Some 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 healthcare 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 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.
The silicone used in The DivaCup – which is 100% plastic-free, BPA-free, and odorless – is the same material and grade approved for healthcare applications.
The DivaCup holds current Medical Device Licenses with both the FDA and Health Canada, and Diva International Inc. is ISO 13485 certified to meet medical device requirements of Health Canada. This certification ensures that The DivaCup is manufactured, packaged, and sold following specific procedures that assure the highest quality, safety and effectiveness of the product.