reproduction of the patient information sheet. A BRIEF HISTORY The concept of fat grafting to the breast is not a new idea in plastic surgery. In 1895, Czerny 11 described the first clinical case of breast reconstruction by transplantation of fatty tissues. Other authors later contributed to the development of the technique The technique was further refined by Bircoll, 16 who sparked a controversy with his work on cosmetic breast augmentation, in which he used autologous fat and liposuction techniques. In 1987, Bircoll and Novack 17 reported the case of a patient undergoing breast augmentation by fat grafting for symmetrization after contralateral reconstruction of the transverse rectus abdominis myocutaneous (TRAM) flap. 17 Several equally controversial responses were published in the Journal of Plastic and Reconstructive Surgery Detractors considered that autologous fat grafting was responsible for the formation of calcifications and cysts that might possibly interfere with the detection of breast neoplasms. However, it is known that 10% of women are likely to develop breast cancer at some point in their lives whether they have undergone lipomodeling or not, 21 and Bircoll 22 argued that cancer-related calcifications cannot be mistaken for calcifications associated with fat transplantation, because the two types of calcifications occur at different sites and have different radiologic aspects. In 1987, the American Society of Plastic and Reconstructive Surgeons (ASPRS) stated the following: The committee is unanimous in deploring the use of autologous fat injection in breast augmentation. Much of the injected fat will not survive and the known physiological response to necrosis of this tissue is scarring and calcification. As a result, detection of early breast carcinoma through xerography and mammography will become difficult and the presence of disease may go undiscovered. There were no explicit scientific findings to support this view and the report only expressed the opinion of the members of the committee. Despite the lack of scientific evidence and although it had long been recognized that any mammary surgery can be responsible for the occurrence of fatty cysts or/and mammographic changes the injection of fat into the breasts became taboo among surgeons. Ironically, also in 1987, a retrospective study of mammographic changes after breast reduction published in the same journal 23 reported that calcifications were detectable in 50% of all mammograms two years postoperatively. Although its use in breast reconstruction was controversial at that time, fat grafting was still being used for facial rejuvenation or reconstruction. 24,25 Considering the very encouraging results obtained from its use in facial surgery, we decided to apply the same technique to breast reconstruction and focused our research on the subject in First, we used fat grafting along with autologous latissimus dorsi flap reconstruction. 26,27 The very satisfactory results obtained in our first patients encouraged us to extend the method to other types of breast reconstruction and then to apply the same technique to the management of patients with breast deformities or sequelae of breast conservative treatment (and, more recently, to breast augmentation). Our first presentations before the Société Française de Chirurgie Plastique, Reconstructrice et Esthétique (SOFCPRE) 28 and at the meeting of the International Society of Plastic, Reconstructive and Aesthetic Surgery in Sydney 29 raised considerable debate. The discussants revisited the issues raised in 1987, with many similar criticisms. Point-by-point rebuttal and further presentations of our work gradually dispelled the opposition of our colleagues. The senior author s (ED) experience now includes more than 880 lipomodeling procedures, of which 734 were performed for breast reconstruction, 106 for the correction of congenital deformities, 30 for aesthetic breast surgery, and 10 for the correction of previous surgery defects. As our first patients have been followed for 10 years, reliable data on long-term followup are available. CONSULTATION WITH THE SURGEON Preoperative consultations are a critical step for patients undergoing autologous fat transfer for breast reconstruction. As is the rule in plastic surgery (as and is required by French law), the patient is entitled to receive precise, complete, and up-to-date information about the different aspects of the procedure. Because lipomodeling has been only recently introduced in breast plastic surgery, the information given to the patients must include both the state of scientific knowledge on the subject and the potential uncertainties of the technique. Appropriate selection and prioritization of the information is necessary to help them make an Patient Information Before Aesthetic Lipomodeling (Lipoaugmentation) Volume 29 Number 5 September/October

3 informed decision and give properly informed consent. We have selected and organized the information that we consider crucial to the decision-making process. Our purpose is purely didactic; we do not intend to provide a rigid frame for the medical consultation, but only to emphasize some landmarks that we think should be of interest at each step of the process. The main principles of the preoperative consultation before aesthetic lipomodeling are as follows: (1) identifying the patient s expectations; (2) analyzing each individual case; (3) providing information on the different treatment options; (4) describing the major steps of the procedure; (5) describing achievable outcomes; (6) describing potential risks and complications; (7) addressing issues relating to fat grafting and cancer detection; (8) providing other information of interest; (9) describing follow-up care; (10) ensuring sure that the patient understands the information delivered to her; and finally, (11) providing accurate financial data with a detailed estimate of costs. Identifying the Patient s Expectations Any gap between patient expectations and the practical limits of surgery may naturally affect the patient s satisfaction with the procedure. 30 Benefits and limitations must therefore be made very clear beforehand. In particular, the patient must be told that fat grafting cannot totally replace breast prosthesis placement; the indications for the two procedures vary with the type of morphologic change needed (volume of the breast, underlying muscles) and with the donor site (volume of fat cells available for harvesting). Because of these limitations, the surgeon must help the patient to reformulate any unrealistic, unattainable expectations. This is particularly true because the procedure, which combines liposuction of excess fat and augmentation of small-sized breasts, may appear very attractive and seemingly magical to many women; therefore, it could raise unrealistic expectations. Fortunately, today s patients are generally well informed. They are able to access and understand the information now available through advances in communication, such as the Internet. They can usually verify the information given to them by the physician and assess its usefulness. They can also assess the quality of the explanations and care provided by the surgeon, along with his or her understanding of their needs. This is why it is crucial to provide complete, accurate, and timely information at every step of the procedure. Analyzing Each Individual Case Indication for surgery is based on a detailed case history, on the patient s familial and personal medical history, and on a complete clinical investigation. Any personal or family history of breast malignancy should be evaluated in all patients undergoing plastic surgery of the breast. This information is critical not only to assess the indication for surgery, but also to decide whether a more indepth preoperative evaluation should be provided. This is particularly important because patients with any history of breast malignancy are prone to fat cell necrosis and are at a higher risk of developing breast cancer. 9 This focus on each patient s individual case is a crucial step of the procedure. The surgeon has a responsibility to provide the patient with accurate information about her status at the time of the visit; therefore, any sign or condition possibly interfering with the procedure or its result (and thereby influencing the final decision of the patient) must be taken into consideration and discussed. For instance, an important focal point is the volume of fat cells available for harvesting, which is often the limiting factor of the technique. Similarly, the indication for fat grafting will be discussed as a function of the initial shape of the breast: patients with breast ptosis who desire both mastopexy and augmentation can benefit from the procedure, but they must be aware that the degree of augmentation will be reduced, because most of the fat will be injected into the pectoralis major muscle and the upper breast quadrant to restore cleavage. Providing Information on Different Treatment Options The Agence Française de Sécurité Sanitaire des produits de Santé the French equivalent of the US Food and Drug Administration recommends that the patients receive information on all available treatment options. 31 In France, the most frequent alternative to fat grafting for patients who desire aesthetic breast augmentation is the placement of silicone gel filled implants. The benefits and drawbacks of both options must be discussed and compared with the patient. Other options, such as saline or hydrogel implants, are also available (although they are less common) and must also be mentioned. Describing the Major Steps of the Procedure A detailed description of the surgical procedure and treatment modalities must be given to the patient. This includes date and hour of hospital admission, one-day hospitalization (outpatient clinic), and general anesthesia. Apart from usual preoperative evaluation (biologic work-up and consultation with the anesthetist), a precise radiologic evaluation of the breasts (digital mammography and ultrasound) must be performed by an expert radiologist skilled in breast imaging and in the examination of augmented breasts. Whenever possible, preoperative and postoperative evaluations should be performed by the same radiologist. Preoperative radiologic evaluation is essential to minimizing the risk of concomitant cancer in patients undergoing fat grafting. Images also serve as a reference for subsequent follow-up examinations. The precise data gathered from systematic pre- and postoperative workup can be used for further retrospective studies and objective assessment of the technique. In the absence of suspicious findings, follow-up examinations will include only a digital mammography and ultrasound examina- 388 Volume 29 Number 5 September/October 2009 Aesthetic Surgery Journal

4 tion, at a frequency determined by the radiologist responsible for the one-year follow-up evaluation. Describing Achievable Outcomes Fat grafting cannot completely replace breast prosthesis placement. The indications for the two procedures are different. Prosthesis placement is most appropriate for women who desire large breast augmentation and complete reshaping with round, firm, bulky breasts. Fat grafting is more appropriate for women who desire only moderate breast augmentation or those who simply want to restore their earlier contour (after weight loss, pregnancy, or breastfeeding). It is also recommended for women who wish to obtain more natural results, with no sensation of a foreign body in their breasts. Of course, the method is not an option in women who have insufficient fat deposits available for liposuction. Consequently, as mentioned before, the surgeon must identify the patient s needs and expectations and make sure that she understands the possible limitations of the technique. In addition, the results of liposuction at the donor site are also a factor in the patient s overall satisfaction with the procedure. If she subsequently loses weight, her breasts may get smaller and she may become disappointed with the results locally. In such cases, it is important to emphasize the benefit obtained at the donor site (ie, the abdominal region or the thighs). It is also important that the patient be aware of the degree of uncertainty associated with the results of the procedure. The fat cells grafted to the patient may not survive. It is generally necessary to account for approximately 30% fat resorption postinjection. In our experience, this rate is actually between 30% and 40%. To the patient, it may seem more like 50%, because she usually compares the final result with the volume of her breasts in the immediate postoperative phase, when the grafted site is swollen and edematous. (A comparison with preoperative photographs can help minimize possible patient disappointment with the results.) This is why the surgeon needs to mention the risk of further breast thinning and insist that the patient must maintain a stable weight postoperatively (because losing weight inevitably results in a loss of breast volume). Describing the Risks and Complications French jurisprudence recommends complete information to the patient by the surgeon about all risks and possible adverse consequences of surgical treatments. This information concerns all risks known to the medical community that a reasonable patient would consider material to the decision of whether or not to undergo the procedure. These risks are, however, difficult to determine. Our current technique for aesthetic breast lipomodeling is relatively new. Moreover, although many surgeons performed lipomodeling in the past, relatively little has been published in the literature about fat grafting to the breast and its potential complications, in part because of the taboo previously associated with the use of fat grafting for breast augmentation. It is usually the role of medical and scientific societies to provide updated information on the most common techniques. There is considerable information available and experts from scientific societies are the most likely to decide which information is relevant and should be made available to the patients. To fulfill that goal, experts must examine the different options with an objective and critical eye. Our experience with the different drawbacks and complications of breast lipomodeling is outlined below. Postoperative Issues. Postoperative issues in lipomodeling are similar to those developing after liposuction, with patients complaining of pain, bruises, and swelling. Pain is mild and generally amenable to standard pain medication(s). The procedure causes inflammation and swelling, with a peak between 24 and 48 hours postsurgery. Most of the swelling resolves within one month and is completely (or almost completely) controlled within three months postoperatively. The patient must be informed that bruising will probably occur at both the donor site and at the graft site. Complications. Serious complications of fat grafting are rare, as shown in procedures performed at other body sites Although it is the most common complication of surgery, hematoma is extremely rare in patients undergoing fat grafting to the breast. So far, none of the 850 patients treated by the first author (ED) including all fat transfer indications has ever experienced a hematoma. The risk of pneumothorax is low. This complication has been reported in only one of our 850 patients who had undergone lipomodeling after postmastectomy latissimus dorsi breast reconstruction. Fat cells had been injected perpendicularly to the thorax wall to increase breast projection. The diagnosis of pneumothorax was confirmed radiographically after two episodes of oxygen desaturation (during and immediately after the surgical procedure). A pleural drain was inserted to restore normal saturation and the patient returned to her previous clinical condition, with no long-term consequences with respect to the results of lipomodeling. To prevent this complication, we recommend that fat grafting for improvement of periareolar projection should systematically be performed upward, in parallel with the chest wall, from two incisions made in the inframammary crease. There is a theoretical risk, often put forward by detractors of the procedure, that fat cells can be injected in a vessel and cause fat embolism. 36 To avoid this complication, it is advisable to use side-port cannulas and to perform injections while gently pulling the cannula off. No instance of fat embolism was encountered in our series of 850 patients. The major short-term complication is infection. However, there have been exceptionally few reports of infection (principally at the graft site) in the literature published on fat grafting for other indications. Chajchir and Benzaquen 34 reported no infection in their series of 253 patients. Of 145 patients treated by Fulton 37 (corresponding to 399 injections), only three developed infec- Patient Information Before Aesthetic Lipomodeling (Lipoaugmentation) Volume 29 Number 5 September/October

5 A C Figure 1. A, B, Preoperative views of a 28-year-old woman with bilateral hypotrophy associated to moderate tuberous breasts. C, D, Twelve months after two lipomodeling sessions (first session: 250 cc to the right breast, and 90 cc to the left; second session six months later: 320 cc to the right and 210 cc to the left). tion at the graft site. As for the 1350 patients treated by de Pedroza, 35 infection developed in only one (overall infection rate 0.07%), which resolved after the administration of antibiotics. We consider the best preventive strategy against infection to be strict asepsis and proper antibiotic prophylaxis during the procedure. There may be signs of infection, with local redness in the breast area. Removal of the graft suture may result in the loss of a little murky, fatty fluid, but the reaction is generally successfully controlled with antibiotics and the local application of ice. Only six of the first author s 850 patients have developed moderate, transient superficial infection in the breast area. One had an infection in the umbilical area (near the liposuction site), but the local redness promptly resolved with antibiotic therapy and ice. Long-term complications are mainly fat necrosis and irregular body shape at the donor site. Fat necrosis may occur when excess fat cells are forced into already saturated breast tissues, resulting in firm nodes possibly amenable to puncture. The radiologic aspect of necrosis varies from oil cysts to complex, multilocular, liquid or semisolid cystic masses, but necrotic lesions generally do B D not interfere with cancer diagnosis. 38 Puncture generally yields a thick, yellowish, acellular fluid. Fat necrosis is less frequent when the procedure is performed by experienced surgeons. The incidence decreases from 15% with inexperienced surgeons to 3% with more skilled ones (several hundred cases or more), provided that the two major principles of the grafting procedure namely, the use of a three-dimensional grid pattern and discontinuation of fat grafting when the tissues are saturated are satisfied. 1,7 Defects at the donor area may be caused by the irregular suction of fatty tissue. This is why we recommend performing a minilipoaspiration that smoothes the area and increases the patient s overall satisfaction with the procedure. The experience acquired with liposuction is a valuable asset for minimizing the risk of complications and achieving the best aesthetic results possible. The current recommendations correspond to the practice of experienced plastic surgeons working in optimal surgical conditions. It must be kept in mind that breast aesthetic lipomodeling is a full-fledged surgical operation, that it deserves the same care and attention as other plastic 390 Volume 29 Number 5 September/October 2009 Aesthetic Surgery Journal

6 surgery procedures, and that it must always be performed by a skilled plastic surgeon who is experienced with the technique. Defective Results. When the indication is appropriate and the procedure is performed correctly, breast lipomodeling provides real improvement and generally achieves the postoperative results that patients expect (Figure 1). In some cases, a second session, under general anesthesia, is necessary to improve the shape of the breast. Experience with breast reconstruction and reshaping makes it possible to predict (or at least imagine) the final result. The number of sessions may vary and the volume of fat deposits available for collection may also vary within reasonable limits. When two sessions are needed, the patient should be informed beforehand to avoid misunderstandings and disappointment. Similarly, she should receive detailed information on the costs incurred in order to eliminate all potential sources of financial disagreement. In some rare cases, local defects may still be observed, including local undercorrection, mild asymmetry, or irregular shape. Again, a second lipomodeling session performed under local anesthesia can be attempted when the result is stable (three or four months postoperatively). Addressing Fat Grafting and Breast Cancer Issues The Patient s Personal Risk of Developing Breast Cancer. In France, the risk for a woman to develop breast cancer is approximately one in Breast cancer screening and diagnosis are therefore major issues. The purpose of the initial work-up before lipomodeling is to confirm that there is no suspicion of breast cancer before initiation of the procedure, in order to minimize the risk of coincidence between cancer and fat grafting. Patients undergoing lipomodeling must be fully aware of their risk of breast cancer. The clinician can help them by using the Gail risk evaluation. 40 They must also be aware that the breast imaging work-up performed before lipomodeling is essential in determining the risk of concurrent malignancy. In addition, all patients must make a commitment to undergo imaging follow-up at one, two, and possibly three years postoperatively, depending on the recommendations of the radiologist. Finally, patients must be informed that, if they ultimately develop breast cancer, they will benefit from the same treatments as patients who are diagnosed under circumstances other than breast lipomodeling follow-up. Risk of Cancer Dissemination Caused by Fat Grafting. The potential risk of dissemination of cancer cells by fat grafting is similar to the risk attributable to cancer biopsies. The first needle core biopsies of cancer lesions provoked similar debate and there are now sufficient data to show that the risk of cell migration is important, with some studies reporting rates of migration as high as 30%. 9,38,41,42 It has even been shown that cancer cells are able to migrate to the axillary lymph nodes, but with few clinical or prognostic consequences for the patients. 43 The risk of displacement is principally related to the type of tumor and the time interval between biopsy and surgery. Other parameters, such as the volume or the grade of in situ or infiltrating carcinomas and lymph node involvement, have no significant impact on tumor cell migration. 41 The most invasive cancers are actually infiltrating lobular carcinomas, infiltrating ductal carcinomas, and in situ carcinomas. 41 Interestingly, the frequency of tumor displacement is inversely related to the time interval between biopsy and surgery. Sometimes, when patients undergo late surgery, no tumor cell is found. 44 These data suggest that, contrary to sarcoma or ovarian cancer cells that may give birth to a secondary tumor at the site of in - jection, breast tumor cells displaced by the needle are fragile and do not survive after the procedure. No correlation has been shown between tumor biopsy and re - currence. 45 It is clear from the literature that this mechanical transfer of cancer cells may lead to confusion in the interpretation of histologic data, such as the overestimation of the size of a small infiltrating carcinoma, the erroneous diagnosis of infiltrating carcinoma when cells from an in situ tumor are disseminated throughout the stroma, or even the erroneous diagnosis of lymph node involvement. As is the case for biopsies, it is reasonable to think that cells detached from a small tumor undetected by preoperative work-up and displaced by fat grafting will not survive after the procedure. Breast cancer cells are fragile and the dissemination of cancer by lipomodeling is therefore very unlikely, as confirmed by the case of one of our patients who underwent fat grafting for breast reconstruction. At the time of the procedure a local recurrence was developing in this patient; this had gone undiagnosed in the preoperative work-up. The local recurrence was detected soon after the procedure, and a mastectomy was performed. Histologic examination of the surgical specimen revealed no dissemination of the tumor to other quadrants of the breast. 9 These results should be confirmed on larger retrospective series of patients. Contribution of Lipomodeling to the Early Detection of Breast Cancer. As is generally the case with breast surgery, lipomodeling modifies the structure and therefore the radiologic aspects of the breast. One of the most debated issues is the risk that fat grafting might confuse radiologic screening tests and hinder breast cancer detection. In the authors experience, this risk is very low. Only one of our patients developed a breast tumor and she was treated quickly. 9 The procedure may even sometimes accelerate cancer detection because the patients undergoing lipomodeling are kept under strict radiologic control and close postsurgical follow-up. There are three major concerns when performing fat grafting to the breast: technical considerations, followup modalities, and the management of postlipomodeling breast modifications. Very few authors have explored the technical aspects of the procedure or the outcome of the fat cells grafted to the patient using strict methodologic criteria. Patient Information Before Aesthetic Lipomodeling (Lipoaugmentation) Volume 29 Number 5 September/October

7 There is no standardized procedure for fat grafting to the breast. Virtually every surgeon who performs this procedure uses a different technique. 46 Very little research has been done involving a large clinical series and most reports on fat necrosis describe isolated clinical cases. In addition, postlipomodeling swelling cannot be systematically attributed to fat necrosis. In our experience, modern fat grafting techniques induce little or no fat necrosis. 1,7 As mentioned previously, the development of any such necrosis 47 is probably a telltale sign of technical flaws during the procedure. Whatever the technique or the clinical situation, careful breast monitoring is mandatory: clinical examination, surveillance of lesions (such as occurrence of skin wrinkles, shrinkage, or palpable lumps, nipple retraction, and diffuse inflammatory reactions) and signs of progression (such as a malignant lesion not resolving spontaneously). Mammography remains the most accurate tool for breast cancer detection and screening. Based on equivocal mammography or ultrasound findings, some studies have banned the use of fat grafting for breast augmentation on the grounds that calcifications and fat necrosis might delay or prevent cancer detection and treatment. 48,49 In reality, mammography is a very sensitive tool and radiologists can generally distinguish calcifications caused by surgery from those that are indicative of breast cancer. 50 The clinical management of breast modifications is always the same, whether they occur after lipomodeling or in nonoperated breasts. The diagnosis of cancer must be confirmed histologically by percutaneous needle biopsy. Cytologic aspiration is simple and rapid, albeit with low sensitivity and specificity. Aspiration may yield acellular material of no diagnostic value and cannot be relied upon to determine tumor extension (either in situ or infiltrating lesions). Only needle biopsy can provide nearly as much information as surgical biopsy. This is why a needle biopsy should be systematically performed in all patients who present with swelling breast lesions or with atypical and probably malignant radiologic images. Our conclusion is that lipomodeling does not hinder early cancer diagnosis, especially when strict preand postoperative control is performed. On the contrary, we believe that lipomodeling could facilitate cancer detection over time. Our hypothesis is that when the procedure is performed correctly, the mammographic density of breast tissues decreases and screening for breast cancer becomes easier, thereby allowing for earlier detection of the disease. This hypothesis is supported by radiologists who believe that fat is their ally because the fat graft remains radiologically clear, which greatly enhances contrast and facilitates the detection of abnormalities. Confirmation of this hypothesis should be obtained from a large-scale study focusing on this issue. However, it should be impressed upon patients that radiologic examination of the breast has its limitations and, as reported in several of our patients, 9 the absence of radiologic evidence of cancer (on mammography, ultrasound, or MRI) is not necessarily equivalent to the absence of cancer. Approximately 8% of breast cancer patients have normal mammographic findings 51,52 and 3% have both normal mammographic and sonographic findings. 53 Protective Effect of Fat Grafting? Although we do not as yet have the observational evidence to prove it, our current research on fat-derived stem cells seems to indicate that these cells might exert some antitumor activity. If this intuitive expectation is confirmed by further study, it would show a possible protective role of fat grafting in defending against breast cancer. In addition, breast mammographic density is widely accepted to be an important independent risk indicator for the development of breast cancer and even represents a risk factor for cancer in itself. It seems logical to assume that reducing breast tissue density by grafting fat cells may also help reduce the risk, probably via an indirect positive effect on stromal cells, which are known to be largely involved in the development of breast cancer. Education of Breast Imaging Radiologists and Experts. Misinterpretation of the potential causal relationship between breast cancer and fat grafting is easy to understand. It is a common mistake to jump too quickly to conclusions based on outdated or erroneous information and there has long been a prejudice against fat grafting. The central issue seems to be the level of knowledge and training of experts and radiologists involved in breast imaging. On May 12, 2007 and June 7, 2008, two meetings that focused on breast imaging after plastic surgery and, more specifically, after breast lipomodeling ( Imagerie du sein et chirurgie plastique ) were organized in Lyon, France, for the purpose of sharing best practices among breast imaging radiologists. Experts unanimously confirmed that fat grafting to the breast is not responsible for errors or delays in breast cancer diagnosis. We believe that radiologists involved in the diagnosis of breast cancer (or of breast cancer recurrence when lipomodeling is intended for reconstruction after conservative cancer treatment) should be well-informed and trained specifically in the interpretation of breast images after fat grafting. Moreover, after a breast tumor has been diagnosed in a given patient, the radiologists should make sure that they introduce no unwarranted assumptions with respect to any causal connection between cancer and lipomodeling. Experts in plastic surgery and oncology should also receive the same training. They must have a sufficient scientific understanding of lipomodeling to convincingly discount the controversies that will inevitably occur again on this issue (because cooccurrence between cancer and fat grafting is relatively frequent and because so many cancer patients feel depressed and view their situation as unfair), and to refute the suggestion of a relationship between fat grafting and the occurrence or recurrence of breast cancer. This point is particularly important because many people remain wary of the pro- 392 Volume 29 Number 5 September/October 2009 Aesthetic Surgery Journal

8 cedure; any hostile, unfriendly, or inappropriate word from expert professionals might aggravate a situation (ie, an occurrence of breast cancer or relapse) that is already stressful for the patient and would serve only to exacerbate their distress. It is essential to avoid unnecessary alarmism and to preserve the peace of mind of both the patients and the physicians involved. 9 There is no reasonable basis to establish a correlation between the occurrence of breast cancer and a history of fat grafting to the breast. However, as the procedure is performed more often, the number of coincidences is obviously going to grow. This is why radiologists should be fully aware of the risk, be able to make an early diagnosis, and be able to adapt their communication accordingly. Providing Information on Other Issues of Interest Microcalcifications. Calcifications are a normal consequence of lipomodeling 2,9,10,38 and of any standard breast surgery. 23,58,59 A recent small series of 17 nonhomogeneous plastic surgery patients undergoing fat grafting for aesthetic enhancement or breast reconstruction found that 27% of patients had some sort of calcification. 58 Whatever the surgical procedure, calcifications have no diagnostic or therapeutic significance and are usually noncancerous. 23 There is no or little literature and virtually no systematic research on the occurrence of calcifications after lipomodeling. On the other hand, it has been shown that 50% of patients undergoing breast reduction surgery have calcifications within two years of the surgical procedure, 23 but it has never been suggested that breast reduction surgery might interfere with cancer diagnosis. Calcifications caused by fat cell necrosis are easily recognizable; these usually benign, dystrophic calcifications are easily distinguishable from calcifications indicating breast cancer. 23,59 Three different studies conducted by our group have assessed the radiologic impact of fat grafting in patients undergoing breast lipomodeling after latissimus dorsi flap reconstruction 10 for the correction of breast conservative treatment sequelae 2,9,38 or for the correction of breast deformity. All three studies have shown that lipomodeling has no deleterious consequences for breast follow-up or radiologic detection of malignancies. As reported above, the conclusion of the two meetings in May 2007 and June 2008 was that there is no increased risk of missing the diagnosis of cancer after fat grafting to the breast when the procedure is performed by a skilled surgeon. On the contrary, some of the experts, as mentioned above, even reported that fat is the radiologist s ally because the fat graft remains radiologically clear, therefore enhancing the contrast and facilitating the detection of abnormalities. Breastfeeding. There is currently no known contra - indication to breastfeeding after fat grafting. Because the surgeon uses autologous fat cells similar to those present in the natural breast, there is no risk of functional changes that would forbid breastfeeding. However, it must be noted that there are no statistical data available to back up this information. Describing Patient Follow-Up Patients must be aware of the necessity to have a complete imaging work-up before undergoing fat grafting in order to rule out the risk of concurrent malignancy. They must make a commitment to undergo imaging follow-up at one, two, and possibly three years postoperatively, as recommended by the radiologist. They must also arrange a visit with the surgeon after one year, making sure that the radiological follow-up has been correctly carried out. Careful breast follow-up with complete clinical and radiologic examination of the breasts is mandatory, independently of the clinical context (aesthetic or reconstructive surgery). Ensuring That Your Patient Fully Understands the Information Given In France, physicians are required to provide as much information as possible so that the patients can make an informed decision about their disease and treatments. In accordance with the code of public health, all patients are entitled to receive information and must be given an opportunity to participate in their own healthcare decision-making. No medical decision can be taken and no treatment can be started without free and voluntary agreement from the patient involved. This agreement can be cancelled at any time (law L , section 1). Each patient must receive clear and unequivocal information sufficient to enable her to weigh the risk benefit ratio associated with the procedure. To avoid hasty decisions, the law requires a cooling-off period before the patient can make any decision to participate. In accordance with French law, it is the responsibility of the surgeon to make sure that the patient fully understands the information delivered to her. How can surgeons show that the patient has both received and understood the information? As acknowledged by the law, there are many possible ways of proving that the information has been correctly delivered: the number of preoperative visits, length of the cooling-off period, consultations with the attending physician, letters to the patient, information sheets, or an informed consent form signed by the patient. It is essential that the patients be given a written information sheet before undergoing fat grafting. It is also desirable that they sign a discharge form to show that they have both read and understood the specific information delivered to them. Signing the form serves as both a legal protection for the surgeon and as a psychological deterrent against further unjustified claims from the patient. Providing an Accurate Cost Estimate As for any other plastic surgery procedure, French law requires that the surgeon provide a complete and detailed estimate of the costs incurred by patients. The estimate must also comply with all legal provisions relevant to the particular situation, notably the compulsory cooling-off period (15 days) between the drafting of the estimate and the start of the procedure. When a sec- Patient Information Before Aesthetic Lipomodeling (Lipoaugmentation) Volume 29 Number 5 September/October

9 ond session is necessary, the surgeon must produce a second estimate or, if the same document is used, the patient must give a second signature to confirm her agreement. Providing detailed and precise information on the costs incurred is useful for eliminating further sources of financial disagreement. CONCLUSIONS We have explored the different elements of information that must be given to the patients undergoing fat grafting. A precise report of current clinical applications and medical knowledge relating to fat grafting seems essential until the technique becomes more widely available for aesthetic breast lipomodeling. However, to ensure the accuracy and reliability of the information given, this state-of-the-art report will need to be updated periodically as processes and procedures are changed or upgraded. The key is to ensure that the patient understands that the surgeon s concern is accurate cancer screening and that caregivers will not to overlook potential signs of malignancy. The radiologic data gathered to date in patients undergoing reconstructive fat grafting to the breasts or the chest are satisfactory and encourage the extension of the procedure to aesthetic breast surgery, provided that it is based on a multidisciplinary collaboration between surgeons and skilled radiologists. It is reasonable to advocate the use of lipomodeling for aesthetic breast surgery as long as the patient undergoes a complete, specific radiologic evaluation before and one year after the procedure, and as long as a histologic biopsy is performed in cases where there is suspicion of cancer during follow-up. The data recorded over the years will also make it possible to perform multicentric retrospective studies in order to evaluate the quality and confirm the safety of the procedure. Clinical information is a tripartite process: the first person involved is the patient herself, as required by law; the second is the surgeon, who must possess solid and updated technical knowledge; and the third is the radiologist, who must be aware of the specific imaging features associated with fat grafting to the breast. The quality of the information process is crucial. The patient must acknowledge (with her signature) that she understands the purpose and possible risks and benefits of the procedure, and that she has received clear, complete, objective, evidence-based written information during her first visit with the surgeon. This is why the information sheet must be created with utmost care. The text of the patient information document provided in the Appendix (available online at has been carefully drafted and revised. It is readily available for use by the community of plastic surgeons when seeing patients who are candidates for breast lipo modeling. REFERENCES 1. Delay E, Delaporte T, Sinna R. Breast implant alternatives [in French]. Ann Chir Plast Esthet 2005;50: Delay E, Gosset J, Toussoun G, Delaporte T, Delbaere M. Efficacy of lipomodelling for the management of sequelae of breast cancer conservative treatment [in French]. Ann Chir Plast Esthet 2008;53: Hollos P. Breast augmentation with autologous tissue: an alternative to implants. Plast Reconstr Surg 1995;96: Van Landuyt K, Hamdi M, Blondeel P, Monstrey S. Autologous breast augmentation by pedicled perforator flaps. Ann Plast Surg 2004;53: Allen RJ, Heitland AS. Autogenous augmentation mammaplasty with microsurgical tissue transfer. Plast Reconstr Surg 2003;112: Glicenstein J. History of augmentation mammaplasty [in French]. Ann Chir Plast Esthet 2005;50: Delay E. Lipomodeling of the reconstructed breast. In: Spear SE, editor. Surgery of the Breast: Principles and Art, 2nd ed. Philadelphia: Lippincott, Williams and Wilkins; 2006: Delaporte T, Sinna R, Perol D, Garson S, Vasseur C, Delay E. Bilateral breast reconstruction with the autologous latissimus dorsi flap (a retrospective study of 31 consecutive cases) [in French]. Ann Chir Plast Esthet 2006;51: Gosset J, Flageul G, Toussoun G, Guérin N, Tourasse C, Delay E. Lipomodeling for correction of breast conservative treatment sequelae. Medicolegal aspects. Expert opinion on five problematic clinical cases [in French]. Ann Chir Plast Esthet 2008;53: Pierrefeu-Lagrange AC, Delay E, Guerin N, Chekaroua K, Delaporte T. Radiological evaluation of breasts reconstructed with lipomodeling [in French]. Ann Chir Plast Esthet 2006;51: Czerny V. Plastischer ersatz der brustdrüse durch ein lipom. Zentral Chir 1895;27: Lexer E. DeGesame wiederherstellugs-chirurgie. Leipzig: J Barth; Bames HO. Augmentation mammaplasty by lipo-transplant. Plast Reconstr Surg (1946) 1953;11: Longacre JJ. The use of local pedicle flaps for reconstruction of the breast after subtotal or total extirpation of mammary gland and for the correction of distortion and atrophy of the breast due to excessive scar. Plast Reconstr Surg (1946) 1953;11: Peer LA. The neglected free fat graft. Plast Reconstr Surg 1956;18: Bircoll M. Cosmetic breast augmentation utilizing autologous fat and liposuction techniques. Plast Reconstr Surg 1987;79: Bircoll M, Novack BH. Autologous fat transplantation employing liposuction techniques. Ann Plast Surg 1987;18: Hartrampf Jr CR, Bennett GK. Autologous fat from liposuction for breast augmentation. Plast Reconstr Surg 1987;80: Bircoll M, Linder RM. Fat autografting. Plast Reconstr Surg 1987;80: Breast augmentation by autologous fat injection. Plast Reconstr Surg 1987;80: Shons AR. Breast cancer and augmentation mammaplasty: the pre - operative consultation. Plast Reconstr Surg 2002;109: Bircoll M. Reply. Plast Reconstr Surg 1987;80: Brown FE, Sargent SK, Cohen SR, Morain WD. Mammographic changes following reduction mammaplasty. Plast Reconstr Surg 1987;80: Coleman SR. Long-term survival of fat transplants: controlled demonstrations. Aesthetic Plast Surg 1995;19: Coleman SR. Facial recontouring with lipostructure. Clin Plast Surg 1997;24: Delay E, Gounot N, Bouillot A, Zlatoff P, Rivoire M. Autologous latissimus breast reconstruction: a 3-year clinical experience with 100 patients. Plast Reconstr Surg 1998;102: Delay E, Gounot N, Bouillot A, Zlatoff P, Copmarin JP. Breast reconstruction with the autologous latissimus dorsi flap. Preliminary report of 60 consecutive reconstructions [in French]. Ann Chir Plast Esthet 1997;42: Delay E, Delaporte T, Jorquera F, El Berberi N, Vasseur C. Lipomodelage du sein reconstruit par lambeau de grand dorsal sans prothèse. Presented at the 46th Congress of the French Society of Plastic, Aesthetic and Reconstructive Surgery, Paris, France, October 17 19, Volume 29 Number 5 September/October 2009 Aesthetic Surgery Journal