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Is the silicone The DivaCup™ is made of safe?
Some women are concerned that silicone is dangerous because of its association with breast implants. However, there is a major difference between the silicone in breast implants, and the silicone used in The DivaCup™. The older breast implants that caused all the problems were made from a sac filled with silicone gel. In the past, problems occurred when the sacs were rupturing or improperly sealed valves were allowing the silicone gel to leak into the body.The DivaCup™ is made of a high quality soft medical grade silicone that starts as a liquid, and then the molecules are bound together (or vulcanized) with very high heat to form a solid stable piece of silicone (similar to the feel of soft rubber). The DivaCup™ is also cured after production in an oven at a very high temperature to make sure all the molecules are bound and chain linked together. The material has gone through substantial testing to make sure none of the molecules will break away from the product. Since the end product is a solid rubber-like material, there is no possible way for anything to leak into the body (no leaching).
This form of silicone is 100% hypoallergenic, has antibacterial properties, is latex-free and odorless. It has been used safely in medical applications for over 50 years in products such as medical tubing, baby bottle nipples, breast pumps, contact lenses and even permanent medical internal body parts such as heart valves and joint replacements. It is also approved by the FDA (United States) and Health Canada.
More about silicone:
The three most common elements found on earth: hydrogen, carbon and silicon are combined to create silicone. Silicon is the second most abundant element in the earth's crust and found in sand, quartz and rocks.
Silicone products have been shown to be biocompatible (i.e. accepted by the human body without adverse reaction), durable, flexible, and easy to sterilize. Silicone materials have been extensively tested in laboratory studies, as well as clinical studies that study human health.
Silicone comes in oil, liquid, gel and solid forms. Solid silicone differs from the silicone gel used in breast implants. The DivaCup™ is made from medical grade silicone in the solid form where the molecules are chain-linked and bound together. Solid medical grade silicone does not leach into the body and has been used for over 50 years in medical procedures such as joint prostheses and heart valve replacements.
Because silicone is manufactured in various forms, it appears in a wide variety of products that most of us use every day. Hairsprays, medicines, cosmetics, suntan lotions and moisturizing creams are just some of the consumer products that contain one form of silicone called dimethicone.
The DivaCup™ (including the silicone) was reviewed and approved by the FDA (Food and Drug Administration in the USA) and Health Canada in 2002. It is also available for sale in many other countries including any of the countries in the European Union (EU).
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