Fw: Safety concerns regarding silicone gel-filled breast implants

[Guest guest]

I got this today in response to my recent letter through the Command Trust Network "Take Action" link.

----- Original Message ----- From: , Samie Niver

'fdp3@...'

Sent: Tuesday, July 29, 2003 11:05 AM

Subject: RE: Safety concerns regarding silicone gel-filled breast implants

Thank you for the email you sent to the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA).

FDA appreciates your concerns regarding our review of premarket approval (PMA) applications for silicone gel-filled breast implants. We would like to assure you that we intend to perform a thorough review of all the data in the PMA applications in determining whether they demonstrate a reasonable assurance of the safety and effectiveness of these devices. The majority of the emails we have received about this matter suggest that we would consider approving silicone gel-filled breast implants based on 2-year clinical data; however, that is not correct. In our review of these PMAs, we will consider data collected in the core clinical study (the primary study from the investigational device exemption (IDE) application), as well as information from the larger adjunct study (the public health need study for reconstruction and revision patients), medical device reports from a variety of databases, and published scientific literature. Additionally, we intend to seek input from an Advisory Panel of outside experts on the data contained in the applications. We also expect the Panel to consider whether labeling for these devices can provide adequate information to enable women to make informed decisions as to whether or not to get these breast implants.

During any Advisory Panel meeting, there are opportunities for public discussion of the PMA under review. No Panel meeting has been scheduled yet for a silicone gel-filled breast implant PMA. However, when one is scheduled, we will publish a Federal Register notice announcing when and where it will be held and a person to contact if you would like to participate in the open public session.

FDA assures you that your concerns about the safety and effectiveness of breast implants and the need to provide adequate information to women regarding the risks of breast implants are important to us.

For additional breast implant information, please visit our breast implant website at http://www.fda.gov/cdrh/breastimplants/.

We appreciate your taking the time to contact us.