Clinical Results of Mentor MemoryGel Xtra Breast Implants From the GLOW Clinical Trial.

BACKGROUND: Mentor MemoryGel Xtra breast implants (Mentor Worldwide LLC, Irvine, CA) were designed to maintain the soft, natural feel of MemoryGel implants while increasing fullness and projection and minimizing wrinkling, rippling, and related complications through optimization of shell gel-fill. OBJECTIVES: To measure 3-year safety and effectiveness of MemoryGel Xtra breast implants in the Mentor MemoryGel and MemoryShape Combined Cohort Clinical Study. METHODS: Participants were implanted with MemoryGel Xtra breast implants in a prospective, multicenter clinical trial. Rates of complications and reoperations were analyzed to assess device safety and BREAST-Q was employed to assess device effectiveness. RESULTS: Two hundred eighty-seven females receiving MemoryGel Xtra breast implants were enrolled. Complication rates in the primary augmentation cohort included rates of 1.5% for implant-related reoperation, 2.3% for explantation, and 1.5% for Baker grade III or IV capsular contracture. For the revisional augmentation cohort, these rates were 2.8% for implant-related reoperation, 4.3% for explantation, and 3.0% for capsular contracture. For the primary reconstruction cohort, these rates were 12.0% for implant-related reoperation, 12.3% for explantation, and 7.3% for capsular contracture. For the revisional reconstruction cohort, these rates were 7.1% for capsular contracture, with zero implant-related reoperations or explantations. There were no reports of infection or implant malposition or displacement in any of these cohorts. Each cohort showed significantly improved satisfaction with breasts and psychosocial and sexual well-being at 1 year following the primary procedure. CONCLUSIONS: These data are consistent with legacy clinical data for MemoryGel and provide the first published safety and effectiveness data regarding the use of MemoryGel Xtra breast implants for breast augmentation and reconstruction.

A 16-Year Review of Clinical Practice Patterns in Liposuction Based on Continuous Certification by the American Board of Plastic Surgery.

BACKGROUND: The American Board of Plastic Surgery has collected data on cosmetic surgery tracers as part of the Continuous Certification process since 2005. The current study was performed to analyze evolving trends in liposuction from the American Board of Plastic Surgery database. METHODS: Tracer data from 2005 through 2021 were reviewed and grouped into an early cohort (EC) (2005-2014) and a recent cohort (RC) (2015-2021). Fisher exact tests and two-sample t tests were used to compare patient demographics, techniques, and complications. RESULTS: A total of 2810 suction-assisted liposuction cases were included (1150 EC, 1660 RC). In-office procedures increased (36% EC versus 41% RC). The use of general anesthesia remained the same (63% EC versus 62% RC). The use of power-assisted liposuction increased (24% EC versus 40% RC) and use of ultrasound-assisted liposuction decreased (5% versus 2%). With respect to body areas treated, liposuction of the abdomen (64% EC versus 69% RC), flanks (60% EC versus 64% RC), and back (22% EC versus 34% RC) increased; treatments of thighs (36% EC versus 23% RC), and knees (8% EC versus 5% RC) decreased. Intraoperative position changes are more common (30% EC versus 37% RC), as is liposuction of multiple areas in one case (28% EC versus 36% RC). The volume of lipoaspirate also increased (1150 cc EC versus 1660 cc RC). CONCLUSIONS: This study highlights evolving trends in liposuction over 16 years. Liposuction is becoming more common as an outpatient procedure performed concomitantly with other procedures. Despite multiple emerging technologies, the popularity of power-assisted liposuction is increasing. Although adverse events have not significantly increased with these changes, the authors stress careful preoperative evaluation of patients to identify factors that increase the risk of complications.

Understanding the Basics of Restrictive Covenants in Employment Agreements.

BACKGROUND: Restrictive covenants are common in contractual agreements involving physicians and need careful consideration to minimize potential conflict during the term of the contract and on physician departure from a group practice or hospital system. METHODS: A general overview of the different components of restrictive covenants is provided, including specific information related to noncompetes, nonsolicitations, and nondisclosure agreements. RESULTS: In general, states will uphold restrictive covenants if the elements of the noncompete are reasonable regarding geographic distance restrictions (e.g., <20 air miles), time restrictions (e.g., <2 years), and scope of services. However, states vary considerably in the interpretation of restrictive covenants. Other components of the contract, such as alternative dispute resolution (mediation and/or arbitration) and buy-out clauses (i.e., liquidated damages provisions), should be considered at the time the agreement is negotiated. CONCLUSIONS: States are balancing the protection of business interests with the protection of free trade. It is important that physicians seek counsel with an experienced health care attorney with respect to restrictive covenants in his or her specific state. A simple, well-written, and reasonable restrictive covenant can often help limit legal conflict and expense.

Measuring Outcomes in Cosmetic Abdominoplasty: The BODY-Q.

The BODY-Q is a condition-specific patient-reported outcome measure that enables a comprehensive assessment of outcomes that are specific to patients undergoing body contouring procedures such as abdominoplasty. The BODY-Q scales were designed to be responsive to the effects of abdominoplasty on health-related quality of life and appearance outcomes. The BODY-Q covers a range of content domains, and the independently functioning scales enable surgeons to tailor the BODY-Q to their needs. The application of the BODY-Q in cosmetic clinics internationally may give rise to better understanding of abdominoplasty outcomes and optimize the care delivered to patients undergoing these procedures.

The BODY-Q: A Patient-Reported Outcome Instrument for Weight Loss and Body Contouring Treatments.

BACKGROUND: Body contouring performed for cosmetic purposes, or after weight loss, has the potential to improve body image and health-related quality of life (HRQL). The BODY-Q is a new patient-reported outcome (PRO) instrument designed to measure patient perceptions of weight loss and/or body contouring. In this article, we describe the psychometric properties of the BODY-Q scales after an international field-test. METHODS: Weight loss and body contouring patients from Canada, United States, and United Kingdom were recruited between November 2013 and February 2015. Data were collected using an iPad directly into a web-based application or a questionnaire booklet. Rasch measurement theory analysis was used for item reduction and to examine reliability, validity, and ability to detect change. RESULTS: The sample included 403 weight loss and 331 body contouring patients. Most BODY-Q items had ordered thresholds (134/138) and good item fit. Scale reliability was acceptable, ie, Person separation index >0.70 for 16 scales, Cronbach α ≥0.90 for 18 of 18 scales, and Test-retest ≥0.87 for 17 of 18 scales. Appearance and HRQL scores were lower in participants with more obesity-related symptoms, higher body mass index, and more excess skin and in those pre- versus postoperative body contouring. The 134 weight loss patients who completed the BODY-Q twice, either 6 weeks (weight loss/nonsurgical body contouring program) or 6 months (bariatric program) later, improved significantly on 7 appearance and 4 HRQL scales. CONCLUSION: The BODY-Q is a clinically meaningful and scientifically sound patient-reported outcome instrument that can be used to measure outcomes in patients who undergo weight loss and/or body contouring.

Self-Report Scales to Measure Expectations and Appearance-Related Psychosocial Distress in Patients Seeking Cosmetic Treatments.

BACKGROUND: The use of screening scales in cosmetic practices may help to identify patients who require education to modify inappropriate expectations and/or psychological support. OBJECTIVES: To describe the development and validation of scales that measure expectations (about how one's appearance and quality of life might change with cosmetic treatments) and appearance-related psychosocial distress. METHODS: The scales were field-tested in patients 18 years and older seeking facial aesthetic or body contouring treatments. Recruitment took place in clinics in the United States, United Kingdom, and Canada between February 2010 and January 2015. Rasch Measurement Theory (RMT) analysis was used for psychometric evaluation. Scale scores range from 0 to 100; higher scores indicate more inappropriate expectations and higher psychosocial distress. RESULTS: Facial aesthetic (n = 279) and body contouring (n = 90) patients participated (97% response). In the RMT analysis, all items had ordered thresholds and acceptable item fit. Person Separation Index and Cronbach alpha values were 0.88 and 0.92 for the Expectation scale, and 0.81 and 0.89 for the Psychosocial Distress scale respectively. Higher expectation correlated with higher psychosocial distress (R = 0.40, P < .001). In the facial aesthetic group, lower scores on the FACE-Q Satisfaction with Appearance scale correlated with higher expectations (R = -0.27, P = .001) and psychosocial distress (R = -0.52, P < .001). In the body contouring group, lower scores on the BODY-Q Satisfaction with Body scale correlated with higher psychosocial distress (R = -0.31, P = .003). Type of treatment and marital status were associated with scale scores in multivariate models. CONCLUSIONS: Future research could examine convergent and predictive validity. As research data are accumulated, norms and interpretation guidelines will be established. LEVEL OF EVIDENCE: 2 Risk.

Prospective Analysis of Primary Breast Augmentation on Body Image Using the BREAST-Q: Results from a Nationwide Study.

BACKGROUND: The Breast Implant Follow-up Study is a large, ongoing observational study of women who received Natrelle round silicone-filled or saline-filled breast implants. This analysis describes patient-reported outcomes in the cohort who underwent breast augmentation. METHODS: Subjects prospectively completed two validated scales of the BREAST-Q (satisfaction with breasts and psychosocial well-being) preoperatively and at 1 and 4 years postoperatively. Effect size and z tests were used to compare differences between preoperative versus postoperative scores; multivariate mixed models were used to compare differences in scores between silicone-filled and saline-filled implants. RESULTS: Of 17,899 subjects completing the BREAST-Q preoperatively, 14,514 (81.1 percent) completed the postoperative questionnaire (12,726 received silicone-filled implants and 1788 received saline-filled implants). Overall, satisfaction with breasts and psychosocial well-being increased significantly at postoperative year 1 (p < 0.0001 for both), and the improvement was sustained at year 4 (p < 0.0001 for both). Large effect sizes were observed for satisfaction with breasts (2.0 at year 1; 1.8 at year 4) and psychosocial well-being (1.2 at year 1; 1.0 at year 4). In the multivariate model, silicone-filled implants were associated with significantly greater improvement compared with saline-filled implants for satisfaction with breasts and psychosocial well-being at year 1 (p < 0.0001 for both) and year 4 (p < 0.0001 and p < 0.0019, respectively). CONCLUSIONS: Breast implants are effective in improving women's quality of life. The authors found significant and sustained improvements in satisfaction and psychosocial well-being in women undergoing breast augmentation with Natrelle silicone-filled or saline-filled implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Complications After Mastectomy and Immediate Breast Reconstruction for Breast Cancer: A Claims-Based Analysis.

OBJECTIVE: To evaluate complications after postmastectomy breast reconstruction, particularly in the setting of adjuvant radiotherapy. BACKGROUND: Most studies of complications after breast reconstruction have been conducted at centers of excellence; relatively little is known about complication rates in irradiated patients treated in the broader community. This information is relevant for decision making in patients with breast cancer. METHODS: Using the claims-based MarketScan database, we described complications in 14,894 women undergoing mastectomy for breast cancer from 1998 to 2007 and who underwent immediate autologous reconstruction (n = 2637), immediate implant-based reconstruction (n = 3007), or no reconstruction within the first 2 postoperative years (n = 9250). We used a generalized estimating equation to evaluate associations between complications and radiotherapy over time. RESULTS: Wound complications were diagnosed within the first 2 postoperative years in 2.3% of patients without reconstruction, 4.4% patients with implants, and 9.5% patients with autologous reconstruction (P < 0.001). Infection was diagnosed within the first 2 postoperative years in 12.7% of patients without reconstruction, 20.5% with implants, and 20.7% with autologous reconstruction (P < 0.001). A total of 5219 (35%) women received radiation. Radiation was not associated with infection in any surgical group within the first 6 months but was associated with an increased risk of infection in months 7 to 24 in all 3 groups (each P < 0.001). In months 7 to 24, radiation was associated with higher odds of implant removal in patients with implant reconstruction (odds ratio = 1.48; P < 0.001) and fat necrosis in those with autologous reconstruction (odds ratio = 1.55; P = 0.01). CONCLUSIONS: Complication risks after immediate breast reconstruction differ by approach. Radiation therapy seems to modestly increase certain risks, including infection and implant removal.

Patient-reported Quality of Life and Satisfaction With Cosmetic Outcomes After Breast Conservation and Mastectomy With and Without Reconstruction: Results of a Survey of Breast Cancer Survivors.

OBJECTIVE: Although breast conservation is therapeutically equivalent to mastectomy for most patients with early-stage breast cancer, an increasing number of patients are pursuing mastectomy, which may be followed by breast reconstruction. We sought to evaluate long-term quality of life and cosmetic outcomes after different locoregional management approaches, as perceived by patients themselves. METHODS: We surveyed women with a diagnosis of nonmetastatic breast cancer from 2005 to 2007, as reported to the Los Angeles and Detroit population-based Surveillance, Epidemiology, and End Results registries. We received responses from 2290 women approximately 9 months after diagnosis (73% response rate) and from 1536 of these 4 years later. We evaluated quality of life and patterns and correlates of satisfaction with cosmetic outcomes overall and, more specifically, within the subgroup undergoing mastectomy with reconstruction, using multivariable linear regression. RESULTS: Of the 1450 patients who responded to both surveys and experienced no recurrence, 963 underwent breast-conserving surgery, 263 mastectomy without reconstruction, and 222 mastectomy with reconstruction. Cosmetic satisfaction was similar between those receiving breast conservation therapy and those receiving mastectomy with reconstruction. Among patients receiving mastectomy with reconstruction, reconstruction type and radiation receipt were associated with satisfaction (P < 0.001), with an adjusted scaled satisfaction score of 4.7 for patients receiving autologous reconstruction without radiation, 4.4 for patients receiving autologous reconstruction and radiation therapy, 4.1 for patients receiving implant reconstruction without radiation therapy, and 2.8 for patients receiving implant reconstruction and radiation therapy. CONCLUSIONS: Patient-reported cosmetic satisfaction was similar after breast conservation and after mastectomy with reconstruction. In patients undergoing postmastectomy radiation, the use of autologous reconstruction may mitigate the deleterious impact of radiation on cosmetic outcomes.

Shared medical appointments for preoperative evaluation of symptomatic macromastia.

BACKGROUND: Shared medical appointments combine individual patient-physician encounters with a group educational segment. This allows for patients' needs to be addressed individually and for patients to benefit from shared learning. Shared medical appointments enhance knowledge, understanding, and management of disease by providing a variety of perspectives and experiences. In addition, physician-patient contact time and clinic efficiency are increased. This study assesses patient satisfaction and provider efficiency with shared medical appointments for symptomatic macromastia. METHODS: Patients were offered a shared medical appointment or traditional individual appointment. After the appointment, patients completed a satisfaction survey. Provider efficiency was measured by comparing visits per hour. RESULTS: Over 6 months, 26 of 28 shared medical appointment patients and 26 of 29 traditional individual appointment patients completed the survey. Patients reported 89 percent satisfaction with traditional individual appointments and shared medical appointments (p = 0.1), and both groups reported 92 percent satisfaction with thoroughness of care (p = 0.1). Seventy-seven percent of the shared medical appointment group said it was very or extremely likely they would participate in a shared medical appointment in the future. Provider efficiency increased nearly 250 percent, as patients-per-hour averaged 6.4 for shared medical appointments versus 2.67 for traditional individual appointments. CONCLUSIONS: Shared medical appointments for macromastia resulted in high patient satisfaction. Results were comparable to those of traditional individual appointments. No patients were dissatisfied, and provider efficiency improved. Shared medical appointments have unique benefits in patient education without compromising thoroughness or patient satisfaction, and offer an alternative delivery model that improves efficiency.

ASPS clinical practice guideline summary on breast reconstruction with expanders and implants.

LEARNING OBJECTIVES: After reading this article, participants should be able to: 1. Understand the evidence regarding the timing of expander/implant breast reconstruction in the setting of radiation therapy. 2. Discuss the implications of a patient's risk factors for possible outcomes and complications of expander/implant breast reconstruction. 3. Implement proper prophylactic antibiotic protocols. 4. Use the guidelines to improve their own clinical outcomes and reduce complications. SUMMARY: In March of 2013, the Executive Committee of the American Society of Plastic Surgeons approved an evidence-based guideline on breast reconstruction with expanders and implants, as developed by a guideline-specific work group commissioned by the society's Health Policy Committee. The guideline addresses ten clinical questions: patient education, immediate versus delayed reconstruction, risk factors, radiation therapy, chemotherapy, hormonal therapy, antibiotic prophylaxis, acellular dermal matrix, monitoring for cancer recurrence, and oncologic outcomes associated with implant-based reconstruction. The evidence indicates that patients undergoing mastectomy should be offered a preoperative referral to a plastic surgeon. Evidence varies regarding the association between postoperative complications and timing of postmastectomy expander/implant breast reconstruction. Evidence is limited regarding the optimal timing of expand/implant reconstruction in the setting of radiation therapy but suggests that irradiation to the expander or implant is associated with an increased risk of postoperative complications. Evidence also varies regarding the association between acellular dermal matrix and surgical complications in the setting of postmastectomy expander/implant reconstruction. Data support the use of an appropriate preoperative antibiotic, but antibiotics should be discontinued within 24 hours of the procedure, unless a surgical drain is present. Furthermore, postmastectomy expander/implant breast reconstruction does not adversely affect oncologic outcomes.

Access to breast reconstruction after mastectomy and patient perspectives on reconstruction decision making.

IMPORTANCE: Most women undergoing mastectomy for breast cancer do not undergo breast reconstruction. OBJECTIVE: To examine correlates of breast reconstruction after mastectomy and to determine if a significant unmet need for reconstruction exists. DESIGN, SETTING, AND PARTICIPANTS: We used Surveillance, Epidemiology, and End Results registries from Los Angeles, California, and Detroit, Michigan, for rapid case ascertainment to identify a sample of women aged 20 to 79 years diagnosed as having ductal carcinoma in situ or stages I to III invasive breast cancer. Black and Latina women were oversampled to ensure adequate representation of racial/ethnic minorities. Eligible participants were able to complete a survey in English or Spanish. Of 3252 women sent the initial survey a median of 9 months after diagnosis, 2290 completed it. Those who remained disease free were surveyed 4 years later to determine the frequency of immediate and delayed reconstruction and patient attitudes toward the procedure; 1536 completed the follow-up survey. The 485 who remained disease free at follow-up underwent analysis. EXPOSURES: Disease-free survival of breast cancer. MAIN OUTCOMES AND MEASURES: Breast reconstruction at any time after mastectomy and patient satisfaction with different aspects of the reconstruction decision-making process. RESULTS: Response rates in the initial and follow-up surveys were 73.1% and 67.7%, respectively (overall, 49.4%). Of 485 patients reporting mastectomy at the initial survey and remaining disease free, 24.8% underwent immediate and 16.8% underwent delayed reconstruction (total, 41.6%). Factors significantly associated with not undergoing reconstruction were black race (adjusted odds ratio [AOR], 2.16 [95% CI, 1.11-4.20]; P = .004), lower educational level (AOR, 4.49 [95% CI, 2.31-8.72]; P < .001), increased age (AOR in 10-year increments, 2.53 [95% CI, 1.77-3.61]; P < .001), major comorbidity (AOR, 2.27 [95% CI, 1.01-5.11]; P = .048), and chemotherapy (AOR, 1.82 [95% CI, 0.99-3.31]; P = .05). Only 13.3% of women were dissatisfied with the reconstruction decision-making process, but dissatisfaction was higher among nonwhite patients in the sample (AOR, 2.87 [95% CI, 1.27-6.51]; P = .03). The most common patient-reported reasons for not having reconstruction were the desire to avoid additional surgery (48.5%) and the belief that it was not important (33.8%), but 36.3% expressed fear of implants. Reasons for avoiding reconstruction and systems barriers to care varied by race; barriers were more common among nonwhite participants. Residual demand for reconstruction at 4 years was low, with only 30 of 263 who did not undergo reconstruction still considering the procedure. CONCLUSIONS AND RELEVANCE: Reconstruction rates largely reflect patient demand; most patients are satisfied with the decision-making process about reconstruction. Specific approaches are needed to address lingering patient-level and system factors with a negative effect on reconstruction among minority women.

Implant breast reconstruction and radiation: a multicenter analysis of long-term health-related quality of life and satisfaction.

BACKGROUND: Indications for radiotherapy in breast cancer treatment are expanding. Long-term satisfaction and health-related quality of life (HR-QOL), important outcomes after alloplastic breast reconstruction and radiation, have not been measured in irradiated patients by using a condition-specific, validated patient-reported outcomes instrument. The aim was to evaluate patient satisfaction and HR-QOL in patients with implant breast reconstruction and radiotherapy. METHODS: A multicenter cross-sectional survey of patients who underwent implant-based breast reconstruction from three centers in the United States and Canada, with and without radiation, was performed. Satisfaction with breasts, satisfaction with outcome, psychosocial well-being, sexual well-being, and physical well-being outcomes were evaluated using the BREAST-Q(©) (Reconstruction Module). Multivariable analysis was performed to evaluate the effect of radiotherapy on patient satisfaction with breasts with adjustment by patient and treatment characteristics. RESULTS: The response rate was 71 %, with 633 completed questionnaires returned. Mean follow-up was 3.3 years for irradiated patients (n = 219) and 3.7 years for nonirradiated patients (n = 414). Patients with radiation had significantly lower satisfaction with breasts (58.3 vs. 64.0; p < 0.01), satisfaction with outcome (66.8 vs. 71.4; p < 0.01), psychosocial well-being (66.7 vs. 70.9; p < 0.01), sexual well-being (47.0 vs. 52.3; p < 0.01), and physical well-being (71.8 vs. 75.1; p < 0.01) compared with nonirradiated patients. Multivariable analysis confirmed the negative effect of radiotherapy on satisfaction with breasts (ß = -2.6; p = 0.03) when adjusted for patient and treatment factors. CONCLUSIONS: Radiotherapy has a negative effect on HR-QOL and satisfaction with breasts in patients with implant reconstruction compared with nonirradiated patients. The information provided here can inform decision-making and help set appropriate expectations for patients undergoing implant breast reconstruction and radiation.

Understanding the effect of breast augmentation on quality of life: prospective analysis using the BREAST-Q.

BACKGROUND: The aim of this study was to prospectively evaluate patient satisfaction and quality of life with elective breast augmentation. METHODS: Patients with bilateral submuscular breast augmentations prospectively completed the BREAST-Q preoperatively and 6 weeks and 6 months postoperatively; t tests compared preoperative and postoperative scores at 6 weeks and 6 months, and standard indicators of effect sizes were calculated. Logistic regression was used to evaluate the association between patient and surgical factors on satisfaction outcomes. RESULTS: The study sample included 611 female patients with the following characteristics: (1) mean age of 33.5 years; (2) mean body mass index of 21.7; (3) and mean implant volume of 360; with (4) 73 percent having received a silicone implant. Significant improvements were found in patient satisfaction with breasts (p < 0.001), psychosocial well-being (p < 0.001), and sexual well-being (p < 0.001) at 6 weeks and 6 months postoperatively, and all were associated with a very large Kazis effect size of 3.66, 2.39, and 2.56 at 6 months, respectively. However, at both 6 weeks and 6 months postoperatively, physical well-being remained significantly below preoperative baseline scores. In addition, satisfaction with breasts and with the overall surgical experience was significantly lower among older patients (p = 0.01 and 0.02, respectively). CONCLUSIONS: Breast augmentation is associated with high patient satisfaction and significant improvements in quality of life. However, physicians should inform patients that submuscular augmentations are associated with a delay in recovery of physical functioning and be aware that older patients may experience diminished satisfaction and should counsel accordingly. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.