Brief overview of Standards and Regulations concerning Breast Implants

Q

QA-Man

Can anyone give me an brief overview of standards and regulations concerning breast implants (both saline & silicon) and any delivery systems?

Device classification around world, biocompatibility, sterilization, etc. Basically any specific requirements or practices related to these devices.

I already have a broad range of knowledge and experience in the industry but I need a crash course in breast implants.
 
Y

yana prus

Hi,

I would start with the FDA requirements - they are the most detailed:

for the classification of the breast implants you should go to
http ://www. accessdata. fda .gov/ scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm - OBSOLETE DEAD LINK UNLINKED
and type breast implants.

There you get two product codes: FWM (for saline filled implants) and FTR (for silicone-gel filled implants). Both of them are class 3 devices that require PMA submission. There is an FDA guidance for Saline, Silicone Gel, and Alternative Breast Implants. http ://www. fda. gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071233.pdf - OBSOLETE DEAD LINK UNLINKED

In EU, breast implants are class III devices, as appears on 2003/12/EC directive on the reclassification of breast implants.
EUR-Lex - 32003L0012 - EN there is a harmonized standard for the breast implants - EN ISO 14607:2009.

Health Canada provides rather valuable info for breast implants:
http ://www. hc-sc.gc. ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/md-im/index-eng.php - OBSOLETE DEAD LINK UNLINKED

Good Luck,

Yana
 
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