Evaluating outcomes of Implant-based breast reconstruction
The iBRA Study
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Please click on the links below to view the forms used in the study.
Patient information leaflet used to introduce the study to ladies undergoing implant-based reconstruction
Implant based breast reconstruction is where either a silicone, part silicone part saline (salty water) filled, or totally saline-filled breast implant is placed under the larger pectoral muscle (pectorals major) after a mastectomy.
A reconstruction can either be performed at the same time as having a mastectomy (immediate) or can be done at a later date (delayed).  

In this diagram the pectorals major muscle has been lifted up from the chest wall after a mastectomy and a piece of specialised matrix mesh has been sewn between the edge of the muscle and the chest wall, to create an "internal bra". This "internal bra" is also sometimes created using some of the patients own skin this is called a dermal sling.
A drain can be seen running along the edge of the mesh, to remove any fluid build up to help ensure that the mesh become part of the body tissues.
The implant can be placed under the muscle with/or without the use of a specialised matrix mesh.
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Are there other breast reconstruction options?
As well as using an implant (with or without a matrix mesh or dermal sling) to recreate a breast, a patient's own tissue can be moved to recreate a breast shape. The most common procedures involve either using a flap of skin/fat and muscle from the back (an LD (latissimus dorsi muscle)) flap, or using skin, fat and muscle from the tummy (TRAM flap) or skin and fat from the tummy (DIEP) flap. Other areas of the body that can also be used to donate skin/fat/muscle to recreate a breast shape include the buttock or thigh.
These other methods of reconstruction are not explained in detail on this site but you can follow this link for further information.
If you are a patient considering breast reconstruction then please discuss your options fully with your surgeon.
There are a number of different acellular matrixes that are used with an implant-based breast reconstruction to form an "internal bra". This can help with the shape of the reconstruction and provide a good cover for the implant.
These matrixes can be formed from animal or synthetic sources. Different surgeons have different preference as to which brand they use. This study will collect data as to which brand is used for each case so comparisons can be made.
A dermal sling is where some of the patients own skin, (with the topmost layer carefully removed) is used to create the "internal bra" rather than a matrix. Not all ladies are suitable for this and it needs to be discussed for individual cases.

Why are we only looking at implant-based reconstruction?
A large and well conducted national audit was performed a few years ago (National Mastectomy and breast reconstruction audit, click this link to see its reports). This gave good information as to the outcomes of other types of breast reconstruction. The use of the "internal bra" matrix meshes have been taken up widely since this audit was conducted, we therefore need to look at these implant-based reconstructions in more detail.
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What data are we collecting?
At the time of surgery details about patient age, general fitness, smoking status, Body Mass Index (BMI) will be collected. All patients are anonymous, no patient identifiable data is collected. Specific factors during the operation will also be collected including length of the procedure, how the procedure was done and what type of implant (silicone, silicone and saline, or saline alone) will also be asked for. We will also document what type of matrix mesh, if any was used. After the surgery, if the operation was for a breast cancer, (rather than to reduce the risk of developing breast cancer in a high-risk patient (risk-reducing/prophylactic)) details about the type of tumour will be recorded. We will also look at whether there were any complications in the first 30 days after surgery.(back to top)
These are paper or electronic questionnaires that will be sent out to the ladies that have agreed to receive them at 3 months and 18 months after surgery.
The questionnaires will be sent from the University of Bristol.
The hospital team that looks after the patient does not get to see the questionnaire results from individual patients that they have treated.
The 3 month questionnaire asks questions about:
Satisfaction with information
3 month after surgery complication data
Additional (adjuvant) treatment information
The 18 month questionnaire asks questions about:
Psychological well being (BREAST-Q)
Sexual well being (BREAST-Q)
Satisfaction with breasts (BREAST-Q)
Satisfaction with outcome (BREAST-Q)
Late complications
Additional surgery  
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Implant-Based Breast Reconstruction evAluation

Ensuring quality through collaborative research. The iBRA Study. 2014-2017.