French Breast Implants Scare

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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EyeTechCare News!

The Medical Technology Blog

In the first post of our medical technology blog, we take a look at EyeTechCare. The original idea for the company came from Fabrice Romano in 2006, and the company was eventually formed in 2008, when Romano brought two other team members on board, Laurent Farcy and Philippe Chapuis, to become the co-founders of EyeTechCare.

EyeTechCare has completed a EUR 7.5 million funding round, with funds provided by Lyon, France-based insurance company SHAM, a first time investor, and Crédit Agricole Private Equity (CAPE), one of EyeTechCare’s existing shareholders. SHAM has subscribed EUR 3 million to the financing, whilst Crédit Agricole Private Equity provided the balance of EUR 4.5 million.

In its first funding round in July 2008, EyeTechCare raised EUR 1.2 million from CAPE and CEA-Investissement, which enabled it to complete preclinical studies of its device for the treatment of glaucoma. The funds raised in this second financing will be used to complete the first clinical trial in man, as well as establish the manufacturing facilities and the sales and marketing force required for this first product, whose market launch is scheduled for early 2011. The company aims to break even in 2013.

Based in Rillieux-la-Pape, near Lyon,EyeTechCare is developing non-invasive therapeutic medical devices for the ophthalmology market based on high-intensity focused ultrasound (HIFU), which allows ambulatory and rapid treatment to be performed, thereby limiting the cost and the risk for the patient. The company’s first device, EyeOP1, is for the treatment of glaucoma, a disease that affects about 2 per cent of the world population and can lead to blindness. The device uses the UC3 (ultrasound circular cyclo-coagulation) procedure, which makes it possible to reduce intraocular pressure by partially and accurately destroying the ciliary bodies that produce aqueous humour.

Interesting and exciting times ahead for ETC I think, and we wish them well with their product launch next year. A treatment that both reduces cost and limits risk to a patient can only be a good thing, we’ll be watching them closely in the coming months.

Looking towards Europe, Switzerland is opening up more to European trade and is radically changing its hospital financing system within the next few years. The country has, as of March 2010, officially aligned its medical device regulations with European law. Medical technology products such as CT scans, medical implant diagnostic tests, pacemakers and artificial joints are now subject to free trade within the EU. In Switzerland the medical technology sector is seen as having strong potential for growth.

With hospital costs continuing to grow, Switzerland has decided to move towards a DRG-system of hospital finance, which is due to be implemented throughout the country in 2012. In June 2010, the government approved an agreement to standardise costs for compulsory healthcare insurance. The tariff system, once prices are agreed, will allocate a set amount per treatment or hospital stay for each Diagnosis Related Group (DRG).

Good news for the medical device industry I guess, and eventually the Swiss population. Well I hope you enjoyed the first of many, regular posts on The Medical Technology blog, if you have any views on the above please don’t hesitate to comment, and I’ll get back to you as soon as possible.

Drop back soon, cheers, Paul.



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