Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Mentor preparing silicone breast implant Phase III study protocol.

This article was originally published in The Gray Sheet

Executive Summary

MENTOR SILICONE BREAST IMPLANT PHASE III PROTOCOL SUBMISSION TO FDA could occur as early as September, according to the com-pany. While final details of the protocol have not been worked out, Mentor says the clinical trial will involve a small number of investigators and several hundred women who have never had breast implants. The trial -- the third and final phase of a study called for by FDA in 1992 -- will include both reconstruction and augmentation procedures.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT004506

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel