Revealed, breast implants cause rare cancer

An Australian, Carol Camilleri, was operated on for a bad implant in 2014. Three years later, he was convicted of a rare blood cancer.

He did the implant to correct his uneven bad. But later, he had a swelling in the left bad. He began to feel pain.

The doctor's examination revealed the presence of anaplastic large cell lymphoma badociated with bad implants (BIA-ALCL) and malignant tumors. This is a rare type of blood cancer.

"It's very scary because they keep saying that it's very rare. All I hear is death, death, death," he says. he told ABC.

Camilleri is just one of many women with cancer because of their textured bad implants.

Unlike fine bad implants, surgeons call bacteria much more likely to grow in the groove of a textured implant, which triggers lymphoma.

The ABC report on the BIA-ALCL case is part of the investigation of the International Consortium of Investigative Journalists (ICIJ) on medical devices implanted in the patients body.

Only 29 out of 72 cases of this type of cancer were recorded in the Therapeutic Goods Administration (TGA) database in Australia.

Surgical Professor Anand Deva, who took the initiative to contact doctors from across Australia to collect data on the prevalence of this case of cancer.

As of April 2018, there were 81 cancer cases in Australia and New Zealand linked to 110 bad implants. Four of them are dead.

Known between 2012 and 2015, the number of new cases of lymphoma rose sharply in Australia, while the TGA ignored the problem due to lack of data.

During this period, the regulator has always said that Australian women do not have to worry about the conditions badociated with bad implants. This implant, he said, is "safe and effective".

Something similar has happened in the United States until 2017. The Food and Drug Supervisory Agency (FDA) allows bad implant suppliers to hide the damage caused by their products to patients.

The ICIJ badysis of FDA data revealed that the number of bad implant injuries has increased to more than 4,500 cases in 2017. Nearly 8,300 cases occurred in the first half of 2018 .

Many doctors do not report

The lack of understanding of the TGA authorities on the emergence of this type of lymphoma in patients does not surprise the Australian experts.

The TGA database allows doctors, patients and producers to record the side effects of their medical equipment on the market.

But these data are incomplete because only manufacturers are required to report and very few patients know it.

Many doctors do not report the side effects of bad implants.

"It's like a black hole, all these implants are made, some women are going to Thailand or elsewhere, we do not know what happened," Professor Deva said.

According to Professor Deva, physicians should be required to report potential problems caused by medical devices such as implants. If you do not, the doctor, for example, can be punished.

An attorney at Libby Brookes of the renowned law firm Maurice Blackburn in Australia has contacted a number of patients, including the Camilleri.

"I was very surprised by the weakness of the regulatory system and surveillance of medical devices and medical implants in Australia," Brookes said.

"In common sense, if patient safety is indeed a priority, there must be an obligation to report to the doctors," he added.

TGA states that it has attempted to solve this problem by requiring implant cards for medical equipment and patient information leaflets.

Surgeons must now choose not to continue bad implant surgery if their actions do not want to be recorded in the bad equipment registration.

This year, 90% of bad surgeons provided patient data, a significant increase over several years ago.

The TGA also organized expert groups in 2016 and 2018 to find out more about the new type of lymphoma.

Answers to producers of bad implants

The largest number of bad implant manufacturers in Australia is Allergan, based in Dublin.

After the first case of ALCL was detected in Australia and in other countries, among which were Allergan products, the company published a study with a very small number.

They mentioned that the level of lymphoma was reached in less than one case per 100,000 bad implants.

But the latest expert opinion actually mentions the case of one in 1,000 bad implants.

According to Professor Deva, the research cited by producers includes the risks for patients.

The TGA itself stated that as a regulatory body in Australia, it used various sources of information to determine the risk of a medical device.

Professor Deva stated that he was struggling to convince his colleagues of this rare blood cancer problem.

"I think when more and more data comes in, it threatens people, threatens their livelihoods," he said.

The ABC News badysis showed that after the publication of a study conducted by Allergan producers in 2012, cancer case reports have become stagnant and warnings authorities have not been updated.

In fact, three years after Allergan's publication, the ALCL case has actually grown.

Allergan responds by saying that patient safety is their highest priority.

"We continue to work with physicians, communities and supervisors around the world for research, understanding and awareness about the effectiveness and safety of bad implants," said Allergan.

There was no product withdrawal

Until the publication of this report, Payuidara implant products related to this cancer had not been removed and most of them were still on the market.

"All the data show that the ALCL case will be very high in the next 12 years," said Professor Deva.

"So, a lot of other cases will still happen," he said.

The spokesman for the TGA said that the product recall was not necessary because the cause of the lymphoma could not be confirmed.

In fact, studies have clearly identified the link between lymphoma and textured bad implants, the combination of certain bacteria and the genetic predisposition to the disease.

Professor John Skerritt, TGA Assistant Secretary, told ABC that the withdrawal of the product could not be justified.

"Remember that this is not only used for cosmetics, but also for women who undergo a mastectomy for cancer," he said.

"The bad device is very important for self-esteem and psychological calm (patients)," added Professor Skrerritt.

Professor Deva said that rather than attracting related products, it is better to provide clearer information about the risks to patients.

For patients like Camilleri, whose condition is now declared tumor free, the slow onset of AGT action is very unfortunate.

"How can they let us risk life like this?" he said.

Posted by Farid M. Ibrahim from ABC Australia article.