For the psychosocial well-being domain, in which the standard deviation is approximately 18 points, the MID is 3.6 for a between-group difference and nine for a change after surgery. As women increasingly choose mastectomy instead of breast-conserving therapy, it is especially important to share information about the PROs of the various options -- specifically, the physical morbidities associated with mastectomy and reconstruction -- during preoperative counseling.

For negatively worded concepts, such as depression, a higher score indicated worse function; for positively worded concepts, such as physical function, a higher score indicated better function. P30 CA008748 to A.L.P. "Regardless of reason for implant failure, this study shows changing to autologous tissue after implant removal is safe," Dr. Disa and coauthors conclude. This study also provides new insights about how women feel and function both before and after surgery. edoc preparation enhancement recipient autologous graft survival fat site As soon as the breast is removed by the breast cancer surgeons, the plastic surgeon reconstructs the breast.

At 1 year after immediate reconstruction: Overall, women who had autologous reconstruction were more likely to be more satisfied with their breasts than women who had implant reconstruction, as well as better psychosocial and sexual well-being. Nine of 11 centers were academic institutions; two were private practices. Statistical power to detect the difference in outcomes between implant- and natural tissuebased procedures on the basis of the projected sample size also was considered. For more information, visit www.wolterskluwer.com, and follow us on Twitter, Facebook, LinkedIn and YouTube. Previous efforts to assess patient-reported outcomes (PROs) have relied on generic measures or ad hoc surveys with limited evidence of reliability, validity, or ability to detect clinically meaningful change.23,24 The development and use of the BREAST-Qa validated PRO instrument designed specifically for patients who undergo breast surgeryhave helped address this gap in knowledge.25-28.

Chemotherapy was defined as treatment received during or after reconstruction and none.

Such information is important to help new patients understand the expected results of reconstruction and make informed decisions. These differences were all statistically significant, which means they were likely because of the type of reconstruction and not just due to chance. Table 2.

I = Immediate Family Member, Inst = My Institution. For over 75 years, Plastic and Reconstructive Surgery has been the one consistently excellent reference for every specialist who uses plastic surgery techniques or works in conjunction with a plastic surgeon.

We also did not include patients whose reconstruction had failed because of the small number (n = 25) and heterogeneous clinical outcomes.

Patients who had a mixed approach to reconstruction (bilateral reconstruction with unilateral implant and unilateral flap) also were excluded. Permissions, Authors Reconstruction does not, however, undo the physical morbidity of mastectomy surgery and, in the case of implant surgery, may even contribute to symptoms of pain and tightness.

For patients in both implant and autologous groups, anxiety and depression were improved at 1 year. Breast Reconstruction With Postmastectomy Radiation: Choices and Tradeoffs, Surveillance, Epidemiology, and End Results (SEER): Cancer Statistics Review 19752009 (Vintage 2009 Populations). Mean patient-reported outcome (PRO) scores at baseline and at 1 year after surgery, as well as the mean difference in PRO scores before and after surgery, were summarized separately for patients who underwent implant and autologous procedures.

Women underwent implant-based or autologous tissue reconstruction.

This project involved 57 plastic surgeons at 11 academic and private practice sites across the United States and Canada. Dr. Disa and colleagues analyzed 137 women who underwent autologous breast reconstruction after failed implant reconstruction. 2499-2506. The following represents disclosure information provided by authors of this manuscript. The study included 1,183 women who had been diagnosed with either invasive breast cancer or DCIS between February 2012 and July 2015.

Clinical and Demographic Characteristics of the Study Cohort by Procedure Type. The research was published online on March 27, 2017 by the. Conquer Cancer Foundation After analysis was controlled for baseline values, patients who underwent autologous reconstruction had greater satisfaction with their breasts than those who underwent implant-based reconstruction (difference, 6.3; P < .001), greater sexual well-being (difference, 4.5; P = .003), and greater psychosocial well-being (difference, 3.7; P = .02) at 1 year.

Though you'll be able to see the difference between the rebuilt breast and your other breast when you're naked, reconstruction usually looks very natural when you're wearing a bra or bathing suit. Analysis of BREAST-Q responses showed "a high degree of satisfaction and quality of life" after autologous reconstruction.

Mean changes in PRO scores were summarized.

Wolters Kluwer (WKL) is a global leader in professional information, software solutions and services for the clinicians, nurses, accountants, lawyers and tax, finance, audit, risk, compliance and regulatory sectors.

Other patients had infections or other implant-related complications, or were dissatisfied with the appearance of the reconstructed breast.

edoc preparation enhancement recipient autologous graft survival fat site

Fig 1.

35, no.

Another limitation of the existing literature is the absence of baseline assessment of body image and QOL.

reconstruction breast tissue expander integral filling port dermal acellular matrix adm types implant including anatomical Observed difference in outcomes between procedure types, therefore, may be influenced by certain patient and surgeon preferences.

Wolters Kluwer provides trusted clinical technology and evidence-based solutions that engage clinicians, patients, researchers and students in effective decision-making and outcomes across healthcare. Within the implant procedural subgroups (two-stage TE/implant and direct to implant), when analysis was controlled for baseline outcome and other covariates, no significant differences emerged between these two subgroups in postoperative year-1satisfaction or QOL, as measured by the BREAST-Q or PROMIS-29 domains (results based on mixed-effects regression model, not shown).

breast reconstruction implants silicone implant acellular dermal matrix adm types including

In the United States, an increasing number of breast reconstructions are performed with implants14,33,34; however, this study raises the question of whether patient health care value is being maximized by this approach. On both the BREAST-Q and PROMIS-29, patients reported worse physical well-being of the chest and worse physical function at 1 year.

Did you have a lumpectomy that gave your breast a very different shape than it originally had?

DOI: 10.1200/JCO.2016.69.9561 Journal of Clinical Oncology - For instance, more than 50% of patients underwent bilateral mastectomies, which is higher the national average50,51 and may reflect patterns of practice in more urban, academic practices. For patients who undergo implant reconstruction, new techniques, such as prepectoral placement of implants (which minimizes muscles dissection and stretching) may be beneficial, but rigorous PRO data are still lacking.43,44. Ann Surg [epub ahead of print on March 8, 2016], 2318 Mill Road, Suite 800, Alexandria, VA 22314, 2022 American Society of Clinical Oncology.

These factors also may limit the generalizability of our findings. Outcomes were assessed using the validated BREAST Q questionnaire, which evaluates various aspects of quality of life after breast reconstruction. The new study is one of only a few to assess the outcomes of autologous reconstruction after failed implant-based reconstruction, and the first to use the validated BREAST-Q questionnaire. We thank all of the patients who participated in the Mastectomy Reconstruction Outcomes Consortium study. Written informed consent was obtained from all participants. Representing more than 7,000 physician members, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. Will your insurance pay for all the reconstruction procedures? Enter words / phrases / DOI / ISBN / authors / keywords / etc. Adjusted Mean Difference Between Procedure Types in 1-Year Postreconstruction Patient-Reported Outcomes. JCO Clinical Cancer Informatics Patient characteristics between the two procedure groups (autologous v implant) were analyzed with the two-sample t test for continuous variables and the 2 test for categoric variables.

In your unique situation, will breast reconstruction involve several surgeries over a long period of time? In total, 2,308 patients in the MROC study had a breast cancer diagnosis, underwent immediate reconstruction, and completed a baseline survey (Fig 1). PROMIS-29 scores were collected with the PROMIS Profile29 (version 1), a self-administered survey system for evaluation of patient-reported symptoms and QOL.

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Baseline characteristics of the responders and nonresponders were compared, and, to reduce potential bias from missing PROs at 1 year, analyses were weighted by the inverse of the probability of response. Implant and autologous reconstruction each have advantages for breast reconstruction after mastectomy. But when implant-based reconstruction fails, autologous reconstruction using the patient's own tissues is a safe procedure that improves patient outcomes, reports a study in the February issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS). To meaningfully compare the outcomes of reconstruction, baseline status must be taken into account. This study did not include a control population of patients who underwent mastectomy without reconstruction or breast-conserving therapy; thus, interpretation of findings is limited to a comparison of the outcomes of postmastectomy reconstruction techniques. Specifically, although current techniques may restore how a woman looks, they do little to address how she feels physically. breast implants silicone implant gel reconstruction fda types surgery devices filled lawsuit cancer woman safety acellular matrix dermal adm including Here are some questions you might want to think about as you're making your decision about breast reconstruction: For more information, including types of reconstruction, the timing of reconstruction, and questions to ask your breast surgeon and plastic surgeon, visit the Breastcancer.org. 2022 Breastcancer.org - All rights reserved. Procedure Type and Response Rate by Site.

Contact Us "Autologous breast reconstruction after failed implant-based reconstruction is associated with significantly improved patient satisfaction and quality of life," concludes the study by ASPS Member Surgeon Joseph J. Disa, MD, and colleagues of Memorial Sloan Kettering Cancer Center, New York. Relationships are self-held unless noted. We archive older articles so you can still read about past studies that led to today's standard of care.

All statistical analyses were performed with SAS 9.4 (SAS Institute, Cary, NC), and statistical significance was set at .05.

Click here to read "Autologous Breast Reconstruction after Failed Implant-Based Reconstruction: Evaluation of Surgical and Patient-Reported Outcomes and Quality of Life", Article: "Autologous Breast Reconstruction after Failed Implant-Based Reconstruction: Evaluation of Surgical and Patient-Reported Outcomes and Quality of Life" (doi: 10.1097/PRS.0000000000005197).

An important finding is that patients who underwent implant reconstruction reported satisfaction with their breasts at 1 year that was similar to baseline. Another consideration is that patients who had two-stage implant reconstruction generally would have had relatively recent surgery at the time of the 1-year outcome assessment, whereas patients who had autologous reconstruction would have had a year to recover; this may bias the finding that physical well-being of the chest and upper body was superior in patients in the autologous reconstruction group. Table 3. Although satisfaction with breasts was equal to or greater than baseline levels, physical well-being was not fully restored.

Founded in 1931, the society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.

Both groups of women had worse physical well-being of the chest after surgery. An additional benefit of the BREAST-Q is that it was developed with Rasch psychometric methods, which improve the ability to interpret the clinical impact of differences across procedures. In this study, patients who underwent implant reconstruction reported mean satisfaction with breasts of 64. is a co-developer of the BREAST-Q and receives royalties when it is used in for-profit industry-sponsored clinical trials. Specifically, although current techniques may restore how a woman looks, they do little to address how she feels physically. Table 4. Health care value is defined as the relationship between cost and quality across the full cycle of care for the medical condition of a patient, so health policy changes should be aligned to steer patients, providers, and the medical system in the direction of the greatest value.38 In this study, we report outcomes at 1 year; longer-term follow up of this patient cohort will shed more light on differences between reconstructive methods over time. About one-fourth of patients filled out the BREAST-Q after both implant procedures. There are many ways to reconstruct a breast. Sexual well-being was restored among patients who underwent autologous but not implant reconstruction (mean difference pre- to postsurgery, 5.2; P = .005). Women who had implant reconstruction had less fatigue after surgery. Some women prefer to wear a prosthesis instead of having reconstruction. Bethesda, MD, National Cancer Institute, 2012, Wong SM, Freedman RA, Sagara Y, et al: Growing use of contralateral prophylactic mastectomy despite no improvement in long-term survival for invasive breast cancer. The results suggested that autologous reconstruction after failure of initial implant reconstruction is a safe procedure.

Editorial Roster Once radiation is completed and the tissues have recovered (about 4 to 6 months), the expander or implant is removed and replaced with either your own tissue or a long-term implant. posters

The transformed scores range from 0 to 100, and higher scores indicated greater satisfaction or QOL.

Clinical and Demographic Characteristics of Patients by Survey Response Status at 1 Year Postoperation, Table A2. published online before print reconstruction breast tissue expander integral filling port dermal acellular matrix adm types implant including anatomical Although analysis was adjusted for variables known to be predictive of outcomes,52,53 such as radiation and laterality, it is possible that additional demographic and clinical variables not measured in this study may influence outcomes and thus introduce bias. With the projection of 75% of patients to undergo an implant-based procedure patients versus 25% to undergo a natural tissuebased procedure, and given a within-surgeon-site correlation of 0.002, we expected to have 83% power to detect a between-procedure difference of 0.135 standard deviation by using a .01-level two-sided test. Each model included procedure type and baseline values of the corresponding outcome variable as well as patient demographic and clinical characteristics.

If you have diabetes, circulatory problems, or a bleeding disorder, it may take your body longer to heal from reconstruction surgery than someone who doesn't have these conditions. This study also has limitations.

It is important to consider not only the statistical significance of our findings but also the extent to which these differences are clinically meaningful.

Still, women who had autologous reconstruction had more pain than they did before surgery.

The results show improvements in physical and psychological well-being for this group of breast cancer survivors, as well as increased satisfaction with the appearance of the reconstructed breast or breasts.



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Loss of Volume, Not Just 'Sagging'.

All relationships are considered compensated.

PRO scores at 1 year were missing for approximately 30% of patients. Cookies, Sample Size Calculation and Statistical Methods, AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST, Patient-Reported Outcomes 1 Year After Immediate Breast Reconstruction: Results of the Mastectomy Reconstruction Outcomes Consortium Study.

On the basis of these definitions, autologous procedures show a statistical difference and MID compared with implant procedures in terms of satisfaction with breast, psychosocial well-being, and sexual well-being.

Doctors call this autologous reconstruction. Patients were encouraged to complete the questionnaires electronically. March 27, 2017.

Specifically, the probability of response was estimated on the basis of data from all eligible study participants, by using a separate logistic regression model for each outcome measure, in which the dependent variable was an indicator of nonmissing response status and the predictors included baseline patient characteristics as well as baseline values of the outcome variable. Still, women who had autologous reconstruction had more pain than they did before surgery. Last updated on February 22, 2022, 9:56 PM, By submitting my email, I agree to receive newsletters from Breastcancer.org. Physical well-being of the chest was not fully restored in either the implant group (difference, 3.8; P = .001) or autologous group (2.2; P = .04), nor was physical well-being of the abdomen in patients who underwent autologous reconstruction (13.4; P < .001). The views expressed in Ask a Surgeon and the Patient Community are those of the participants and do not necessarily reflect the opinions of the American Society of Plastic Surgeons. This group had significant improvements in satisfaction with the appearance of the breasts, psychosocial well-being, and physical well-being of the chest. Doctors wanted to know how women perceived the outcomes of immediate breast reconstruction.

Both procedures are safe and provide good reconstructive outcomes. Patient-Report Outcomes 1 Year After Immediate Breast Reconstruction: Results of the Mastectomy Reconstruction Outcomes Consortium Study.. Tissue from the back, belly, buttocks, or other part of the body can be used to create a new breast.

While there may be some additional challenges related to previous breast cancer treatment and reconstruction, they add, "The procedure has an acceptable complication rate.". MROC, Mastectomy Reconstruction Outcomes Consortium; TE, tissue expander; TE/I, TE/I, tissue expander implant. A concerning finding was that physical well-being at 1 year did not return to baseline levels for women in either group. Compared with baseline measures, patients in the autologous group reported significantly increased levels of pain interference (P = .006), and patients in the implant group reported decreased fatigue (P = .035). 22

This population also had relatively limited ethnic and racial diversity, and the participating sites were largely academic, high-volume centers.

Appropriate institutional review board or research ethics board approval was obtained from all sites. Help us learn how we can improve our research news coverage. Find out what your insurance company will cover.

In comparison, the mean score for women who underwent autologous reconstruction was 68, which means that they were very satisfied with how bras fit and with how their reconstructed breasts feel to the touch.

Women who had autologous reconstruction reported more pain that interfered with their daily lives after surgery. The goals of immediate postmastectomy breast reconstruction are to minimize deformity and optimize quality of life as perceived by patients. Many, but not all, women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed.

This study also provides evidence that immediate reconstruction restores the look and feel of a womans breasts, as evidenced by patient-reported satisfaction with their breasts that was equal to or greater than preoperative levels.

The women also reported improved satisfaction with overall well-being on the BREAST-Q. Do you have any other medical conditions that might affect your ability to heal after surgery? This analysis, for example, was underpowered to determine whether different approaches to harvest the abdominal flap may result in less abdominal morbidity. Future research to explore potential reasons for this finding would be worthwhile. The BREAST-Q (reconstruction module) is a condition-specific PRO instrument that measures breast-related QOL and satisfaction in patients undergoing breast reconstruction. The official journal of the American Society of Plastic Surgeons, Plastic and Reconstructive Surgery brings subscribers up-to-the-minute reports on the latest techniques and follow-up for all areas of plastic and reconstructive surgery, including breast reconstruction, experimental studies, maxillofacial reconstruction, hand and microsurgery, burn repair and cosmetic surgery, as well as news on medico-legal issues.

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