The United States Federal Food and Drug Administration (FDA) determined that it is necessary that Before the breast implant procedure is performed, both patients and physicians will need to sign a list detailing possible side effects, among which are pain, scars, rupture and even a rare type of cancer.
This, with the aim of improving the communication and information that exists about the risks associated with implants.
Implant manufacturers will also be required to place a warning on their product packaging, as is currently done on drugs or other products that carry higher risks.
The measure becomes relevant because About 400,000 people receive breast implants each year, making this the most common procedure in the United States, despite the fact that these devices have been linked to health problems for decades. Notably, people who previously had breast cancer also undergo the procedure.
These measures had been proposed as optional in 2019, but are now becoming legal requirements that must be met by manufacturers and doctors. Companies that sell implants and do not comply with the requirements will be sanctioned and fined. Doctors, meanwhile, should periodically review patients with implants and subject them to tests, to detect possible ruptures of the devices in time.
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