A woman inspects x-rays while sitting at a desk.

Photo: Professional ballerina Lily Bones had Allergan breast implants after a double mastectomy following breast cancer. (ABC News: Alison Branley)

A group of women who underwent mastectomies following breast cancer is considering legal action after having reconstructions with a brand of implant that’s now been linked to a rare type of lymphoma.

Key points:

  • The TGA is set to meet to decide whether lymphoma risks warrant a total ban
  • Recent research shows the risk of developing cancer for those with highly textured implants was about 1 in 2,800
  • Australian women who received Allergan implants after mastectomies are considering a class action

It comes as the Therapeutic Goods Administration (TGA) calls an emergency meeting to decide whether to follow the lead of French regulators, who last week decided to ban textured breast implants.

There are more than 13,300 breast implant procedures in Australia each year, mostly for cosmetic reasons.

Among those closely watching the outcome of the TGA meeting is professional ballet dancer Lily Bones.

She was diagnosed with breast cancer after finding a lump at the age of 29.

A woman looks at the camera as she poses for a photograph while seated at a table.

Photo: Ms Bones’ implants have ruptured mildly but not severely enough to qualify for Medicare funded MRI scans. (ABC News: Alison Branley)

“For me at the time, it seemed very out of the blue, quite a surprise,” she said.

“You feel like a bit of a leper, it’s quite lonely, especially in a ballet company.”

Wanting to get back to work as quickly as possible, Ms Bones took part in a clinical trial where she had a double mastectomy and breast implants in one surgery.

A ballerina in costume smiles as she poses for a photo with her hands on her hips

Photo: Ms Bones was in Swan Lake in the Slovak National Ballet in 2015. (ABC News: Supplied)

“We didn’t talk a lot about implant choices. Basically, I was just told what would be involved,” she said.

“I was told that my implants wouldn’t rupture, I remember that quite distinctly.”

A decade on, the Allergan implants she was given have started to rupture.

Now the mother of a two-year-old, she is concerned about the continuing threat that leaking silicone and the risk of lymphoma pose.

“I’ve got enough to worry about. I don’t need other issues to be playing on my mind,” she said.

“I’ll be very interested to know what they [the TGA] decide obviously since Europe’s already rejected them. That really just raises alarm bells in my mind as to the safety of having those implants in my body.

“I think that they should put women’s health first.”

The safety of medical implants has been under the spotlight after the ABC and the International Consortium of Investigative Journalists revealed women around the world were suffering significant health problems after regulators failed to the detect the threat from receiving textured breast implants.

Regulator to consider total ban

The TGA meeting, to be held on Monday night, will consider whether the risk of developing Breast-Implant-Associated Anaplastic Large Cell Lymphoma, or BIA ALCL, warrants a total ban.

France banned implants made by six manufacturers, including Allergan.

Countries that have banned textured implants

  • France
  • Canada
  • The Netherlands
  • Australian implants with European approval mark after December 17, 2018 can’t be sold

(The Allergan brand has also gone by the name of Natrelle and McGhan prior to company takeovers.)

Australian surgeon Professor Anand Deva sits on the TGA expert panel and is hoping for swift action.

He said his latest research showed for women with highly textured implants, the risk of developing the cancer was around 1 in 2,800.

“We would be hoping that the TGA makes a decision sooner rather than later,” he said.

Australian women are particularly affected by the health scandal because doctors here are much more likely to use textured rather than smooth implants.

A breast implant infected with bacteria looks yellow.

Photo: US health authorities have called for more data on the risks of breast implants. (Supplied)

Are textured implants still used in Australia?

Late last year, the TGA followed the European regulators lead and removed the approval of any textured implants with a European stamp of approval, prior to December 17.

But it meant that technically, any existing implants in warehouses or on hospital shelves with approval prior to that date could be used.

What is BIA-ALCL?

  • Breast implant-associated anaplastic large cell lymphoma is a type of blood cancer
  • It often presents as a build-up of fluid in a sac on the breast, and grows in the scar tissue around the breast
  • It is thought to be linked to a bacteria that grows in a groove of textured implants and enters during the initial surgery
  • Symptoms typically appear after about seven years
  • Any women with concerns should consult their surgeon

The Australian Society of Plastic Surgeons told the ABC they understood that its surgeons were no longer using the Allergan textured implants.

But the ABC has received anecdotal reports from patients of surgeons continuing to offer the products early in 2019.

A number of Australian women who received Allergan implants after mastectomies are now considering a class action.

The law firm Slater and Gordon has also been contacted by a number of women and they are currently looking at their cases.

President of the Australian Society of Plastic Surgeons, Professor Mark Ashton said surgeons always had a discussion with patients about the risk of BIA ALCL and textured implants.

“The Australian Society of Plastic Surgeons would support the TGA should it decide to ban Allergan textured implants,” he said.

He said they would also support banning of a second newer type of implant made from polyurethane, which has also been linked to the lymphoma.

How long have authorities known about the link?

US health authorities began investigating the link between the textured breast implants and the risk of developing BIA ALCL, a form of non-Hodgkin’s lymphoma, in 2011.

A spokesman for the Food and Drug Administration said in most cases, BIA ALCL was found in the scar tissue and fluid near the implant, but in some cases it could spread throughout the body.

Last week, the FDA held two days of meetings to discuss the long term risks of textured implants and cancer.

It did not issue any recommendations after the meeting, and instead called for more data.

In the past, the FDA has not recommended that surgeons stop using the implants, or that they be removed

“Because it has generally only been identified in patients with symptoms such as pain, lumps, swelling, or asymmetry that occur after the surgical incision has fully healed, breast implant removal in patients without symptoms or other abnormality is not recommended” the FDA website said.

As of September 30, 2018, the FDA had received a total of 660 medical device reports (MDRs) of BIA ALCL worldwide, including the death of nine patients.

In Australia and New Zealand, 90 patients have been identified, including four who have died.

Manufacturers say they are safe

The makers of Allergan textured implants defend the product, saying its safety was supported by extensive data.

Mark Marmur, from Allergan, said patient safety and product quality were the company’s highest priorities.

“There is more than a decade of successful European and US clinical use as well as a large number of peer-reviewed and published studies,” he said.

He said the company strongly disagreed with the French decision to restrict the use of highly textured implants ‘because this decision was made without any new safety information”.

Ballerinas stretch their arms horizontally and raise their left legs as they practice moves in a studio

Photo: Ms Bones has to pay $500 for every scan she needs to assess the state of her implants. (ABC News: Chris Taylor)

Women left high and dry

Ms Bones’ concerns have been compounded by the lack of services in the health system for women in her position.

She faced extensive delays in the public system but after having breast cancer, she does not have the funds to get scans in the private system.

She has mild rupturing of her implants, not severe enough to qualify for a Medicare funded MRI.

“I need to pay $500 for an MRI every time I need to monitor the state of the implants,” she said.

“The reality is I have a chronic illness which I have to live with and I have to manage along with the trying to maintain normality, which is very much expected of me.”

Source: ABC News

First posted

As we wait for our regulator, the Therapeutic Goods Administration, to deliberate before making its final decision on whether to suspend a variety of textured breast implants linked to cancer in Australia, news of the now worldwide recall of a particular type of Allergan implant linked to cancer has broken. The recall was prompted by the US regulator announcing a sudden increase in deaths from what was once thought to be a “rare” form of Lymphoma related to breast implants.

I do feel for the regulators trying to protect the public. They are often held to account for failure in cases where the blame lies first with commercial forces and greed. Undertrained or untrained doctors get their hands on an implant and then place them badly into a poorly informed, impressionable and vulnerable patient, primarily for the purposes of making a profit. This is not a failure of the device or even a failure of regulation, it is a failure of ethics, standards and professionalism.

And even as the ink is yet to hit the paper on the lastest regulatory action, we are witnessing another example of profit before professional ethics: the sudden rise of the “explant” surgeon. These professionals build business and marketing plans designed to target women who are now understandably anxious from reading the bad news about implants.

One of the most recently minted websites lists that the low-cost breast explant option (which is unsurprisingly the same price for low-cost breast augmentation) is for women who have no local complications at all, i.e. a normal breast and a normal implant.

Let me be clear. No one advocates preventative removal of an implant that does not have a problem. All this will do is create deformity where there is none and subject a healthy, but frightened, woman to the not inconsiderable risk of unnecessary surgery.  And this surgery can be major because often surgeons recommend not just removing the implant but all the tissue surrounding the implant. It can be a very destructive operation, particularly if the implant is placed under muscle.

But in a way I am not surprised – the same doctors that made money from implants going in can now make money from implants going out. I guess this instantly doubles their market opportunity!

So where will it all end? Where we have landed with crisis, anxiety, unnecessary and potentially dangerous surgery is the result of not truly tackling the root cause – which is to ensure that we dial down the sales and marketing and become more focused on being good doctors by putting the patient’s interests first.

Professor Deva is an Australian clinician and academic. He is the founder and director of the Integrated Specialist Healthcare Education and Research Foundation and head of plastic and reconstructive surgery at Macquarie University.

Source: The Sydney Morning Herald

First posted