Canada will follow France and ban textured breast implants over fears they have caused cancer in hundreds of women
- Health Canada has warned it could revoke the product licence within 15 days
- Manufacturer Allergan has been told to come up with new safety evidence
- Textured implants were banned in France today because of cancer fears
- More than 450 women worldwide have had implant-related lymphoma
Canada is set to become the second country this month to ban textured breast implants over cancer fears.
The country’s health department has warned it will follow France’s lead if no new evidence proving their safety is produced in the next two weeks.
France withdrew the implants from sale today because they have caused cancer in more than 450 women worldwide.
Health Canada has warned the implant manufacturer, Allergan, that if it can’t reveal new safety evidence for its Biocell implants it will lose its licence for the products.
The health department today announced Allergan will be allowed a 15-day window to fight its case.
Textured implants were banned in France today and now the Canadian government is threatening to follow suit unless the manufacturer can prove they are safe (stock image)
But, if no satisfactory information is submitted to the government, textured implants will be withdrawn from the Canadian market.
The French National Agency of Medicines and Health Products (ANSM) yesterday announced the implants would no longer be used in the country.
It said there was a ‘rare but serious danger’ of women developing anaplastic large cell lymphoma – a type of white blood cell cancer – from the implants.
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A total of 457 women around the world have been diagnosed with this illness, called BIA-ALCL when triggered by implants, according to the FDA in the US.
In Canada there have been 28 cases linked to breast implants, with 24 of them involving Allergan’s Biocell implant, Health Canada said.
Textured implants, of which Allergan is the sole supplier in Canada, are designed to stick to the breast to avoid slipping out of position.
But researchers have found they could rub against the internal tissue and cause swelling which could lead to tumours forming.
WHAT IS BIA-ALCL?
BIA-ALCL is breast implant-associated anaplastic large cell lymphoma.
It is a rare but treatable cancer that develops around breast implants.
The US Food and Drug administration has had reports of 457 patients developing the disease.
Per its latest statistics, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recorded 48 cases of BIA-ALCL since 2011.
The cancer most commonly occurs among women who have had breast implants with a textured surface.
The disease is a type of T-cell lymphoma, which means it affects lymphocytes, more commonly known as white blood cells.
These can start a cancer when one mutates to become abnormal or out of control, then divides into more cancerous cells which spread.
BIA-ALCL is a relatively treatable cancer and many patients are declared cancer-free after having the implants and surrounding tissue removed.
The survival rate for patients with BIA-ALCL is 89 per cent for five years after being declared cancer-free.
It is unclear how many women have the textured implants but, in the UK, as many as 99 per cent of women with implants may have them.
The company stopped selling them in Europe after France refused to renew its licence in December last year, introducing a de facto ban.
UK and US governments, however, have not taken the same action.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has noted 48 cases of BIA-ALCL since it started recording in 2011.
It has not banned the implants from being used but the issue remains controversial, and the MHRA urges surgeons to explain the risks to women considering having them.
A spokesperson for the MHRA said: ‘We are aware of ANSM’s announcement concerning breast implants.
‘Patient safety is our highest priority and we always investigate where there are safety concerns raised about a medical device.
‘Based on our analysis of the latest scientific evidence and expert clinical advice input our advice remains unchanged: there is no new evidence of an increased risk to patients and there is no need for people with breast implants to have them removed.
‘If individuals people have any questions about their implants, they should speak to their implanting surgeon or general practitioner.’
Advisers to the US Food and Drug Administration (FDA) last week finished a hearing about the pros and cons of breast implants.
The agency has not yet proposed any change to how implants are used.
Allergan is reviewing Health Canada’s notice and intends to respond within the deadline, a company spokeswoman told Reuters.
MailOnline has contacted Allergan for further comment.
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