Consumer advocates asked Congress Tuesday to investigate the Food and Drug Administration’s plans to return silicone gel-filled breast implants to the market, contending the agency is violating its own safety standards.
Last year, the FDA told implant manufacturers to provide long-term data on the durability of implants prone to breaking and on the consequences of silicone leaking into women’s bodies if they wanted to lift a decade-plus near-ban of the devices.
But last month, the FDA said it would approve Mentor Corp.’s implants if the company met certain conditions — not publicly disclosed — even though Mentor’s main study tracked implant recipients for only three years.
While implants have largely been exonerated of causing serious or chronic illnesses, broken ones require surgical removal or replacement; infection and painful, rocklike scarring also are side effects.
Also Tuesday, the National Organization for Women and a dozen other women’s and health groups urged FDA to release findings of its criminal investigation of Mentor in the late 1990s, to settle concern that implant problems were hidden.
The FDA closed that probe without taking any action against Mentor, which has denied underreporting problems.
FDA’s scientific advisers recommended approval of Mentor’s implants in April, and agency spokeswoman Julie Zawisza said the 2004 advice to manufacturers wasn’t mandatory. As for the Mentor probe, some of FDA’s findings are releasable and the agency is processing requests for it, she said.