The Ministry of Food and Drug Safety said Thursday it approved FemmyCycle as the first menstrual cup to be sold in Korea.
FemmyCycle, developed by U.S.-based Femcap, is currently sold in 10 countries, including the U.S., Canada, and Europe.
A menstrual cup is a feminine hygiene product made from silicon, inserted into the body to collect menstrual blood. Unlike tampons and pads, these cups collect, not absorb, menstrual blood and can be reused for up to an average of five years.
Because the cup is reusable, it is cheaper than buying tampons and pads but carries a higher upfront cost. In the U.S., FemmyCycles costs around $35 (38,185 won).
Many Korean women are expressing interest in the cups amidst mounting fear over the possibility of toxic pads from a health scare in August.
Earlier this year, the Korean Women’s Environmental Network, a women’s health activist group, found 65 percent of 3,009 women who used Lilian pads, developed by Klean Nara, experienced an altered menstruation cycle. The survey also found almost 86 percent saw a reduction in blood flow and 68 percent felt more menstrual pain, among other problems.
The Lilian pads were taken off the shelves despite the food and drug safety ministry finding no toxic chemicals in them in a follow-up report. The Ministry of Environment said last month that it would conduct a separate investigation to uncover the health impact of the pads on addressing ongoing public concern.
Analysts are now expecting the increase in the number of menstrual cups to be approved and sold in the country. The ministry is currently reviewing one domestically developed cup and two imported products for approval.
The ministry said FemmyCycles had proved safe through a review of various factors such as cytotoxicity, skin irritation, durability, purity, and presence of heavy metals. The cups also passed a test that screened for 10 highly hazardous volatile organic compounds, the ministry added.
Results from a human application test submitted by Femcap also revealed no cases of toxic shock syndrome, a potentially fatal bacterial illness characterized by high fever, vomiting, diarrhea, and dizziness, after use, the ministry said.
The efficacy has been proved through a trial that lasted for three menstrual cycles to assess the level of activity, odor, comfort, convenience, and leaking when using the cups, according to the ministry.
Menstrual cups may be used for up to 12 hours, depending on the level of blood flow or physical activity. The ministry recommends getting a new cup every one or two years. FemmyCycles should be washed with clean water and disinfected with boiling water for up to five minutes before use. They should not be sterilized with the microwave or alcohol, the ministry said.
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