FDA Sets Stronger Safety Warnings for Breast Implants

FDA Sets Stronger Safety Warnings for Breast Implants
A silicone gel breast implant is shown at Mentor Corp., a subsidiary of Johnson & Johnson, in Irving, Texas on Dec. 11, 2006. Donna McWilliam/AP Photo/file
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WASHINGTON—U.S. health regulators on Wednesday finalized stronger warnings for breast implants, including a new requirement that people receive detailed information about their potential risks and complications before getting them.

The Food and Drug Administration announced the new regulations mainly aimed at implant manufacturers, who are also being required to add a boxed warning message—the most serious type—to their written patient materials.