Evidence linking breast implants to cancer is mounting up.

09 January 2017

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The link between breast implants and cancer has been brought into the limelight by a global collaboration, including researchers from the University of Cambridge.  Investigation has shown a rare form of cancer known as Anaplastic Large Cell Lymphoma (ALCL) may develop as a consequence of breast implant procedures.

ALCL is a relatively rare, mostly childhood cancer of the lymphatic system, derived from infection-fighting immune cells known as T-Cells. Under typical circumstances, ALCL develops in lymph nodes, skin, lungs and soft tissue. Intriguingly, incidences of ALCL have now been reported in women who have undergone breast augmentation with implants. This new form of ALCL has been called breast-implant-associated ALCL (BIA-ALCL) or implant ALCL (iALCL) and occurs in women of all ages following implants for cosmetic or reconstructive purposes.

Over 200 cases of BIA-ALCL have been reported worldwide to date and almost exclusively in the context of textured implant shells. BIA-ALCL, generally occurs in the scar tissue that forms around the implant; the so-called capsule, and is usually present as one of two forms: seromas (a liquid swelling in one of the breasts) and much more rarely, solid masses or lumps; the latter of which has a worse prognosis and is associated with fatalities.

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As mentioned above, ALCL is a rare disease and presents as one of three distinct disease categories: systemic ALCL, ALK+, systemic ALCL, ALK- and cutaneous ALCL. ALK is a cancer-causing gene and its presence in the cancers is usually an indicator of good prognosis (5-year overall survival (OS) of 88-95% in children and young adults) whereas ALCL, ALK- has a worse outcome (49% OS) although as the latter is largely diagnosed in adults (40-65 years of age), it is unknown whether age of diagnosis also influences treatment outcome. Whilst both forms of the systemic disease have similar symptoms and presentations, cutaneous ALCL is largely seen as a persistent skin rash or irritation. It has been proposed that BIA-ALCL represents a fourth disease entity that whilst being ALK-negative is more similar to ALK-positive ALCL in its therapeutic outcome.

The incidence of BIA-ALCL is presumed to be largely underestimated; in spite of the fact that only 1-6 cases of iALCL are reported for every 3 million breast implants, 250 BIA-ALCL cases have been identified worldwide - 22 in the UK and 18 in France since 2011 alone.  Professor Clemens, an Associate Professor of Plastic Surgery at the University of Texas, believes this is a considerable misrepresentation. In early 2016 the Daily Mail reported Clemens stating: "A figure of one in 500,000 has been quoted, but this is a vast underestimate. It does not take into account that it takes on average ten years after an implant for symptoms to occur. Given this, the actual number is one in 50,000."

The driving forces behind this rare cancer are still unknown and research is in its infancy. Some scientists have suggested bacteria on the outer shell of the implant during implantation leads to immune system changes which trigger oncogenesis; epidemiological evidence suggests that chronic inflammatory states trigger greater incidences of cancer perhaps through the elicitation of immune cells to become cancerous over time, albeit this mechanism remains unclear. Others suggest silicon, an apparently biologically-inert material, is the main protagonist. Silicone is generally found in all breast implants in some capacity, either as the filling or a component of the outer shell. There are two opinions as to the potential mechanisms by which silicone may act as a carcinogen: first, silicone and its degradation products are directly toxic and second, even though silicone is considered biologically inert in itself, over time it may induce a ‘non-self immune response’. There is evidence to support both of these hypotheses; silicone particles have been found in the armpit lymph nodes of over 90% of breast implantees increasing levels of  pro-inflammatory chemical messengers. Additionally, silicone degradation products have been observed in the fibrous capsule which envelopes the implant. As such, research is focussing on whether BIA-ALCL is caused by the implants and/or infection at the site of the implant.

This isn’t the first time the safety of breast implants has been drawn into dispute. In 2010, a French firm by the name of Poly Implant Prothèse (PIP) was pre-emptively liquidated on discovering they had been manufacturing breast implants from industrial grade (as opposed to medical grade) silicone. These sub-standard implants were found to have almost double the rupture rate of other implants. After global concern and investigation, no evidence of an increased cancer risk was found for PIP implants although symptoms including pain and inflammation have been reported.  It has been calculated over 300,000 women across 65 countries received PIP implants including 47,000 Brits.

Dr Suzanne Turner of Cambridge University, a leading scientist conducting research into BIA-ALCL, assures undue fear isn’t necessary as the rate of incidence is so low. This being said, women undergoing augmentative implant surgery or those who have undergone the surgery in the past deserve to be informed of the risks involved, no matter how low. Women and medical practitioners should be made aware of the symptoms of BIA-ALCL so as to detect and treat this cancer as soon as possible; BIA-ALCL, like the bulk of cancers, is most successfully treated at early stages of development. These thoughts have been echoed by the French Minister of Social Affairs, Health and Women’s Rights, Marisol Touraine who recommends that women with these implants do not have them removed and instead be vigilant for symptoms which often consist of persistent seroma (a fluid swelling usually in one breast), pain, lumps and ulceration. Furthermore, breast implants in France, by law, must now carry a warning of the “clear link” between silicone implants and BIA-ALCL.

By and large treatment for BIA-ALCL is successful when diagnosed early, and most patients enter remission simply on removal of the implant and surrounding capsule without the need to undergo abrasive chemo- and radiotherapies. This fact strengthens the suggestion that BIA-ALCL is stimulated by the body’s abnormal immune response to the implants. Chemotherapy is required in certain cases, particularly when masses develop that cannot be removed with surgery. This being said, four deaths have been reported due to BIA-ALCL out of 63 cases investigated by Hart et al. in 2014. However, a relatively new form of ‘targeted’ cancer therapy called brentuximab vedotin has shown success in the treatment of BIA-ALCL resistant to standard chemotherapies.

Comments

So did i undestand well? Only 1-6 woman at 3 milion woman implanted were found with Alcl?
Is that a statistic/probability of getting ALCL OF 1 in 5000-10.000

Thank you for spreading awareness on this under reported diagnosis. Symptomatic women are struggling to have their PS test the pathology (CD30) of aspirated fluid & capsule tissue. Why is this? About 25% of us require additional Cancer treatment. In my case of Stage IV, I had to fail 2 standard Lymphoma Chemotherapies (CHOP & GDP) before receiving Brentuximab under Clinical Trial. Brentuximab worked & allowed me to proceed with Stem Cell Transplant & Radiation. I'm currently 4 months into recovery from Transplant. I was not symptomatic before Dx, my Pathology was confirmed on Capsule during standard Implant Replacement due to Rupture.

Thank you for the article. We have a Facebook group called ALCL in Women With Breast Implants (BIA-ALCL). We have a good working relationship with both Dr. Clemens and Dr. Turner. We have approx 25 women in the group diagnosed and several members who have lost a relative to this disease. Any public awareness is good. Thank you for spreading the word. I would like to add that all recent publications stress the importance of specific CD30 immunohistochemistry testing to "rule out BIA-ALCL". This can't be ruled out just by general histology examination. Women are having a difficult time getting their surgeons to do the appropriate tests, even when symptomatic. Thanks again.

Very interesting Stephen! Welcome to Cambridge. Have any links between ALCL and the HER2 gene been established??

Roger.

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