Interventional procedure consultation document

Breast reconstruction using lipomodelling after breast cancer treatment

Restoring breast volume after breast cancer surgery using injections of the patient’s own fat  

Surgical treatment for breast cancer involves either removal of the breast (a mastectomy) or removal of the tumour and some adjacent breast tissue (breast-conserving surgery or lumpectomy). Following mastectomy, many women choose some type of breast reconstruction. However, after breast-conserving surgery, which can produce a significant deformity, very few options are normally offered. This procedure involves taking fat from the abdomen or thighs and injecting it into the breast in the area of the deformity caused by surgery.

The National Institute for Health and Clinical Excellence (NICE) is examining breast reconstruction using lipomodelling after breast cancer treatment and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about breast reconstruction using lipomodelling after breast cancer treatment.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 21 April 2011

Target date for publication of guidance: July 2011

1   Provisional recommendations

1.1  Current evidence on the efficacy of breast reconstruction using lipomodelling after breast cancer treatment is adequate and the evidence raises no major safety concerns. Therefore this procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.

1.2  There is a theoretical concern about any possible influence of the procedure on recurrence of breast cancer in the long term, although there is no evidence of this in published reports. NICE therefore encourages long term data collection on this procedure.

1.3  Patient selection should be carried out by a breast cancer multidisciplinary team.

1.4  Breast reconstruction using lipomodelling after breast cancer treatment should only be carried out by surgeons with specialist expertise and training in the procedure.

2   The procedure

2.1   Indications and current treatments

2.1.1  Breast reconstruction following surgery for breast cancer may be done during the same operation or at a later date, and may involve  prosthetic material (implant) alone, or autologous tissue (tissue from elsewhere in the body, usually the abdomen, buttocks or back), or a combination of the two.

2.2  Outline of the procedure

2.2.1  Lipomodelling uses the patient’s own fat cells to replace volume after breast reconstruction, or to fill defects in the breast following breast conserving surgery. It can be used on its own or as an adjunct to other reconstruction techniques. The procedure aims to restore breast volume and contour without the morbidity of other reconstruction techniques. However, a degree of fat resorption is common in the first 6 months and there are concerns that it may make future mammographic images more difficult to interpret. Furthermore, it could possibly induce recurrence of cancer (although there is no evidence that this has occurred).

2.2.2  With the patient under general or local anaesthesia, fat is harvested by aspiration with a syringe and cannula, commonly from the abdomen, outer thigh and flank. The fat is usually washed and centrifuged to remove dead cells and debris. In addition, a device may be used to concentrate the adipose-derived stem cells prior to injection into the breast. Patients usually undergo 2–4 sessions of treatment depending on their condition. Commencement of lipomodelling treatment may be delayed in order to reduce the theoretical risk of cancer recurrence.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/845/overview

2.3   Efficacy

2.3.1  In a case series of 734 procedures for breast reconstruction the results of lipomodelling following conservative surgery (lumpectomy and radiotherapy) were judged to be ‘very good’ in 50% of procedures, ‘good’ in 40% and ‘moderately good’ in 10% (based on clinical examination, photographs and patient opinion: absolute numbers not stated).

2.3.2  A case series of 820 patients, including 381 with asymmetry after mastectomy and breast reconstruction, reported that the majority of patients had a ‘significant improvement in their breast size and/or shape postoperatively’. Long-term breast asymmetry was reported in 4% (34/820) of patients.

2.3.3  A case series of 69 patients (74 breasts) reported a ‘good to very good’ improvement in 87% (64/74) of breasts and a ‘moderate’ improvement in 14% (10/74) of breasts (assessment from photographs by 2 independent surgeons).

2.3.4  A non-randomised comparative study of 61 patients (62 breasts) treated by lipomodelling (n = 20) or standard treatment only (n = 42) (not described) reported mean aesthetic results of 3.1 and 4.3 points respectively at 3-month follow-up (p ≤ 0.032) (evaluated using a 5-point scale: 5 = very good).

2.3.5  The Specialist Advisers listed key efficacy outcomes as volume change, aesthetic assessment of breast shape, quality of life and body image assessments.

2.4   Safety

2.4.1  The case series of 734 procedures for breast reconstructionprocedures reported that 10 years of oncological follow-up did not reveal any increased risk of local recurrence after mastectomy or after conservative treatment. In a case series of 137 patients who had a modified radical mastectomy, 96% were free from recurrence and 98% were free from distant metastasis at 5-year follow-up (absolute figures not stated).

2.4.2  The case series of 880 procedures reported 1 intraoperative pneumothorax (probably caused by the transfer cannula piercing the pleura), which resolved with insertion of pleural drain.

2.4.3  A case series of 880 procedures reported local infection in less than 1% of procedures (6/880): all resolved with treatment and had no impact on the final result. There was also an infection at a harvesting site in one case which resolved with antibiotics.

2.4.4  The case series of 880 procedures reported a 3% rate of fat necrosis (absolute figures not stated). Liponecrotic cysts were reported in 7% (5/74) of breasts at 3-month follow-up in the case series of 69 patients and in 5% (2/43) in a case series of 37 patients.

2.4.5  The Specialist Advisers listed adverse events known from reports or experience as oil cysts, haematoma, calcification, donor and breast site deformity, complete resorption of fat, uncertain findings on clinical surveillance and mammography. They raised the theoretical possibility of an increased rate of breast cancer recurrence and fat embolism.

2.5   Other comments

2.5.1  The Committee noted that there have been concerns about possible interference as a result of the procedure with imaging of the breast for cancer surveillance. However, it was advised that this ought not to be an issue with current techniques for lipomodelling and with expert interpretation of subsequent images.

2.5.2  The Committee noted that the techniques used for lipomodelling continue to evolve.

3   Further information

3.1  For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

March 2011

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}