The FDA will limit the sale and distribution of breast implants to physicians and healthcare facilities that give patients a checklist of safety risks created by the agency. Physicians must go over the checklist with prospective patients and ensure they understand the risks involved with breast implants. The physician must sign the checklist before the surgery can proceed, and the patient must be also given the opportunity to sign, to acknowledge the information was reviewed and discussed.
The FDA is also requiring new warning labels for certain silicone gel-filled implants that encourage recipients to get screened regularly to detect potential ruptures or leakage.
The new safety requirements come after years of complaints from patients who experienced a condition known as “breast plant illness,” which can cause brain fog and fatigue, among other health issues, according to The Washington Post.
Some breast implants have also been linked to a rare form of cancer, the publication said.
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