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

Silicone Breast Implant Research and Information Act

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers would be required to update package inserts and informed consent documents to reflect accurate information about the rupture rate of the devices under legislation introduced June 10 by Sen. Barbara Boxer (D-Calif.). Firms also would be required to provide informed consent documents at "the initial or earliest possible consultation regarding breast prosthesis, inform women on how to obtain a Medwatch (adverse event reporting) form, and provide potential study participants with the inclusion criteria for the trial and the toll-free consumer information number." In general, the bill authorizes the National Institutes of Health to expand research on the health implications of silicone breast implants, including undertaking a large neurological/immune dysfunction study of women implanted with the devices for at least eight years
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT010207

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