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 are also 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 gels.
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. The salt crystals are then washed away leaving the textured surface.
What Breast Implants Are In The Allergan Range?
The main range is dominated by the Natrelle implant but there is also the BRST TM implant range to consider. Both include a large number of round and anatomical designs. These come in different widths varying in 0.5cm increments and different profiles varying the degree of roundness or projection. Both the Natrelle and BRST range of textured implants can therefore be selected in round or anatomical shapes to fit most patient requirements.
What Are The Pros And Cons of Smooth versus Textured Breast Implants?
This is a complex area with only a limited number of studies of good quality to give scientific evidence of benefit of one type over another. On the whole the European market has traditionally been dominated by the use of textured products and 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 your surgeon should consider and advise you on. 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 capsular contraction events. For sub-glandular implants there is good evidence that the capsular contraction rate is lower if a textured implant is used compared to a smooth implant. 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, others the implant might rotate if it was just smooth. Mentor’s Siltex texture of 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 texture 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 and round implants comprise a wide range of high quality products that provide individual solutions, low complication rates, leading to patient satisfaction. I have been using these products for over 15-years because Allergan is 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.
Natrelle Inspira Smooth
Allergan have one of the broadest range of breast implants, resterilizable sizers and tissue expanders to suit all of our patient needs. They are 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 part of the round implant range, and these are the type that are best placed in sub muscular pockets.
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, or even much fuller more rounded shapes if desired. They can therefore meet the needs of patients desiring a natural look, and slightly fuller shape in the upper breast or even a more rounded look and even 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.
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.
Textured implants have a unique BiocellTM texture to promote tissue adherence, and to reduce the risk of capsular contraction. This texturing is important for implants placed in a sub glandular pocket, pocket 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 linked to the texture.
The FDA Core study results at 6 and 10-years for primary augmentation showed 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
Submuscular Implant placement
Allergan Implants and Breast Implant Associated Anapaestic Large Cell Lymphoma (BIA-ALCL)
After an implant has been placed the body heals with a thin layer of car tissue around the implant. We call this layer the capsule. The capsule is your body’s natural barrier to 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 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. 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 so 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 texture. For Siltex the rate in 2017 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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Allergan Breast Implants
