Regulator under fire in row over breast implants

They accused the Medicines and Healthcare Products Regulatory Agency (MHRA) of failing to take action to deal with complaints and of dismissing serious health problems linked to the devices.

More than 270 women in the UK intend to sue those clinics where they underwent surgery to be fitted with the implants, manufactured by French company Poly Implant Prostheses (PIP), which has now closed.

Lawyers say the number of complainants is growing rapidly and they have lodged class action cases.

The implants have been linked to the death of a French woman from a rare form of cancer 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.

French authorities are expected to formally announce today that up to 30,000 women who received the implants in France can 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.

Figures from the MHRA suggest 84,300 PIP implants have been sold in the UK since 2001.

Based on the assumption that each woman has two implants, at least 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.

Mark Harvey, a partner at Hugh James solicitors, which is representing more than 250 women, said some of his clients had complained of inflammation, fatigue and fibromyalgia, a musculoskeletal pain disorder.

In a statement, Mr Harvey added: “I have written again to the MHRA to urge them to react to the developments in France and, similarly to France, to set up a suitable protocol for women affected in this country.

“I do not believe that MHRA’s reaction to date has been satisfactory; it is unbelievable that the MHRA have not ensured that they were involved with the consultations in France about a product that affects such a large amount of women in this country.

“I am and have been very critical of their role throughout the history of this product.

“This stems from allowing this company to sell these implants in the UK in the first place, their refusal to respond when I alerted them to the problems, their refusal to meet with any of my clients to discuss their concerns and now this latest health concern.”

Kevin Timms, from Garden House Solicitors, has lodged a group action with the High Court and expects a hearing may be held by summer next year.

The action involves 27 complainants and 13 defendants who are the clinics where patients had their surgery. He said patients had suffered a number of health complaints due to their PIP implants rupturing, rippling or moving, including pain, swelling, lumps of silicone moving around and a bubbling sensation.

Some have experienced pins and needles in their fingers while others have numbness.

Last night, a spokesman for the Department of Health said the MHRA had consulted experts in nine countries over the safety concerns. All agreed there was no evidence of an increased risk of cancer from the implants, said.

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

Data from the MHRA shows it has received 411 reports of PIP implants failing in British patients since 2001. This would suggest around 1 per cent of women in the UK with PIP breast implants have suffered implant failure, including rupture.

All implants have the potential to rupture, although experts say PIP devices are more likely to split.

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

In June, the US Food and Drug Administration (FDA) said women with breast implants may have a very small but increased risk of developing a rare type of lymphoma.