Information about Breast Implants from CDRH

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Date: Mon, 22 Aug 2005 10:08:52 -0400

Sender: Information about Breast Implants from CDRH

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From: CDRH Breast Implants <[log in to unmask]>

Subject: THE AUGUST 2005 BREAST IMPLANT LISTSERV

MESSAGE

THE AUGUST 2005 BREAST IMPLANT LISTSERV MESSAGE

WELCOME to the Center for Devices and Radiological

Health (CDRH) Breast Implant Listserv.

The Breast Implant Listserv will provide you current

information on the following topics:

New Literature/Articles, Public Meetings, Recalls,

Safety Alerts, New Device Approvals, Additional

Information on Breast Implants, Frequently Asked

Question(s), and Resources.

Not all topics will have new information each month.

Breast Implant messages are archived for two years and

can be accessed from the page below.

To view the previous messages, please go to

http://list.nih.gov/archives/breast-implants.html

You can submit comments and questions about breast

implants by visiting the Food and Drug

Administration's (FDA) webpage.

Please go to http://www.fda.gov/cdrh/bicl

NEW LITERATURE/ARTICLES (No New Items)

PUBLIC MEETINGS (No New Items) RECALLS (No New Items)

SAFETY ALERTS (No New Items)

NEW DEVICE APPROVALS (No New Items)

ADDITIONAL INFORMATION ABOUT BREAST IMPLANTS - FDA

Statement on Approvable Letter to Mentor Corporation -

July 28, 2005

http://www.fda.gov/bbs/topics/news/2005/new01213.html

-

Mentor July 28, 2005 News Release:

http://ir.mentorcorp.com/phoenix.zhtml?c=76343 & p=irol-mediaNewsArticle & ID=73

Inamed July 18, 2005, News Release:

http://phx.corporate-ir.net/phoenix.zhtml?c=90325 & p=irol-newsArticle & t=Regul

FREQUENTLY ASKED QUESTION AND ANSWER

Question: Is there any FDA Requirement/Guideline

regarding the disposal of an explanted breast implant?

Answer: There is no FDA Requirement/Guideline

regarding the disposal of an explanted breast implant,

but the patient may want to contact the company to

find out if they would be interested in receiving the

breast implant.

ADVERSE EVENT REPORTS To do a search and get

information from the Adverse Event Reports, please go

to the following websites and use the product codes

listed below:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.CFM

Product codes FTR: prosthesis, breast, non-inflatable,

internal silicone gel filled

FWM: prosthesis, breast inflatable, internal, saline

LCJ: expander, skin, inflatable

MRD: sizer

MWZ: expander

RESOURCES Breast Implant Website The breast implant

website is a valuable source of information on implant

procedures, special surgical concerns, post-operative

care, and topics to discuss with your surgeon that can

help you make your decision.

The breast implant website also includes the breast

implant consumer handbook and patient labeling for the

approved Mentor and INAMED saline-filled breast

implant products.

Please go to the breast implant website at:

www.FDA.gov/CDRH/breastimplants/ MedWatch MedWatch is

FDA's program for reporting serious reactions and

problems with medical products, such as drugs and

medical devices.

To access the MedWatch website please go to

http://www.fda.gov/medwatch Breast Implant Listserv

If you would like to join or leave the Breast Implant

Listserv, please go to

http://list.nih.gov/cgi-bin/wa?SUBED1=breast-implants & A=1