Health Secretary stands firm on the issue of removal of faulty breast implants

By Dr. Ananya Mandal, MDJan 12 2012

Britain’s Health Secretary Andrew Lansley intends to take cosmetic industry companies that are refusing free operations to women wanting substandard breast implants removed to court. Lansley is ready to take action after the declaration of the Harley Medical Group that it will not pay for removal of the PIP implants that have triggered great anxiety in women in the UK and in France. Transform and the Hospital Group have also said that women will have to pay.

Lansley invited women refused free help to go to their GP, who will refer them to an NHS hospital for removal – although not replacement – if that is what they want. But Lansley says the taxpayer should not be expected to foot the bill and the government will actively seek to recover the cost from the private chains. “We will pursue them extremely aggressively through the courts,” a source close to Lansley said. “We will go after them.” Lansley believes the clinics are turning their backs on their patients. “For them to abdicate responsibility we think is immoral,” said the source.

On Friday Lansley announced that the NHS would remove and replace implants for free, where women wanted it, if their operation had originally been on the NHS. This would normally have been breast reconstruction after cancer surgery. The big providers of private health care who also perform some cosmetic surgery, including Nuffield Health, BMI and Spire, have all said they will follow suit.

Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons, said, “We find it outrageous…when women’s peace of mind is at stake, some clinics are refusing to honor their ostensible commitment to duty of care, particularly when they made a profit by using cheaper products and resources.”

Lansley is now urging Harley to rethink. “Eight private companies are offering to replace implants for their patients – Harley Medical Group should follow suit,” he said. “Today the professional bodies for cosmetic surgery have sent out a letter to all surgeons calling on them not to charge for their time when they remove these implants. That should significantly reduce the costs for all companies and I would urge Harley to rethink its decision in light of this. All providers have a duty of care to their patients. It is unacceptable for wrangling over liabilities to get in the way of this. These providers should offer help to women who need it and deal with liabilities later.”

The Harley Medical Group was by far the biggest buyer of the cut-price and, as it turned out, substandard implants from Poly Implants Prosthese in France, which used silicone gel filler of industrial grade intended for mattresses. Its surgeons operated on 13,900 women between 2001 and 2010, while Transform did around 4,000 implants. Transform says it will charge £2,800 for removal. A third chain, the Hospital Group, says it will only replace those that have ruptured.

The private chains say they will go out of business if they have to pay for all the operations and blame authorities such as the Medicines and Healthcare products Regulatory Agency for allowing the implants into the country. The Harley Medical Group's chairman, Mel Braham, told the BBC the firm did not have the resources, the surgeons, or the operating facilities needed to do the surgery. He said the government had a moral responsibility to replace the PIP implants, because of what he called the failure of regulation by the MHRA. “We're only sitting here today because the Medicines and Healthcare products Regulatory Agency (MHRA), their own regulatory authority, has approved these implants and obviously hasn't done their proper checking. We're an innocent victim like everyone else, we're attempting to do our best for our patients ... We can't take on this whole thing on our own, especially when it wasn't our fault,” he said.

The European Union is reviewing the EU Medical Devices Directive to see whether tightening of the rules would prevent another PIP scandal. Lansley said there will also be an investigation into what happened to allow the implants into the UK. Mr Lansley also pointed the finger at Germany, by naming it as the country that approved the French-made PIPs for use in Europe.