Medtech Insight is part 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

This article was originally published in The Gray Sheet

Executive Summary

A determination as to whether the breast implant maker may have violated federal securities laws is requested by House Commerce Committee Chairman Thomas Bliley in an April 3 letter to the Securities and Exchange Commission Enforcement Division. The issue relates to a recent Mentor public statement denying the firm is the subject of a criminal investigation by FDA based on "allegations of serious irregularities in breast implant studies" (1"The Gray Sheet" March 27, p. 14). Mentor has publicly denied the investigation is based on these particular allegations, contradicting FDA assertions. Bliley made the request since Mentor's denial apparently caused the firm's stock to rebound sharply after initially falling up to 50% upon an initial news report in the March 23 USA Today. FDA's General and Plastic Surgery Devices Advisory Panel recommended at a March 1 meeting that Mentor's saline filled breast implants should remain on the market (2"The Gray Sheet" March 6, p. 3). FDA has indicated that it will make its decision on Mentor's PMA by May 12

You may also be interested in...



Mentor Investigation Does Not Involve Breast Implant PMA Data, Firm Says

Conversations between Mentor Corp. and FDA's Office of Criminal Investigations have not "related in any way to our research or our [clinical] studies" of saline-filled breast implants, Mentor President and CEO Anthony Gette reported at a March 23 teleconference.

Mentor, Inamed Saline Breast Implants Deemed Approvable By FDA Panel

Saline breast implants manufactured by Mentor Corp. and Inamed Corp. should remain on the U.S. market provided the device manufacturers beef up labeling and physician training to help insure that patients are fully informed of any possible adverse outcomes, FDA's General and Plastic Surgery Devices Advisory Panel recommended at a March 1 meeting in Gaithersburg, Maryland.

Sun Denied Over US Antitrust Challenge

India’s Sun Pharma has been denied leave to appeal against a US court decision rejecting the company’s bid for dismissal of a multi-district antitrust lawsuit.

UsernamePublicRestriction

Register

MT013223

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