2005-07-30 Breast-Implant Maker Gets Approvable Letter From FDA -- Yahoo/Reuters
The U.S. Food and Drug Administration issued an "approvable letter" Thursday to Mentor Corp. for its application to bring silicone gel-filled breast implants back to the American market. The agency said federal law prohibited it from disclosing the specific contents of the letter. An approvable letter is one of several intermediate steps in the FDA review process of new products, and is often a sign a product is nearing final regulatory clearance.
2005-07-29 FDA Nears OK on Silicone Breast Implants -- Yahoo/Reuters
Silicone-gel filled breast implants are a step closer to returning to the market. The Food and Drug Administration on Thursday told Mentor Corp. that its implants meet the criteria for approval, one of several steps on the way to a final OK. The company still must meet certain conditions before the implants are allowed back on the market. "We are very encouraged by this communication from the FDA, and view this letter as a positive sign for women and their surgeons that another option will soon be available," said Joshua H. Levine, president of the Santa Barbara, Calif.-based company.
2005-07-28 Silicone implants back on the scene -- The Australian News
Silicone-gel-filled breast implants may once again be an option for American women seeking a bigger bust, after health officials yesterday backed a safer version of the product.The implants have been banned for most women since 1992 amid allegations that leaking silicone caused disabling, long-term illnesses.
2005-07-27 FDA moves toward silicone implant OK -- CNN Health
Silicone gel-filled breast implants moved a step closer to the U.S. market after the Food and Drug Administration said Thursday it has issued an "approvable" letter to Mentor Corp. for its implants. Though regulations prohibit the government from discussing the contents of the letter, it is one of several steps in the FDA review process for new products.
2005-07-26 End to silicone ban appears likely -- USA Today
The Food and Drug Administration indicated Thursday that it probably will lift a 13-year ban on silicone-gel breast implants. The FDA sent a letter to Mentor Corp. stating that its silicone-gel breast implants would be approved if certain questions were resolved. The FDA would not reveal the letter's contents. "This is a very big moment for our company," Mentor CEO Joshua Levine said. "It's a very big moment for our industry".