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Mentor comments on new FDA breast implant guidance.
2004 FEB 5 - (NewsRx.com & NewsRx.net) -- William F. Coffin, 818-789-0100
Mentor Corp. (MNT) responded to the new draft guidance document for breast implant sponsors that the U.S. Food and Drug Administration (FDA) released.
Chris Conway, CEO of Mentor Corp., stated, "We are not surprised that the FDA has taken this step to obtain additional information for its review of breast implant marketing applications. This is an important review which has generated considerable public interest. We have stated previously our view that the FDA review of silicone gel breast implants would be methodical and thorough, involving intense scrutiny of all available scientific data. It was apparent at the October panel meeting that some of the questions raised by public participants and panel members were not completely answered by the data presented. The FDA is now taking steps to ensure that the appropriate data becomes available for ...
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...is planning to reconsider silicone-gel breast implants a year after the agency turned down the...tentatively has scheduled a hearing on silicone breast implants in April. Inamed Corp. and Mentor Corp., the last two remaining U.S. manufacturers...
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...and your purse strings -- silicone-gel breast implants are back. Allergan Inc. and Mentor Corp. both received Food and Drug Administration...Maine) to delay approval and investigate Mentor Corp. A former employee accused the company...
- HEALTH AND SAFETY - Mentor may go on selling breast implants
- Newspaper article from: Biomedical Materials May 1, 1994 700+ words
US firm Mentor Corp, based in California, says it may continue selling silicone breast implants, given certain circumstances. According...allows Mentor to continue selling silicone breast implants if a global settlement of implant lawsuits...