22 Dec 2011

Women to sue over implant cancer scare

At least 250 women in the UK plan legal action following concerns that their breast implants are linked to cancer.

women to sue over breast implant cancer scare (Image: Getty)

Reports say women intend to sue the clinics where they underwent surgery to be fitted with the implants, manufactured by French company Poly Implant Prostheses (PIP).

French authorities are expected to formally announce today that up to 30,000 women who received a specific type of implant in France could have them taken out.

But UK regulators have insisted there is no link with cancer and there is no need for women to have them removed.

The Guardian has reported that at least 250 women with PIP breast implants intended to sue at least six clinics in the UK.

Mark Harvey, a partner at Hugh James solicitors, which is taking the legal action, said it had initially wanted to pursue claims against PIP or its insurers. PIP has closed down.

Clinics had entered into contracts with women, promising the implants would last a lifetime and would not rupture or leak silicone, he said.

Mr Harvey said some of his clients had complained of inflammation, fatigue and fibromyalgia, a musculoskeletal pain disorder.

“Whether it is ultimately linked, we don’t know,” he told the Guardian.

The Daily Telegraph said dozens of women intend to sue, including some who say they have been left unable to work due to a pins-and-needles sensation in their arms and hands, and constant pain.

Kevin Timms, a lawyer with Garden House Solicitors in Hertford, is representing some of the women.

The Government said UK regulators had consulted experts in nine countries over the safety concerns.

The Medicines and Healthcare products Regulatory Agency (MHRA) had spoken to health and regulatory teams and all agreed there was no evidence of an increased risk of the disease from the implants, the Department of Health said.

A spokesman said: “They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates. This is in line with UK findings.

“MHRA is currently advising that women with any concerns should make an appointment with their implanting surgeon and have a full discussion.”

The implants have been linked to the death of a French woman from a rare form of cancer called anaplastic large cell lymphoma (ALCL), and are implicated in another seven or eight cancer cases.

The implants are filled with an unapproved non-medical grade silicone believed to be made for mattresses and there have been reports that the protective barriers are faulty.

New figures from the MHRA suggest 84,300 of the implants, manufactured by PIP, have been sold in the UK since 2001.

Based on the assumption that each woman has two implants, an estimated 42,000 women in the UK could be affected, according to the MHRA.

But the figure could be higher because women undergoing breast reconstructive surgery following cancer may only have had one implant.

Data from the MHRA also shows it has received 411 reports of PIP implants failing in British patients since 2001.

This would suggest around 1% of women in the UK with PIP breast implants have suffered implant failure, including rupture.

This contrasts with figures from French medical regulators, which suggests a failure rate in France, including rupture, of around 5 per cent.

All implants have the potential to rupture, although experts say PIP devices are more likely to split – 10% of them within the first year.

Around 95 per cent of PIP implants in the UK have been used in the private sector for cosmetic surgery, according to the MHRA.

Less than 5 per cent of the implants have been used in the NHS for operations such as reconstructive surgery following breast cancer.

Douglas McGeorge, consultant plastic surgeon and former president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said that patients with breast implants should check whether they have a PIP implant and be monitored by their clinic.

“These implants have a higher failure rate so there will be women who might choose to have their implants removed before that happens, whereas others will be happy to be monitored,” he said.

In June, the US Food and Drug Administration (FDA) said women with breast implants may have a very small but increased risk of developing ALCL, which is a rare type of non-Hodgkin’s lymphoma.

It said a literature review identified 34 cases of ALCL in women with breast implants worldwide.