HADC INFO--FDA APPROVES SILICONE

[Guest guest]

"Human Adjuvant Disease Corp." <humanadjuvantdisease@...> wrote: Date: Fri, 17 Nov 2006 15:08:58 -0800 (PST)From: "Human Adjuvant Disease Corp." <humanadjuvantdisease@...>Subject: HADC INFO--FDA APPROVES SILICONEhumanadjuvantdisease@...http://edition.cnn.com/2006/HEALTH/11/17/implants/index.htmlFDA allows silicone breast implants back on marketPOSTED: 2218 GMT (0618 HKT), November 17, 2006 WASHINGTON (CNN) -- The FDA is allowing siliconebreast implants to be sold again, 14 years after theywere removed from the market by the same agency overquestions of safety.The approved silicone implants are made by twocompanies, Inamed Aesthetics and Mentor.In 1992, then-FDA Commissioner Dr. Kessler tooksilicone breast implants off the market,

citingconcerns over their safety, including how often theyruptured in a woman's body and whether leakingsilicone could lead to diseases as some women claimed.After the ban, the implants were available only towomen in clinical trials who needed them aftersurgery, especially after breast cancer. At thatpoint, lawsuits over the products drove one of themanufacturers, Dow Corning, into bankruptcy.Since then, most studies have failed to link theimplants to serious or chronic diseases such as cancerand lupus, but questions remained over how often theimplants rupture and what happens if the siliconeenters the body.In a meeting before an FDA advisory committee in April2005, Inamed said its implants have a 14 percentlikelihood of rupturing over a 10-year period. Mentorconducted a three-year study and said the rupture rateat that point was negligent.To help answer questions on long-term safety,

the FDAis requiring Inamed and Mentor each to study 40,000women for 10 years to assess potential healthproblems.The consumer advocacy group Public Citizen, which haslong opposed silicone implants, criticized thedecision and called it "a terrible reminder of thedouble standard for women versus men" and noted thatthe FDA has not approved silicone gel testicularimplants because of inadequate testing.____________________________________________________________________________________Sponsored Link$420k for $1,399/mo. Think You Pay Too Much For Your Mortgage? Find Out! www.LowerMyBills.com/lre