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Thin Film Composite Silicon Elastomers for Cell Culture and Skin Applications: Manufacturing and Characterization

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Published on: July 3, 2018

Silicone breast implant materials.

¹University of Basel, Switzerland. au.daniels@unibas.ch

Swiss Medical Weekly

|July 25, 2012

Summary

This summary is machine-generated.

Poly Implant Prosthese (PIP) silicone breast implants may pose risks due to potential biocompatibility and biodurability issues. Further investigation is needed regarding the safety of these widely used medical devices.

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Area of Science:

Biomaterials Science
Medical Device Safety
Plastic Surgery

Background:

Public concern has arisen regarding silicone breast implants manufactured by the defunct company Poly Implant Prosthese (PIP).
Over 300,000 PIP devices have been implanted globally.
This article addresses the materials, safety, and specific concerns related to PIP prostheses.

Purpose of the Study:

To provide an overview of silicone breast implant materials.
To describe the general safety profile of these materials.
To summarize available information on Poly Implant Prosthese (PIP) devices.

Main Methods:

Literature review of silicone breast implant materials and safety data.
Analysis of publicly available information and regulatory disclosures concerning PIP implants.

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Main Results:

Current generation silicone implants generally exhibit good biocompatibility.
Implant shell biodurability remains a concern, with an estimated rupture rate of ~10+% at 10 years.
Emerging data suggests PIP implants may have biocompatibility and biodurability problems, potentially using non-medical-grade silicone.

Conclusions:

While current silicone implants are largely biocompatible, shell integrity (biodurability) is a significant factor.
Poly Implant Prosthese (PIP) implants warrant further investigation due to potential material safety issues.
Regulatory agencies are evaluating actions to ensure patient safety concerning PIP devices.