THE WALL STREET JOURNAL

November 15, 2001

Dow Jones Newswires

EU Proposes Tougher Rules On Breast Implants

BRUSSELS (AP)--Under pressure from the European Parliament and advocacy groups, the European Union's head office on Thursday announced plans to tighten rules on the use of breast implants to improve the quality and safety of the product.

With the use of implants increasing across Europe, E.U. Enterprise Commissioner Erkki Liikanen said that more needed to be done to ensure that the implants were safe. "Health issues are a major public concern, and it is our task to ensure that they are addressed in the best possible way, so as to provide European citizens with the highest possible level of safety," Liikanen said in a statement.

While the E.U. considers that the devices pose no general health risk, it does advise caution, recognizing that "some specific problems do occur, and that several relate to product design or characteristics."

"We should be aware that, like with all implants and medical interventions, there may be inconveniences, and that patients may react in different ways," Liikanen said. "Patients should know the advantages and the disadvantages of implants, and be given all the relevant information, that allows them to make a well informed and thoroughly considered decision."

The Commission proposal sets out "essential safety requirements" the medical devices have to meet before being used, including minimum standards of design, which have to be tested and notified to E.U. and national authorities.

The proposal also calls for mandatory information kits to be distributed to patients who want to receive the implants, which should include data on different types of implants - silicone or saline - and their characteristics as well as differences.

The kits will also have to include benefits and risks, especially in the case of rupture or bleeding of the implant, as well as the expected life span. The proposal will now be studied and reviewed by the European Parliament in the months ahead before it can be approved.