Question

Which imaging procedure is most suitable for women with silicone prostheses?

Recommendation

There is no standard procedure available for women with silicone prostheses.

The guideline development group is of the opinion that the radiologist, together with the laboratory technician, must determine the choice and sequence of clinical imaging on the basis of consistency, relative size and localisation of the prosthesis.

 

Screening

Women with silicone prostheses between 50-75 years of age are eligible for participation in the national screening programme. Only if mammography does not work or the mammogram cannot be evaluated, they are advised to have their screening examination conducted in the hospital radiology department. At the hospital, it is expected that the radiologist and technician perform additional imaging. The radiologist may decide to screen using ultrasound (if required).

 

Screening with MRI is not recommended.

 

Diagnostics:

Mammography and ultrasound are performed if there are symptoms.

 

If mammography does not work, ultrasound is the procedure of choice.

Conclusions

 

Level 1

It has been demonstrated that the incidence of carcinoma does not increase in the presence of prostheses, but remains the same or is lower than in the general population.

 

A2    Deapen 2007, Pukkala 2002, Friis 2006

 

Level 1

It has been demonstrated that cancer stage and survival in women with prostheses are comparable to the stage and survival in the general population.

 

A2    Deapen 2007, Pukkala 2002, Friis 2006, Handel 2007

 

Level 3

Carcinomas in women with prostheses are more often detected as palpable abnormalities, they are more often invasive with lymph node metastases and false negative mammograms.

 

A2    Handel 2007

Literature summary

There are no evidence-based guidelines or meta-analyses about screening and diagnostics in patients with silicone protheses. Most data is derived from (long-term) retrospective cohort studies.

Retrospective cohort studies show that the incidence of breast cancer in the presence of prostheses is not higher and survival is not poorer than expected [Deapen, 2007]. In some studies, the incidence is even lower. A Finnish study included 2,171 women; 30 developed breast cancer out of 33.7 expected carcinomas (SIR 0.9. 95%CI 0.6-1.3). A Danish study compared 2,763 women with silicone prostheses with a control group; less breast cancers were found here too than expected (SIR 0.7. 95%CI 0.5-1.0). The breast cancer stage and survival in these 2 studies were comparable to that in the general population [Pukkala, 2002; Friis, 2006]. Handel (2007) compared 129 carcinoma in women with silicone prostheses with the general population and found more palpable abnormalities, invasive tumours, positive lymph nodes and false negative mammograms. Follow-up was a maximum of 23 years; no difference in survival was found. Tumour detection was usually by means of physical examination (palpable abnormality); mammography was the most reliable imaging technique, followed by ultrasound.

Considerations

Patients with silicone prostheses form a heterogenous group. The extent to which the prostheses mask the fibroglandular tissue varies greatly, in general overprojection reduces with increasing age, due to an increase in fatty tissue in the breast. Other factors also play a role in the ability to perform and evaluate a mammogram: capsule formation, large prosthesis in a small breast and prepectoral localisation are unfavourable, but performing and evaluating a mammogram in the case of postpectoral localisation is generally not a problem. Digitalisation of the mammogram also has a positive influence here.

The chance of rupture with the old generations of silicone prostheses (which contain an almost fluid core) is much greater than with the most recent prostheses, consisting of much firmer cohesive gel. Due to their more anatomical shape, they are much more formable and pliable, this is tested during the production process. They have a much lower chance of rupture than the older types: 98% was rupture-free after 5 years and 83-85% after 10 years [McLaughlin, 2007].

Mammography is generally considered the method of choice. Only a minority in the national screening programme cannot be evaluated, see 1.2.2. In the radiology departments of hospitals, the responsibility lies with the radiologist. The radiologist should provide further instructions to the technician when the mammogram is made: in applying compression, the consistency and location of the prostheses (pre- or retropectoral) should be taken into account. The technician should strive for images according to Eklund and an extra projection direction, for example mediolateral [Eklund, 1988].

Ultrasound is indicated as an addition to mammography for palpable abnormalities, both for the detection of leakage and for masses. There are no good studies available on ultrasound as screening method with prostheses. In the 14-centre study by Berg [2008], no women with implants were included. This study did show that in individual cases screening with ultrasound may be worthwhile, if screening using mammography does not work, see 1.1.4.

In the United States, MRI is approved by the FDA as method to determine leakage or rupture with asymptomatic patients, but the evidence for this is doubtful, partly due to the quality of third generation prostheses. However, MRI is very sensitive in determining a rupture if there are symptoms [McCarthy, 2008]. MRI as screening method in women with prostheses and with the risk profile of the general population is not recommended, because there are no indications that their prognosis is worse if breast cancer develops.

Regular breast self examination is not recommended in the general population, see 1.1.1. However, because most carcinomas in women with prostheses are discovered by palpation, this method may be worthwhile here.

Authorization date and validity

Last review : 13-02-2012

Last authorization : 13-02-2012

The national Breast Cancer guideline 2012 is a living guideline, in other words there is no standard term of revision. NABON continually watches at new developments and clinical problems in the areas of screening, diagnostics, treatment and aftercare, and whether this requires an update.

Initiative and authorization

Initiative : Nationaal Borstkanker Overleg Nederland

Authorized by:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Psychiatrie
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Radiotherapie en Oncologie

General details

Approximately 14,000 women (and 100 men) are diagnosed with invasive breast cancer each year in the Netherlands, and about 1,900 have an in situ carcinoma. A woman's risk of having breast cancer over the course of her life is 12-13%. This means that breast cancer is the most common form of cancer in women in the Netherlands. Early detection, particularly via national breast cancer screening, combined with adjuvant therapy followed by locoregional treatment, improves the prognosis in women with breast cancer

The guideline on Breast Cancer Screening and Diagnostics, published in 2000, was updated in 2007. In 2002, the first multidisciplinary National Breast Cancer Guideline was published, it was revised in 2004, 2005 and 2006. In 2008 both guidelines were combined to Breast Cancer Guideline, which 2012 revision is now effected.

Scope and target group

This guideline is written for all the members of the professional groups that have contributed to its development.

 

This guideline is a document with recommendations and instructions to support daily practice. The guideline is based on the results of scientific research and expert opinion, with the aim of establishing good medical practice. It specifies the best general care for women with (suspected) breast cancer and for those who are eligible for screening. The guideline aims to serve as a guide for the daily practice of breast cancer screening, diagnostics, treatment and aftercare. This guideline is also used in the creation of informational materials for patients, in cooperation with the KWF (Dutch Cancer Society).

Member of workgroup

A core group consisting of a radiologist, surgeon, pathologist, medical oncologist and radiation therapist began preparing for the revision of the breast cancer practice guidelines in 2009. A multidisciplinary guideline development group was formed in early 2010 to implement the revision. This group consisted of mandated representatives from all of the relevant specialisations concerned with breast cancer, plus two delegates from the BVN (Dutch Breast Cancer Society) (see list of guideline development group members). The benefits of such a multidisciplinary approach are obvious: not only does it best reflect the care, but it offers the greatest possible expertise for the guideline. In composing the development group, geographic distribution of the members, balanced representation of the various organisations and agencies concerned, and a fair distribution in academic background were taken into account as much as possible.

 

The guideline development group received procedural and administrative support from IKNL (Comprehensive Cancer Centre for the Netherlands) and support on methodology from Bureau ME-TA. Partial funding was obtained from SKMS (Quality Funds Foundation of Dutch Medical Specialists). This subsidy would not have been possible without the extensive assistance provided by the NVvR (Radiological Society of the Netherlands).

Declaration of interest

Partial funding for the guideline revision was obtained from the Society of Dutch Medical Specialists in the framework of the SKMS. IKNL sponsored some of the cost. On two occasions, as well as at the beginning and end of the process, all of the members of the guideline development group were asked to fill out a statement of potential conflicts of interest, in which they stated their relationship with the pharmaceutical industry. A list of these statements of interest can be found in the appendices.

Patient involvement

In developing this guideline, four clinical questions were formulated. These questions emerge from an inventory of clinical problems collected in the field from professionals, patients and patient representatives.

 

Also, A multidisciplinary guideline development group was formed in early 2010 to create and implement the revision. This group consisted of mandated representatives from all of the relevant specialisations concerned with breast cancer, plus two delegates from the BVN (Dutch Breast Cancer Society).

 

Method of development

Evidence based

Implementation

Feasibility has been taken into account in developing the guideline. This included attention to factors that could promote or hinder putting the advice into practice. Examples include the implementation of an analysis of problems, the multidisciplinary composition of the guideline development group, and making active use of support from the guideline development group members. Presenting the draft guideline to the field and communicating what, if anything, is being done with the responses, also promotes implementation. In this manner, a guideline has been developed that answers current questions in the field.

The guideline is distributed widely and is available in digital form on the Dutch Guideline Database. The guideline may also be brought to the attention of a wider audience in other periodicals or continuing education sessions, for example. To promote use of the guideline, we recommend that the regional tumour working groups and group practices, as well as scientific and professional organisations, repeatedly bring the guideline to the attention of their members. Any problems that may arise in using the guidelines can then be discussed and, when appropriate, submitted to the national guideline development group, as it is a "living" guideline. If desirable, parts of the guideline can be made more explicit by formulating regional additions or translation to the local situation in departmental and/or hospital protocols.

In principle, indicators are determined during development of the guideline that can be used to monitor implementation of the recommendations. Via a documentation project, these indicators can then be used to determine the extent of compliance with the guideline. The information from the documentation project becomes input for the revision of the guideline.

Methods and proces

This module has been evidence-based revised in 2008 and consensus based updated in 2012.

 

A revision of an existing guideline consists of revised and updated text. Revised text is new text based on an evidence-based review of the medical literature; updated text is the old guideline text which has been edited by the experts without performing a review of medical literature. Each section of the guideline states what type of revision has taken place. Each chapter of the guideline is structured according to a set format, given below. The purpose of this is to make the guideline transparent, so that each user can see on what literature and considerations the recommendations are based on.

 

Description of the literature

To the greatest extent possible, the answers to the fundamental questions (and therefore the recommendations in this guideline) were based on published scientific research. The articles selected were evaluated by an expert in methodology for their research quality, and graded in proportion to evidence using the following classification system:

 

Classification of research results based on level of evidence

A1

Research   on the effects of diagnostics on clinical outcomes in a prospectively   monitored, well-defined patient group, with a predefined policy based on the   test outcomes to be investigated, or decision analysis research into the   effects of diagnostics on clinical outcomes based on results of a study of   A2-level and sufficient consideration is given to the interdependency of   diagnostic tests.

A2

Research   relative to a reference test, where criteria for the test to be investigated   and for a reference test are predefined, with a good description of the test   and the clinical population to be investigated; this must involve a large   enough series of consecutive patients; predefined upper limits must be used,   and the results of the test and the "gold standard" must be   assessed independently. Interdependence is normally a feature of situations   involving multiple diagnostic tests, and their analysis must be adjusted   accordingly, for example using logistic regression.

B

Comparison   with a reference test, description of the test and population researched, but   without the other features mentioned in level A.

C

Non-comparative   trials

D

Opinions   of experts, such as guideline development group members

 

Conclusions

Based on the medical literature, one or more relevant conclusions are made for each section. The most important literature is listed according to the level of evidential strength, allowing conclusions to be drawn based on the level of
evidence. All the medical literature included in the conclusion is described in the bibliography.

 

Classification of conclusions based on literature analysis

1

Based   on 1 systematic review (A1) or at least 2 independent A2 reviews.

2

Based   on at least 2 independent B reviews

3

Based   on 1 level A2 of B research, or any level C research

4

Opinions   of experts, such as guideline development group members

 

Other considerations

Based on the conclusion(s), recommendations are made. However, there are other considerations that contribute to formulation of the recommendation besides literature evidence, such as safety, the patients' preferences, professional expertise, cost-effectiveness, organisational aspects and social consequences. The other considerations are mentioned separately. In this manner, it is clear how the guideline development group arrived at a particular recommendation.

 

Recommendations

The final wording of the recommendation is the result of the scientific conclusion, taking into account the other considerations. The purpose of following this procedure and drawing up the guidelines  in this format is to increase transparency.

 

References

An alphabetical list of literature references can be found at the end of the guideline.

 

All draft texts have been discussed by the guideline development group.

Search strategy

Searches are available upon request. Please contact the Richtlijnendatabase.