Implant or tissue for breast reconstruction
Question
What is the position of breast reconstruction using only an implant or with autologous tissue?
Recommendation
When speaking with patients about the choice between immediate reconstruction using an implant or autologous reconstruction, be sure to discuss:
- all of the risk factors for complications listed below need to be added together:
- smoking, BMI>30 kg/m2, bilateral surgery;
- age >55 years, direct placement of a definite prosthesis.
- more surgical and medical complications with a BMI >30 kg/m2;
- more repeat surgeries are required after reconstruction with an implant than after autologous reconstruction;
- greater morbidity and complications in the first month after autologous reconstruction;
- there is always an additional donor site scar in case of autologous reconstruction.
When speaking with patients about the choice between delayed reconstruction using an implant or autologous reconstruction, be sure to discuss:
- there are fewer complications after autologous reconstruction compared with implant reconstruction;
- patients are generally more satisfied after autologous reconstruction;
- A BMI>30 kg/m2 is associated with significantly more surgical and medical complications, resulting in more frequent repeat surgery.
Considerations
Immediate implant reconstruction versus immediate autologous reconstruction:
If a patient can choose immediate breast reconstruction, a good choice between different methods is only possible based on valid information (Nelson et al, 2013). All advantages and disadvantages of each oncologically justified method must be discussed. Furthermore, technical feasibility of the intervention must be taken into consideration. Not every clinic can perform every method, and not all methods can be performed in every patient. The advantage of implant reconstruction is that it is a relatively straightforward procedure that can be performed without additional scarring resulting in a faster psychological recovery (Al Ghazai et al, 2000). The disadvantage is the higher number of complications, such as a greater risk of infection, which can even result in the loss of the new breast (Strålman et al, 2008; Fischer et al, 2013). In the longer term, capsular contracture can develop, requiring repeat surgeries. The breast is often firmer and rounder, with a less natural appearance due to the difficulty in creating natural ptosis (Spear et al, 2008; Eriksen et al, 2012).
A softer, more ptotic and natural looking breast shape is the primary advantage of autologous reconstruction. Additionally, the reconstructed breast will look better over time (Alderman et al, 2007; Fischer et al, 2013). The disadvantages of an autologous reconstruction are the longer surgical time with greater blood loss, a longer recovery period and the risk of necrosis of the transplanted fat and skin. Thus, morbidity of autologous reconstruction is higher, particularly in the immediate postoperative phase (Fischer et al, 2013). Additionally, donor site complications can develop in the abdomen, such as weakness and scar problems (Cordeiro, 2008).
After immediate implant reconstruction, patients will undergo more procedures in the longer term than after immediate autologous reconstruction. This may be explained by the risk of capsular contracture, which can require additional surgery. This occurs in 40 to 70 percent of patients within 10 years of reconstruction (FDA, 2011). The additional interventions in patients with autologous reconstruction mostly occur in the early phase after the reconstruction. This is due to the risk of revision in the first postoperative week (Hofer et al, 2007), wound complications due to longer surgical time (Fischer et al, 2013) and any addition correction interventions in the longer term (Damen et al, 2010). These additional interventions are usually completed during the first postoperative years (Strålman et al, 2008; Rusby et al, 2010) and then stabilize. Interestingly, patient satisfaction in both immediate implant and autologous groups is almost the same, despite the risk of repeat surgery and lower aesthetic scores in the group undergoing implant surgery (Spear et al, 2008).
The risk analysis performed by Fischer et al (2013) for implant loss within the first 30 days after immediate reconstruction in 14,585 patients identified the following risk factors. In a multivariable regression analysis, BMI higher than 30 kg/m2 and smoking were identified as significant major risk factors. Age (>55 years), bilateral surgery, larger breasts and direct implantation of the definite prosthesis were also associated with an increased risk. Loss of an implant after immediate breast reconstruction is a multifactorial process related to various preoperative risk factors (Warren Peled et al, 2012; Leyngold et al, 2012; Davies et al, 2011; Woerdeman et al, 2007). The risk of complications or implant loss increases with the number of preoperative risk factors present. Therefore, for example overweight smokers with an indication for bilateral, immediate reconstruction might be better served by a delayed autologous reconstruction strategy (Fischer et al, 2013; Woerdeman et al, 2007; Davies et al, 2011).
Interestingly, in an analysis of 15,937 patients, an elevated BMI was associated with a significantly higher risk of wound complications, general medical issues, infections, implant loss and loss of the surgical flap for both autologous and implant reconstructions. These patients also all underwent more repeat surgeries (Fischer et al, 2013).
If postoperative radiation therapy is required, it may negatively affect the result of the reconstruction. If it is clear preoperatively that radiation therapy will have to be administered postoperatively, immediate reconstruction is often delayed due to the high risk of complications and capsular contracture after implant reconstruction and the risk of severe fibrosis or fat necrosis after autologous reconstruction (Rusby et al, 2010; Lentz et al, 2013; Lam et al, 2013).
Comparison of delayed implant reconstruction versus delayed autologous reconstruction
For delayed reconstruction, the quality and amount of remaining skin and underlying muscle tissue is important when choosing a reconstructive method. If sufficient good quality tissue is present that can be stretched to create an acceptable breast shape, reconstruction using a tissue expander may be considered. This method has the advantage of reducing length of hospital stay, no additional scarring and potential donor site morbidity, and no addition of skin with a different color or texture. An acceptable result can be achieved for women with small to medium sized breasts. However, this is a time-consuming procedure for the patient, as it can take weeks to fill the tissue expander to the desired volume, meaning multiple outpatient clinic visits. A second operation is eventually required to exchange the tissue expander for a definite prosthesis. The prosthesis results in a less natural breast shape with less ptosis and the risk of future capsular contracture.
If there is not sufficient usable skin over the chest, tissue will need to be added. An autologous reconstruction results in a soft-feeling breast with a more natural ptosis, comparable to that of the contralateral breast. This does come at the cost of an additional scar, longer surgical time and longer recovery time. The skin of the added tissue may differ from the thoracic skin in terms of texture and pigmentation.
The type of delayed reconstruction is associated with a difference in patient satisfaction. Women who underwent a delayed autologous reconstruction were generally more satisfied (Christensen et al, 2008; Gopie et al, 2013; Yueh et al, 2010; Fisher et al, 2013). Particularly, satisfaction with breast symmetry was significantly better for autologous reconstruction than implant reconstruction.
This does not mean that patients with an implant reconstruction are unsatisfied. The literature suggests a woman is often satisfied with her own choice, regardless of what that choice is (Christensen et al, 2008). Health-related quality of life and time since reconstruction are the primary predictors for satisfaction (Yueh et al, 2010).
The choice for a delayed reconstruction method should take risk factors for complications into consideration, such as smoking, BMI>30 kg/m2, age>55 years and previous radiation therapy (Christensen et al, 2011; Fischer et al, 2013). In case these risk factors are present, addition of autologous tissue can be a better solution for a delayed breast reconstruction (Cordeiro et al, 2008; Christensen et al, 2011).
The risk analysis in another review of 14,585 patients by Fischer et al (2013) showed a significantly higher risk of complications for elevated BMI (>30 kg/m2) for both implant and autologous reconstruction. This was also seen for active smoking and age above 55 years (Fischer et al, 2013).
Evidence
Background
Various breast reconstruction methods have been described, but three techniques are most commonly used. These are reconstruction with an implant, the pedicled latissimus dorsi flap, with or without an implant, and autologous reconstruction using vascularized abdominal fat and skin, with or without the rectus abdominis muscle (TRAM or DIEP flap, respectively). The choice of reconstruction method is primarily based on technical considerations, expertise and preference of the plastic surgeon or patient.
Conclusions
1. Comparison of immediate implant reconstruction versus immediate autologous reconstruction.
|
Very low (GRADE) |
Aesthetic result
Aesthetic result appears to be better for immediate autologous reconstruction compared with immediate reconstruction using an implant.
Sources (Rusby et al, 2010) |
|
Very low (GRADE) |
Postoperative complications - repeat surgery
The risk of repeat surgery is likely higher for immediate reconstruction using an implant rather than autologous tissue.
Sources (Strålman et al, 2008) |
|
- |
Quality of life, local control, POWI
No comparative studies examined the effect of an immediate implant reconstruction compared to immediate autologous reconstruction on quality of life, and local control and POWI occurrence. |
2. Comparison of delayed implant reconstruction versus delayed autologous reconstruction.
|
Very low (GRADE) |
Aesthetic result
Delayed autologous reconstruction may provide a better aesthetic result compared with delayed implant reconstruction.
Sources (Christensen et al, 2011) |
|
Very low (GRADE) |
Postoperative complications
There appears to be no difference in the risk of postoperative complications for delayed implant reconstruction compared with delayed autologous reconstruction.
Sources (Christensen et al, 2011) |
|
Very low (GRADE) |
Quality of life
There appears to be very little difference in quality of life after delayed implant reconstruction compared with delayed autologous reconstruction.
Sources (Christensen et al, 2011) |
|
- |
Local control
There is a lack of evidence for the effect of delayed implant reconstruction compared with delayed autologous reconstruction on local control. |
Literature summary
1. Comparison of immediate implant reconstruction versus immediate autologous reconstruction:
Two studies compared patients with immediate implant reconstruction to immediate autologous reconstruction ((Rusby et al, 2010; Strålman et al, 2008). The follow-up was 34 months (Strålman et al, 2008) and 4.4 years (Rusby et al, 2010).
Aesthetic result
Rusby et al (2010) compared the outcome measure aesthetic result. The number of repeat surgeries (within five years) was considered a measure for achieving and maintaining an acceptable aesthetic result. Of the 70 patients with 5 year follow-up, 23 of the 35 patients in the prosthesis group, and 12 of the 35 patients in the autologous group required repeat surgery (P=0.20).
Strålman et al (2008) also examined the number of repeat surgeries as a measure for long-term result. Charts for 167 patients were reviewed for the number of complications that led to repeat surgery. The results showed a statistically significant benefit for the group that underwent autologous reconstruction. 28 of the 82 patients (34%) in the prosthesis group required repeat surgery. In the autologous group treated with pedicled TRAM flaps, five of the 23 patients (15%) required repeat surgery, along with three of the 26% patients (12%) who underwent reconstruction using a latissimus dorsi flap.
Quality of life and local control
The outcome measures quality of life and local control were not studied.
Level of evidence of the literature
The level of evidence for the outcome measure aesthetic result and postoperative complications (repeat surgery) is very low, as the study is not randomized (highly significant limitations in study design) and the number of patients with complications is low (imprecision).
The level of evidence for the outcome measures quality of life, local control and POWI cannot be assessed, as these were not studied.
2. Comparison of delayed implant reconstruction versus delayed autologous reconstruction
One retrospective study (Christensen et al, 2011) compared the results of delayed implant reconstruction with delayed autologous reconstruction (using both pedicled TRAM and latissimus dorsi flaps). A total of 363 patients were described, with a mean follow-up of 7 years (range: 3.3 - 16.8 years).
Aesthetic result and quality of life
To assess aesthetic results, patient satisfaction was assessed using the EORTC QOL BR-23 and SF-36 questionnaires, previously described for surgical procedures, supplemented by additional questions (symmetry, shape, size, color, any donor site morbidity). Data were also obtained during follow-up using standardized photographs and examination by the same investigator.
The same questionnaires were used to assess quality of life.
Based on the questionnaire results, patients who underwent delayed autologous reconstruction were more satisfied with the results of the reconstruction than patients with a delayed implant reconstruction (>80% of the autologous group vs. 64% of the implant group, p=0.002).
Women with delayed autologous reconstruction also reported higher satisfaction (latissimus dorsi flap 12/17 [71%] and pedicled TRAM flam 66/78 [85%]) during follow-up than women with delayed implant reconstruction (37/85 [44%], p<0.0001). Radiation therapy had an overall negative effect on the result for both methods.
Quality of life
A total of 114 of the 137 (83%) patients with delayed implant reconstruction reported improvement in quality of life, compared with 23/36 (88%) of patients with a latissimus dorsi flap reconstruction and 90/100 (90%) of patients with a pedicled TRAM flap reconstruction (p=0.149).
Postoperative complications
Minor and major complications were reviewed to assess the postoperative complications endpoint. Minor complications included: seroma, signs of infection, asymmetry, shifting of the implant, pain lasting more than 3 months, hypertrophic scarring, abdominal herniation, limited necrosis and delayed wound healing. Fifty-six of the 206 (27%) patients with delayed implant reconstruction experienced these minor postoperative complications, compared with 7/34 (21%) patients with a latissimus dorsi flap reconstruction and 43/123 (35%) patients with a pedicled TRAM flap reconstruction (p=0.30).
Major complications were: necrosis of a significant portion of the flap, total flap loss, postoperative evacuation of a hematoma, prosthesis rupture, wound dehiscence or necrosis leading to implant loss and capsular contracture. Twenty-six of the 206 (13%) patients with delayed implant reconstruction experienced these major postoperative complications, compared with 0/34 (0%) patients with a latissimus dorsi flap reconstruction and 12/123 (13%) patients with a pedicled TRAM flap reconstruction (p=0.84).
Local control
Local control was not examined.
Level of evidence of the literature
The level of evidence for the outcome measures aesthetic result, postoperative complications and quality of life was very low, as the study was not randomized (highly significant limitations in study design) combined with inadequate data analysis (multivariable analysis) and the low number of patients (imprecision).
The level of evidence for the outcome measure local control could not be assessed as it was not studied.
Search and select
To answer the primary question, two systematic literature analyses were performed on the following questions:
- What is the difference between immediate implant and autologous reconstruction on the aesthetic result, postoperative complications, quality of life and local control?
- What is the difference between delayed implant and autologous reconstruction on the aesthetic result, postoperative complications, quality of life and local control?
Search and selection (Method)
See primary question: What is the role of implants in immediate breast reconstruction?.
Of the 1186 references identified, three studies met the selection criteria (Rusby et al, 2010; Strålman et al, 2008; Christensen et al, 2011) and were included in the literature analysis.
Methods
Authorization date and validity
Last review : 01-03-2015
Last authorization : 01-03-2015
Planned reassessment : 01-01-2019
The Board of the Dutch Society for Plastic and Reconstructive Surgery (NVPC) will assess whether this guideline is still up-to-date in 2018 at the latest. If necessary, a new working group will be appointed to revise the guideline. The guideline’s validity may lapse earlier if new developments demand revision at an earlier date.
As the holder of this guideline, the NVPC is chiefly responsible for keeping the guideline up to date. Other scientific organizations participating in the guideline or users of the guideline share the responsibility to inform the chiefly responsible party about relevant developments within their fields.
General details
Guideline development was funded by the Quality Fund for Medical Specialists (SKMS) and The Netherlands Organization for Health Research and Development (ZonMw).
Scope and target group
Guideline goal
To develop a multidisciplinary, evidence-based guideline for breast reconstruction in women undergoing breast conserving therapy or mastectomy for breast cancer, or following prophylactic mastectomy.
Guideline scope
The guideline focuses on all patients with an indication for breast reconstruction following breast conserving therapy or mastectomy. Additionally, the guideline may be applied to breast reconstruction in patients who have undergone surgical treatment for a benign breast condition. The guideline does not comment on the treatment of breast cancer. We refer the reader to the NABON guideline for the treatment of breast cancer (www.richtlijnendatabase.nl), which this guideline complements.
Unfortunately, circumstances did not permit a medical oncologist representing the NVMO to participate in the working group. Thus, the current version lacks a module on chemotherapy and breast reconstruction. The working group strives to create such a module for this guideline in the near future.
Intended audience for the guideline
The guideline aims to provide practical guidance for plastic surgeons and members of the multidisciplinary breast cancer team (surgical oncologist, medical oncologist, radiation oncologist, radiologist, pathologist, psychologist, breast care nurse specialist). A version for patients has recently been developed (https://www.b-bewust.nl/pif_borstreconstructie).
Samenstelling werkgroep
A multidisciplinary working group was appointed to develop the guideline in October 2011, consisting of representatives from all relevant specialties involved in the care for patients with breast reconstruction (see above for working group membership). Working group members were mandated by their professional organizations. The working group worked on developing the guideline for 2 years. The working group is responsible for the full text of this guideline.
- Dr. M.A.M. Mureau (President), MD, PhD, plastic surgeon, Erasmus MC Cancer Institute, Erasmus University Medical Center Rotterdam
- Professor Dr. R.R.W.J. van der Hulst, MD, PhD, plastic surgeon, Maastricht University Medical Center/Orbis Medical Center/Viecuri Medical Center, Maastricht
- Dr. L. A.E. Woerdeman, MD, PhD, plastic surgeon, Antoni van Leeuwenhoek / Netherlands Cancer Institute, Amsterdam
- Drs. A.A.W.M van Turnhout, MD, plastic surgeon, Tergooi Hospital, Hilversum Site
- N.A.S. Posch, MD, plastic surgeon, Haga Hospital, The Hague
- Dr. M.B.E. Menke-Pluijmers, MD, PhD, oncologic surgeon, Albert Schweitzer Hospital, Dordrecht
- Dr. E.J.T. Luiten, MD, PhD, oncologic surgeon, Amphia Hospital, Breda
- Drs. A.H. Westenberg, MD, radiotherapist/oncologist, Arnhem Radiotherapy Institute, Arnhem
- Dr. J.P. Gopie, PhD, psychologist, Leiden University Medical Center, Leiden
- Dr. H.M. Zonderland, MD, PhD, radiologist, Academic Medical Center, Amsterdam
- Drs. M. Westerhof, MSc, Netherlands Breast Cancer Association, Utrecht
- E.M.M. Krol-Warmerdam MA, V&VN Nurse Specialists, Leiden University Medical Center, Leiden
With support from
- Drs. B.S. Niël-Weise, MD, microbiologist / epidemiologist, senior advisor, Knowledge Institute for Medical Specialists
Declaration of interest
Working group members declared any (financial) ties with commercial companies, organizations or institutions involved in the field covered by the guideline for the past five years in writing. An overview is available on request from the office of the Knowledge Institute for Medical Specialists (KIMS).
Patient involvement
Patients are represented by a delegate from the Netherlands Breast Cancer Association in this guideline.
Method of development
Implementation
Guideline implementation and practical applicability of the recommendations was taken into consideration during various stages of guideline development. Factors that may promote or hinder implementation of the guideline in daily practice were given specific attention.
The guideline is distributed digitally among all relevant professional groups. The guideline can also be downloaded from the Dutch Society for Plastic and Reconstructive Surgery website: www.nvpc.nl, the guideline website: www.richtlijnendatabase.nl and the Quality Organization for Medical Specialists.
Methods and proces
AGREE
The guideline has been drafted in accordance with the requirements outlined in the ‘Guidelines 2.0’ report of the Guideline Advisory Committee of the Council on Science, Education and Quality (WOK). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreecollaboration.org), an instrument designed to assess the quality of guidelines with broad international support.
Primary questions and outcome measures
Based on the outcomes of the bottleneck analysis, the president and advisor formulated draft primary questions. These were discussed and defined together with the working group. Subsequently, the working group determined which outcome measures were relevant for the patient for each primary question, examining both desired and undesirable effects. The working group valuated these outcomes based on their relative importance as crucial, important and unimportant.
Literature search and selection strategy
Specific search terms were used to identify published scientific studies related to each individual primary question in Medline, Cochrane and, where necessary, Embase. Additionally, the references of the selected articles were screened for additional relevant studies. Studies offering the highest level of evidence were sought out first. Working group members selected articles identified by the search based on predetermined criteria. The selected articles were used to answer the primary question. The searched databases, the search string or terms used during the search and selection criteria applied are listed in the chapter for each individual primary question.
Quality assessment of individual studies
Individual studies were assessed systematically based on predefined methodological quality criteria in order to assess the risk of biased study results. These assessments may be found in the column ‘Study quality assessment’ in an evidence table.
Literature summary
The relevant study results from all selected articles were presented clearly in evidence tables. The key findings from the literature are described in the literature summary. If studies were sufficiently similar in design, data were also summarized quantitatively (meta-analysis) using Review Manager 5.
Assessment of the level of scientific evidence
A) With regard to intervention questions:
The level of scientific evidence was determined using the GRADE method. GRADE is short for ‘Grading Recommendations Assessment, Development and Evaluation’ (see http://www.gradeworkinggroup.org/) (Atkins et al, 2004).
B) With regard to questions about the value of diagnostic tests, harm or adverse effects, etiology and prognosis:
GRADE cannot be used (yet) for these types of questions. The level of evidence of the conclusion was determined based on the accepted EBRO method (van Everdingen et al, 2004).
Formulation of conclusions
With regard to questions about the value of diagnostic tests, harm or adverse effects, etiology and prognosis, the scientific evidence is summarized in one or more conclusions, listing the level of evidence for the most relevant data.
For interventions, the conclusion does not refer to one or more articles, but is drawn based on the body of evidence. The working group looked at the net benefits of each intervention. This was done by determining the balance between favorable and unfavorable effects for the patient.
Considerations
When making recommendations, scientific evidence was considered together with other key aspects, such as working group member expertise, patient preferences, costs, availability of facilities and/or organizational aspects. Insofar as they are not part of the systematic literature review, these aspects are listed under ‘Considerations’.
Formulation of recommendations
Recommendations provide an answer to the primary question, and are based on the best scientific evidence available and the most important considerations. The level of scientific evidence and the importance given to considerations by the working group jointly determine the strength of the recommendation. In accordance with the GRADE method, a low level of evidence for conclusions in the systematic literature review does not rule out a strong recommendation, while a high level of evidence may be accompanied by weak recommendations. The strength of the recommendation is always determined by weighing all relevant arguments.
Development of indicators
Along with developing a draft guideline, internal quality indicators were developed to allow monitoring of the implementation of the guideline in daily practice. More information about the method for indicator development may be requested from KIMS.
Knowledge gaps
During the development of this guideline, systematic searches were conducted for research contributing to answering the primary questions. For each primary question, the working group determined whether (additional) scientific research is desirable.
Commentary and authorization phase
The draft guideline was submitted to the (scientific) organizations involved for comment. The guideline was also submitted to the following organizations for comment: Netherlands Breast Cancer Association (BVN), Netherlands Society for Medical Oncology (NVMO), Dutch College of General Practitioners (NHG), Healthcare Insurers Netherlands (ZN), The Dutch Healthcare Authority (NZA), Health Care Insurance Board (CvZ), the Health Care Inspectorate (IGZ), Achmea, CZ, Menzis and VGZ. Comments were collected and discussed with the working group. The draft guideline was updated and finalized by the working group based on the comments. The final guideline was submitted for authorization to the (scientific) organizations involved and authorized by them.
Legal standing of guidelines
Guidelines are not legal prescriptions, but contain evidence-based insights and recommendations that care providers must meet in order to provide high quality care. As these recommendations are primarily based on ‘general evidence for optimal care for the average patient’, care providers may deviate from the guideline based on their professional autonomy when they deem it necessary for individual cases. Deviating from the guideline may even be necessary in some situations. If care providers choose to deviate from the guideline, this should be done in consultation with the patient, where relevant. Deviation from the guideline must always be justified and documented.