A private group founded by consumer advocate Ralph Nader sued the Food and Drug Administration Wednesday, seeking restrictions on saline-filled breast implants.
Public Citizen accused the FDA of delays in investigating 13,477 reports, dating to 1991, of injuries associated with the implants. They include ruptures, infections and mysterious autoimmune disorders.
“The FDA’s inaction on this dangerous device is unconscionable,” said Public Citizen’s Dr. Sidney Wolfe.
The silicone shells filled with saltwater are the only product still widely available for reconstructive breast surgery and enlargement. The FDA in 1991 restricted silicone-gel implants to breast cancer survivors in special scientific studies, after thousands of women claimed they had been sickened by leaking gel.
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