Breast Augmentation Patients Research Articles

Motivational factors and psychological processes in cosmetic breast augmentation surgery

We investigated how and why prospective cosmetic breast augmentation patients decide to undergo such surgery. The results can offer important insights to plastic surgeons in addressing their patients' motives and expectations, and thereby avoiding potential patient dissatisfaction and disappointment. It is also a necessary first step to better understand the increasing tendency among women in the Western society to seek cosmetic breast augmentation. A qualitative, descriptive and phenomenological design was employed. Fourteen female prospective breast augmentation patients, aged 19-46 years, were recruited from a private plastic surgery clinic and interviewed in depth based on an informant-centred format. The interviews were tape-recorded, transcribed verbatim and coded and analysed phenomenologically using a QSR-N*Vivo software program. We detected four psychological processes associated with cosmetic breast augmentation surgery (create, improve, repair and restore). The data could further be categorised into one basic drive (femininity), six generating factors (appearance dissatisfaction, ideal figure, self-esteem, comments, clothes and sexuality) and five eliciting factors motivating the decision (media, knowledge of former patients, physicians, finances and romantic partner). These new insights into how and why women seek cosmetic breast augmentation may aid plastic surgeons in enhancing their communication with patients. This can be achieved by addressing the patient's psychological process and motives, and thereby better assist them in making the best decision possible in their particular situation. It may also lay the groundwork for future quantitative studies on the prevalence of certain motives for undergoing such surgery and, as such, help explain the increasing popularity of cosmetic breast-augmentation surgery.

Contralateral Pain Reduction in Augmentation Mammaplasty Using Pain Control Catheters and Controls

, Kazmier et al. describe their findings of a prospective, double-blind, controlled trial comparing a continuous pain pump on one side to controls involving the opposite side ina series of augmentation mammaplasty patients. They concluded that “the pain pump appears to provide breastaugmentation patients marginal improvement in pain control, although this advantage did not reach statisticalsignificance in this study.”The lukewarm results in this study may be attributable to the effects of local anesthesia on one side, causing areduction of pain on the opposite side. This was noted in our study comparing bolus anesthesia administrationin one breast to a continuous flow catheter on the opposite side.

A Prospective, Multi-Center Study of Psychosocial Outcomes After Augmentation With Natrelle Silicone-Filled Breast Implants

Psychosocial outcomes are believed to be a critical factor in determining the success of cosmetic surgery, but little research has focused on measuring these factors in breast augmentation patients. In the multicenter study for FDA approval of Natrelle silicone-filled breast implants, 455 augmentation patients completed paper and pencil measures of body image, self-esteem, and quality of life before implantation and at 1, 2, 4, and 6 years postimplantation. Subjects' satisfaction with their implants was uniformly high throughout the follow-up period, from 99% in the month after implantation to 95% at 6 years. Satisfaction with breast size, shape, and feel improved significantly postimplantation and continued through 6 years. Significant improvements in body image were found postoperatively and remained throughout the study. Improvements in health-related quality of life, however, were not observed. Results provide additional information on patient satisfaction and improvement in body image that typically occur after breast augmentation.

Efficacy of Pocket Irrigation With Bupivacaine and Ketorolac in Breast Augmentation

Breast augmentation is the most common cosmetic surgery procedure performed in the United States. The optimal approach to postoperative pain management in these patients, however, has yet to be determined. The objective of this study was to investigate the efficacy of pocket irrigation with bupivacaine and ketorolac in reducing pain, narcotic use, and methocarbamol use following subpectoral breast augmentation. A prospective, double-blinded, randomized trial was performed. Fifty primary breast augmentation patients were randomized to 1 of 2 treatment groups: 1) pocket irrigation with bupivacaine and ketorolac, and 2) no pocket irrigation. Patients who received pocket irrigation had significantly lower Visual Analog Pain Scores in the early postoperative period (1 and 6 hours postoperatively). There was no difference in early postoperative narcotic use in patients who received pocket irrigation and those who did not. Patients who received pocket irrigation, however, reported higher narcotic use at 1-3 days following surgery. There was no difference in postoperative methocarbamol use between patient groups. This study suggests that pocket irrigation with bupivacaine and ketorolac can significantly decrease patient-reported pain in the early postoperative period following subpectoral augmentation. It also demonstrates, however, that there is an increased requirement for narcotics between 1-3 days after surgery. These findings suggest that intraoperative administration of analgesics into the implant pocket may thus facilitate an early postoperative recovery; yet, patients should be advised that they might require more pain medication at home for the first few days.

Indications for Extra Full Projection Anatomical Cohesive Silicone Gel Implants in Cosmetic and Reconstructive Breast Surgery

In 2003, a new extra full projection (EFP) anatomic cohesive silicone gel breast implant was introduced onto the European market. This review presents the early experience of a single surgeon with this new implant over a 29-month period. Between 2003 and 2006, the McGhan Style 410 EFP breast implants were inserted for highly selected indications. Twenty-eight patients received a total of 47 EFP implants. Their age range was 23 to 66 years (mean: 46 years). The implant was used in 6 primary and 7 revisional cosmetic breast augmentation patients. The series included 9 postmastectomy breast reconstructions. In further, 6 patients the implant was used to revise existing breast reconstructions. After a mean follow-up period of 31 months, there were no infections, malrotations, or significant capsular contractures and no patients have required revisional implant surgery. The novel implant was successfully used to address specific challenges in cosmetic and reconstructive breast surgery. These included large skin envelopes in breast augmentation patients declining mastopexy, complicated implant exchanges, and suboptimal prosthetic breast reconstructions. This prosthesis may prove a useful addition to the range of breast implants available, especially when there is an overlap of challenging esthetic problems.

Filling of Adjustable Breast Implants Beyond the Manufacturer’s Recommended Fill Volume

Adjustable breast implants are widely used for both reconstructive and cosmetic breast surgery. They provide unique postoperative versatility and allow for more effective management of numerous conditions that would otherwise require surgical intervention. Findings have shown that in a clinical setting, it often is necessary to overexpand saline implants beyond the manufacturer's recommended fill volumes for positive results and optimal patient satisfaction. The authors investigated their breast-augmentation patients, comparing implants expanded beyond the manufacturer's fill volume with implants that remained within the recommended parameters. A total of 138 patients (270 implants) undergoing breast augmentation mammoplasty with Smooth Round Spectrum implants were evaluated postoperatively. To determine the effects of overexpansion, the incidence of leakage was assessed as well as the possibility of increased firmness. Patients completed a satisfaction questionnaire. The findings showed no evidence of increased leakage with implants expanded beyond recommended fill volumes, and 97% of the patients reported a perfect score for satisfaction ratings. Of the 270 implants evaluated in the study, only 7 were given a less than perfect score. By exceeding the recommended fill volume, the authors were able to use the implant to its maximal potential, with increased patient satisfaction. The authors were able to correct problems and avoid complications that could not have been resolved without deviating from the manufacturer's recommended fill volumes. Nonvalidated restrictions on fill volumes severely limit the efficacy of adjustable implants.

A Prospective, Randomized, Double-Blind, Controlled Trial of Continuous Local Anesthetic Infusion in Cosmetic Breast Augmentation

Narcotic pain medications are a significant component of most postoperative pain control regimens. Although they are usually effective, they produce several untoward side effects and sometimes provide inadequate analgesia. The continuous infusion of local anesthetic agents (via pain pump) has been used to supplement narcotic analgesics after various surgical procedures. The purpose of this study was to examine the effectiveness of the pain pump after cosmetic breast augmentation. Twenty-five women were enrolled in the study; five were eliminated from analysis because of data inadequacy or device problems. After bilateral augmentation, the remaining 20 patients received a 4-day continuous infusion of bupivacaine in one breast pocket and saline in the other. Laterality of bupivacaine infusion was randomized and blinded to both the patient and the surgeon. Patients completed a questionnaire on postoperative days 1, 2, 3, 4, and 7, rating their pain on a scale of 0 to 10, with 10 being worst. On postoperative day 1, the mean pain score was 4.7 on the bupivacaine side versus 5.4 on the saline side (p = 0.36). On postoperative days 2, 3, 4, and 7, the mean scores were 4.3 versus 4.6 (p = 0.63), 3.3 versus 3.8 (p = 0.50), 3.4 versus 3.6 (p = 0.78), and 3.4 versus 3.1 (p = 0.63) for the bupivacaine and saline sides, respectively. The pain pump appears to provide breast augmentation patients marginal improvement in pain control, although this advantage did not reach statistical significance in this study. The benefit, if real, also appears to wane over the first postoperative week.

Locally Administered Ketorolac and Bupivacaine for Control of Postoperative Pain in Breast Augmentation Patients: Part II. 10-Day Follow-Up

Previously, it was shown that locally applied intraoperative ketorolac and bupivacaine significantly reduced pain in the recovery room. The objective of this study was to test the effectiveness of the same solution over the first 10 days. This study was a prospective, randomized, double-blind clinical trial with ethical approval. Fifty submuscular breast augmentation patients were enrolled, and informed consent was obtained. Standard anesthetic and surgical protocols were followed. Either normal saline or ketorolac and bupivacaine (30 mg and 150 mg, respectively) were placed into the pocket. The power of this study to detect a 20 percent difference was 0.90, and values of p < 0.05 were considered significant. The primary outcome was pain measured with the visual analogue pain scale recorded in a take-home diary. The secondary outcome was codeine usage. Forty-five patients completed the study. Of the patients who did not, three were in the normal saline group (n = 22) and two were in the ketorolac-bupivacaine group (n = 23). The ketorolac-bupivacaine combination significantly reduced pain over the first 5 days. By the tenth day postoperatively, the effect had dissipated. These patients also used less codeine. There were no significant complications. Locally applied, intraoperative ketorolac and bupivacaine significantly reduced pain for 5 days after surgery in women who had undergone primary breast augmentation.

Textured Surface Breast Implants in the Prevention of Capsular Contracture among Breast Augmentation Patients: A Meta-Analysis of Randomized Controlled Trials

Textured Surface Breast Implants in the Prevention of Capsular Contracture among Breast Augmentation Patients: A Meta-Analysis of Randomized Controlled Trials

Long-Term Cosmetic Outcome After Breast Implantation

All women who underwent breast augmentation at 1 public and 1 private clinic in Denmark from 1973 to 1988, and available for follow-up, were invited to participate in a clinical study including a self-administered questionnaire, medical record abstraction, and a clinical examination. One hundred ninety (52%) out of 368 eligible women participated. Mean time with implants in situ was 19 years (range, 5-35). Sixty-one percent of the women had 1 implantation, 23% had 2 implantations, 16% had 3 or more implantations. Nineteen women (10%) had no implants at the time of examination. A large proportion of the women (62%) had clinically significant capsular contracture, and only half of the study women were found to have satisfactory overall breast appearance at examination. In contrast, the majority of women reported satisfaction with their implant surgery (60%). The women tended to grade themselves more positively than the examining physicians.

The Psychological Aspects of Cosmetic Breast Augmentation

The psychological aspects of cosmetic breast augmentation have been the focus of a great deal of empiric study over the past 40 years. Studies investigating the preoperative characteristics and psychosocial status of women interested in breast augmentation are reviewed. Investigations of postoperative satisfaction and psychosocial changes are discussed. The results of the seven epidemiologic studies that have identified a relationship between cosmetic breast augmentation and suicide are detailed. Methodologic limitations of the studies investigating the preoperative psychosocial status of breast augmentation candidates make it difficult to draw firm conclusions about the potential psychological differences between these women and those not interested in breast augmentation. Postoperative satisfaction rates are high, and several studies suggest that patients experience improvements in body image following surgery. The effects of breast augmentation on other areas of psychological functioning are less clear. Based on the seven epidemiologic studies published to date, the suicide rate among women with cosmetic breast implants is two to three times the expected rate. The literature in this area should be used to guide the psychosocial assessment and management of cosmetic breast augmentation patients. There currently is little evidence to support a recommendation that all women who present for cosmetic breast augmentation be required to undergo a psychiatric evaluation before surgery. Given the relationship between breast implants and suicide, however, it is recommended that women with a history of psychopathology who present for breast augmentation, or those who are suspected by the plastic surgeon of having some form of psychopathologic abnormality, should undergo a mental health consultation before surgery.

Is Reoperation Rate a Valid Statistic in Cosmetic Surgery?

“Beauty in things exists merely in the mind which contemplates them.” —David Hume Reoperation rates are being introduced into the plastic surgery literature and marketing as a basis for judging the effectiveness of a surgical procedure, the safety of an implantable device, and even the quality of an individual surgeon. They may have value in some medical procedures where results and complications are purely objective, but in cosmetic surgery, there is a subjective component to the indication for secondary surgery that can affect reoperation rates. In cosmetic surgery, there are two primary indications for secondary surgery. First, as in all surgery, there is the occurrence of a true, recognized complication, such as a hematoma or an infection. These complications are generally irrefutable and a second operation is usually mandatory. Although complications such as these can happen even with the best care, a high reoperation rate due to complications is an objective measure that a problem exists. Second, there are indications for reoperation that are subjective in nature, and whether a particular patient ever has a secondary surgery can be affected by a variety of factors. As the old saying goes, “beauty is in the eyes of the beholder,” and this, too, is true for the aesthetic quality of a surgical result. We have all experienced the postliposuction patient who wants a little more fat removed or a breast augmentation patient who wants to be a little bigger. These are subjective aesthetic issues that may or may not lead to reoperation, based on a variety of factors. First, the surgeon must agree with the patient's concerns, believe that secondary surgery can improve the result, and be willing to reoperate. While one surgeon may have a higher rate of secondary surgery simply by trying to attain a more perfect result, another may choose to avoid reoperations. Patients may be discouraged from revisional surgery in other ways. For example, a surgeon's financial policy that makes reoperation costly may prevent the patient from having a revision (at least with that surgeon). Insurance companies have clearly demonstrated the effectiveness of financial disincentives in the use of copayments and deductibles. The surgeon may also dissuade the patient by overemphasizing the risks of reoperation. We all know the influence we, as physicians, can have in patients' decision making. In addition, there are some complications that may have subjective indications for reoperation. Capsular contracture is the perfect example. A patient may have firm breasts, but her breasts might maintain an attractive appearance. The patient may complain about the firmness, and the surgeon may choose to address it surgically or may advise the patient to avoid surgery. If the patient does not undergo corrective surgery, the reoperation rate will not reflect this complication, despite its presence. In cosmetic surgery, the aesthetic success of a procedure is subjective, and thus the indications to revise that surgery for cosmetic reasons are also subjective. The existence of an indication for secondary surgery only translates to a “reoperation” if the patient undergoes surgery. Reoperation rates may be artificially high or low based on a surgeon's assessment of the result, practice policy, and personal philosophy. Therefore, comparing reoperation rates for cosmetic procedures is not a valid analysis of the safety or efficacy of an operation, device, or surgeon.

Effect of Bupivacaine (Marcaine) Injection into the Breast Pocket on Postoperative Pain in Patients Undergoing Augmentation Mammoplasty

Introduction: Bupivacaine (Marcaine) is known to be an effective local anesthetic agent. The question arises as to whether there is a role for placing this anesthetic into the breast implant pocket in breast augmentation surgery to achieve a greater degree of postoperative pain relief. The purpose of this study was to test the effectiveness of locally administered intraoperative bupivacaine into the breast pocket during augmentation mammoplasty. Materials and Methods: The study group consisted of 62 consecutive female breast augmentation patients ranging in age from 17 to 58 years. The clinical trial took place between December 2003 and March 2005 and was conducted in a prospective, randomized, double-blinded fashion using patient opinion on a postoperative pain scale rated from 1–10. Bupivacaine (150 mg) was placed into the implant pocket of the random test side after implant insertion, while no anesthetic was placed for the control group. Data were collected at time points of 0, 1, 3, and 6 hours after surgery as well as 1 week following surgery. The 0-hour data point was collected as soon as the patient was alert at the end of the procedure. Data were analyzed using paired t tests with the Bonferroni correction applied. Results: Based on the 10-point pain scale, the only statistically relevant difference occurred at the 1-hour postoperative time point, at which the mean pain level for the bupivacaine injected side was 3.0, while the mean pain level for the noninjected side was 4.2 with a P value of .01. There were no dropouts in the study. No hematomas or complications requiring reoperation were noted. Conclusion: The use of locally injected bupivacaine into the breast pocket during breast augmentation may be beneficial in alleviating some of the postoperative pain associated with augmentation mammoplasty.

PR50 TANSAXILLARY ENDOSCOPIC BREAST AUGMENTATION

Transaxillary endoscopic breast augmentation is a very attractive option for women who desire increased mammary volume and projection but do not want a scar on their breasts. For primary augmentations, the procedure offers advantages over the traditional blunt axillary technique due to direct visualization and precise pectoralis muscle dissection and hemostatis. While the technique has been performed for submuscular and subglandular placement, the procedure has been most commonly used over the past decade with saline implants in the submuscular position. Smooth and textured silicone implants can also be used via transaxillary access into a subpectoral location. The results have been satisfactory with improved placement and a reduction incomplications associated with traditional transaxillary augmentation including hematoma, capsular contracture and implants which are positioned too high.Methods Transaxillary endoscopic breast augmentation was performed under general anesthesia with the patient in a prone position with arms are abducted to ninty degrees. Local anesthesia with epinephrine was injected into the axillary incision and in the soft tissue overlying the anterior axillary fold for hemostasis. A 2–3 cm incision (4–5 cm when silicone implants are used) was placed in the axilla in one of the natural folds within the hair‐baring zone. Dissection was carried out infero‐medially until the lateral edge of the pectoralis major was identified. Under direct visualizaion, the pectoralis fascia was divided with scissors and the subpectoral space entered. The subpectoral pocket was initially created bluntly with an Agris Dingman retractor to create a bloodless optical cavity without avulsing any muscle. The endoscope and retractor were inserted and the undersurface of the pectoralis muscle was divided with the Bovie electrocautery. The infero‐medial quadrant of pectoralis muscle was partially released from the chest wall. The prepectoral fascia, however was preserved to prevent synmastia, inferior implant migration and palpability. Pocket irrigation and hemostasis were performed. When saline implants were used, the device was rolled, inserted and inflated to the desired volume. When silicone devices were used, the tunnel was bluntly widened with Ashe forceps. A marcaine pain pump can be placed in the pocket for postoperative pain control.Results Over 12 years 384 primary breast augmentations have been performed using this method by the senior author. Over 90% of the implants were Mentor smooth round saline implants. The average patient age was 30. High or excellent levels of patient and surgeon satisfaction was present in over 95%. Complications requiring re‐operation were present in less than 2% of patients. The rate of long‐term revision was capsular contracture in 5%. The most common cause of revision was asymmetry or desire to be larger.Conclusions Transaxillary Endoscopic breast augmentation is an attractive option for the primary breast augmentation patient which avoids placement of a scar directly on the breast. The advantages are for patients with no ptosis or inframammary fold within which to hide the scar or breasts with a small areolar diameter. Additional advantages include controlled and precise surgical dissection and hemostatis which have reduced the complications associated with traditional blunt transaxillary techniques. Potential disadvantages may include the need for a second inframammary scar if reoperative surgery is required, theoretical interference with sentinel lymph node dissection if required in the future, and the additional technical equipment required to perform the procedure.

Textured Surface Breast Implants in the Prevention of Capsular Contracture Among Breast Augmentation Patients: A Meta-Analysis of Randomized Controlled Trials

Textured Surface Breast Implants in the Prevention of Capsular Contracture Among Breast Augmentation Patients: A Meta-Analysis of Randomized Controlled Trials

A Review of Psychological Outcomes and Suicide in Aesthetic Breast Augmentation

Aesthetic surgery is an essential component of plastic surgery and has become increasingly popular in American society. In 2002, 1.8 million surgical cosmetic procedures were performed in the United States, representing a 294 percent increase from 1992. The 1992 U.S. Food and Drug Administration moratorium on silicone breast implants arose in response to numerous reports of connective tissue disease associated with silicone gel breast augmentation and has led to a decade-long battle over the safety of silicone breast implants that continues today. Numerous scientific and epidemiologic studies of the past decade have established that there is no association between silicone breast prostheses and systemic disease. Recently, a new front has opened in the conflict regarding the safety of breast augmentation: the psychological impact of breast augmentation. Quality studies assessing the psychological characteristics of breast augmentation patients and the psychological impact of breast augmentation surgery are few and most studies are flawed in their methods. Recent reports have provided corroborating evidence to support the psychological benefits of cosmetic surgery and breast augmentation. New reports citing an increased risk for suicide among women with breast implants have brought renewed concerns but are unable to demonstrate a cause-and-effect relationship between breast implants and suicide. The present challenge is to determine whether the increased risk reported in epidemiologic studies is falsely associated with breast implants or whether it represents underlying risk factors or psychopathology in women undergoing breast augmentation that puts them at increased risk for suicide. The purpose of this article is to review the literature regarding the psychological impact of breast augmentation and assesses current scientific findings, with emphasis on the validity of suicide risk in breast augmentation patients.

Importance of the New Position of the Nipple-Areola Complex in Breast Augmentation Surgery

When the results of breast augmentation surgery are evaluated, the respective points of view of the surgeon and the patient can differ. Because of the nature of plastic surgery, evaluation of the results puts more emphasis on the patient's satisfaction than on medical knowledge. Among the patients who are satisfied with the size of their breasts after breast augmentation surgery, the factor that affects their satisfaction with their breast shape is the position of the nipple-areola complex. This is because the relative position of the nipple-areola complex on the inserted implant makes the most apparent change. Therefore, the relative position of the nipple-areola complex on the implant can be seen as one of the most important standards in evaluating the results. Using a standardized protocol and standards based on analysis of the measurements of 100 patients (200 nipples), the author divided breast augmentation patients according to position of the nipple-areola complex. The operations were planned with this factor as the central consideration. The author also provided preoperative education to each group. Between January 1, 2001, and July 31, 2004, 368 patients were divided into four types based on the position of the nipple-areola complex when the patient was in the upright position. By performing the operations based on the nipple-areola complex, according to individual characteristics, predictable and desirable postoperative results were obtained.

Achieving a Predictable 24-Hour Return to Normal Activities after Breast Augmentation: Part II. Patient Preparation, Refined Surgical Techniques, and Instrumentation

The goal of this study was to develop practices that would allow patients undergoing subpectoral augmentation to predictably return to full normal activities within 24 hours after the operation, free of postoperative adjuncts. Part I of this study used motion and time study principles to reduce operative times, medication dosages, perioperative morbidity, and recovery times in augmentation mammaplasty. Part II of the study focuses on details of patient education, preoperative planning, instrumentation, and surgical technique modifications that were identified, modified, and implemented to achieve the results reported in part I. Two groups of 16 patients each (groups 1 and 2) were studied retrospectively for comparison to a third group of 627 patients (group 3) studied prospectively. Patients in group 1 had axillary partial retropectoral breast augmentations in 1982-1983, using dissociative anesthesia, blunt instrument implant pocket dissection, and Dow Corning, double-lumen implants containing 20 mg of methylprednisolone and 20 cc of saline in the outer lumen of the implants. Patients in group 2 (1990) had inframammary, retromammary augmentations by using a combination of blunt and electrocautery dissection, Surgitek Replicon polyurethane-covered, silicone gel-filled implants, and general endotracheal anesthesia. Patients in group 3 (1998 to 2001, n = 627) had inframammary partial retropectoral, inframammary retromammary, and axillary partial retropectoral augmentations under general endotracheal anesthesia. Refined practices and surgical techniques from studies of groups 1 and 2 were applied in group 3. Videotapes from operative procedures of groups 1 and 2 were analyzed with macromotion and micromotion study principles, and tables of events were formulated for each move during the operation for all personnel in the operating room. Extensive details of surgical technique were examined and reexamined in 13 different stages by using principles of motion and time studies described in part I of this study to maximize efficiency without any change in quality. Unnecessary or unproductive motions and techniques were progressively eliminated, and essential, productive techniques were streamlined to eliminate wasted time and motion. Instrumentation and surgical techniques were evaluated in detail and modified to minimize bleeding and tissue trauma. Detailed data were presented in part I of this study that document shorter operative times, recovery times, time to discharge home, and time to return to normal activities. This part focuses on the patient education, preoperative planning, instrumentation, and surgical technique changes that were implemented on the basis of the findings in part I of the study. More extensive patient information integrated with staged informed consent resulted in a more in formed and confident patient. Applying motion and time study principles to analysis and refinement of instrumentation and surgical techniques resulted in a substantial reduction in perioperative morbidity and a simpler, shorter 24-hour return to full normal activity for 96 percent of the patients undergoing breast augmentation in group 3 compared with groups 1 and 2. More than 96 percent of patients in group 3 were able to return to normal activities, lift their arms above their heads, lift normal-weight objects, and drive their car within 24 hours after their partial retropectoral breast augmentation. Patient education, preoperative planning, instrumentation, and surgical technique modifications based on motion and time study video analyses reduced surgical trauma and bleeding, reduced perioperative morbidity, and allowed 96 percent of 627 breast augmentation patients in group 3 a predictable return to full, normal activity in 24 hours or less. Specific surgical factors that contributed to these results included (1) prospective hemostasis techniques with a zero tolerance for even the smallest amount of bleeding, (2) strict "no-touch" techniques for periosteum and perichondrium, (3) eliminating all blunt dissection, (4) performing all dissection under direct vision, (5) modified and simplified instrumentation, and (6) optimal use of muscle relaxants during subpectoral dissection.

Achieving a Zero Percent Reoperation Rate at 3 Years in a 50-Consecutive-Case Augmentation Mammaplasty Premarket Approval Study

Excessively high reoperation rates in breast augmentation premarket approval studies are a major concern of patients and the U.S. Food and Drug Administration. Over the past two decades, reoperation rates have remained between 13 and 20 percent at 3 years in three different premarket approval studies for three different types of implant devices, indicating that high reoperation rates are not device dependent. The hypothesis of this study was that implementing specific peer-reviewed and published processes can significantly reduce reoperation rates in a premarket approval study. Fifty consecutive primary breast augmentation patients were enrolled in a premarket approval study for the Inamed Style 410 form stable, cohesive gel implant. All patients were treated specifically according to the premarket approval protocol. The series was monitored throughout the study by an independent clinical review organization and by a U.S. Food and Drug Administration inspection of the patient records on site at the author's practice. Specific content and processes were applied to patient management in patient education and informed consent, patient and surgeon decision-making processes, preoperative assessment and operative planning, implant selection based on individual patient tissue characteristics, surgical techniques, and postoperative care techniques. Follow-up was 100 percent (50 of 50 patients) at 1 year, 98 percent (49 of 50 patients) at 2 years (one patient could not be reached), and 94 percent (47 of 50 patients) at 3 years. No reoperations were performed on any patient followed at 3 years in the 50-consecutive-patient series. Implementing the peer-reviewed and published processes described in this study, no reoperations were performed in a prospective 50-consecutive-case series of primary augmentation mammaplasty patients in a premarket approval study with 94 percent follow-up at 3 years.

Validation of the Breast Evaluation Questionnaire for Use with Breast Surgery Patients

: Reliable and valid assessment instruments in aesthetic surgery are a vital factor in assessing patient satisfaction with physical appearance. Appearance and satisfaction assessments are needed to adequately evaluate quality of life related to changes in the female breast across a variety of surgical interventions. The Breast Evaluation Questionnaire was designed to assess satisfaction with breast attributes. : The Breast Evaluation Questionnaire is a 55-item assessment that was validated on 1244 women seeking augmentation mammaplasty. : Subscales of the Breast Evaluation Questionnaire include comfort not fully dressed, comfort fully dressed, and satisfaction with breast attributes. The questionnaire has been demonstrated to be valid and reliable for assessing these factors. : The assessment is easy to administer and interpret and is recommended for assessing outcomes among breast augmentation patients, breast reconstruction patients, mastectomy patients, lumpectomy/breast-sparing surgery patients, breast reduction patients, and patients who have sustained trauma or injury to their breasts.