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L & # 39;French health agency for the safety of medical products decided to withdraw from the market a type of product implant of bad implants with a surface covered with polyuritene, because of the risk badociated with the occurrence of a rare tumor form. However, the agency does not recommend preventive explantation for women who have such prostheses. Italian Health Minister Giulia Grillo has asked for an urgent opinion from the High Council of Health.
The opinion is requested "in the light of the decision of the French authorities to remove such prostheses from the market", linked to the risk of development of anaplastic lymphoma, but also "to initiate possible initiatives for manufacturers involved in the production of risk devices ".
The measure decided by the French health agency (Ansm) provides for the prohibition of the placing on the market of these prostheses, prohibition of distribution and use and removal of prostheses present. The measure will come into force from April 5th. In 2017, the number of women carrying this type of bad implants in France is estimated at 400,000. Since 2011, according to the agency, 59 cases of ALCL badociated with these bad implants have been reported in France.
Ansm also renews the recommendation to use preferably smooth bad implants in cosmetic or reconstructive surgery. The agency explains that the precautionary measure was decided to "reduce the exposure of women to the risk of large-cell anaplastic lymphoma, which remains a rare but serious risk". However, given the "scarcity of this risk" – says the Ansm – the agency does not recommend the preventive explant for women carrying such plants. "Ansm has also activated a toll free number and women carriers of these plants are advised to consult their doctor if in doubt or problem.
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