EU breast implant scandal may affect FDA's view on faster device approvals

As the EU reels from the recent breast implant scandal, some experts now think the scandal could have an impact on the debate over faster device approvals in the U.S. 

In the U.S., industry and government officials have gone back and forth over whether the FDA should make its device review process more like the one in Europe. Instead of having reviews like the FDA's, the EU relies on a decentralized network of about 70 notified bodies that are hired by companies, as Bloomberg notes. Approval by one body means a company can sell their product throughout the EU, but some are crying foul, saying this sets up the potential for conflict of interest.

But can the U.S. adopt a similar system to speed up reviews? Congress is mulling a revamp of the device review process and is supposed to make a decision by the fall; however, the breast implant scandal could cause lawmakers to be more cautious, as Bloomberg notes. "All the industry guys in the U.S. say, 'we should have access to these products much sooner, like in Europe,'" explained Oxford University's Carl Heneghan, who has studied device recalls. "The flip side is, the European people are being used as guinea pigs."

However, ask those in the device industry, and you'll find that many find the U.S. system slow and overly burdensome. Over the past few years, U.S. companies have looked to Europe as a way to get their products to market faster. In fact, roughly two-thirds of smaller device and diagnostics companies seek approval there first, according to a 2011 survey from Northwestern University. This situation represents a problem because U.S. patients aren't getting innovative products quickly enough. At the time, Jeffrey Shuren, head of the FDA's Center for Devices and Radiological Health, said he appreciated the researchers' efforts, but added that there were some limitations with the survey. He pointed out that there are more than 5,000 device companies in the U.S., but the survey only included responses from 350 individuals.

Still, some in Congress agree that something must be done to get innovative devices more quickly to the U.S. market. "We must do everything in our power to prevent instances like those in France from occurring,"  Rep. Phil Gingrey (R-GA) told Bloomberg in an emailed statement. "On the other hand, we must also do everything possible to prevent the FDA from standing between patients and life-saving treatments."

The breast implant crisis began after word spread that the now-defunct French implant maker Poly Implant Prothese produced substandard implants. Indeed, the company's founder, Jean-Claude Mas, has even admitted that he used unapproved silicone in breast implants, Reuters reported recently.

In the wake of the PIP scandal, British officials are asking for a review of cosmetic and plastic surgery regulation by the National Health Service, a move welcomed by the British Association of Aesthetic Plastic Surgeons. The same surgeons are even discussing a ban on advertising plastic surgery--something that is already seen with certain drugs.

- check out more from Bloomberg
- see the story from The Telegraph

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