There is no such thing as risk free cosmetic surgery.

Every cosmetic procedure including the “non-surgical” injectables have risk. Soft tissue death and blindness are well documented complications of soft tissue filler injections.

Beware of the training of your injector. Do your homework. Some injectors are well trained and know how to minimise risk, others simply don’t.

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.

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.

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.

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.

(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.

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.

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”.

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 April 9th 2019

The TGA is asking manufacturers to provide in-depth data on implants. (ABC News: Jack Fisher)

Textured breast implants linked to a rare cancer will continue to be available to Australian women having surgery, despite a crackdown on similar products by regulators in France and Canada.

The Therapeutic Goods Administration asked an expert panel for advice on whether to follow the lead of these countries and on Tuesday released its decision.

Textured implants are used in about 90 per cent of Australian breast augmentations and there are more than 13,300 procedures in Australia each year.

Instead of banning the products, the TGA will write to all implant manufacturers, asking them to provide in-depth data on how many implants have been supplied as well as physical samples of the products within 10 days.

“After receiving information from suppliers, the TGA will consider whether to suspend or cancel particular products from the Australian Register of Therapeutic Goods,” a spokesman said.

Many patients have contacted the ABC saying they were not told about the risk of breast implant-associated anaplastic large cell lymphoma (ALCL) when their doctors discussed giving them textured implants.

The cancer is believed to be caused by a bacteria which builds up in the grooves of highly textured implants, causing infections. (Supplied)

A female doctor, who did not want to be identified, had both breasts removed because of cancer and was given textured implants.

She said her plastic surgeon never mentioned the potential risk.

“Despite seeing a top plastic surgeon, my surgeon provided me with absolutely no information on [the possible link]. It was not mentioned once,” she said.

Australian health regulators have urged doctors to use the Australian Breast Device Registry to record details of removal of implants and lymphoma.

Currently about 10 per cent of surgeons do not use the register.

Specialist plastic surgeons said that to be effective, the registry should be made mandatory.

Australian Society of Plastic Surgeons president Professor Mark Ashton said a full register would allow clinicians to contact every woman with an affected implant, let them know whether they were at risk, and what action to take.

“At the moment there are lots of patients out there who are saying: ‘Am I at risk? I don’t know what my implants are’ or ‘They gave me some information but I’ve lost it’, or ‘I don’t even know if I can find my surgeon’ or he might have died or moved on, or so forth,” he said.

“So it would be enormously helpful if we could have, in one central location, a record of every breast implant that’s inserted into Australian women.”

Infection control the key to cancer

Plastic surgeons said the rising rates of lymphoma could be traced back to some “cosmetic” surgeons who weren’t as qualified as fully trained specialist plastic surgeons.

The lymphoma is believed to be caused by a bacteria which builds up in the grooves of highly textured implants and reacts in those who have a genetic predisposition.

Professor Ashton said it was possible the bacteria was being introduced by surgeons with improper infection-control procedures.

He pointed to high numbers of cases being traced back to commercial cosmetic surgery companies and practitioners.

“One of the key components is that the implant must become infected, so if it has been put in in a proper hospital by a proper surgeon, then the chances of that occurring are very low,” he said.

But he emphasised patients with Allergan or other highly textured implants didn’t need to be concerned if they had no symptoms.

“It’s not that if you have an Allergan product you need to have your implant removed,” he said.

“It means that you need to be aware of your implant, and like everything else you need to monitor it and keep in close contact with your surgeon.”

If people do develop the rare cancer, it can be treated.

“If we get onto it within 12 to 18 months, it is eminently treatable and curable,” Professor Ashton said.

“It’s a very rare disease affecting a very select group of people and can be cured but it is something, like everything, we need to be aware of.”

The society has also published a list of specialists who are offering free consultations to women with concerns who have a referral from their GP.

Source: ABC NEWS

First posted 9 Apr 2019, 3:56pm