The Implant Files reveal how breast implants linked to rare cancer set off alarm bells

Updated

When Carol Camilleri had her breast implant surgery in 2014, she had no idea the model she was about to put in her body had been causing alarm in medical circles.



Key points: The investigation reveals serious flaws in the way authorities detect problems with implants

The flaws meant the TGA was unaware how many cases of cancer had been linked to implants

New reporting practices have led to more breast implant surgeries being officially registered



It was just three years after her procedure to fix an uneven chest when the complications began.

First it was the unusual swelling in her left breast. Then in April, as Ms Camilleri was driving home, her seatbelt started giving her chest pain.

It was a large lump and she immediately went to see her surgeon.

Within a fortnight she had a diagnosis: breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) with a malignant tumour — a rare blood cancer.

"It was really scary because they all kept on saying it was so rare. I just heard death, dying, dead," she said.

Ms Camilleri was among a growing number of women whose textured breast implants had been linked to this form of cancer.

Unlike smooth implants, surgeons believe bacteria are much more likely to grow in the grooves of textured implants, triggering lymphoma.

An ABC News investigation into BIA-ALCL has exposed serious flaws in the way the Therapeutic Goods Administration (TGA) detected this emerging problem with textured breast implants.

It is part of a joint investigation into medical devices with the International Consortium of Investigative Journalists (ICIJ) in which reporters analysed the TGA's publicly available adverse events database.

What it revealed was that only about 29 of 72 cases of this type of cancer linked to the implants recorded in Australia actually found their way into the database.

It took academic and plastic surgeon Professor Anand Deva to contact doctors' groups around the country to manually collect more accurate data on its prevalence in Australia.

ABC News found that when Ms Camilleri was getting her implants, the TGA knew of just eight cases of the rare blood cancer linked to breast implants, but the actual number was four times higher than that, according to Professor Deva's research.

As of April 2018 there were 81 cases in Australia and New Zealand linked to 110 implants, including four deaths.

The data has also revealed exactly how, between 2012 and 2015, cases of the new type of lymphoma continued to rise sharply around the country while the TGA remained unaware of the scale of the problem because of flaws in its database.

At the time the regulator was telling Australian women they did not need to be concerned about the emerging condition because "the totality of the evidence presently available" showed implants were "safe and effective".

It is a similar story in the United States where, until 2017, the Food and Drug Administration (FDA) allowed breast implant suppliers to shield the full extent of harm caused by their products from the public.

An ICIJ analysis of FDA data found that the number of suspected breast implant injuries jumped from fewer than 200 a year in 2016 to more than 4,500 in 2017 and almost 8,300 in the first half of 2018.

Do you know more about this story? Email backgroundbriefing@abc.net.au or Specialist.Team@abc.net.au



'Like a black hole'

In Australia's case, the fact the TGA was unaware of the scale of the emerging lymphoma problem has not come as a shock to experts in the field.

The TGA's adverse events database allows doctors, patients and manufacturers to log potential side-effects of devices once they are already on the market.

But it is incomplete because it is only manufacturers who are mandatory reporters and it is rare that patients know the database exists.

Many doctors, who are at the coal face of emerging side effects, do not routinely report to the database.

"It's like a black hole. All these implants are going in and some women are going to Thailand or whatever. We've got no idea what's going on," Professor Deva said.

What is needed, according to Professor Deva, is a more stringent approach forcing doctors to report potential problems with medical devices such as implants. If they do not, the doctors should be penalised.

Maurice Blackburn principal lawyer Libby Brookes has spoken to a number of women — including Ms Camilleri — who have developed ALCL following implants. She said doctors should be forced to report issues.

"I've frankly been shocked at the weaknesses in the Australian system of regulation and monitoring of medical devices and implants," she said.

"Common sense says that if patient safety is to be a priority, then there must be mandatory reporting obligations imposed on doctors."

The TGA said it was trying to address some of these issues with new mandatory medical device implant cards and patient information leaflets.

Also, patients must now explicitly choose to opt-out if they do not wish to have details about their implant recorded on the Breast Device Registry — a change that will mean more data is likely to be collected.

However, the registry still remains opt-in for doctors performing breast surgeries.

As of this year, 90 per cent of all breast surgeons now supply data on patient outcomes, a sharp rise in participation rates in recent years.

Further, the TGA said it had convened "expert working groups" in 2016 and 2018 to get a better understanding of the emerging form of lymphoma.

Makers of major implant shut down debate

Compounding problems with detecting the new type of lymphoma was the role of the leading makers of breast implants, Dublin-headquartered healthcare multinational Allergan.

Its products are linked to the highest number of lymphoma cases in Australia.

After the initial cases of ALCL were detected in Australia and overseas, which included Allergan products, the company published a study using what Professor Deva described as "crude" figures.

It estimated a rate of lymphoma that was close to one case of every 100,000 implants.

Latest expert opinion suggests it could be as high as one in 1,000 implants.

"It looked at broad risk and there's lots of flaws in doing that."

Professor Deva said the study played down the risk to patients and effectively served to silence debate among academics and regulators on the emerging issue.

"It kind of gave a false sense of security and potentially said, 'oh look, it's not really a problem'."

Background Briefing How safe are medical devices?

At their best, they save lives. At their worst, they cut them short. More than 57,000 medical devices are approved for use in Australia, but are patients aware of the risks? About

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At their best, they save lives. At their worst, they cut them short. More than 57,000 medical devices are approved for use in Australia, but are patients aware of the risks?

The TGA disputes this saying as a regulator it "utilises multiple sources of information to determine the risk associated with a device".

Professor Deva, a leading expert on ALCL, said he too had trouble convincing the medical profession the blood cancer was an issue at the time.

"I think when the data started to come out increasingly, it threatened people," he said.

"It threatened their business models. It threatened their livelihood."

An ABC News analysis has found that in the years after the 2012 Allergan study, published case reports stagnated and warnings from regulators about this illness were not updated.

But for the next three years, the data showed cases of ALCL continued to mount.

In a statement Allergan said patient safety was its "highest priority" and their welfare was supported by extensive testing, monitoring and research.

"We continue to collaborate with clinicians, societies and worldwide regulatory authorities to advance research, understanding and awareness about breast implant effectiveness and safety," the statement read.

Despite rising cases, still no recalls

Until now, none of the implants linked to this illness have been recalled over their association to the cancer, and most implants are still on the market.

"All the data shows the numbers [of ALCL] will actually rise to a peak at 12 years," Professor Deva said.

"So, we've still got more to come."

A TGA spokesman said regulatory action was taken based on the risk versus the benefit and that it would continue to monitor the situation and work with suppliers to address safety issues.

He said a recall "wasn't appropriate" because the cause of the lymphoma could not be confirmed.

This is despite research clearly identifying the lymphoma's links to textured implants, a combination of a specific bacteria and a genetic predisposition to the disease.

TGA deputy secretary Professor John Skerritt told ABC News he did not think suspension of the products was warranted.

"Remember these things are not just used for cosmetic use and are used for women who have had mastectomies for cancer … and breast devices are very important for self-esteem and psychological wellbeing," he said.

Professor Deva also believes that rather than recalling affected devices, better information should be provided to patients about the risk.

"So, I think in the early days it wasn't clear how big a problem it was," he said.

"But as soon as the number of cases and reports started to increase, then I think there's been a very proactive move to get clarity."

For Ms Camilleri, who has just been given the all clear, the TGA's inaction is not good enough.

"How could they do that? How could they let us risk our lives?" she said.

"We don't get implants to be vain. It's very personal. It's wrong."

Explore the International Medical Devices Database, a searchable portal that gathers global recall notices, safety alerts and field safety notices

Topics: doctors-and-medical-professionals, health, medical-procedures, medical-research, australia

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