Industry Says EU Medical Device Sales Healthy, Silicone Scandal May Change ThatFeb 10th, 2012 | By Jane Akre | Category: Feature
February 10, 2012 ~ A survey by a medical device consultant, Emergo Group, released Friday, (news release here) February 10, finds that overseas sales of medical devices outpaced domestic business in 2011. Surveying more than 2,600 medical device makers, 53 percent reported a rosy sales picture last year. Compare that to 42 percent reporting positively about domestic sales.
The survey underscores the global issue of medical devices. The acronym BRIC, stands for Brazil, Russia, India and China where device makes have their sites set, according to a news release by Emergo. China is emerging as the prime market for the largest five-year growth potential.
Device manufacturers, and lawmakers who represent their interests to the FDA, constantly remind the agency that if rules are not relaxed device makers will take their products and profits overseas. But overseas may be learning from experience. Nearly 22 percent of those who were surveyed said the European market became more strict in 2011 requiring more clinical data. More than half of participants said the FDA has been more difficult since 2010.
Nearly 40 percent said they would choose Europe as the first place to market a new device.
All that may be changing with the PIP breast implant scandal. Thousands of women were implanted with breast implants made in France using industrial-grade silicone. (background story here). Regulators are now calling for tighter controls to safeguard patients. Weaker regulations in Europe are blamed for allowing Poly Implant Prothese (PIP) implants onto the market. Hundreds of thousands of women used the implants for up to a decade reports Reuters (here).
The national scandal in France has the government recommending women have the implants taken out with the government footing the bill. France did not offer to pay for replacement breast implants.
Green Party Says Meshes Need Review Too
|During a debate in Brussels on defective silicone gel breast implants, French Green Party member, Michèle Rivasi brought up the topic of “meshes”, reports Maria S. to MDND. The European Commission is currently working on a revision of the legislation around medical devices and now planning “stress-tests” to see where things go wrong within the current regulatory and legal framework.
Maria S. Says later that day a couple of Dutch and French Green Party members sent a mail to the Directorate-General for Health (DG Sanco) of the European Commission with additional information. They asked if it would be possible to also include the problems with meshes in those stress-tests and in the revision of the legislation. Below you can read the text of their email: