Health

PIP breast implants: Harley Medical Group will not replace implants

  • 11 January 2012
  • From the section Health

The Harley Medical Group, which fitted more PIP breast implants than any other UK cosmetic surgery firm, says it will not replace them free of charge.

It claimed replacing the banned implants would put the company out of business.

The government says private clinics who fitted implants have a "moral duty" to remove them.

However, the NHS will pay to remove, but not replace, implants if a private clinic refuses or no longer exists.

Around 40,000 women in the UK have been fitted with PIP implants. The Harley Medical Group said it fitted 13,900 women with the implants between September 2001 and March 2010.

Its chairman Mel Braham said the company had neither the resources, the surgeons, nor the operating facilities needed to do the surgery.

He said the government must accept "moral responsibility" for replacing the PIP implants.

"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."

He added: "We're an innocent victim like everyone else, we're attempting to do our best for our patients."

Mr Braham was in agreement that implants should be removed and replaced if that was the patient's decision.

But he said: "We can't take on this whole thing on our own, especially when it wasn't our fault."

Instead he said the Harley Medical Group would supply the NHS with the replacement implants.

Nigel Robertson, the head of the cosmetic surgery firm Transform, said: "Private sector providers with large volumes of patients do not have the resources to ensure the removal and reaugmentation of all PIP implants free of charge."

He said the government plans were "unworkable" and again blamed "a catastrophic failure of the regulation" by the MHRA.

'Put things right'

Speaking in the House of Commons, the health secretary Andrew Lansley said: "Every provider has a responsibility to put things right."

He said it was not fair for the taxpayer to foot the bill and that if the NHS was forced to remove an implant "the government would pursue private clinics to seek recovery of our costs".

Mr Lansley also announced a review of how the situation emerged in the UK: "The blame for what happened lies with PIP, but this review will enable us to learn lessons to improve future regulatory effectiveness."

A register of implants put into patients, which would include heart valves and joint replacements as well as breast implants, will also be considered.

The MHRA said the implants were allowed to be used in any EU member state as they had a CE Mark and the regulatory body said its role was to "investigate adverse incidents".

A spokesperson said: "We have continually monitored the safety of these breast implants. Once we were notified of the issue from France, we swiftly issued advice that these implants should not be used in the UK and commissioned testing to evaluate the safety of the implants.

"We will be working closely with other health departments and regulators in Europe to consider whether there are wider implications for the regulation of implants and other medical devices."

Free time

A joint letter to plastic surgeons, by the British Association of Aesthetic Plastic Surgeons and the British Association of Plastic, Reconstructive and Aesthetic Surgeons, has called for surgeons to offer their time for free when operating on patients with PIP implants.

It also warned that "NHS facilities might well struggle to manage the bulge in service requests for a limited period of time".

Unlike the rest of the UK, the Welsh government said it would pay to both remove and replace banned breast implants from women who were treated privately.

On Tuesday, the Welsh health minister, Lesley Griffiths, said: "Removing the implants and not replacing them could result in unsightly scarring, loose skin, and potentially the accumulation of fluids, need for drainage, and risk of infection."

A spokesman for the Department of Health said it did not recognise the Welsh argument.

The French authorities have offered to pay for implants to be removed due to a high risk of them rupturing.

The Czech and German health authorities state the implants should be removed. On Wednesday the Dutch health authorities said: "Even if there is no rupture, it is advisable ... to have the prothesis removed."

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