Fear of cancer spurs breast implant recall

By Dr. Ananya Mandal, MDDec 21 2011

There are concerns regarding breast implants and the association with cancer. UP to 30,000 French women and perhaps tens of thousands more around the world may need to have defective breast implants removed after several suspicious cancer cases. The final decision on recall of the implants, produced by the Poly Implant Prothese (PIP) company will be made by the end of the week, after a report from France's National Cancer Institute on December 23.

“Today, we're in the process of evaluating these breast implants because of the apparent cancer risk,” said French government spokeswoman Valerie Pecresse. “The government will announce its action plan between now and the end of the week,” she added in an appearance on the LCI television news network. According to a health ministry official said no “causal link” between the implants and cancer had yet been established and that “there is no urgent health risk”.

It was not immediately clear how many foreign women have been given PIP products but the firm was once the world's third-largest producer of silicone implants, producing 100,000 per year and exporting 80 per cent of its output. PIP was shut down and its product banned last year after it was revealed to have been using non-authorized silicone gel that caused abnormally high rupture rates of its implants.

Fears about the safety of PIPs surfaced 18 months ago when surgeons noticed they were rupturing much more quickly than other brands. An inquiry ordered by the French health watchdog reported 'serious irregularities' in the implants. But when the gel's manufacturer was asked for studies on the safety of the filler, it said it did not have any – because it believed it was to be used in the manufacture of mattresses. It also emerged that many of the implants were missing a protective coating designed to stop them from splitting and prevent any gel that leaked from spreading through the body.

Health officials said last week that eight cases of cancer, mainly breast cancer, had been reported in women who had received the PIP implants. “It is urgent for all women who have PIP implants to return to see their surgeons,” Ms Pecresse, the French government spokeswoman, told LCI television, adding that costs of removal would be covered by state health insurance. She said that, before the government announces its action plan this week, “we must first of all proceed with a census of women who received these implants and are potentially in danger.”

Laurent Lantieri, one of France's best-known cosmetic surgeons and a member of a health department committee on the issue, said there was no choice but to order the implants' removal. “We all agree on the necessity of this decision,” he said. “We are facing a health crisis linked with a fraud. The entire profession is aware of this. There is no urgency but we no longer have any choice - all these implants must be removed.” So far 523 women who received PIP implants have had them removed.

The French newspaper Liberation quoted France's director general for health, Jean-Yves Grall, as saying that while the state would cover the costs of removing implants, it would not pay for implanting new ones unless the women involved had reconstructive surgery following a mastectomy. “This does not shock me,” Lantieri said. “It is not up to society, in a time of crisis, to pay for a new implant for aesthetic reasons.”

Up to 50,000 women in UK also have the Poly Implant Protheses, or PIPs, which were among the cheapest on the market and widely used in cosmetic clinics both here and abroad. UK Government advice is that any woman who is concerned about her implants should speak to the surgeon that put them in.

The Medicines and Healthcare products Regulatory Agency says there is insufficient evidence to indicate any association with the implants and cancer. But Douglas McGeorge, of the British Association of Aesthetic Plastic Surgeons, said, “People with PIP implants do have a higher failure rate and there is a significant risk at some point they might rupture. If this is a worry for patients, the sensible thing to do is to get them replaced earlier rather than later.”

The NHS does take out damaged implants but won't pay for new ones to be put in, meaning patients could be left with a bill that runs into tens of thousands of pounds, as well as the trauma of additional surgery.

Meanwhile, 27 British women are suing their clinics to pay for the operation and for compensation for scarring and emotional trauma. Kevin Timms, of Hertford-based Garden House Solicitors, said those worst affected could be in line for tens of thousands of pounds. The firm is also trying to compile a national register containing details of all those who have the implants.