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Q&A: PIP breast implants health scare

 

French breast implants have caused a health scare in Europe and South America due to a high risk of rupturing in the body.

 

The response has varied, notably between the UK and France.

French authorities have reported a high rupture rate and are offering to remove all implants.

UK figures report a lower rupture rate. For now the government says there is no need for routine implant removal, but it is conducting a review.

What is the problem?

The issue is with silicone breast implants made by the French company Poly Implant Prothese (PIP).

The firm's products were banned in 2010 when it emerged that industrial, rather than medical grade, silicone was being used in the implants.

No increased risk of toxicity has been reported, but the implants are at greater risk of rupturing.

What happens when a silicone implant ruptures?

When an implant ruptures, the silicone gel filling can leak into the body. Some women will not notice anything at all and there is no evidence of an increased cancer risk.

However, it can result in the formation of scar tissue which can change the shape and feel of the breast. The gel can be an irritant, causing pain and inflammation. It can also be more difficult to remove an implant once it has ruptured.

The French authorities have highlighted an unknown potential risk from the untested silicone gel.

How many women are affected?

Globally, more than 300,000 implants have been sold in 65 countries in the last 12 years. Europe was a major market, but more than half of the implants went to South America.

It is thought that about 40,000 British women have the implants. Private clinics fitted 95% of the implants, mostly for breast augmentation. Five per cent were performed by the NHS.

But how many implants have actually ruptured?

There are various figures depending on which organisation or country is reporting them. The French authorities say the rupture rate is 5%.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has a figure of 1% and said that after speaking to other countries, there was "no evidence of any disproportionate rupture rates other than in France".

A major UK private clinic, Transform, was reported as saying it had a rupture rate of 7%. It says this was based on a sample of 108 patients.

The organisation which represents private breast implant clinics, The Independent Healthcare Advisory Services, says that after looking at data from thousands of patients the rupture rate was within the industry standard of 1-2%.

Should the implants be removed?

In France the answer is yes. Authorities say the implants should be removed as a precaution. Venezuela has taken the same stance.

In the UK the advice is that they should not be removed. Chief Medical Officer Prof Dame Sally Davies said: "We currently have no evidence to make us think they should have the PIP breast implants removed.

"Because of this, and because removing these implants carries risk in itself, we are not advising routine removal of these implants."

However, there is not universal agreement. The president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), Tim Goodacre, said: "Given the fact there is a degree of uncertainty and a lack of knowledge, we're recommending all implants come out."

A review, led by NHS Medical Director Prof Bruce Keogh, will analyse the rupture data and report back this week.

Who will pay?

The French government has offered to foot the bill for the 30,000 French women affected to have their implants removed.

The Venezuelan health minister Eugenia Sader said the government would cover the costs of removing the implants, but would not pay for replacements.

In the UK, the answer will depend on Prof Keogh's findings.

Where should women go for advice?

For now, women are being advised to speak to the surgeon who operated on them.