May 2 (Reuters) - The U.S. Food and Drug Administration said on Thursday it would not ban textured breast implants at this time as the agency investigates the implant and raises awareness related to safety of these devices that have been linked to a type of cancer.
Countries such as France have banned or restricted some textured implants. Canada’s health agency said in April it planned to ban drugmaker Allergan Plc’s textured breast implants, months after the company took these devices off the market in Europe.
In February, the FDA issued a statement warning doctors about a type of lymphoma linked to breast implants after receiving reports of the disease.
“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act,” the agency said on Thursday.
The agency said makers of all breast implants will have to file individual reports on adverse events instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.
The FDA also said it would work with patient groups and other stakeholders on content and format of any changes to the labels of these devices that could include a boxed warning - the FDA’s strictest.
Breast implant makers’ previous reports, which were filed as a summary of all adverse events every quarter, would also be made available in the FDA’s public database in the coming weeks, the agency said.
The agency’s move comes a month after a panel of its experts held a meeting to recommend steps the FDA could take to address concerns around safety of these devices.
In March, the FDA issued warning letters to Sientra Inc and a Johnson & Johnson unit for failing to comply with the post-approval study requirements for their breast implants. (Reporting by Manas Mishra in Bengaluru; Editing by Maju Samuel)