ParfumGigi@aol.com ParfumGigi@aol.com
24 août, 2005 12:50
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://phx.corporate-ir.net/phoenix.zhtml?c=90325&p=irol-newsArticle&t=Regul
- 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
