The Ministry of Health asks the Allergan pharmaceutical company, based in Dublin, to stop marketing its breast implants and to remove them from the market. It has also claimed to the centers and health professionals that have these implants that do not place any more. This requirement comes after the National Agency for the Safety of Medicines and Health Products of France (ANSM, for its acronym in English) ordered the withdrawal to relate them to a rare form of cancer, anaplastic large cell lymphoma. Neither those responsible for communication of the company in Spain, nor the central offices of London have given information on the number of women affected.
The Spanish Agency of Medicines remember that patients should follow their regular check-ups and, if they experience health problems and believe that they may be due to their implant, they should see their doctor following the usual behavior guidelines. It also reminds healthcare professionals of their obligation to report any incident related to the product.
The suspension of sales derives from the expiration last Sunday of the CE marking granted by the French Notified Body. This dictates the compliance of the implants with European regulations and evaluates compliance with the essential requirements of safety, efficacy and quality. By not having this certificate in force, the implants can not be marketed. In France, an investigation into this type of product is under way due to its possible relationship with 53 cases of a rare type of lymphoma, according to the French drug agency.
This association with cancer occurs with implants with a rough surface, not with those that are smooth. The company has announced that it does not agree with the decision and that it will appeal. The French agency has convened a group of experts who will review the risks in February. The communication managers of the company in Spain insist that the withdrawal from the market does not imply that the implants of the users have to be removed.
Allegar has defended the safety of these implants and has ensured that the request of the French body has not been based on any new scientific evidence, nor has it identified any immediate risk to the health of the women who have used the implants. However, the pharmaceutical company, which will withdraw any remaining supply of implants in Europe, has reported that the decision does not affect sales in the United States and that it is fully cooperating with the French authority.