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Separating Facts from Fiction in relation to Cancer Risk from Breast Implants

Posted on Sunday, 27 May 2018

In response to today’s Sunday Telegraph (27 May 2018) article by Sue Dunlevy, it is important to clarify some errors and misconceptions in the data and comments made.

These comments by Associate Professor Mark Magnusson, President of the Australasian Society of Aesthetic Plastic Surgeons are all supported by data from peer-reviewed scientific publications.  Current data that has been scrutinised by strict and blinded statistical analysis, the World Health Organisation (WHO) and from national regulatory agencies such as the Food and Drug Administration (FDA) in the United States and the Therapeutic Goods Administration (TGA) in Australia.

The facts

  • Breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare form of Non-Hodgkins Lymphoma of the breast in women with breast implants. It is associated with textured breast implants, bacteria, time and there appear to be genetic factors as well putting some at higher risk.
  • The risk of any lymphoma in Australian women living to the age of 85 is 1:50.
  • BIA-ALCL is a rare disease. Of 35 million women around the world with textured breast implants, there are just over 500 confirmed cases and 16 documented deaths. The most accurate data at present shows that the risk of this lymphoma varies from 1:2700 up to 1:80000 depending upon the type of textured surface. Smooth breast implants on their own have not been associated with this disease.
  • There is also published evidence that suggests applying bacterial mitigation strategies at the time of surgery in the form of the 14-Point-Plan reduces the incidence of this disease.
  • BIA-ALCL usually presents with delayed swelling of the affected breast or less frequently with a lump (or both) for no apparent reason from two to 14 years after the original implant surgery (average over seven years). However, most delayed breast swelling after breast implants are not going to be BIA-ALCL.
  • As with all cancers, there are those who present in an early stage and those who present with more advanced disease. The disease had an indolent/slow course with most women diagnosed and treated in an early stage (>85%) with symptoms for eight months on average. At this stage, the disease is cured with surgery alone without the need for chemotherapy, radiotherapy and with no recurrence when appropriately performed. To date, all patients with early-stage disease who receive appropriate treatment are cured with surgery alone.
  • In contrast, patients who present with more advanced stage disease (<15%) have had symptoms on average for 22 months (almost two years) before definitive treatment, highlighting if symptoms are not investigated and left untreated the likelihood of more advanced disease increases as with other cancers.

Assoc Prof Magnusson said that with a greater understanding of the disease and standardisation of treatment protocols patient outcomes are improving even further including for advanced disease.

There are apparent inaccuracies in the published article by Sue Dunlevy.

The article stated that data published by Prof Anand Deva from Macquarie University and Assoc Prof Magnusson with others in a multidisciplinary task force had been challenged.

Contrary to the statement by Ms Dunlevy, data published by Professor Deva and Assoc Prof Magnusson have been acknowledged by the FDA in the US and the TGA in Australia as the best estimate of risk and incidence for BIA-ALCL in the literature to date. Global BIA-ALCL research groups support the data.

The TGA has received a full data set of the research which was independently verified by independent statistical analysis.

Although Australia and New Zealand (ANZ) data were the first in the literature, there are similar studies now appearing in the peer-reviewed literature from other countries that are confirming the ANZ figures in their population.

There is no published analysis of the ANZ data in an academic peer-reviewed forum questioning the original findings.

Assoc Prof Magnusson and Prof Deva have recently submitted an update of the ANZ experience for peer review and publication.

Dr Tansley indicated his group had performed a detailed analysis of the ANZ data. His group have never had access to that data, so there is no evidence to support his statement.

Reference was made of the report of the two cases of BIA-ALCL with a suggestion that one resolved and the other regressed.

The scientific accuracy of that paper has been questioned in the academic peer-reviewed literature.

In one of the cases, the original pathology was checked by an expert haematologist at MD Anderson Cancer Centre in Houston, Texas as part of the peer review process.  The report found that the original diagnosis of no residual disease was, in fact, incorrect since evidence of lymphoma was still present. This wasn’t reported in the final paper, but a letter to the editor outlined the actual findings which have subsequently been published.

The accurate diagnosis of regression and resolution have very precise oncological criteria to avoid inaccurate comments. The paper does not meet these criteria which are pointed out in a second letter to the editor by Assoc Prof Magnusson and Prof Deva which has also been published after peer review.

By contrast, the most recent update to the ANZ data by Assoc Prof Magnusson and Prof Deva looks at 81 patients and shows that 85% of women are treated in the early stage, and our data also demonstrates 60% have no residual disease at definitive surgery. This does not represent regression but reflects the indolent nature of this disease for most patients, which we already know.

The WHO outlined the diagnostic criteria for this disease in 2016.

At present, there is no evidence that supports the diagnosis of two separate types of this disease as opposed to different stages of the same entity which presents at a more advanced stage when symptoms are present for longer durations, just like other cancers.

It is a dangerous message to suggest that this disease will resolve on its own without definitive evidence as it may lead to patients refusing treatment because they believe it will spontaneously regress. What we do know from examining 500 worldwide patients is that even in an early stage, incomplete or inappropriate treatment of this disease has led to disease recurrence and even death. For a disease where death is such an uncommon event, it would be an absolute tragedy for this to occur because the illness wasn’t treated properly by unsupported comments.

Scientific investigation is ongoing in several Australian Academic Institutions with Australian Plastic Surgeons and Haematologists well represented among the world leaders for this disease. This includes the cause, risk factors, risk mitigation strategies and treatment protocols.

Patient safety and best outcomes must always remain the primary focus regardless of what field of medicine we discuss.

Ends

Media contact: Julia Power, National PR and Marketing Manager, 0414 276 990

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