Implant in breast reconstruction
Question
What is the role of the implant in immediate breast reconstruction?
Recommendation
Prosthesis/tissue expander:
When speaking with patients about the choice for immediate reconstruction using only an implant, be sure to discuss:
- that all of the risk factors for complications listed below can negatively affect the result of the reconstruction: smoking, BMI ≥30 kg/m2, bilateral surgery, age >55 years, direct placement of a definite prosthesis, larger breasts;
- that more surgical complications occur with a BMI ≥30 kg, smoking and co-morbidities (e.g. diabetes mellitus, hypertension).
It is preferable not to perform immediate breast reconstruction with an implant in patients with more than two preoperative risk factors for complications.
It is preferable not to perform immediate implant reconstruction if there is a high likelihood of postoperative radiation therapy.
Use a tissue expander first in case of:
- significant skin loss after a skin-sparing mastectomy;
- the patient desires a larger breast size.
Implant with/without latissimus dorsi transposition:
Combine an implant with a latissimus dorsi transposition if performing immediate reconstruction after salvage mastectomy.
If possible, use a(n) (extended) latissimus dorsi without an implant.
Considerations
Immediate breast reconstruction using a definite breast prosthesis versus immediate breast reconstruction using a temporary tissue expander:
Of the two methods involving an implant, the 2-stage method, where a temporary tissue expander is inserted first, which is later replaced by a definite prosthesis, is the more popular procedure. In recent years, there has been growing interest in direct implantation of a definite prosthesis after skin-sparing mastectomy. The goal is to avoid subjecting patients to a second operation. It is a technically more attractive solution in nipple-sparing mastectomy, as It allows better estimation of the nipple position (Singh et al, 2012). A complete reconstruction during a single surgery is also a more attractive solution for patients undergoing a bilateral prophylactic mastectomy (Singh et al, 2012).
The choice to first place a tissue expander in immediate breast reconstruction is primarily based on the desire to ensure the implant can be placed adequately and with minimal tissue strain. This reduces the risk of skin necrosis and undesirable shifting of the implant. It has been suggested this also reduces the risk of postoperative infection and capsular contracture (Alani et al, 2013) An additional benefit of first using a tissue expander following skin-sparing mastectomy is that it facilitates sizing of the definite prosthesis. It also allows the skin to be stretched out a little further before the definite prosthesis is implanted during a second procedure. This allows better control of volume and shape, and allows minor imperfections to be corrected during a second procedure. Others consider this stretching to be a disadvantage, as it may lead to thinning of the subcutis and to adherence of the subcutis to the underlying pectoralis major, which may occur at an early stage during expansion, resulting in undesirable breast size and shape (Cassileth et al, 2012) The biggest disadvantage of the tissue expander method is that two surgeries are required, along with multiple outpatient clinic visits before final breast volume is achieved (Singh et al, 2012).
The primary insertion of a tissue expander is particularly useful if there is a lot of skin loss during mastectomy, making it impossible to directly reach the final volume using the remaining skin envelope. If there is a desire for larger breasts, the skin envelope will also often not be sufficient to allow direct insertion of a larger volume prosthesis.
Direct placement of a definite prosthesis offers a number of significant advantages, such as avoiding a second surgery with additional risks, morbidity and costs. The amount of time required for rehabilitation is also reduced and body image is restored sooner (Singh et al, 2012). However, this immediate 1-stage procedure is also considered a more difficult technique, requiring greater experience and expertise from the plastic surgeon. Even for experienced plastic surgeons, additional surgical correction is sometimes required due to dissatisfaction with the obtained result. Singh et al (2012) retrospectively examined 1316 patients, including 95 women who directly received a definite prosthesis, and 1221 women who first underwent tissue expander implantation followed by a prosthesis. The number of repeat surgeries was an outcome measure for successful breast reconstruction. The number of planned repeat surgeries during the first 18 months postoperatively was higher in the tissue expander group (52/100) than in the prosthesis group (6/100; RR 15.4, p<0.05). The number of unplanned repeat surgeries due to complications such as skin necrosis, infection, hematoma, and complications with the implant was slightly higher in the direct prosthesis group (167/100 direct prosthesis patients vs. 128/100 tissue expander patients; RR=1.66, p<0.05). All repeat surgeries combined (both planned and unplanned) showed a slightly higher number of implant revisions in the tissue expander group than in the prosthesis group (180 vs. 174 per 100 patients, respectively; RR=1.22, p<0.05). The impression exists that acellular dermal matrix products were used in an unknown number of patients in this series, which may have affected the results (Singh et al, 2012).
However, the percentage of planned additional surgeries was also similar after both methods in other studies (6.9% vs. 7.5%; Davila et al 2013 and 28% vs. 28.6 %; Roostaeian et al, 2011). In 2-stage implant breast reconstruction, more repeat surgeries were performed during the expansion period of the tissue expander than after placement of the definite prosthesis (Hvilsom et al, 2011). The risk of complications was comparable for both methods in some studies (14% vs. 14.3%; Roostaeian et al, 2011 and 28.4% vs. 27.4; Singh et al, 2012), or slightly elevated after 1-stage reconstruction (6.8% vs. 5.4%; Davila et al 2013 and 21.8% vs. 15%; Fischer et al, 2013). Both methods are safe, reliable and achieve acceptable aesthetic results.
The chance of postoperative complications, or even implant loss as the most serious complications following immediate breast reconstruction, is associated with a variety of perioperative factors. Implant loss is a rare but extremely unpleasant complication after breast reconstruction, often leading to patient dissatisfaction and an increase in costs. In a recent risk analysis published by Fischer et al (2013) in 14,585 patients, the perioperative risks associated with implant loss were investigated for immediate reconstructions. The most common factors were: age over 55 years; BMI>30 kg/m2; smoking; bilateral reconstruction and direct placement of a definite prosthesis. Smoking and BMI >30 kg/m2 were found to be more significant risk factors within this population. Unfortunately, the authors did not describe how they weighted the significance of the risk factors. Furthermore, only 15% of patients underwent direct implantation of a definite prosthesis, and it is unclear how often an acellular dermal matrix product was used in this group (used in 18.5% of the total number of patients). Like previous studies, this study suggests that loss of the implant after immediate breast reconstruction is a multifactorial process related to various perioperative risk factors (Warren Peled et al, 2012; Leyngold et al, 2012; Davies et al, 2011; Woerdeman et al, 2007). These other studies also found that larger breasts and comorbidities were additional risk factors. The occurrence of a deep wound infection was a predictive factor for loss of the implant. The risk of complications or implant loss increases with the number of preoperative risk factors present. Considering these factors when selecting immediate reconstruction with an implant may lead to improved patient selection and a lower risk of complications.
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 with an implant is often delayed due to the high risk of complications and capsular contracture (Rusby et al, 2010; Lentz et al, 2013; Lam et al, 2013). See Chapter 5 for more information.
There are no prospective randomized studies comparing the outcomes of an implant reconstruction in one versus two stages. Thus, no clear recommendation can be given regarding a preference for one method over the other. Which method will be used depends on the preference and experience of the plastic surgeon, along with the patient’s informed choice.
Comparison of immediate reconstruction with an implant versus immediate reconstruction with an implant in combination with a latissimus dorsi flap.
After skin-sparing mastectomy and immediate reconstruction with an implant, there is generally sufficient skin for a good cosmetic result. The chance of local recurrence after skin-sparing mastectomy is not higher compared to conventional mastectomy and immediate breast reconstruction does not interfere with detection and follow-up of a potential local recurrence (Sandelin et al, 2004; NABON breast cancer guideline, 2012; Agrawal et al, 2013; Piper et al, 2013).
There is no evidence-based absolute indication for adding the latissimus dorsi flap to an immediate reconstruction. The use of the latissimus dorsi flap is based primarily on the fact that this muscle provides good coverage of the implant. Additionally, if a latissimus dorsi is used for an immediate reconstruction, direct implantation of a definite prosthesis is often feasible (Hammond, 2009). However, the latissimus dorsi is generally reserved as a salvage procedure, because it is a crucial tool for breast and chest wall reconstruction following prior unsuccessful breast reconstruction and in the event of local recurrence of breast cancer requiring a more extensive resection (Bakri et al, 2011).
Performing an immediate breast reconstruction using only the latissimus dorsi without an implant is feasible for reconstruction of small to average sized breasts (Kim et al, 2012). Subcutaneous fat and fat tissue below the back muscle is included to create sufficient volume of the new breast, creating an extended or autologous latissimus dorsi (Bailey et al, 2011). If insufficient volume is available to make a match for the contralateral breast, a combination with an implant may be required.
If a salvage mastectomy is performed following radiation therapy, use of the latissimus dorsi muscle is of added value. It improves the quality of the damaged tissues and results in less capsular contracture around the implant compared with immediate reconstruction using an implant alone after previous radiation therapy (Cordeiro et al, 2012) A skin island can also be included if the skin envelope after salvage mastectomy is insufficient. Postoperative radiation therapy does yield a less aesthetically pleasing result, but does not appear to result in a difference in quality of life (Winters et al, 2013; Thomson et al, 2008).
Evidence
Background
An immediate breast reconstruction using a subpectoral implant can be performed either by directly inserting the definite prosthesis after skin-sparing mastectomy (1-stage) or by first implanting a tissue expander and replacing it with a definite prosthesis at a later stage (2-stage). It is unclear whether one of these procedures is preferable to the other. Furthermore, it is insufficiently clear whether it is advisable to perform a latissimus dorsi transposition when placing an implant.
Conclusions
1. Comparison of immediate definite prosthesis reconstruction versus immediate tissue expander reconstruction.
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Aesthetic result, postoperative complications, quality of life and local control.
No comparative studies examined the effect of immediate reconstruction with a definite prosthesis compared with initial use of a tissue expander on the aesthetic result, postoperative complications, quality of life and local control. |
2. Comparison of reconstruction with an implant versus reconstruction with an implant in combination with a latissimus dorsi flap.
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- |
Aesthetic result, postoperative complications, quality of life and local control.
No comparative studies examined the effect of an immediate reconstruction with an implant with an implant in combination with a latissimus dorsi flap on the aesthetic result, postoperative complications, quality of life and local control. |
Literature summary
1. Comparison of immediate definite prosthesis reconstruction versus immediate tissue expander reconstruction:
The working group found no comparative studies answering this question.
2. Comparison of reconstruction with an implant versus reconstruction with an implant in combination with a latissimus dorsi flap.
The working group found no comparative studies answering this question.
Search and select
A systematic review of the literature was performed for the following questions in order to answer the primary question:
- What is the effect of an immediate reconstruction with a definite prosthesis on the aesthetic result, postoperative complications, quality of life and local control compared to immediate reconstruction with initial placement of a tissue expander?
- What is the effect of an immediate reconstruction with an implant on the aesthetic result, postoperative complications, quality of life and local control compared to immediate reconstruction with an implant combined with a latissimus dorsi flap?
Search for the primary questions:
Medline (OVID) and Embase databases were searched for immediate and delayed reconstruction using an implant. The literature search yielded 1186 results. Studies that met the following selection criteria were included in the literature summary: original studies; comparative studies; systematic review of comparative studies; comparison of different reconstructions using an implant or comparison of breast reconstruction with a tissue expander and prosthesis at a later time or direct insertion of a definite prosthesis; reconstruction with an implant with the addition of a latissimus dorsi flap, and with one of the following outcome measures: aesthetic result, patient satisfaction, postoperative complications, quality of life and local control.
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.
Search strategy
Searches are available upon request. Please contact the Richtlijnendatabase.