Breast implant rupture risk scrutinized and assessed in depth

By Dr. Ananya Mandal, MDJan 2 2012

According to Tim Goodacre, one of the members of the government-commissioned panel investigating the PIP breast implant scandal, the rupture rates found by the country’s biggest cosmetic surgery company were ‘unacceptable’. Mr. Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) and an Oxford University lecturer, said that if the panel confirmed the findings – in which almost one in 14 implants had leaked – then they should all be taken out in every case.

He spoke to The Daily Telegraph saying, “With this sort of level of implant failure, particularly with this sort of material that isn’t medical grade, it’s sensible that they be removed. I think that would be a reasonable way forward.”

However, the tens of thousands of women who have received the French-made implants could now face a lengthy wait for an official recommendation, due in part to arguments over who should fund the £150 million prospective cost of removals. At the moment the Department of Health is only prepared to fund removal of the ‘PIP’ implants if they have already ruptured, causing industrial-grade silicone to leak into surrounding tissue. However, that advice was based on the rupture rate quoted by the Medical Healthcare and products Regulatory Agency (MHRA) of just one per cent.

This weekend Transform, Britain’s biggest cosmetic surgery company disclosed that its own figures showed seven per cent of PIP implants had ruptured since 2006. As a result Andrew Lansley, the Health Secretary, has asked the MHRA to review the data amid concerns incidents have been under-reported. Mr. Lansley has also asked a group of experts to look at the figures as well, and make recommendations about what can be done about the situation.

Mr. Goodacre said that all the faulty implants should be removed if Transform’s seven per cent figure is validated. “Certainly to get rupture rates that Transform are talking about is entirely unacceptable,” he said. “If that is happening and they can validate the data in any meaningful way, then these implants need to be taken out.” Should the review panel reach such a conclusion, it would enormously increase the pressure on the Department of Health to fund blanket removal, which could cost £150 million.

Mr. Lansley has asked the MHRA and the expert panel, led by Professor Sir Bruce Keogh, medical director of the NHS, to report back to him later this week. They are due to meet on Wednesday. Other members include Richard Rainsbury, president of the Association of Breast Surgeons, and Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons. However, Mr. Goodacre thought it unlikely that the Department of Health would make a decision on whether or not to recommend blanket removal until it had scrutinized data from across the industry in more detail.

Mr. Goodacre emphasized that women with PIP implants were not at imminent risk of them rupturing, and appealed for them to remain calm. He advised those with worries to contact their operating surgeon, or failing that their GP. Hundreds of women have already joined online support groups to swap information and express their anger at being given faulty implants. Many said they were planning to fund removal operations themselves.

Professor Dame Sally Davies, Chief Medical Officer of the NHS, said women with PIP implants “should not be unduly worried”. She added, “We currently have no evidence to make us think they should have the PIP breast implants removed. Because of this, and because removing these implants carries risk in itself, we are not advising routine removal of these implants.” Nonetheless, women whose PIP implants have ruptured have reported significant pain, particularly below the arm, with lymph nodes becoming clogged with the silicone gel. There is also the risk of long-term problems, not least because the gel has not been medically tested.

The French state has already agreed to fund such removals – some 30,000 operations – due to the high risk of rupture. In France the official rupture rates with the PIP implants is five per cent.