The Food and Drug Administration (FDA) stated on Wednesday that it would take several steps to enhance breast implant safety regulations, including mandating manufacturers and plastic surgeons to inform patients about the dangers before undergoing surgery.
To guarantee that patients considering breast implants can make educated judgments regarding devices, the new agency rule also establishes new controls on how they can be sold and disseminated.
The FDA has also approved new labelling for all lawfully sold breast implants. Women who receive silicone gel-filled breast implants include a boxed warning, a patient decision checklist, and screening suggestions.
According to a statement released by the government on Wednesday, the agency is also updating information on the status of breast implant manufacturer post-approval studies.
“In recent years, the FDA more focusing towards improving patient access to clear and understandable information regarding the advantages and dangers of breast implants. The FDA is aiming to narrow information gaps for anybody considering breast implant surgery by increasing safety requirements for manufacturers.”
The new standards come after tens of thousands of women have complained for years about symptoms including brain fog, exhaustion, and other health difficulties that are commonly referred to as “breast implant disease,” according to The Washington Post.
A rare and potentially lethal form of cancer has been linked to some patients. According to the FDA, there have been 573 cases of that cancer globally, with 33 fatalities.
According to the Washington Post, in the midst of these recurring concerns, activists have long advocated for a more standardised process to educate patients choosing breast implants properly.
Manufacturers should include an enclosed warning in a black box on the label to indicate probable risks connected with breast implants, according to regulators in 2020.
According to the guidance, medical officials should use a patient checklist to assist clients through potential hazards.