The FDA has issued new breast implant guidance, recommending that manufacturers include serious warning labels about the potential complications and risks.
The Food and Drug Administration issued new breast implant guidance on Wednesday, recommending that manufacturers include serious warning labels about the potential complications and risks.
"We believe women should have thoughtful and balanced discussions with their health care providers about both the benefits and risks of breast implants based on clear and current information," the statement said."We have heard from many women that they are not fully informed of the risks when considering breast implants. They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves.
In July, pharmaceutical company Allergan recalled several models of its textured breast implants that were directly linked to BIA-ALCL. The company announced the decision following a recommendation from the FDA. It said the risk of BIA-ALCL in patients with Allergan BIOCELL textured implants is around six times higher than the risk of it in patients with textured implants from other manufacturers in the U.S.
The administration also recommends that manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure.
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