Are menstrual cups dangerous? Scoon Cup is the only bio-tested menstrual cup.

Even in Japan, I sometimes see cheap menstrual cups being sold illegally, and I would like to explain just how dangerous it is to choose a menstrual cup based solely on the ease of it being cheap.

In the United States, menstrual cups are required to be registered with the FDA (Food and Drug Administration), but being "registered" is completely different from being "reviewed and certified."

For example, the Scoon Cup has passed the FDA's medical device review known as 510(k) and is "registered" as a "certified medical device." In other words, it has been registered as a brand after passing safety tests.

Many other cups, even those made in the same U.S., have simply "registered" their names. Most other menstrual cups sold in the Japanese market have not undergone the 510(k) review process, which is critical for confirming safety. Furthermore, illegal menstrual cups that are not even "registered" as medical devices remain on the market and are sold in Japan on shopping malls like Rakuten Ichiba and Yahoo! Shopping.

What makes the Scoon Cup different from other menstrual cups is that, in addition to its ease of use due to the latest molding technology and innovative design, its safety has been officially confirmed through thorough bio-testing. Among the menstrual cups currently officially sold in Japan, the Scoon Cup is the only one that has been reviewed and cleared by both the Japanese and U.S. FDA.

So, what exactly is this bio-test? Let's take a look at them one by one.

Types of Bio-tests

Toxicity

The Scoon Cup uses the highest grade of medical-grade silicone. This is the same grade of silicone used in surgical procedures. While the silicone used in baby bottle nipples may seem safe at first glance, it does not have sufficient safety guarantees for silicone intended for long-term insertion into the body. The Scoon Cup has been tested for toxicity from 12 perspectives, confirming that it is a safe material for contact with the body.

Sensitization

Sensitization refers to a process in which the reaction to a stimulus gradually increases due to repeated stimulation. Sensitization is often tested in relation to repeated stimulation to determine whether a specific reaction occurs as a result of an immune response to a foreign substance entering the body.

Genotoxicity

This tests for genetic changes in somatic cells and thoroughly examines whether there is any possibility of causing genetic changes (mutations) in somatic and germ cells, which could have serious effects on human health. In the development of pharmaceuticals and medical devices, genotoxicity testing is extremely important for the purpose of predicting serious irreversible toxicity that could lead to carcinogenicity or teratogenicity in humans.

Pyrogen Study

This is a test to ensure that the product does not contain substances that act as exogenous pyrogens within the body, and here too, it has been confirmed that the Scoon Cup does not contain exogenous pyrogens.

Vitro Hemolysis

Hemolysis is a phenomenon caused by the destruction of red blood cell membranes, and it is said that this destruction of cell membranes can be specific to red blood cells or can also act on cells other than red blood cells.

Intracutaneous Reactivity

This refers to a reaction where the skin becomes red or develops wheals when a small amount of antigen is injected intradermally. Tests for allergic reactions fall under this category.

These are important results among the numerous tests that have confirmed the safety of the Scoon Cup, but various other test results have also been conducted to maintain quality. Since Scoon is a company that started as a brand for organic cotton baby products, we pursue safety for those who use our products with multiple layers of caution.

To ensure consumer safety, Scoon Cup has undergone thorough bio-testing and has cleared the pharmaceutical laws of both Japan and the United States. Even when we say medical-grade silicone, there are various grades and types. Just because it is silicone used in baby bottles does not mean it is safe and secure when kept inside the body as a menstrual cup.When choosing a menstrual cup, please be sure to select the bio-tested Scoon Cup.