13 août, 2005 04:51
Groups Decry FDA's Approval Of Silicone Breast Implants
August 11, 2005 8:00 a.m. EST
Yvonne Lee - All Headline News Staff Reporter
Washington, DC (AHN) – Consumer advocates are asking Congress to investigate the Food and Drug Administration's plans to return silicone gel-filled breast implants to the market.
Last month, the FDA announced it would approve Mentor Corp’s silicone implants if the company meets certain conditions.
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 want to lift the near-ban of the devices.
However, Mentor Corp’s main study only tracked implant recipients for three years. The National Organization for Women and a dozen other women’s and health groups are urging the FDA to release findings of its criminal investigation of Mentor in the late 1990s, to settle concern that they hid problems with the implants.
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.
