© Nevit Dilmen, Breast MRI Implant T1FSE T2FSE InPhase STIR Silicon 21, CC BY-SA 3.0
Breast surgeons across the UK must ensure women are aware of BIA-ALCL, a non-Hodgkin’s lymphoma that is associated with implants; and more responsibility must be taken to diagnose and report cases, surgeons attending the 2018 London Breast Meeting have warned. Hundreds of breast specialists from around the world met at the Royal College of Physicians for the four-day conference this autumn, which heard that women receiving breast implants were not always being told of the risk of developing a cancer called Breast Implant Associated-Anaplastic Large Cell Lymphoma, or BIA-ALCL.
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Nigel Mercer, a consultant plastic surgeon, who chairs the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) for the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) committee looking at BIA-ALCL, said: “I know for certain, because I have seen patients who have not been warned there is a risk of BIA-ALCL by the clinic or surgeon they have seen.”
The conference urged surgeons to take the condition seriously. Mercer, who is the past president of the British Association of Plastic Reconstructive and Aesthetic Surgeons, said that all patients needed to be told from the outset about the risk, and that for women who had already suffered from breast cancer, the implications of facing new cancer risk could be particularly “devastating”. “If you see a woman who has been one of the 1 in 8 women unlucky enough to develop breast cancer and who is seeking an implant based reconstruction and then you say that type of reconstruction carries a 1 in 28,000 risk of developing another form of cancer, that will need another form of cancer treatment, for that patient who has already undergone cancer treatment – that is pretty devastating news,” he said.
The MHRA issued a joint statement with several of the UK’s leading surgeons’ associations in July, advising it is “essential” that all patients considering a breast implant for reconstructive or cosmetic purposes are made fully aware of the potential risks by their surgeon. The current estimated risk in the UK is believed to be around 1 in 28,000. However, the conference was also urged to better diagnose cases and report them to national regulators so that the condition could be tracked.
Dr Dennis Hammond, a US based globally respected authority on breast aesthetic and reconstructive surgery, urged the UK to take BIA-ALCL “just as seriously as the rest of the world”. “There have been patient deaths associated with this disease,” he told delegates. “And this may have occurred as a result of an adverse reaction to what the body sees as a “foreign object”, namely the breast implant. he said. “That’s an issue. That is something we need to recognise and approach with a fair degree of intellectual honesty and scientific acumen.” He told surgeons: “You need to contact your pathologist, and if you have to hand carry a fluid sample down to the pathologist [then] do so, and tell them what you are looking for. We have a responsibility to properly diagnose this disease, and then if we see it, we have a responsibility to properly treat it, and then report it so that we can track these numbers.”
Many of these doctors will never have seen a case and when they do get one they won’t know what is going on unless we educate themNigel Mercer
Mercer, also re-emphasised the importance of reporting cases to the MHRA through the Yellow Card Scheme, which the organisation uses to monitor the safety of healthcare products in the UK. “If you get a case please, please report it. And also report it to the implant register,” he said. The PRASEAG’s role is to advise the MHRA and to ask them when does this become a matter of public health concern, what level of incidence does it have to be to become a public health issue? At the moment that is being monitored very carefully. I understand that the current U.K. figure of 1 in 28,000 is not deemed to be a public health risk.”
The conference, which heard that the aetiology of BIA-ALCL remains unknown, also heard that surgeons needed to educate colleagues in other disciplines to improve diagnoses, with early identification understood to be key to successful treatment. “We have to educate our pathologists, we have to educate our radiologists, and we are doing that with the Royal College of Radiology and the Royal College of Pathologists,” said Mercer. “Many of these doctors will never have seen a case and when they do get one they won’t know what is going on unless we educate them”
Commenting on the debate, Professor Jian Farhadi, co-chair of the London Breast Meeting and former director of the Department of Plastic & Reconstructive Surgery at Guy’s and St. Thomas’ Hospital in London, said: “However small the risk may be, women must be made aware that they could develop cancer associated with breast implants, and potentially even die. Surgeons must do this before their patients agree to undergo procedures, although in many cases this does not appear to be happening. “Debate at the London Breast Meeting has highlighted the importance of greater investment in education, so that we can do more to identify cases of BIA-ALCL, better equip pathologists to support this mission, and better understand the state of the disease across the UK and the rest of the world.”
Source: Association of Breast Surgeons (ABS), the British Association of Aesthetic Plastic Surgeons (BAAPS), the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), and the Medicines and Healthcare products Regulatory Agency (MHRA)