Allergan Breast Implants

 

Latest Update published 19th December 2018

The CE certificate for textured breast implants and tissue expanders manufactured by Allergan expired as of 16 December 2018. This does not affect Allergan textured implants placed prior to this date, but is naturally a concern to women with Allergan textured implants. Allergan are working with their notified body GMED, based in France, to resolve the issue. In the interim, they have stopped selling textured breast implants and textured tissue expanders and intend to withdraw any remaining supply in European markets. The UK regulator, the MHRA, is acting as lead co-ordinator to make sure Allergan takes a consistent EU-wide approach. The MHRA have stated that ‘there is currently no evidence of an increased risk to patients and there is no need for people who have Allergan breast implants to get them removed or have any additional clinical follow-up.”

Allergan is a multinational company. According to the FDA around 10-20 million women world wide have breast implants. Allergan is a market leader in breast aesthetics. Allergan have also been the market leader for beast implants sales in the UK. It’s breast implant range includes implants for breast augmentation and breast reconstruction.

Allergan (formerly MgGhan and then Inamed) makes many different implant types. There are silicone filled and saline filled breast implants. There are hundreds of different sizes and shapes. This includes a very wide range of smooth and textured shelled implants. They all contain a range of their class leading high cohesive medical grade silicone gel and the implants have a robust barrier layer to reduce silicone gel bleed.

How Are Allergan Breast Implants Made?

All of Allergan’s breast implants begin life from a range of special molds of different sizes and shapes, called mandrels.These are dipped into silicone to create several layers, including a middle barrier layer, and then cured to form the outer shell. There is a hole in the back through which silicone is injected to a pre-determined volume. A round silicone patch is used to create the seal. At this stage the implant is smooth on the outside and the process is already complete if the implant is destined to remain as a smooth shell implant. If a textured implant is being made, the implant is dipped into silicone again, and then pressed into salt crystals of a pre-determined size. The salt crystals are then washed away leaving the textured surface. The standard texture in their main range of Natrelle round and anatomical implants is called ‘Biocell’. This is often referred to as a macro-texture these days. It has previously been used very favorably by surgeons to allow accurate positioning of implants and to prevent them moving out of place. This texture often integrates well with the breast tissue so that it doesn’t slide around. There are some other different types of texture available with other Allergan implants. Allergan has been planning to expand their range to offer more choice in 2019 by introducing a less textured surface called ‘Microcell’. This was because of changing trends, moving away form the most textured ‘Biocell texture’ as there is some thought that in very small numbers of women (overall UK statistic in December 2018, provided by the MHRA = 1 in 24,000 risk per implant) with textured implants their body over-reacts and it stimulates the white blood cells in the tissue next to the implant to divide more quickly and cause a lymphoma (see section below). This risk is being thoroughly researched to help understand more about it. Fortunately for those small numbers of cases where a lymphoma forms next to the implant, when caught early, it is readily treatable by simply removing the implant and the surrounding capsule scar. This is because the lymphoma cells appear to form on the inner aspect of the scar initially, (not in the breast tissue) and usually causes a build up of fluid around the implant making an obvious breast swelling as a warning sign.

 

What Breast Implants Are In The Allergan Range?

The main range has been dominated by the Natrelle textured implant. They also provided the  BRST TM implant range with a slightly different texture. In 2019 Allergan were intending to introduce the MicrocellTM range (microtextured), but only after CE approval had been obtained, and that is currently on hold. The other implant made by Allergan was the CUI implant, which was another textured device. Allergan also continue to manufacture and sell their CE approved smooth shell implant range, which also contains its best silicone gel and barrier layer and is not affected. All of their textured implants include round and anatomical designs. These come in different widths varying usually between 2.5mm to 5mm increments. They also have different profiles which varies the degree of flatness or roundness, which we also refer to as the projection.  Both the Natrelle, BRST and Microcell ranges of textured and microtextured implants can therefore no longer be selected in either round or anatomical shapes until the regulator re-issues the CE mark and that will only happen if Allergan can provide the necessary information that was sought re-certification. In the mean time, if a textured device is required, we would prefer to use another manufacture whose implant is classed as microtextured as there is some evidence that the ALCL occurrence is rarer with lesser texturing. And furthermore, we would also prefer to use no texture at all and therefore select a smooth shell implant.

 

What Are The Pros And Cons of Smooth versus Textured Breast Implants?

This is a complex area and the information I base decisions on in 2018/2019, is far different to that from earlier years. We now need to look at the very latest information relating to the benefits and drawbacks of each type, to weigh this up against the individual situation for your surgery, and make a balanced decision that suits you best. Implants can cause complications in the long term, some minor but others that are less common but can be significant. So from a safety perspective, choosing the right surgeon, the right implant and right technique is very important. There are a number of published reports and studies from 2017 and 2018 that I am very familiar with, which guide evidence of benefit of one type over another. On the whole the European market had traditionally been dominated by the use of macro-textured products and conversely the USA market by the use of smooth shelled products.The pros and cons of smooth versus ‘micro texture’ versus ‘macro texture’ relate to a host of characteristics that you and your surgeon should consider and that your surgeon can advise you on; much of this information relating to rare problems is quite new in 2018, so you must ensure you see a specialist when discussing these points. There are trade-offs with making these choices between having benefits in some areas with one particular surface characteristic and drawbacks in others. Texture might be considered to reduce implant movement, malposition or some capsular contraction events. For sub-glandular implants there is evidence that the capsular contraction rate is lower if a textured implant is used compared to a smooth implant. On the other hand, it might be preferable to select a smooth implant if you opt for sub-muscular silicone breast implant placement.  The capsular contraction rate seems to be similar between textured and smooth implants in a sub-muscular pocket. If you need an anatomical implant you need to decide between different types of texture, otherwise the implant might rotate if it was just a smooth surface. Speak to your surgeon about the pros and cons regarding Mentor’s Siltex texture or Allergan’s more pronounced Biocell macro texture. My advice in 2018 is to take account of the risk of BIA-ALCL (see below), and to avoid the more aggressive macro textured implants now and consider the evidence for the lowest risk of occurrence of ALCL first of all. But you do also need to weigh up if a micro texture or smooth implant should be used as there are potential drawbacks with all implant devices and there is no perfect type that is suitable for all patients in all circumstances. It is very important that you consult with a knowledgeable specialist surgeon, like Mr Turton, to discuss this.

 

Tell Me More About the Natrelle Implant Range.

Natrelle’s TM style 410 (anatomical implants), textured round implants, and their smooth surface round implants are all part of the Natrelle range.  These  implants comprise a wide range of high quality products that provide individual solutions, and have generally been associated with low complication rates when used by specialists and this has lead in general to good patient satisfaction. Allergan has been a trusted leader in safety and aesthetic innovations. Overall there are 900 implant options! Surgeons will tell you that the Natrelle collection has a reputation built on quality – from manufacturing to performance to safety. They are used in 79 countries worldwide. They have extensive clinical data supporting the safety of their products making Natrelle TM one of the most studied range of implants. On the back of every implant you will always find a stamped identify marker stating the implant is Allergan, and it will have a unique serial number and lot number. Allergan has always done this, and this is something that has not always been seen in the past by some of the other manufactures.

A Natrelle Inspira Smooth shell implant

 

Allergan have one of the broadest range of breast implants, resterilizable sizers and tissue expanders to suit most of our patient needs. They have FDA approved anatomical implants. There are 400 implant options in the round product range, and 205 in the style 410 anatomical range. The smooth implants are specific to the round implant range, and these are the type that are best placed in sub muscular pockets.

Sometimes people have a preconceived idea that all round implants will produce a round breast shape, but this is far from true. Studies have shown that very similar natural cosmetic results can be produced. The Inspira range of round implants include natural moderate profiles that can look incredibly similar to anatomical implants, or can be selected in slightly fuller profiles; some patients desire an even fuller look and in those the more rounded shapes can be considered. The implant range can therefore meet the needs of patients whether desiring a natural look, fuller shape in the upper breast or even the more rounded look and fuller upper pole. Optimal gel filling is designed to reduce rippling.

Each implant takes 12 days to manufacture, and undergoes a total of 93 quality control tests meeting all national and international quality control standards.

Fatigue testing

For testing of breast implant durability and strength the implants are compressed to 80% of their size, 2 million times (this is 3 times a second, 24-hours a day for over a week).

Rupture resistance

In this test the implants are compressed under an extreme force of 250Kg which is ten times the recommended maximum force of a routine mammogram.

Long term durability- extensive EU and US studies demonstrate that Allergan’s Natrelle silicone filed breast implants have low long-term rupture rates. 1.7% rate at 8-years median implantation time (n = 163) Heden P et al, (2009) Long term safety and effectiveness of style 410 highly cohesive silicone breast implants. Aseth Plast Surg. 33, 430-436. However, I am also aware of MRI studies that suggest there is a silent rupture rate that is similar to other manufactures that is probably around 10% by the 10 year mark, which is why I think patients should consider regular checkups or renewal.

Long-term patient satisfaction across all aspects of breast surgery at 10 years with  96.2% of augmentation patients and 87.5% of revision augmentation patients being satisfied stating that breast implantation had been advantageous. Up to 11-years after surgery most patients reported improved self-esteem, body perception, feeling of wearing clothes, personal charisma and attraction ability (Maxwell G P et al, (2015) Ten-year results from the Natrelle 410 Anatomical Form-stable silicone breast implant core study. Aesth Surg J. 35(2): 145-155

Unique shell design

High performance silicone elastomer layers for enhanced shell integrity. 360 degree IntrashielTM minimises silicone gel diffusion.

  

The most textured implants that Allergan make have the unique BiocellTM texture to promote tissue adherence, and to reduce the risk of capsular contraction. Some texturing is important for implants placed in a sub glandular pocket. However, patients might want to consider the alternative micro texture or smooth shelled implants to reduce the rare occurrence of lymphoma which might be caused by bacterial inflammation or chronic inflammation linked to the texture. The risk of this specific lymphoma with the Biocell texture is thought to be low, at 1 in 1000 to 1 in 2000 in some studies (possibly as low as 1 in 24,000 according to overall data from the MHRA in December 2018), but the rate may be lower still with lesser texturing and even rarer with smooth implants. Research will undoubtedly refine these figures as time passes.

 

The FDA Core study is quite old now, but it showed results at 6 and 10-years for primary augmentation and revealed the following:

5-10.2% rupture rate

0.7-.09% rippling rates

2.3-4.7% malposition rate

4.6-9.2% Baker 3 or 4 capsular contraction rate

1.4-0.4% seroma rate

 

Subglandular Implant Placement. The implant is behind the breast tissue, but the muscle layer has not been disturbed.

Submuscular Implant placement. The implant is partly behind the pectoral muscle.


Allergan Implants and Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

After an implant has been placed under the breast tissue the body begins a healing process and creates a thin layer of scar tissue around the implant. We call this layer the ‘capsule’. The capsule is your body’s natural barrier to the presence of a foreign body. Capsules form around all implanted devices, such as pacemakers, replacement joints, and grafts. Capsules contain a number of cells from the immune system. The commonest is the fibroblast that makes the scar. But there are also white blood cells in there too. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare lymphoma of the white blood cells in the tissue that can sometimes form in this layer of tissue adjacent to the implant- when it forms it therefore begins in the ‘capsule tissue’. It is reported to be extremely rare with smooth shelled implants (actually no occurrences have ever been reported world-wide where this has been the only type of implant used as of December 2018. This includes data going back since the first case report of this rare disease in 1997). Some implants from different manufactures have different types of texture, that have been created using different techniques. For example, the texture on Mentor textured implants is sometimes referred to as a micro texture although there have been no specific studies prior to 2018 that have analysed and stratified texturing scientifically.  But there do seem to be differences emerging in the association of this rare lymphoma with some of the different types of texturing. But as the ALCL type of lymphoma is rare there are some implant manufactures that have never been associated with a case, perhaps simply because their implants represent such a small fraction of the global implant market.

The Mentor Siltex texture (sometimes referred to as a microtexure by the manufacturer’s UK representatives) has had lower estimated rates of ALCL reported in 2017 compared to the Allergan Biocell texture. For Siltex the rate in a 2017 study published in Australia (Loch-Wilkinson) is thought to be between 1 in 30,000 to 1 in 60,000. The rate could be higher than this but it is probably less than a 1 in 1000 level of risk.  Data will clarify this over time. For the macro textured group (e.g. Allergan Biocell macro texture) the risk estimate may be 1 in 1000 to 1 in 10,000. It could be more frequent than this and future date collection will help to clarify this.

 

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