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Thoughts on Breast Implant Associated Anaplastic Large Cell Lymphoma
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a manmade disease. Since 1982 when Cronin and Gerow first implanted liquid silicone contained within a silicone bag into an American woman, Silicone has been the basic ingredient for both the outer shell and usually the content. But there was a 13 year spell where the FDA regulators in the USA needed documented evidence to say that Silicone Implants didn’t cause autoimmune disease and the USA implant manufacturers had to then both sell and promote saline implants in the USA for this period whilst FDA endorsed studies took place. The rest of the world somewhat naively continued to use the Silicone version of these implants, produced in the USA, Holland and eventually Puerto Rico, being heavily influenced by USA and some European Surgeons some say, with financial interests. Millions of women worldwide have breast implants and it is a powerful multibillion dollar industry.
By Professor James Frame
Oct. 12, 2016

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a man made disease. Since 1982 when Cronin and Gerow first implanted liquid silicone contained within a silicone bag into an American woman, Silicone has been the basic ingredient for both the outer shell and usually the content. But there was a 13 year spell where the FDA regulators in the USA needed documented evidence to say that Silicone Implants didn’t cause autoimmune disease and the USA implant manufacturers had to then both sell and promote saline implants in the USA for this period whilst FDA endorsed studies took place. The rest of the world somewhat naively continued to use the Silicone version of these implants, produced in the USA, Holland and eventually Puerto Rico, being heavily influenced by USA and some European Surgeons some say, with financial interests. Millions of women worldwide have breast implants and it is a powerful multibillion dollar industry.

It appears that any implant can associated with this condition including saline implants and this has probably been occurring without the patients or clinicians knowing. There is a similar orthopaedic condition, known as ALVAL, occurring in association with metal on metal hip joints. All of these implants are being removed but it appears that there is no malignant variant of this disease. Those breast implants manufactured with a course outer texturing created using salt extraction technology appear to be the most frequently incriminated in causing BIA-ALCL though. These implants actually only variably adhere in women, contrary to their intended purpose, and a chronic inflammatory process may be promoted by this. It may be that the use of this course texturing needs to be reconsidered. It is definitely not the silicone content of these implants that are causing this condition because saline implants are also causing the disease.

There may well be a spectrum of disease from the presence of mature lymphocyte (Type 4 hypersensitivity) to the presence of immature lymphocyte clones which we call lymphoid tissue. The nuclei in these cells are ‘foetal’ in appearance and they can merely be present within the fibrous capsule that the body generates around the implant or they can proliferate into infiltrating masses or become metastatic. There have been documented deaths. It should be reiterated that this is a rarely found disease but it may be more common than we think. There are now quite a few single case reports or small series and there are a lot of self proclaimed experts- some with relationships with the manufacturers. It is clear that for intracapsular BIA-ALCL simply removing the implant and the capsule will cure the condition, if indeed it is a progressive pathological entity (Fig 1). The use of the sub muscular or dual plane to insert silicone implants should be seriously reconsidered because it is far harder to guarantee full excision of the capsule when it is stuck onto costal cartilages or high in the axilla stuck to muscle.

All sorts of aetiologies are being suggested but the latest theory comes from the USA suggesting biofilm as the cause, the same group of authors previously publishing on how to successfully reduce the risk of biofilm - it seems this get the blame for everything! Chronic inflammation though is definitely a factor but what I don’t understand is that if the incidence of capsular contracture is going down in the USA because of all these antibiofilm prophylactic measures then why is the reported incidence of BIA-ALCL rising so fast! The incidence of BIA-ALCL in the UK is probably nearer 1 in 20,000 or higher and definitely not the 1 in 1 million suggested by one of the manufacturers. The MHRA in the UK should take note. Further evidence is needed on the more advanced and proven metastatic variants of BIA-ALCL. The FDA, ASPS and ASAPS in the USA have taken a very responsible role within this and data collection globally is now required. My view is that we need an alternative to silicone for implant manufacture. The known toxicity of chemicals and ingredients that go into making these products are alarming and Surgeons should certainly be fully informing patients prior to getting consent of breast augmentation. It is up to manufacturers and regulators to produce and endorse the safety of implantable materials and new products are now needed.

Author:
Professor James Frame,Consultant Plastic Surgeon,Anglia Ruskin University,United Kingdom

Paper link:
http://article.sciencepublishinggroup.com/html/10.11648.j.js.20160405.11.html

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