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By Reuters
The US Food and Drug Administration said Thursday that it would not ban textured breast implants at that time, while the agency was investigating the implant and sensitizing people to the safety of these devices related to a type of cancer.
Countries such as France have banned or restricted certain textured implants. The Canadian health agency announced in April its intention to ban textured breast implants from Allergan Plc, several months after the company had removed these devices from the market in Europe.
In February, the FDA issued a statement warning doctors about a type of breast implant-related lymphoma after receiving reports of the disease.
"At the moment, the FDA does not believe that, based on all available data and information, the device complies with the prohibition standard set out in the Federal Food, Drugs and Cosmetics Act," he said. said Thursday the agency.
The agency said manufacturers of all breast implants will have to file individual reports on adverse events instead of the current practice of quarterly summary reports, details of which will now be made available to the public.
The FDA also said it would work with patient groups and other stakeholders on the content and format of any changes to the labels of these devices that may include a boxed warning – the strictest of the FDA.
Previous reports from breast implant manufacturers, which have been categorized as a summary of all adverse events each quarter, will also be available in the FDA's public database in the coming weeks, announced the agency. ;agency.
The agency's decision comes a month after the meeting of an expert panel of experts to recommend what steps the FDA could take to address concerns about the safety of these devices .
In March, the FDA sent warning letters to Sientra Inc. and a Johnson & Johnson unit for not complying with the post-approval study requirements for their breast implants.
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