Most cases of breast-implant associated anaplastic large cell lymphoma (ALCL) may not be invasive cancer but seroma-only disease that typically spontaneously resolves or remains indolent, Australian researchers claim.

With the TGA reporting 56 cases of ALCL associated with breast implants up to 2017, Queensland-based cosmetic surgeons say two cases of spontaneous and rapid remission of ALCL they have seen  – along with epidemiological evidence – suggest the current approach of urgent removal of breast implants represents overtreatment.

In a paper published in Aesthetic Plastic Surgery, the researcher-clinicians describe what’s believed to be the first evidence of spontaneous regression and resolution of confirmed breast implant-associated ALCL in two Australian cases.

In one case a 51-year old woman showed spontaneous regression of ALCL 11 months after first presenting with a late seroma. In a second case a 24-year old woman showed spontaneous resolution of ALCL just eight weeks after being diagnosed.

Dr Daniel Fleming and Patrick Tansley, two cosmetic surgeons specialising in breast augmentation based in Brisbane, say the cases – along with disease epidemiology – strongly suggest that ALCL seroma-only disease is not invasive malignant disease but rather a self-limiting lympho-proliferative disorder.

The World Health Organisation defines that all breast implant associated-ALCL as cancer, but this is not the first time the WHO definition has been challenged based on disease epidemiology.

They note that textured implants have been widely used in Australia since 1991 and the median time from implant to diagnosis of ALCL is 7.5 years.

However the first case of breast implant-ALCL was only recognised in 2007, suggesting that the sudden increase in ALCL cases was due to increased diagnosis of mostly indolent cancers rather than a real increase in invasive disease.

The epidemiology has always been the “elephant in the room”, Dr Fleming told the limbic. “Now we have a link between the epidemiology and the clinical proof that it can go away on its own. ”

“We are diagnosing more people with this disease with lower amounts of fluids. People with no symptoms are now being diagnosed because people are sometimes testing fluids they find incidentally. Everybody will be labelled as having cancer, have their implants removed, and that’s going to be overtreatment for most of them  – because before we started testing, we didn’t do anything and nobody died”

Seventy percent of cases in Australia are seroma-only and “we can’t find a single case of proven seroma only disease that’s gone on to become invasive disease”, he said.

In his report, Dr Fleming noted that of the four deaths attributed to breast implant associated-ALCL in Australia, two were caused by complications of the aggressive treatment that was initially thought to be necessary for all patients

However, given the potentially fatal consequence of inadequate treatment, bilateral explantation and capsulectomies should remain the current recommended minimum treatment, the authors concluded.

Nevertheless, “we need to start thinking about how we can change our thinking about the disease and our management strategies so the vast majority who are diagnosed are not told incorrectly that they have cancer,” Dr Fleming told the limbic.

He said the situation with breast implant-associated ALCL may be similar cervical cancer four decades ago, when it was believed that without intervention all CIN 1 low grade dysplasia would progress to cancer.

“Now people say big deal, come back in a couple of years and we’ll have another look because they know it goes away possibly.

“I think that’s what we’re looking at here. If we’re standing here in five-years time, I think we’ll be saying ok you have lymphomatoid seroma, best keep an eye on it, for most people it goes away.”

Clinical Associate Professor Judith Trotman, director of clinical research unit at the haematology department at Sydney’s Concord Hospital, described the paper’s finding as a “very attractive hypothesis”.

Its plausibility was backed by strong epidemiologic data, she told the limbic, adding that the WHO 2016 diagnostic definition was provisional.

“A prospective study of close monitoring of non-invasive seroma-only disease is warranted,” she said.