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Menstrual cup Claricup : a closer look 

What is in my hygiene protective devices? This is a question that more and more women are asking, and yet it is sometimes very difficult to know what comes into contact with the vagina or what it gets exposed to, 5 days a month, each month of the year, for 30 to 40 years. How is that possible? Where can one find good information? And once you know what your hygiene products are made of, how can you be sure that they are safe for your health?

Many women have now started using menstrual cups, thinking that in addition to being practical, environmental-friendly and economical, the silicone in a cup looks  a priori  safer than bleached white pulp containing endocrine disruptors and pesticides in tampons and sanitary napkins. But is that really the case?

 

 

A recent report from ANSES (French Agency for Food, Environmental and Occupational Health & Safety) confirms this: there are traces of chemical compounds in traditional personal hygiene products (tampons, sanitary napkins and panty liners)

The news was published on July 19, 2018: for 2 years, ANSES (the French Agency for Food, Environmental and Occupational Health & Safety, also known as the National Agency for Hygiene Safety) conducted studies on the composition of traditional hygiene protection products and the list of "worrisome" components is frightening: dioxin, pesticides, phthalates, allergenic fragrances ... as many compounds as the scientific community suspects of causing carcinogenic, mutagenic, or reprotoxic effects.

It is possible that these substances are carried by the raw materials (an example would be the pesticides in cotton) or by manufacturing processes (for example, bleaching fibers with chlorinated derivatives causes the formation of dioxin).

Fortunately, ANSES states that these substances are too small to be dangerous. But it nevertheless recommends modifying manufacturing processes to reduce the risk of contamination AND to put in place regulations that would more effectively govern the use of personal hygiene protection products.

 

Despite the sometimes mixed messages from the media, no study on the chemical components has been made on menstrual cups for the time being, because analyses are more difficult to do (this will be discussed later).

How do we know what's in the Claricup ?

Do not worry, we did not wait for ANSES to ask that question!

 

  • Guarantee #1: We know already that the Claricup has its main components: USP Class VI antimicrobial medical silicone and pharmaceutical dyes. These two raw materials have passed all the biocompatibility testing of Medical Devices: if that's a plus for us, we could also make surgical implants!

 

  • Guarantee #2: As stated by ANSES, whilst raw materials are important to consider, the manufacturing processes are just as important: they can contaminate the product if they are not well controlled. By applying the ISO13485 standard to our Quality Management System, we offer the guarantee that each stage of manufacturing, transporting, packaging and storing is designed and controlled in the same manner that Medical Devices are, which leads to limiting, as much as possible, the risks of unintended or accidental contamination.

 

  • Guarantee #3: It is a good idea to have quality control processes, but once the product is manufactured, how can you be sure that it contains nothing dangerous as planned? Two types of tests help to ensure that a healthy and safe product is launched in the market: biocompatibility and extractable tests. 

 

Biocompatibility tests  performed on the Claricup are the same as those carried out on raw materials. 3 parameters are tested: cytotoxicity, sensitization and irritation. These parameters enable us to know if a product triggers a reaction when the body comes into contact or is exposed to it. It's official: Claricup has passed all these tests with flying colours, so it is biocompatible!

 

Extractable tests reveal exactly what chemical components are in the products. These are the tests that ANSES has difficulty doing on menstrual cups. We know, because we had the same problems when we carried them out on the Claricup! The principle is simple: we soak a product in different solvents (water, alcohol ...) for at least 24 hours. Each solvent makes it possible to extract different types of molecules from the product. Next, we evaporate and analyse each extraction. The problem is that silicone tends to dissolve in some solvents ... so it becomes difficult in these cases to analyse anything ! But by carrying out these tests (and thanks to our super R & D Project Manager who has a PhD in Biomaterials), we managed to establish protocols enabling us to reveal the exact composition of the Claricup :

In the Claricup, there is no : (watch out, this is a competition in pronunciation!)

  • Bisphenol a
  • Nonylphenol
  • 4-Heptylphenol
  • Nonylphenol diethoxylate
  • 4-Tert-octylphenol
  • 4-Tert-Octylphenol monoethoxylate
  • Bis(2-ethylhexyl) phthalate
  • Benzyl butyl phthalate
  • Bis(2-methoxyethyl) phthalate
  • Dipentyl phthalate
  • Diisopentyl phthalate
  • Di-n-hexyl phthalate
  • Heavy metals (Antimony, Arsenic, Cadmium, Copper, Mercury, Nickel, Lead, Manganese, Tin)
  • Chlorine

In the Claricup, there is:

  • Silica (the base of silicone)
  • Silver (the antimicrobial agent)
  • Platinum (which accelerates the hardening of silicone during the manufacturing process)
  • Pharmaceutical dyes (but this is nothing surprising)

There you have it !

Why doesn't everyone do the same thing? Because there is no European regulation that requires them to do this.

In the European health industry, there are 3 main product categories, each of which has its own set of regulations:

  • Drugs are the most strictly regulated. They act on an illness through one or a combination of molecules.
  • Medical Devices which range from sterile wipes to hip prostheses and prophylactics (condoms, rubber). Their mode of action is different from drugs: MDs (medical devices) produce a mechanical action on a disease (a wound to clean, a sexually transmitted infection to treat).
  • Cosmetics are not for the purposes of treating disease, but to clean or improve a person's appearance, including perfumes or make-up for the skin and hair.

If we consider these 3 categories, it would seem logical to put tampons, sanitary napkins, and menstrual cups in the same category as Medical Devices. And yet... since menstruation(fortunately) is not a disease, hygienic protections do not fall into any of these 3 categories in Europe. They are therefore regulated as a consumer product ... like a ballpen, for example.

Other countries have gone further than Europe: the USA, Canada, Japan or Mexico have different regulations: because they are objects that remain in prolonged contact with the vulvar and vaginal mucosa (which, as a reminder, allow more molecules to pass into the blood rather than into the skin), hygienic protections are therefore classified in the category of medical devices. 

What does that change? EVERYTHING!

In Europe, the lack of regulation means that there is no obligation for manufacturers to list the composition of their products or to prove their safety. In terms of hygiene protection, European women are therefore less protected than (almost) other women everywhere else in the world.

 

Fortunately, things are beginning to develop: One of the principal conclusions of the ANSES report is that it is necessary to regulate personal hygiene protection products through a European regulatory framework, a conclusion with which we are obviously in total agreement. And we are proud to confirm that we are the only menstrual cup manufacturer to have responded to their questions addressed in their investigation carried out in complete transparency, and for the safety of everyone.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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