Thousands of women with breast implants have been warned to have check-ups over fears they were given dangerous ones. Up to 50,000 British women have implants filled with a silicone gel that may have been made for mattresses and so has not undergone vital safety tests.
More over, there are concerns that a protective coating, designed to stop the implant from splitting and prevent any gel that leaks from spreading through the body, is missing. The Poly Implant Prothese (PIP) implants were among the cheapest on the market, and so were widely used in commercial clinics in Britain and abroad.
Some days ago, the British Association of Aesthetic Plastic Surgeons (BAAPS) urged women who have had implants to contact their surgeon to find out what brand was used. Women with PIP implants should have an ultrasound test within the next six months to check for flaws and cracks. If there are signs of damage, implants on both sides should be removed.
And the Medicines and Healthcare products Regulatory Agency, which is responsible for the safety of drugs and medical devices, has told surgeons to stop using the implants. To add to the worry for women, PIP, once the world’s third-largest manufacturer of implants, has gone into liquidation – meaning those affected could be footing large parts of the bill themselves.
The alarm was raised in France after surgeons noticed that the PIP implants were rupturing much more quickly than other brands. An inquiry ordered by health watchdogs found ‘serious irregularities’ in the implants, minutes of a meeting held by the French Society of Reconstructive and Aesthetic Plastic Surgeons state.
The meeting also heard that when asked for studies on the safety of the gel, its manufacturer said he did not have any, because he believed it was being used to make mattresses. The minutes contain the caveat that his claims have still to be verified.
A Bristol plastic surgeon and president of BAAPS, Nigel Mercer, said: “This is certainly an unusual situation but so far there is no serious cause for alarm. While further tests are conducted into the substance, we recommend that women who have undergone breast augmentation contact their surgeons to find out what kind of implant was used.”
“If it’s PIP, they should have an ultrasound in the next six months, to establish whether there is any rupture. Removal is recommended in these cases but if there is one ruptured implant, the other one should be taken out as well, as a preventative measure,” he added.
Mr Mercer added that the French investigation firmly lays the blame at the door of the manufacturer and not the surgeons: “This situation is clearly not the fault of the surgeons, who acted in good faith – it would be similar to blaming a dealership for a faulty car.”
Women may be able to be referred for ultrasound through their GP. Otherwise, they will have to pay for it privately. The NHS does remove damaged implants but won’t pay for new ones.
In France, more than 500 women have filed complaints with the prosecutor of Marseilles in which they demand free replacements of their implants and compensation for harm suffered. One, Annick Dejoie, said: “It gave me swollen glands and also severe fatigue that nearly caused a very serious car accident.” [via Daily Mail (UK)]