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

FDA Calls For More Warnings On Breast Implant Labeling

Executive Summary

Suggested revisions to breast implant labeling guidance from the US FDA include a boxed warning, patient decision checklist, and additional information for patients about device ingredients. The changes follow growing concerns over the safety of certain implants.

You may also be interested in...



FDA Issues New Breast Implant Guidance While Giving Another A Nip And Tuck

The US FDA gives recommendations on the labeling of breast implants in a 29 September final guidance doc. The agency also revised a separate breast implant guidance last updated in 2006 to include, among other things, information found in the new labeling guidance.

'Do Your Job': To The Dismay Of Patients, FDA Panelists On Breast Implants Advise Better Risk Warnings, Not Recalls

Despite pleas from breast implant patients at a March 25-26 US FDA advisory committee meeting for the agency to take off the market silicone and saline breast implants that have initiated a serious range of symptoms in some women, the panel instead recommended FDA get out stronger public advisories warning of the risks of breast implants and a lymphoma associated with the products.

COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document

The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.

Topics

UsernamePublicRestriction

Register

SC143384

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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