England’s health secretary orders three new inquiries into safety of cosmetic surgery and devices

13th January 2013

England’s health secretary orders three new inquiries into safety of cosmetic surgery and devices

The UK private surgery firm that carried out the greatest number of implants made by the now discredited and bankrupt French company Poly Implant Prosthèse (PIP) has refused to pay for the removal and replacement of the implants, claiming that the fault lies with the government.

The Department of Health for England meanwhile has launched a new inquiry into how to ensure the safety of people seeking cosmetic interventions and insists that it will pursue private companies for payment of operations if those companies refuse to help affected women.

The row over PIP implants has continued this week with an increasingly belligerent exchange of words between the government and the private cosmetic industry—the BMJ understands that 16 major clinics or companies are involved.

Last December the French government announced that it would pay for all 30,000 women in France with PIP implants to have them removed after concerns that they were made with non-medical grade silicone and were possibly more likely to rupture.

In the UK an expert review commissioned by the government concluded that the 40 000 women with these implants should not have them removed automatically. Rather, women should seek clinical advice and, with their doctor’s blessing, the NHS would pay for removal if this was desired but would pay for replacement only for women who were NHS cases (BMJ 2012;344;e249, doi:10.1136/bmj.e249).

The private sector was expected to follow suit, but this week Harley Medical Group, which carried out 13 900 operations with PIP implants in the UK between September 2001 and March 2010, said that it could not fund replacement procedures.

Since the company started collecting rupture data in September 2004, of the 11 837 PIP implant operations done in the UK up to March 2010, 213 ruptures had occurred—around 1.8%.

Harley’s chairman, Mel Braham, told the BBC: “We’re only sitting here today because the Medicines and Healthcare Products Regulatory Agency (MHRA), their [the government’s] own regulatory authority, has approved these implants and obviously hasn’t done their proper checking.

“These implants were first approved in 2001, and we would expect a regulatory authority to continually do spot checks.”

Mr Braham said that the company did not have the resources to replace the implants in nearly 14 000 patients, adding: “We are not geared up to do this type of work, and if we accepted it, we would not be able to finance it. We’d be put out of business.”

Additional pressure on the government came from the Independent Healthcare Advisory Services (IHAS), which represents most of the private healthcare providers that gave women PIP implants.

Its director, Sally Taber, said, “Whilst the intention of the health secretary was to offer guidance, patients are feeling more confused and anxious now than ever before.

“With the current government position remaining unclear, patients want to know the timeline for the further investigations into PIP implants by the MHRA.

“Members of IHAS are as much a victim of this fraud as the NHS and the patients.”

The Welsh Assembly has announced that it will pay for all women in Wales to have their PIP implants removed and replaced on the NHS, regardless of whether they had them done privately or not—a position that England’s Department of Health has rejected.

Scotland is following England’s example, and there are thought not to be any women in Northern Ireland with PIP implants.

England’s health secretary, Andrew Lansley, speaking in the House of Commons on 11 January, said that eight cosmetic surgery companies—including Nuffield Health, Spire Healthcare, and BMI Healthcare—had agreed to remove and replace PIP implants for their customers.

Mr Lansley said it was right that those women who received their care privately should receive a similar level of service and reassurance from their care provider as those women who had received implants on the NHS.

“I do not think it fair to the taxpayer for the NHS to foot the bill for patients who had their operation privately,” he added.

In those cases in which a private clinic no longer existed or refused to help women, the NHS would pay for those women to have their PIP implants removed, in consultation with their doctor, and would then pursue the clinics to seek recovery of the costs.

Mr Lansley also announced that Bruce Keogh, the NHS medical director, would lead a review to look at the arrangements for ensuring the safety of people seeking cosmetic interventions.

There would also be a review of the regulation of medical devices in the UK, to be led by the undersecretary of state for quality, Frederick Howe; and the NHS watchdog the Care Quality Commission would conduct a review of private clinics that offer cosmetic surgery.