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Mentor will need more breast implant information:

This article was originally published in Clinica

Executive Summary

Following a new US draft guidance document for breast implant sponsors, released by the FDA last week, Mentor says it will need to obtain more information for its premarket approval (PMA) application for its silicone gel breast implants. The Santa Barbara, California firm filed its PMA in December 2003. "The new requirements as outlined in the revised guidelines will require more information," said Mentor CEO Chris Conway. "Some of this information will take time to acquire and analyse for submission." Only last week, rival firm Inamed said that it had failed in its attempt to reintroduce silicone gel breast implants to the US, after the FDA deemed its products "not-approvable".

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