Document Detail

Silicone breast implant materials.
MedLine Citation:
PMID:  22826101     Owner:  NLM     Status:  In-Data-Review    
This opinion article has been written on request because of the recent public controversy over silicone breast implants produced by a now-defunct company, Poly Implant Prosthese (PIP) in France. More than 300,000 PIP devices have been implanted. The purposes of my article are to (1.) provide a general overview of silicone breast implant materials, (2.) to describe the general safety of these materials as reported to date, and (3.) to summarise current publicly available information about these aspects of the PIP prostheses. The materials covered are the silicone rubber from which the implant shells are made and the silicone gel used to fill the shell. The materials safety issues are biocompatibility (especially of the gel) and biodurability of the shell. The literature reviewed indicates that biocompatibility is not an issue with other current generation implants. However, biodurability is. A rough estimate of implant shell rupture rate is ~10+% at 10 years. Information is still emerging about the PIP implants. Initial regulatory disclosures suggest the PIP implants may have both biocompatibility and biodurability problems. They also suggest that PIP implants may have been produced using silicone materials not certified as medical grade. Governmental health and regulatory agencies are just now in the process of deciding what actions should be taken to protect patients.
Au Daniels
Publication Detail:
Type:  Journal Article     Date:  2012-07-23
Journal Detail:
Title:  Swiss medical weekly     Volume:  142     ISSN:  1424-3997     ISO Abbreviation:  Swiss Med Wkly     Publication Date:  2012  
Date Detail:
Created Date:  2012-07-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100970884     Medline TA:  Swiss Med Wkly     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  0     Citation Subset:  IM    
University of Basel, Lab. of Biomechanics & Biocalorimetry, c/o Biozentrum/Pharmazentrum, Basel, SWITZERLAND;;
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