Patients should know exactly what type of implant they have in their body. They should maintain their own records as it is valuable information for the future.
Mr Wilson has come across many patients who have had breast implants in the past who were either never informed or have possibly simply forgotten what type they were implanted with. Implants are made by a number of manufacturers and knowing the precise details has a good advantage to Mr Wilson when renewing, revising or removing implants from previous breast enlargements or reconstructions. The typical information that Mr Wilson provides his patients is the manufacturer’s name, the style of implant, the size in “cc’s”, the unique serial number and the lot number.
For current patients, these details should all be placed on the National Breast Implant Registry database, which has existed since 2016. These details can be searched for by your surgeon in the future should you lose your implant details, if your surgeon has entered them. But if your implants were placed prior to this you should first try to contact your previous hospital – ring the surgeon’s secretary and ask. If over 10-years has lapsed, your records may have been destroyed. In this setting where we simply do not know what implants a patient has, Mr Wilson will take as accurate measurements as possible of the dimensions of your existing implant, which can often be felt within the breast tissue, before planning the revision. Occasionally, an ultrasound scan is required to estimate the volume of the implant.
If there have been minimal changes and you require a simple like-for-like exchange this is particularly important. Where there is a current problem with one or other breast, options may also include explantation, with or without uplift. Changing the profile, and implant size, looking at natural or more projecting round implants and anatomical varieties together with an important discussion about the textures, and how this may reduce or increase future complications, always requires detailed consideration from your specialist surgeon. and this is where years of expertise in the field is an absolute must.
Your right to be informed
You now have a right to access all the information regarding your breast implants, at all times including notifications and instructions, if their device has been the subject of a safety advisory.
Your right to verify
After surgery, through a completely non-invasive procedure, women you have the right to verify all the characteristics of your breast implants, including product family, volume, serial number and lot number. All your personal information is registered, stored and protected on our secured data base, according to International Privacy Regulations.
Below is a list of current and past breast implants.
Allergan has been a market leading silicone breast implant supplier for years. However, recently it faced the need to withdraw further sales of it’s entire textured range of implants. It is a global pharmaceutical leader who acquired Inamed breast implants in 2006. Inamed in turn had previously acquired McGhan implants in 1986. The Allergan (Inamed or McGhan) silicone breast implant type typically used in Europe were the roughly textured type, which is termed “Biocell”. The gel inside the implant is cohesive and depending on the type of implant it may be very firm (as in the anatomical range), intermediate (in the anatomical and round) or their softest gel (just in the round). Allergan were widely regarded by a significant number of surgeons as having the best range of implants until restrictions in December 2018 and then the recall of their textured range from the market by the FDA in July 2019. Patients who already have the implants are reassuringly advised by the FDA that they do not need to have them removed, something reiterated across the world by other regulators, including the MHRA in the UK. The smooth shell implants remain some of the very best on the market and are still very widely used.
B-Lite breast implants are manufactured with either a smooth outer shell or a textured outer shell, which is described by the company as a micro texture. They are available in round shapes with 3 different profiles and also in anatomical variants. All of their implant range have a proprietary extra light weight silicone-borosilicate filler, making this implant range unique in being around 30% lighter than conventional breast implants. These help to tackle the issue of the effects of gravity on larger volume heavier implants on breast tissue.These implants were introduced in 2015 by G&G Biotechnology a company founded in 2005, and taken over by the prestigious German breast implant manufacturer Polytech Health &Aesthetics in 2018. They are CE certified. Find out more about the B-Lite implants here.
Eurosilicone implants are now owned by GC Aesthetics. These implants have a standard silicone outer shell and the implant is filled with a cohesive silicone gel. They are CE marked. This is not an implant range that Mr Wilson uses, but he has had much experience in swapping them out from previous patients augmented in the past with this variety. They have a typical section of differing sizes, projections, tear drop and round styles. The round implants are available with a textured or smooth surface.
Ideal implants are available in the USA as a high profile device with a silicone shell. They are a two-chamber implant with multiple sheets of solid silicone elastomer (the same material that the shell is made of) between the inner and outer chambers. They have a part saline fill. The inner saline chamber is the larger of the two, and there are several solid silicone elastomer baffles (sheets of the silicone shell material) between the larger inner chamber and the smaller outer chamber. Instead of having one fill port as with conventional, single-chamber saline implants, there is an anterior fill port for the smaller outer chamber and a posterior fill port for the larger inner chamber. As with conventional saline implants, the structured Ideal implant is inserted deflated with one fill tubing attached to the outer chamber and another fill tubing attached to the inner chamber. Both chambers are filled once the implant is in place. They have had FDA approval since 2014.
These implants are synonymous with the Allergan implant range having been acquired by Allergan in 2006. The original range of round implants came as a standard profile called the 110, or a higher profile called the 120. The matrix of anatomical implants was huge and provided surgeons and patients with a massive choice to tailor the implant to their unique dimensions. The most popular texture of the implants used from this range in Europe was the “Biocell” type. This is now withdrawn (see information above). They also made a variety of tissue expanders that were usually used for 2-stage “expander-implant” based breast reconstruction. Inamed also acquired another implant manufacturer called CUI (Cox-Uphoff) in 1989 and sold the CUI implant brand alongside the Inamed-McGhan range, although it was an entirely different product with a different texture and had a different gel-fill amongst other characteristics. CUI implants are no longer approved and have been completely withdrawn from the market.
Mentor is an American implant manufacturer who have produce the the MemoryGel range since 2006 and more recently added the MemoryGel Xtra range too (allows for increased projection, fullness and firmness without losing the soft, natural feel patients desire). Johnson and Johnson acquired Mentor implants over 10 years ago. These implants have either a smooth or microtextured silicone outer shell. The inner part is filled with Mentor’s proprietary cohesive silicone gel. The Mentor breast implant range includes a wide selection of round implants in varying profiles and also anatomical shapes. They have had FDA approval for well over a decade.
Nagor implants are made in the UK but are now owned by GC Aesthetics who also own the Eurosilicone range. These implants may come with a textured or smooth surface, in round or anatomical shapes, with silicone or saline. They have CE mark certification and fall under the umbrella company GC Aesthetics. The textured implants were withdrawn in France and suspended in Australia in 2019. They are still available in the UK.
Polytech Health and Aesthetics is a large German implant manufacturer. They are made with smooth, micgrotextured or polyurethane coated shells, in round and anatomical shapes. The implants have CE mark certification. They also now own the BLite implant product range.
Groups Sebbin is a French Company that makes a variety of breast implants and tissue expanders. The implants include round and anatomical variants, with a silicone gel or saline filler. They have a variety or profiles and sizes. The implants have CE mark certification.
Sientra’s breast implants were previously manufactured by Slimed in Rio de Janeiro, Brazil, but more recently are manufactured in the USA. They were originally approved by the FDA in 2012. Sientra added a tradename to its portfolio of breast implants “Sientra OPUS” in 2017. Sientra implants come in round and anatomical shapes, with smooth or textured shells in a broad selection of sizes, profiles, and projections.
Slimed manufactured a micro polyurethane coated breast implant in Brazil which was distributed in the UK by Eurosurgical Ltd and in the USA by Sientra. However they were withdrawn in the UK in 2015 due to a problem found in the manufacturing process where inspectors found sterile particle contamination. Existing patients with the implants were not required to have them removed. Slimed also manufactured a conventional silicone breast implant with a silicone elastomer shell, in a round and anatomical breast implant range, with a silicone gel filler that had FDA approval. However, Sientra put a ‘temporary’ hold on the US sale of these implants in 2015. The CE certificate for devices made by Slimed was suspended and they have not been sold in the UK since 2015. Further information from the MHRA is available here.
In September 2012, VeriTeQ entered into a development and supply agreement with Establishment Labs to produce the Motiva Implant Matrix brand which is available as a smooth, very lightly textured or micro-textured shell. They are filed with silicone gel. They can be purchased with a microchip inside the implant that uses radio frequency transmission to signal what type of implant is in the patient. They may be round, oval or contoured in shape. They received European CE mark approval at the end of 2013.
