FDA posts silicone gel breast implant approval information

NewsGuard 100/100 Score

The U.S. Food and Drug Administration (FDA), has posted information on it's web site related to the Mentor Corporation's silicone gel breast implant pre-market approval (PMA) application, scheduled to be reviewed at a General and Plastics Surgery Devices Advisory Panel meeting April 11-13, 2005.

An important study by the company, the Core Gel Study, tracked the progress of 1,007 women who were implanted with silicone gel-filled breast implants for either augmentation, reconstruction or revision surgery.

The data submitted to the FDA includes information from the 3-year follow-up period as well as longer-term clinical data specific to the integrity of Mentor's silicone gel-filled breast implants. Mentor will present its data on Wednesday, April 13th to the panel.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Food allergies' broad impact on quality of life demands greater awareness