Menstrual Cup Materials : Silicone, TPE, Latex (from our science guy - long but very interesting!!!)

Menstrual Cup Materials : Silicone, TPE, Latex (from our science guy - long but very interesting!!!)

Dec 29th 2018

Menstrual cups are made from three different substances worldwide. Silicones, TPE and Natural Rubber (made of natural gum, latex).

Most are made from silicones. That's simply because the vast majority are manufactured in Asia. Second in prevalence is TPE and lastly natural rubber. Silicone and TPE both fall under the plastics group. Building blocks made of both materials can be found in both groups of substances.

Both are artificial products that are manufactured to hold a certain shape.

Me Luna ® has been producing the Me Luna ® menstrual cups (after careful consideration) from the medically certified TPE from the German manufacturer Kraiburg since 2009. At that time, we decided on TPE, because the labor-intensive silicon processing actually has and for the most part still does take place in China. That was out of the question for us.

From the very beginning, affordable quality has been at the forefront of our minds. The Me Luna ® was intended to give women from all income brackets the opportunity to approach menstruation with recyclable, durable, sustainable menstrual products.

Plastics perform a wide range of tasks in medicine: They serve as containers for infusion solutions, components of medical devices, med. Items (syringes, patches, catheters, tubes, etc.) and implants (heart valves, bone replacements, joints, absorbable bone screws, etc.). For materials that are directly or indirectly in contact with living tissue – such as a menstrual cup- special conditions apply naturally: On the one hand, the plastic must not damage the organism; on the other hand, the biological surroundings do not affect the material properties of the plastic. If these conditions are met, there is talk of biocompatibility. Part of biocompatibility testing is to confirm that no influences interfering with the hormone balance occur. The medical thermoplastic elastomer we use does not contain substances known to have any hormone-disrupting effects.

Both the raw material and the finished cups have undergone extensive testing to eliminate the possibility of any kind of leaching … even leaching of harmless substances.

There are only one or two menstrual cups made of natural rubber worldwide. There are reasons for this. The growing demand for natural rubber (the precursor of rubber) poses a major challenge to the world's population. Southeast Asian farmers are cutting down native forests to grow rubber plantations, leading to the destruction of biodiversity. Furthermore, the resulting monocultures are very susceptible to disease. Since this material always has an increased risk of rubber/latex allergy in the user, latex and rubber allergies also represent occupational hazards, it was out of the question for us. The material of the Me Luna ® can cause absolutely no allergies due to the complete absence of proteins. "Safety first" was, and always is, our motto.

Since the question of silicone as menstrual cup material often comes up, we would also like to address this in a moment:

In nature, only inorganic silicon compounds are found. Namely silicon dioxide, silicates and silica. All other silicon compounds-including silicones-are of synthetic, artificial origin. They can therefore be considered plastics.

Natural silicones are found exclusively in the language of advertising. Why do some think silicone is the better, or even healthier, material for menstrual cups? It’s likely because LSR (Liquid Silicone Rubber) does not produce large quantities of low-cost packaging. Otherwise, the oceans would likely be full of human-produced silicone waste.

Siloxans are building blocks for silicone products. They have long been considered harmless, but newer evidence suggests negative effects on human health and the environment. There are cases of allergies due to the use of menstrual cups documented with the FDA. After incidents involving menstrual cups made of silicone in Mexico, the Ministry of Health there classified menstrual cups as products subject to approval.

Siloxans have a wide range of applications due to their many different properties and are therefore widely used in products worldwide. They have been used in consumer products for three decades, especially in the cosmetics sector as a care and preservative.

Siloxans are silicon compounds, i.e. compounds of the elements silicon (Si), oxygen (O), carbon (C) and hydrogen (H). Siloxan compounds are produced purely synthetically, there are no natural deposits. One distinguishes linear (e.g. L3, L4, L5) and cyclic (e.g. D4, D5 and D6) siloxanas.

For humans, these substances were long considered toxicologically safe, but this can no longer be fully asserted: There are some siloxanes for which there is information on negative health effects through animal testing on rats.

In the EU, only D4 is considered dangerous so far. The effects demonstrated in several studies indicate that it may affect reproductive capacity but may also have harmful effects in waters in the longer term.

By the way, D4 and D5 are not only used in personal care products. They are important raw materials for silicone plastics and can be found as residues in the finished products. Because of the particularly worrying characteristics, the Federal Environment Agency (UBA) considers it useful to include D4 and D5 in the REACH Candidate List. Inclusion in the list of candidates is a clear signal to replace a substance and triggers certain public information requirements for manufacturers, importers and retailers, which consumers can use to make informed decisions.

The Austrian Federal Office has taken a closer look at Siloxane. http://www.umweltbundesamt.at/umweltsituation/schadstoff/silox/

Summary:

The production of a menstrual cup requires a felxible material that does not release harmful substances to the body.

For this purpose we have available two materials that have been used extensively in the production of medical devices: Thermoplastic Elastomers (TPE) and Liquid Silicone Rubber (LSR)

In our production, we focus on:

  • Short distances through 100% Made in Germany. We use raw materials made exclusively in Germany and every further step, from the production of the Me Luna ® Cups to shipping takes place here at the production site.
  • Energy-saving processing on modern machines, as well as electricity generation in-house.
  • The medical TPE we use is basically very recyclable. It can be melted back down by the use of heat (hence the name THERMOplast) and processed into other things. This is not the case with silicone – or natural rubber products. These substances form a new compound irrevocably and can not be recycled into a reusable product.

We have been producing the Me Luna ® menstrual cups directly with us at our company headquarters since 2009.

Our Me Luna ® menstrual cups can be found in many drugstores and supermarkets. There, our products are regularly inspected by the relevant Council and Health Offices.

In the US, menstrual cups are not commodities. There they are considered a Class II medical device. The sale must be approved by the FDA. We received this clearance in 2014 after extensive testing.

The Me Luna ® is an absolutely safe product that has no adverse health effects. In particular, no harmful plasticizers are included that could cause hormonal changes.