EU Advocates Stricter Controls Over Breast Implants

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After the controversial PIP breast implants made headlines, the European Union has recommended tighter controls of medical devices in an effort to restore patient confidence.  The organization’s new plan includes “surprise inspections,” stricter testing of products, and more cooperation from doctors.

EU is also planning to set up registers to trace implants, which are not used by some country-members.

The organization’s willingness to strengthen its existing laws to regulate and monitor prosthetics is an important step to further protect consumers from defective medical devices such as the ones produced by PIP, a now bankrupt French-based company that manufactured breast implants found to be highly prone to leaks.

Fortunately, PIP did not reach the US market since the Food and Drug Administration found its flawed manufacturing practices 10 years before the controversy made headlines.

In a statement, EU health commissioner John Dalli said he is “deeply concerned about the potential health impact for women who had received the defective silicone breast implants manufactured by PIP.”

The faulty silicone breast implants are believed to affect more than 400,000 women who are mostly from Europe, although some of the victims are also from Brazil, Colombia, Spain, Chile, and Venezuela.  About 80 percent of the PIP’s implants were exported outside France.

Because of the extensiveness of the problem, Dalli has written to 27 country-members urging authorities to take immediate action in an effort to protect the public from another defective medical devices.

In many cases, the FDA implements stricter regulations than most health organizations from Europe.  For instance, gummy bear breast implants—which use a silicone gel more cohesive than the one currently used—are still under clinical trials in the US although they are already used in Europe and other parts of the world.

But aside from stricter regulations, some experts believe that the success will also depend on the participation of doctors and more awareness campaigns targeting patients.

Cosmetic Surgery Blogger @ February 14, 2012