The US FDA (Food and Drug Administration) has announced new labels for boxed warnings, to further warn and inform consumer decision-making when considering the risks around breast implants. Included in this announcement, the FDA will also be limiting the sale and distribution of breast implants to providers who agree to provide patients with risk information through a decision checklist, that both parties need to sign. The FDA will also require updated labelling in an effort to mitigate the number of silicone gel-filled breast implant ruptures.
Read more here.
More on: FDA Health News Regulatory