The Medical Technology Blog

Breast implants safety thrown into question as France makes precautionary move to remove controversial PIP implants from patients

Just when the breast implant industry was getting some kind of good safety record, the death of a woman in France who had been implanted with an implant made by the French company, Poly Implants Protheses (PIP) has re-ignited the debate about the safety of the devices.

There’s no doubt the breast implant industry has worked hard to restore its image and relevance since the dark days of the 1980s when the embryonic industry was dogged by safety concerns and mass litigation. However, the spectre of safety has never really gone away completely. Last year, PIP had its breast implants banned after they were found to include a non-medical grade silicone filler. The issue has rumbled on quietly all year in Europe, but has been reignited following the death of a woman implanted in France with a PIP breast implant has been now been associated with an anaplastic large cell lymphoma (ALCL), a rare form of cancer which affects cells of the immune system.

The UK MHRA, in a bid to calm nerves, has pointed out that there is currently no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority is also consistent with consultations it has made with experts in the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta, in terms of rupture events. There has also been no reported cases of lymphoma.

Despite that, authorities in France have recommended that 30,000 women in the country have their faulty breast implants removed as a precautionary measure. The French government, which still says there is no evidence of a cancer link, plans to cover the financial cost. Media reports suggest around 40,000 women in the UK have the implants and the conflicting signals arising from the two countries makes it a very uncertain time for those who have undergone breast implants, let alone those who have directly used PIP implants.
The UK viewpoint basically seems to urge woman to sit tight and discuss the issue with their doctors. Data wise, the agency has a point. The MHRA points out that approximately 1 per cent of women in the UK with PIP breast implants have suffered implant failure, including rupture. This contrasts with information from the French medical device regulatory authority, AFSSAPS, which suggests a failure rate, including rupture, of around 5 per cent in France. It doesn’t go far as trying to explain the reasons behind this anomaly, which doesn’t provide too much consolation.

From an industry perspective, it means the industry is back in the doghouse in terms of respectability. In the US, the FDA hasn’t been spent most of this year formulating plans to tighten up the implant regulatory process even more, with the result that companies are likely to face even more scrutiny than ever. Of course, the social cost makes these responses entirely natural, and agencies cannot fail to acknowledge the issues out there, but it looks like the start of difficult times for the breast implant industry in 2012 unless they can meet these challenges and prove, once and for all, that these implants are effective and safe options for women.

Article source: Article kindly provided by Lawrence Miller, editor of Espicom’s business publication Medical Industry Week, and editor-in-chief of the medical newsletters team.




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