British say French are wrong – industrial PIP silicon breast implants are fine
WILL the British Government command British women to remove the faulty implants made by Marseille’s–based Poly Implant Prothèse (PIP), the French company killed off by news that it used industrial silicon (used in electrical insulation and mattresses) in breast implants?
In the UK, at least 40,000 women have bought the PIP implants.
In France, the country’s Health Ministry will meet the cost of the implants removal. The implants are not killers and the French see it “as a precautionary measure”. Moreover, any woman who had the implants following breast cancer surgery can have news ones fitted at the expense of the State. Will the British Government do likewise?
Sally Davies, the British Chief Medical Officer, says:
“Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture.”
That is true. There is no evidence whatsoever. But there is the worry. A scare story is out of the can, and not one without foundations. The implants can leak. Remove them now and stave off stress in later life.
“While we respect the French Government’s decision, no other country is taking similar steps because we currently have no evidence to support it. Because of this, and because removing these implants carries risk in itself, we are not advising routine removal of these implants.”
What to do?
Andrew Lansley, the Secretary of State for Health, takes a view:
“Our experts will continue to examine any further evidence from France and across the world on this issue, and will keep this situation under close review.”
If you weren’t worried, you are now. The Government’s experts will monitor things, and if they decide that the implants are dangerous you ladies will be the first to know. Women will then have to book in for an operation. There might be a rush. It might be hard to get a decent surgeon. And, then, who pays? And remember that these implants were cheaper than others on the market. It might be that the women who need the best treatment have the least money to spend.
There are more words of comfort from the French ministry, which offers:
“The well established risks linked to these implants are ruptures and the irritant nature of the gel which can lead to inflammatory reactions making it difficult to explant them.”
While the Government sits on its hands, the Times speaks with Mark Harvey, a partner at Hugh James solicitors, which is representing more than 250 women. It claims some of its clients have complained of “inflammation, fatigue and fibromyalgia, a musculoskeletal pain disorder”.
“A number of the clinics went into liquidation when this blew up and aren’t around so in that respect the Government will have to step in, but the reality is there’s still a large number of clinics out there that are still trading and they’re saying if you want the implants removed and replaced you’ll have to pay for them all over again.”
Breast implants are not without risks. The NHS tells patients:
In 2000, the Medicines and Healthcare products Regulatory Agency (MHRA) recommended that women with soya bean implants should have them removed.
Although hydrogel implants are no longer available in the UK, women who have them have not been advised to have them removed because they are not thought to cause an immediate risk. However, the MHRA is continuing to monitor their safety. See the MHRA’s website for more information about hydrogel breast implants.
In 1991, polyurethane coated silicone implants were withdrawn from use in the UK following fears that they could increase the risk of cancer. However, research has shown that the risk is very low (less than one in a million) and in 2005 polyurethane-coated implants were re-introduced.
And then this:
Women who have breast implant surgery rarely keep the same implants for their entire lives. Most breast implants have a life expectancy of between 10 to 15 years, after which time they may need to be replaced.
They need to be changed. Might the sensible move to tell woman that when they are changed anyone with the PIP implants gets the safer saline implants for the same cost as they would have paid for the PPI fillers?
In 2000, the Guardian reported:
Last year 5,000 women with soya bean oil-filled implants were advised to have them removed for fear that fluid leaking into the tissues of the breast could cause cancer or birth defects.
Yesterday’s action against hydrogel implants is a result of the review that the government’s medical devices agency (MDA) undertook following the soya bean oil disaster, when it became clear that the safety data on the implants had been inadequate.
Has safety date improved? Not much. The MRHA tells anyone who may be worried about the PPI implants:
We have continually monitored the safety of these breast implants. In March 2010 we advised clinicians not to implant these devices and at the same time advised patients who were concerned about their PIP implants to consult their implanting surgeon. MHRA commissioned toxicity testing on the unapproved silicone gel used to fill PIP breast implants, including genotoxicity and chemical toxicity. The results of these tests have been discussed with relevant experts and we have concluded that there is no safety issue related to this filler material. Similar testing carried out by the French medicines and medical devices regulator confirmed these conclusions.
Got that? The cheap industrial silicon presents to greater risk to health than the surgical silicon. Which begs the questions:
1. What did PIP do wrong?
2. Why ban the PIP implants?